Palais des Congrès de Montréal - International Journal of MS Care

May 2011 Volume 13, Supplement 3 

The Official Peer-Reviewed Publication of the Consortium of Multiple Sclerosis Centers 

25 Years of Hope 

and Achievement 

1986 - 2011 

Abstracts from the 25th Annual Meeting 

of the Consortium of Multiple Sclerosis Centers 

Palais des Congrès de Montréal 

1–4 June 2011 • Montreal, Quebec, Canada 

This supplement has been supported by an educational grant from Bayer HealthCare Pharmaceuticals, Inc. 

mscare.org

Editorial Board 

Editor in ChiEf 

Lael Stone, MD 

Cleveland Clinic 

Cleveland, Ohio, USA 

Editor EmEritus 

Robert Herndon, MD 

University of Mississippi Medical Center 

Jackson, Mississippi, USA 

WEbsitE Liaison 

Dorothea Pfohl, RN, BS, MSCN 

University of Pennsylvania Health Systems 

Philadelphia, Pennsylvania, USA 

Ex offiCio 

June Halper, MSN, ANP, FAAN 

Hackensack, New Jersey, USA 

ProjECt managEr 

Maria Stadtler, CCRP 



assoCiatE Editors 

Ralph Benedict, PhD 

State University of New York at Buffalo 

Buffalo, New York, USA 

Susan Forwell, PhD, OT(C), FCAOT 

University of British Columbia 

Vancouver, British Columbia, Canada 

Mark Freedman, MD 

The Ottawa Hospital 

Ottawa, Quebec, Canada 

Judy Wollin, RN, PhD 

Griffith University 

Queensland, Australia 

board mEmbErs 

Francois Bethoux, MD 



Jeffrey Dunn, MD 

Stanford University 

Stanford, California, USA 

Mary Filipi, PhD, ARNP 

University of Nebraska Medical Center 

Omaha, Nebraska, USA 

Kathleen Fuchs, PhD 

University of Virginia Health System 

Charlottesville, Virginia, USA 

Eduard Gappmaier, PT, PhD 

University of Utah 

Salt Lake City, Utah, USA 

Myla Goldman, MD 

University of Virginia Health System 

Charlottesville, Virginia, USA 

Pat Kennedy, RN, CNP, MSCN 

The Heuga Center 

Edwards, Colorado, USA 

Robert Motl, PhD 

University of Illinois at Urbana-Champaign 

Urbana, Illinois, USA 

Marie Namey, RN, MSN, MSCN 



Nicoline Schiess, MD 

Johns Hopkins University School of Medicine 

Baltimore, Maryland, USA 

Kathleen M. Zackowski, PhD, OTR 

Kennedy Krieger Institute 

Johns Hopkins School of Medicine 

Baltimore, Maryland, USA 

PubLishErs 

Joseph J. D’Onofrio 

Frank M. Marino 

Delaware Media Group 

66 S. Maple Ave., Ridgewood, NJ 07450 

201-612-7676 

jdonofrio@delmedgroup.com 

managing Editor 

Annette Theuring 

art dirECtor 

James Ticchio 

May 2011 • Vol. 13, Suppl. 3 

CMSC 1986–2011: 

25 Years of Hope and Achievement 

We are pleased to present this electronic supplement 

to the International Journal of MS Care (IJMSC) 

containing the abstracts from the 2011 Annual 

Meeting of the Consortium of Multiple Sclerosis Centers 

(CMSC), held from 1 to 4 June 2011 in Montreal, Canada. 

These abstracts include platform, poster, Whitaker Research 

Track, and “works in progress” presentations delivered at the 

meeting. If you were not able to attend the conference, this is a 

wonderful opportunity for you to appreciate the diversity and 

depth of this outstanding group of presentations. This PDF 

document can be searched using key words to identify abstracts 

on topics of individual interest. In addition to being distributed 

at the meeting and mailed with the Summer 2011 issue of 

IJMSC, this electronic supplement is available on the CMSC 

website at mscare.org. 

We are very grateful to Bayer HealthCare Pharmaceuticals, 

Inc., for an educational grant that allowed us to make these 

abstracts available. 

We hope that this material will assist you in your care of MS 

patients and stimulate your interest in furthering research and 

care in MS. 

—Lael A. Stone, MD 

Editor in Chief 

The Official Peer-Reviewed The Official Peer-Reviewed Publication of Publication the Consortium of the of Consortium Mulitple Sclerosis of Mulitple Centers, Sclerosis Centers, 

Rehabilitation Rehabilitation in Multiple Sclerosis, in Multiple and the Sclerosis, International and the Organization International of Organization Multiple Sclerosis of Multiple Nurses Sclerosis Nurses

PLATFORMS 

SESSION 1: COGNITION/DEPRESSION 

P1 

EVALUATION OF DEPRESSION IN PATIENTS WITH 

MULTIPLE SCLEROSIS FROM THE SENTINEL STUDY 

Adam Kaplin, 1 Kathleen Costello, 1 James Potts, 2 Pamela Foulds 2 

1 Johns Hopkins University School of Medicine, Baltimore, MD; 2 Biogen Idec 

Inc, Weston, MA 

Background: Despite the fact that up to 50% of multiple 

sclerosis (MS) patients experience depression, which may 

be affected by some MS treatments, potential effects of 

natalizumab remain largely unknown. Objectives: To 

evaluate changes in depression scores as measured by the 

Beck Depression Inventory II (BDI-II), a validated assessment 

method, obtained from patients in the SENTINEL study. 

Methods: SENTINEL was a pivotal, randomized phase 3 

trial of the efficacy and tolerability of natalizumab + interferon 

beta-1a (IFNβ-1a) versus placebo + IFNβ-1a. BDI-II 

scores were collected at baseline and weeks 24, 52, 76, 

and 104. Patients with BDI-II scores of ≥19 at baseline were 

defined as depressed. A random intercept model assessed 

changes over time and was adjusted for age, gender, disease 

duration, number of relapses (past year), antidepressant 

use, and baseline BDI-II and Expanded Disability Status Scale 

(EDSS) scores. Interactions of treatment group and time evaluated 

differences in change from baseline BDI-II score between 

natalizumab + IFNβ-1a and placebo + IFNβ-1a treated 

patients. Results: Of 749 patients in SENTINEL (376 in 

natalizumab + IFNβ-1a, 373 in placebo + IFNβ-1a groups), 

there was no difference in change from baseline BDI-II scores 

over time between treatment groups (P = .07). Among 104 

patients depressed at baseline (50 in the natalizumab-treated 

group), there was a significant interaction between time and 

treatment group (P = .04), favoring lower BDI-II scores in the 

natalizumab-treated group across time, suggesting improved 

depression. At week 104, the difference from baseline in 

BDI-II score was 6.2 points lower in the natalizumab + IFNβ- 

1a group versus the placebo + IFNβ-1a group (P = .001), 

indicating more improvement in BDI-II score among the natalizumab-treated 

group compared with the placebo + IFNβ-1a 

group. No between-group differences were seen in baseline 

covariates, except a higher median baseline BDI-II score was 

seen in the natalizumab-treated group (24.5 vs. 21.5, P = 

.002); however, this was adjusted for in the model. Conclusion: 

In SENTINEL patients who were depressed at baseline, 

natalizumab + IFNβ-1a treatment was associated with an 

improvement in depression compared with placebo + IFNβ- 

1a. This analysis provides evidence for further investigation of 

depression in MS patients. 

Disclosure: Adam Kaplin: Nothing to disclose. Kathleen Costello: Biogen 

Idec, Novartis, Teva (consulting fees). James Potts: Biogen Idec (salary). 

Pamela Foulds: Biogen Idec (salary). 

Keywords: Disease-modifying treatment in MS, Psychological issues and 

MS, Psychosocial issues in MS 

P2 

VALIDATING NEURO-QOL COGNITION SHORT 

FORMS FOR MULTIPLE SCLEROSIS PATIENTS 

Deborah Miller, 1 Cindy J. Nowinski, 2 Sarah Buono, 2 James W. Griffith 2 

1 Neurology, Cleveland Clinic, Cleveland, OH; 2 Medical Social Sciences, 

Northwestern University, Chicago, IL 

International Journal of MS Care 

1 

Platforms 

Neuro-QOL is an NINDS-funded health-related quality of life 

(HRQOL) measurement system for major neurologic conditions. 

Two of 13 validated short forms (SFs) are Applied Cognition–General 

Concerns (AC-GC) and Applied Cognition– 

Executive Function (AC-EF). Because the association between 

multiple sclerosis (MS) patients’ self-reported cognition with 

standardized neuropsychological (NP) measures is poorly 

understood, and may be associated with emotional symptoms, 

we examined relationships between the AC-GC and 

AC-EF with the Neuro-QOL protocol NP measures and another 

standard NP battery. We also tested the association of the 

AC-GC and AC-EF with the Neuro-QOL Anxiety (ANX) and 

Depression (DEP) SFs. MS participants in the Neuro-QOL Validation 

Study were recruited from two testing centers to participate 

in this extended validation and completed an additional 

informed consent. Inclusion criteria were age >18, English 

speaking, and confirmed MS diagnosis. Measures included 

Neuro-QOL AC-GC and AC-EF, ANX and DEP SFs, the Oral 

Symbol Digit Modalities test (OSDMT), Consistent Long-Term 

Retrieval from the Selective Reminding Test (CLTR), Controlled 

Oral Word Association Test (COWAT), and Paced Auditory 

Serial Addition Test (PASAT). Statistical analysis used Pearson 

correlations. The total number of MS patients was 106. The 

mean age was 48.9 years (SD = 10.3 years), and the majority 

were female (84.9%), white (82.1%), married (60.4%), 

college-educated (40.6%), either working full time (30.2%) 

or on disability (31.1%), with relapsing-remitting disease 

(59.4%). AC-EF and AC-GC correlated with OSDMT (0.402 

and 0.274, respectively). DEP and ANX did not correlate 

with OSDMT(–0.062, NS, and –0.092, NS, respectively). 

No other NP measures correlated with AC-EF or AC-GC. Correlations 

between AC-EC and DEP and ANX were –0.388 

and –0.368, respectively, and between AC-GC and DEP 

and ANX were –0.390 and –0.532. All P values were .000 

except where noted. The AC-EF and AC-GC demonstrated 

convergent validity with the OSDMT, a simple practical measure 

of processing speed. Lack of correlation of ANX and 

DEP with the OSDMT supports the specificity of the AC-EF 

and AC-GC for measuring cognition. 

Disclosure: Nothing to disclose 

Keywords: Quality of life in MS, Psychosocial issues in MS, Psychological 

issues and MS 

P3 

THE HIDDEN TOLL OF CAREGIVER BURDEN IN 

MULTIPLE SCLEROSIS 

Michelle Stewart, 1 Amy Phillips, 2 Natalie Edwards, 3 Shaloo Gupta, 4 Amir 

Goren 4 

1 Health Outcomes Research, Pfizer, Inc, New London, CT; 2 Health Outcomes 

and Market Access, EMD Serono, Inc, Rockland, MA; 3 Health Services 

Consulting Corporation, Boxborough, MA; 4 Health Sciences Practice, Kantar 

Health, New York, NY 

Background: Multiple sclerosis (MS) and Alzheimer’s disease 

(AD) are chronic and progressive diseases that have the 

potential to impose a significant burden on both caregivers 

and the immediate families of patients. Extensive literature 

has documented MS and AD caregiver burden on physical 

and mental health, but there are no direct comparisons of 

MS and AD caregivers. Objectives: To examine the extent 

of MS caregiver burden compared with noncaregivers and 

caregivers of AD patients. Methods: Data were obtained

Platforms 

from the 2009 National Health and Wellness Survey 

administered online to a US representative adult sample (N 

= 75,000). Respondents reported health status, quality of 

life, work productivity, health-care utilization, and caregiver 

status. Multivariable regressions, adjusting for key characteristics 

(eg, age, gender, marital status, depression), were 

conducted to explore differences between MS caregivers (n 

= 215) versus noncaregivers (n = 69,224), as well as MS 

caregivers versus AD caregivers (n = 1341). Rate ratios (RR) 

and regression weights (b) are reported. Results: Compared 

with noncaregivers, MS caregivers had significantly greater 

activity impairment (RR = 1.41; P = .01) and poorer mental 

(b = –1.44; P = .015), physical (b = –1.96; P = .002), and 

health utility scores (b = –0.03; P = .002), along with more 

traditional health-care provider visits (RR = 1.46; P < .0001), 

emergency room (ER) visits (RR = 2.16; P < .0001), and 

hospitalizations (RR = 2.20; P = .001) after covariate adjustment. 

Compared with AD caregivers, MS caregivers had 

greater activity impairment (RR = 1.29; P = .044) and more 

ER visits (RR = 1.60; P = .017) and hospitalizations (RR = 

1.92; P = .008) after covariate adjustment. Work productivity 

differences were not observed in comparison with either 

group, possibly due to the small number of employed MS 

caregivers in the sample (n = 126). Conclusion: MS caregivers 

had significantly more burden compared with noncaregivers. 

In addition, the results suggest an even greater burden 

on these individuals than observed among AD caregivers. 

The results of this analysis of a national survey reveal the hidden 

toll on those providing care for MS patients and highlight 

the need to recognize their burden so that appropriate measures 

can be implemented. 

Disclosure: Michelle Stewart: Pfizer, Inc (salary). Amy Phillips: EMD 

Serono, Inc (salary). Natalie Edwards: EMD Serono, Inc (consulting 

fee). Shaloo Gupta: EMD Serono, Inc, Pfizer, Inc (consulting fees). Amir 

Goren: EMD Serono, Inc, Pfizer, Inc (consulting fees). 

Keywords: MS and the caregiver/family 

P4 

COMPUTER-ASSISTED COGNITIVE REHABILITATION 

FOR PERSONS WITH MULTIPLE SCLEROSIS 

Alexa K. Stuifbergen, 1 Heather Becker, 1 Frank Perez, 2 Janet Morrison, 1 Vicki 

Kullberg, 1 Ana Todd 1 

1 School of Nursing, The University of Texas at Austin, Austin, TX; 2 College of 

Medicine, Baylor University, Houston, TX 

Background: The effects of multiple sclerosis (MS) on 

cognition have gained increasing recognition as one of the 

major disabling symptoms of the disease. While numerous 

studies have addressed the emotional and physical impact 

of MS, little attention has been given to strategies that might 

help manage the cognitive changes commonly experienced 

by persons with MS. Objectives: The purpose of this study 

was to refine and test the effects of a novel computer-assisted 

cognitive rehabilitation intervention, MAPSS-MS (Memory, 

Attention, & Problem Solving Skills for persons with MS), on 

cognitive performance. The 8-week MAPSS-MS intervention 

pairs a group efficacy-based intervention with a computerassisted 

cognitive rehabilitation component in the participant’s 

home. Methods: A sample of 63 persons with MS 

participated in a randomized clinical trial of the MAPSS-MS 

intervention. The majority of the participants were female 

(87%), and participants ranged in age from 24 to 60 years 


2 

(mean, 48 years) and had been diagnosed for a mean of 12 

years. The majority were white/non-Hispanic (87%) and married 

(65%). Most (65%) had completed postsecondary education, 

and 35% were employed full or part time. The seven 

neuropsychological tests composing the Minimal Assessment 

of Cognitive Function in MS (MACFIMS) were administered 

at baseline, at 2 months (immediately after the intervention), 

and at 5 months. Results: Participants in the intervention 

group had significant (P < .05) postintervention improvements 

in scores on the Paced Auditory Serial Addition Test (PASAT 

2 and 3) and the Judgment of Line Orientation Test. Using 

repeated-measures analysis of variance (ANOVA), significant 

time by group interactions were observed for scores on the 

California Verbal Learning Test as well as a self-report measure 

of use of memory strategies. Although not statistically 

significant, there were small to medium intervention effects 

on the scores of four additional measures of the MACFIMS. 

Conclusion: Findings from this exploratory study with a 

small sample provide preliminary support for the MAPSS-MS 

intervention. Additional research with larger samples is indicated. 

Supported by: National Institute of Nursing Research, National Institutes 

of Health 1R21NR011076 


Keywords: Rehabilitation strategies and therapy and MS, Psychological 


P5 

WHITE MATTER INTEGRITY AND MATH 

PERFORMANCE IN PEDIATRIC MULTIPLE SCLEROSIS: 

A DIFFUSION TENSOR IMAGING STUDY 

Christine Till, 1 Angela Deotto, 1 Vicentiu Tipu, 2 Allison Bethune, 2 John Sled, 3 

Douglas L. Arnold, 4 Rezwan Ghassemi, 4 Sridar Narayanan, 4 Brenda Banwell 5 

1 Psychology, York University, Toronto, ON, Canada; 2 Institute of Medical 

Sciences, University of Toronto, Toronto, ON, Canada; 3 Centre for 

Phenogenomics, The Hospital for Sick Children, Toronto, ON, Canada; 

4 McConnell Brain Imaging Centre, Montreal Neurological Institute, Montreal, 

QC, Canada; 5 Neurology, The Hospital for Sick Children, Toronto, ON, 

Canada 

Background: White matter integrity has been associated 

with math and reading performance in healthy children. 

Objectives: This study investigates whether written arithmetic 

and reading skills are associated with variations in 

white matter microstructure in children and adolescents with 

multiple sclerosis (MS). Methods: Twenty-seven patients 

with childhood-onset MS (mean age, 16.6 ± 2.0 years) and 

27 demographically matched healthy controls participated. 

White matter microstructure was measured using diffusion 

tensor imaging (DTI). Fractional anisotropy (FA) was calculated 

in four corpus callosum regions (genu, anterior body, 

posterior body, and splenium) and lateralized, segmented 

cerebral hemisphere lobes defined using an anatomical 

mask. Performance on tests of academic achievement (WJ-III 

Numerical Operations, Letter-Word Reading, Passage Comprehension, 

Spelling) were correlated with mean FA value. 

Results: Overall mean FA was lower in the MS group relative 

to controls across the genu and splenium and all cerebral 

regions (P < .01). Children with MS were found to be at high 

risk of showing math impairment, with 26.9% of MS patients 

performing one standard deviation or more below normative 

values, compared with 7.4% of controls (P < .05). Deficits 

in reading and spelling were not commonly observed in

children with MS. Math performance was robustly correlated 

with compromised white matter integrity across all segments 

of the corpus callosum and in right frontal, parietal, and 

temporal regions, controlling for age (all r values >0.5, P < 

.01). Reading and spelling performance were not as strongly 

correlated with FA values compared with written arithmetic. 

Conclusion: Findings highlight the functional impact of compromised 

white matter microstructure across diffuse regions of 

the brain on math performance. 


Keywords: Imaging and MS, Psychological issues and MS 

P6 

WALKING AND THINKING IN PEOPLE WITH 


Jacob J. Sosnoff, 1,2 Morgan Boes, 2 Brian M. Sandroff, 1 John H. Pula, 3,4 Robert 

W. Motl 1 

1 Kinesiology and Community Health, University of Illinois at Urbana- 

Champaign, Urbana, IL; 2 Bioengineering, University of Illinois, Urbana, IL; 

3 College of Medicine, University of Illinois, Peoria, IL; 4 Illinois Neurologic 

Institute, Peoria, IL 

Background: Recent evidence indicates that people with 

multiple sclerosis (MS) have a greater decrease in walking 

performance while doing a cognitive task than healthy 

controls. To date, the effect of doing a cognitive task while 

walking has been examined only in individuals with MS who 

have minimal disability. Objectives: This study examined 

the effect of a cognitive task on spatiotemporal parameters of 

gait in people with MS who had mild, moderate, and severe 

disability. Methods: The sample included 40 individuals 

with a definite diagnosis of MS who were divided into three 

groups based on Expanded Disability Status Scale (EDSS) 

scores: mild (EDSS 0–3.0; n = 8), moderate (EDSS 3.5–4.5; 

n = 13), and severe (EDSS 5.0–6.5; n = 19). Participants 

walked at a self-selected pace four times on a 26-foot electronic 

pathway that recorded spatiotemporal parameters of 

gait. In two of the trials, participants completed a word generation 

task, whereas no cognitive task was completed in the 

other two trials. The effect of the cognitive task (eg, dual task 

cost) was quantified as the percent change in spatiotemporal 

parameters of gait. Results: The severe disability group had 

worse gait performance—characterized by a lower functional 

ambulation score, lower velocity, shorter steps, and greater 

percentage of each gait cycle in double support—compared 

with the other two groups (Cohen’s d range, 0.61–2.3). 

There was an overall decline in gait (eg, decreased functional 

ambulation score, decreased velocity, and increased 

double-support percentage) with the cognitive task. Moreover, 

the dual task cost was greatest in the severe disability 

group (Cohen’s d range, 0.71–1.7). Conclusion: The 

results confirm that individuals with MS have more difficulty 

walking while doing a cognitive task. We further demonstrate 

that the adverse effect of a cognitive task on walking function 

is greatest in individuals with severe walking impairment. We 

maintain that difficulty walking while thinking has implications 

for everyday life and may be related to the risk of falls. 


Keywords: Psychological issues and MS, Management of activities of 

daily living in MS 


3 

SESSION 2: DISEASE MANAGEMENT AND 

THERAPEUTICS 

Platforms 

P7 

PREDICTIVE MARKERS OF MORTALITY OVER 21 

YEARS IN MULTIPLE SCLEROSIS PATIENTS 

Joel Oger, 1 Douglas S. Goodin, 2 Anthony T. Reder, 3 George Ebers, 4 Gary 

Cutter, 5 Marcelo Kremenchutzky, 6 Dawn Langdon, 7 Mark Rametta, 8 Karola 

Beckmann, 9 Volker Knappertz 10 

1 Neuroimmunology Laboratories and Multiple Sclerosis Clinic, University 

of British Columbia, Vancouver, BC, Canada; 2 Department of Neurology, 

University of California, San Francisco, CA; 3 Department of Neurology, 

University of Chicago, Chicago, IL; 4 University Department of Clinical 

Neurology, John Radcliffe Hospital, Oxford, United Kingdom; 5 Department 

of Biostatistics, UAB School of Public Health, Birmingham, AL; 6 London Health 

Sciences Centre, London, ON, Canada; 7 Department of Psychology, Royal 

Holloway, University of London Centre, Surrey, United Kingdom; 8 Bayer 

HealthCare Pharmaceuticals, Wayne, NJ; 9 Bayer Schering Pharma AG, Berlin, 

Germany; 10 Bayer HealthCare Pharmaceuticals, Montville, NJ 

Background: The 21-Year Long-Term Follow-Up (LTF) study 

assessed the effects of interferon beta-1b (IFNβ-1b) on mortality 

by studying the fate of the 372 patients who participated 

in the pivotal randomized controlled trial (RCT), where they 

received IFNβ-1b 50 µg, IFNβ-1b 250 µg, or placebo. 

At a median of 21.1 years after RCT enrollment, 98.4% 

(366/372) were identified and 81 deaths recorded (21.8%). 

Those originally randomized to IFNβ-1b 250 µg had a significant 

reduction in all-cause mortality over LTF compared 

with placebo (hazard ratio [HR] = 0.560, P = .0272), with 

a 39.3% reduced risk of death by Kaplan-Meier estimates. 

Objectives: To examine the predictive value of baseline 

characteristics on mortality at LTF. Methods: Demographic 

and baseline clinical and magnetic resonance imaging 

(MRI) variables were examined in unadjusted and adjusted 

(together with treatment) Cox proportional hazards regression 

models. Stepwise multivariate Cox regression analyzed the 

influence of all baseline variables and treatment on survival. 

Results: In unadjusted analyses, assignment to IFNβ-1b 250 

µg, baseline EDSS, baseline T2 burden of disease (BOD), 

and baseline size of the brain’s third ventricle predicted the 

time from pivotal trial randomization to death. In adjusted 

models (IFNβ-1b 250 µg plus each individual baseline 

variable), the HR for the treatment effect on mortality was 

stable (range, 0.53–0.58) and independent of the baseline 

variables’ effects. Gender, T2 BOD, and third ventricle size, 

as well as treatment, significantly influenced the time from pivotal 

trial randomization to death. In the multivariate analysis, 

the IFNβ-1b 250 µg treatment effect on mortality was maintained 

(HR = 0.58), and gender and T2 BOD were retained 

as concomitant predictors of mortality. Similar results were 

seen with IFNβ-1b 50 µg. Conclusion: There was a significant 

survival advantage in this cohort of patients receiving 

early IFNβ-1b treatment versus placebo. The treatment-related 

HR was essentially unchanged by the inclusion of baseline 

variables, even when these variables were themselves associated 

with an increased likelihood of mortality. Thus, the 

effects of early IFNβ-1b therapy on mortality/survival are 

independent of the analyzed demographic and baseline disease 

parameters. 

Disclosure: Joel Oger: Aspreva, Aventis, Bayer, Biogen Idec, EMD 

Serono, Genentech, Schering, Talecris, Teva Neurosciences (honoraria, 

consulting fees, other financial benefits). Douglas S. Goodin: Ares-Serono, 

Merck-Serono, Novartis, Berlex Laboratories, Bayer-Schering Health

Platforms 

care, Biogen Idec, Schering AG, Teva Neuroscience (other financial benefits). 

Anthony T. Reder: Abbott Laboratories, Aventis Pharma, Bayer 

HealthCare Pharmaceuticals, Berlex Laboratories, BioMS Medical 

Corp, Biogen and Biogen Idec, Boehringer Ingelheim Pharmaceuticals 

Inc, Caremark Rx, Centocor, Inc, Malvern, Cephalon, Inc, CroMedica 

Global Inc, Elan Pharmaceuticals, Inc, Eli Lilly and Company, Genentech, 

Genzyme Corporation, GlaxoSmithKline, Hoechst Marion Roussel 

Canada Research, Inc, Hoffman-LaRoche, Immunex, Johnson & 

Johnson, Pharmaceutical Research & Development, LLC, CT & Barrow 

Neurological Institute, Neurocrine Biosciences, Novartis Corporation, 

Parke-Davis, Pfizer Inc, Pharmacia & Upjohn, Protein Design Labs, 

Inc, Quantum Biotechnologies, Inc, Leval, Quintiles, Inc, RENEW 

study, Novartis, Sention, Inc, Schering, Serono, Smith Kline-Beecham, 

Takeda Pharmaceuticals, Teva-Marion (consulting fees); Bayer, Serono, 

Teva, MSociety (other financial benefits). George Ebers: Roche, Biopartners, 

EISAI, MVM Life Science Partners (consulting fees); MS Forum, 

Bayer Schering Pharma (honoraria). Gary Cutter: Sanofi-Aventis, 

Cleveland Clinic Foundation, Daichi-Sankyo, Glaxo Smith Klein 

Pharmaceuticals, Genmab Biopharmaceuticals, Eli Lilly, Medivation, 

Modigenetech, Ono Pharmaceuticals, PTC Therapeutics, Teva, Vivus, 

University of Pennsylvania, NHLBI, NINDS, NMSS, NICHD (other 

financial benefits); Alexion, Bayhill, Bayer, Novartis, Consortium of MS 

Centers, Genzyme, Klein-Buendel Inc, Nuron Biotech, Peptimmune, 

Somnus Pharmaceuticals, Sandoz, Teva, UTSouthwestern Visioneering 

Technologies, Inc (consulting fees). Marcelo Kremenchutzky: MS Society 

of Canada: Royalty; endMS research and training network, the Research 

Scientific Foundation of the MS Society of Canada, Bayer, Berlex, Bio- 

MS, Biogen Idec, Boehringer-Ingelheim, Bristol-Mayers Squibb, Elan, 

EMD Serono, Eli Lilly, Genzyme, GSK, GW, Novartis, PDL, Parexel, 

Quintiles, Roche, Sanofi-Aventis, Schering, Teva, UCB pharma (consulting 

fees). Dawn Langdon: Bayer Schering Pharma AG/Bayer Health- 

Care Pharmaceuticals (other financial benefits); Bayer Schering Pharma 

AG/Bayer HealthCare Pharmaceuticals, Biogen, Hoffman La Roche, 

Merck-Serono, Novartis, Sanofi-Aventis, Serono Symposia (honoraria); 

Bayer Schering Pharma, Merck-Serono (consulting fees). Mark Rametta: 

Bayer HealthCare Pharmaceuticals (salary). Karola Beckmann: Bayer 

Schering Pharma (salary). Volker Knappertz: Bayer HealthCare Pharmaceuticals 

(salary). 

Keywords: Natural history of MS 

P8 

GMS-CLASSIFIER2 PREDICTS EARLY CONVERSION 

TO CLINICALLY DEFINITE MULTIPLE SCLEROSIS AT 

FIRST EVENT SUGGESTIVE OF MULTIPLE SCLEROSIS 

Georgina Arrambide, 1 Carmen Espejo, 1 Jennifer Yarden, 2 Ella Fire, 2 Larissa 

Spector, 2 Nir Dotan, 2 Alex Rovira, 1 Xavier Montalban, 1 Mar Tintoré 1 

1 Clinical Neuroimmunology Unit, Vall d’Hebron University Hospital, 

Barcelona, Spain; 2 Research and Development, Glycominds, Modi’in, Israel 

Background: gMS-Classifier2 was constructed based on 

the placebo arm of the BENEFIT trial, as a classification rule 

for identifying clinically isolated syndrome (CIS) patients with 

higher risk for early conversion to clinically definite multiple 

sclerosis (CDMS)¹ (log-rank test, P = .0025). Objectives: 

Analyze gMS-Classifier2 prediction value for earlier conversion 

of CIS patients to CDMS. Methods: Serum samples, 

cerebrospinal fluid (CSF), and magnetic resonance imaging 

(MRI) data were acquired at baseline from CIS patients with 

monophasic neurologic symptoms from Vall d’Hebron University 

Hospital, Barcelona. Clinical data were prospectively 

acquired. Patient sera (n = 249; mean [SD] age, 31.6 [7.9] 

years; 187 female) with masked data were screened for 

gMS-Classifier2 ([1.171 – (0.082 × age)+ [0.015 × anti- 

P63 IgM units], Glycominds, Israel). Kaplan-Meier and Cox 

proportional hazards regression analyses were performed. 

The endpoint was time to conversion to CDMS, survival fac- 


4 

tor was gMS-Classifier2 positive/negative status (positive 

≥0.258 units) or units, and follow-up time was 2 years and 

5 years. Covariate factors were number of Barkhof criteria 

(0, 1–2, 3–4), T2 lesions (0, 1–9, ≥10), and CSF findings at 

baseline. Results: Median time to CDMS of patients positive 

for gMS-Classifier2 (n = 72) was 1157 days; patients 

negative for gMS-Classifier2 (n = 174) did not reach median 

survival time, only 43.5% converted to CDMS by 5 years, 

and three patients were lost to follow-up. gMS-Classifier2 

predicted early conversion to CDMS within 2 years from 

CIS (hazard ratio [HR] = 1.8; 95% confidence interval [CI], 

1.1-2.9; log rank P = 0.01) and within 5 years from CIS 

(HR = 1.5; 95% CI, 1.0-2.4; log rank P = .03). gMS-Classifier2 

was an independent predictor for earlier conversion 

to CDMS within 5 years (HR = 1.6, P = 0.02; HR = 1.5, P = 

0.04) when tested with either number of Barkhof criteria or 

number of T2 lesions, respectively, but not when tested with 

CSF findings. gMS-Classifier2 continuous unit values were an 

independent predictor (HR = 1.3, P = .001; HR = 1.2, P = 

.007) when tested with number of T2 lesions alone or with T2 

lesions together with CSF findings, respectively. Conclusion: 

gMS-Classifier2, constructed in the BENEFIT trial, was an 

independent predictor for earlier conversion of CIS patients to 

CDMS in a hospital cohort. 

1. Freedman et al., Mult Scler 2009;15:S71. 

Disclosure: Georgina Arrambide: Nothing to disclose. Carmen Espejo: 

Nothing to disclose. Jennifer Yarden: Glycominds (salary, ownership 

interests). Ella Fire: Glycominds (salary, ownership interests). Larissa 

Spector: Glycominds (salary, ownership interests). Nir Dotan: Glycominds 

(salary, ownership interests). Alex Rovira: Bayer Schering Pharma 

(other financial benefit); Sanofi-Aventis, Bayer Schering Pharma, 

Bracco, Merck Serono, Teva Pharmaceutical Industries Ltd, Biogen Idec 

(honoraria); Novartis (consulting fee); American Journal of Neuroradiology 

and Neuroradiology (other financial benefits). Xavier Montalban: 

Bayer Schering Pharma, Biogen Idec, EMD Merck Serono, Genentech, 

Genzyme, Novartis, Sanofi-Aventis, Teva Pharmaceuticals, Almirall 

(honoraria). Mar Tintoré: Teva Pharmaceuticals, Novartis, Sanofi- 

Aventis (consulting fees); Bayer Schering Pharma, Merck Serono, Teva 

Pharmaceuticals, Sanofi-Aventis, Biogen Idec, Novartis (honoraria). 

Keywords: Immunology and MS 

P9 

THE IMPACT OF IMMUNOABLATION AND 

AUTOLOGOUS STEM CELL TRANSPLANT ON LONG- 

TERM QUALITY OF LIFE AND FATIGUE IN PATIENTS 

WITH AGGRESSIVE MULTIPLE SCLEROSIS 

Marjorie J. Bowman, 1 Harold L. Atkins, 2,3 Mark S. Freedman 1,4 

1 MS Research, Ottawa Hospital Research Institute, Ottawa, ON, Canada; 

2 Blood and Marrow Transplant Program, The Ottawa Hospital, Ottawa, ON, 

Canada; 3 Centre for Cancer Therapeutics, Ottawa Hospital Research Institute, 

Ottawa, ON, Canada; 4 MS Clinic, The Ottawa Hospital, Ottawa, ON, Canada 

Background: High-dose chemotherapy and autologous 

stem cell transplantation (ASCT) is a potential treatment for 

aggressive multiple sclerosis (MS) but can be associated with 

significant morbidity and mortality. Any gains from treatment 

must not be offset by reductions in quality of life (QOL) or 

worsening fatigue. Objectives: We have noted a short-term 

benefit for QOL and fatigue in patients receiving this novel 

therapy, but the long-term outcome is unknown. Methods: 

The Canadian MS/BMT trial is a nonrandomized phase 2 

trial of intensive chemotherapy and purified ASCT in patients 

with aggressive MS who have not responded to ≥1 year of

standard treatment. The first transplant occurred in October 

2001. Multiple Sclerosis Quality of Life–54 (MSQOL-54) 

questionnaires and fatigue impact scales (FIS) were completed 

by all patients in the 3 months pre-transplant and every 6 

months thereafter for 3 years in the primary study and every 

6 months in the long-term extension study. Results: A total 

of 24 patients received the treatment and remained free of 

MS relapses or any new magnetic resonance imaging (MRI) 

activity for at least 15 months and up to 9 years of followup. 

Nine patients have completed more than 36 months of 

follow-up. There was a 29% improvement in the Overall QOL 

scores, 27% in the physical QOL, 13.6% in the mental QOL, 

and 38% in the FIS over the pre-transplant values. A significant 

improvement was found in the overall QOL (P = .027) 

with a trend toward improvement noted in physical QOL (P 

= .054), mental QOL (P = 0.074), and fatigue (P = .054). 

The lack of significance is due to small patient number and 

interpatient variability. Conclusion: Intensive chemotherapy 

and ASCT stabilizes or improves very aggressive MS patients 

without compromising patient-related outcomes of well-being 

measured by the MSQOL-54 and FIS. Despite the study’s 

limitation by the small sample size, these preliminary results 

suggest that patient QOL and fatigue are not worsening and 

perhaps are improved more than 3 years after ASCT. 

Disclosure: Marjorie J. Bowman: Nothing to disclose. Harold L. 

Atkins: Nothing to disclose. Mark S. Freedman: BayerHealthcare (consulting 

fee); BayerHealthcare, Genzyme, EMD Canada, Teva Canada 

Innovation (honoraria); Genzyme, EMD Canada, Novartis, Sanofi- 

Aventis, Teva Canada Innovation (consulting fees). 

Keywords: Disease-modifying treatment in MS 

P10 

ALEMTUZUMAB IMPROVES CLINICAL OUTCOMES IN 

HIGHLY ACTIVE RELAPSING-REMITTING MULTIPLE 

SCLEROSIS 

Ann Bass, 1 on behalf of the CAMMS223 Study Group 2 

1 Neurology Center of San Antonio, P.A., San Antonio, TX; 2 Genzyme 

Corporation, Cambridge, MA 

Background: Alemtuzumab is a humanized monoclonal 

antibody that selectively alters the circulating lymphocyte 

pool. In a 3-year, phase 2 trial with early, active relapsingremitting 

multiple sclerosis (RRMS) patients, alemtuzumab’s 

efficacy was superior to that of subcutaneous interferon beta- 

1a (SC IFNβ-1a), significantly reducing the relapse rate and 

risk for 6-month sustained accumulation of disability (SAD). 

Notable alemtuzumab-related adverse events included infusion 

reactions, infections of predominantly mild-to-moderate 

severity, and secondary autoimmunity, principally thyroid 

disorders and immune thrombocytopenia. Objectives: To 

evaluate alemtuzumab’s efficacy in highly active RRMS on 

freedom from clinical disease activity (CDA) and sustained 

reduction in disability (SRD). Methods: A total of 334 early, 

active RRMS patients were randomized 1:1:1 to IFNβ-1a (44 

µg SC 3 times/wk) or 12 mg/d or 24 mg/d alemtuzumab, 

intravenously administered during two or three brief annual 

cycles. A subgroup with highly active RRMS was defined as 

having ≥2 relapses in the year prior to randomization and at 

least 1 gadolinium-enhancing lesion at baseline (a study entry 

criterion). Expanded Disability Status Scale (EDSS) score 

was assessed quarterly by a blinded rater. Relapses were 

assessed as needed. CDA-free was defined as no relapses 


5 

Platforms 

and no 6-month SAD during the 3-year study period. SRD 

was defined as a ≥1-point decrease from baseline EDSS 

during the 3-year study period that was sustained for 6 

consecutive months in patients with baseline EDSS ≥2. Both 

endpoints were analyzed with the Kaplan-Meier method and 

Cox proportional hazards regression model. Alemtuzumab 

dose groups were pooled for this post hoc analysis. Results: 

A total of 125 (56%) alemtuzumab patients and 60 (54%) 

IFNβ-1a patients were classified as highly active. Risk for 

CDA was 73% lower for alemtuzumab compared with IFNβ- 

1a (HR = 0.27; 95% confidence interval [CI], 0.16-0.47; P < 

.0001). Among the highly active patients with baseline EDSS 

≥2 (n = 73 alemtuzumab, n = 39 IFNβ-1a), alemtuzumab 

patients were 4.8 times more likely to experience SRD than 

IFNβ-1a patients (HR = 4.76; 95% CI, 2.13-10.64; P = 

.0001). Both alemtuzumab dose groups were significantly 

better than the IFNβ-1a group on both endpoints. Conclusion: 

Alemtuzumab is superior to SC IFNβ-1a for attaining 

freedom from CDA and increasing the likelihood of SRD 

among highly active RRMS patients. 

Disclosure: Ann Bass: Genzyme Corporation (other financial benefit); 

Teva, Serono, Pfizer, Biogen, Novartis (consulting fees, honoraria). On 

behalf of the CAMMS223 Study Group: Genzyme Corporation (salary, 

consulting fee, honoraria, other financial benefit). 


P11 

RITUXIMAB TREATMENT FOR NEUROMYELITIS 

OPTICA 

William A. Sheremata, 1,2 Gurdesh Bedi, 1 Nida Usmani, 1 Byron L. Lam 1,2 

1 Neurology, Miller School of Medicine, Miami, FL; 2 Ophthalmology, Miller 

School of Medicine, Miami, FL 

Background: Neuromyelitis optica (NMO) is a severe 

demyelinating disease often leading to early disability. Antiinflammatory-immunosuppressant 

drugs have been used 

empirically for more than 3 decades. Abundant evidence 

now implicates humoral mechanisms in its pathogenesis, 

and recently rituximab treatment has been used. However, 

the number of subjects reported and treatment duration have 

been limited. Objectives: To evaluate the impact of rituximab 

on relapse rate and disability in NMO. Methods: An 

institutional review board–approved retrospective longitudinal 

study of NMO was conducted, which included rituximab 

treatment among other modalities. Results: We identified 

53 NMO patients, 23 of whom were treated with rituximab. 

There were 2 men and 21 women with a mean ± SD age of 

37.1 ± 14.6 years at diagnosis. Eight were treatment-naive. 

All but the initial four received 2 biweekly doses of 1000 

mg every 6 months. Four had doses of 375 mg/M 2 initially, 

but all reverted to biweekly dosage after failure. The median 

relapse rate declined significantly from 1.87 relapses/ 

patient/year to 0 following rituximab. The Expanded Disability 

Status Scale (EDSS) score was stable or improved in all 

patients. Conclusion: Use of rituximab is associated with a 

significant reduction in relapses and disability in NMO. 

Disclosure: Nothing to disclose

Platforms 

P12 

CONFIRMATION OF 6-MINUTE WALK TEST UTILITY 

IN MULTIPLE SCLEROSIS SUBJECTS 

Myla Goldman, 1 Yoojin Suh, 2 Madeline Weikert, 2 John Pula, 2 Jacob J. Sosnoff, 2 

Robert W. Motl 2 

1 Department of Neurology, University of Virginia, Charlottesville, VA; 

2 Department of Kinesiology and Community Health, University of Illinois, 

Urbana-Champaign, IL 

Background: Loss of mobility is an ultimately ubiquitous 

feature of multiple sclerosis (MS). Patients report walking as 

being among the most valuable bodily functions. Optimal 

measurement of ambulation is an important aspect of MS 

research. Current MS disability scales measure ambulation 

but suffer from important limitations. Emerging evidence indicates 

that the 6-Minute Walk (6MW) is a promising measure 

of ambulation in MS. Objectives: 1)Confirm validation 

of the 6MW in a second independent MS population. 2) 

Explore new relationships between the 6MW and other 

outcome measures in MS subjects. Methods: Subjects with 

a definite diagnosis of MS were assessed in a single study 

visit. Subjects received an Expanded Disability Status Scale 

(EDSS) evaluation from a neurostatus-certified neurologist. 

Subjects were further divided into EDSS subgroups: mild 

(EDSS 0–3.5), moderate (EDSS 4.0–5.5), and severe (EDSS 

6.0–6.5). Subjects completed the 6MW, Timed 25-Foot 

Walk (T25FW), Multiple Sclerosis Walking Scale–12 

(MSWS-12), and four GAITRite trials to measure overall gait 

function using the Functional Ambulatory Performance (FAP). 

Results: A total of 42 subjects with confirmed MS completed 

the study. The EDSS subgroups included the following: 

mild, n = 8; moderate, n = 16; and severe, n = 18. Total MS 

group 6MW and T25FW scores were strongly correlated (r 

= –0.855, P < .001). However, 6MW and T25FW scores 

were not significantly correlated in the mild EDSS subgroup 

(r = 0.474, P = .118. The 6MW and T25FW performance 

decreased as EDSS-ranked disability increased. The 6MW 

(F = 25.86, P < .001) and T25FW (F = 8.31, P < .001) 

differed across EDSS subgroup category. However, the 

6MW demonstrated 32% more precision compared with 

the T25FW. Within subgroup comparisons, only the 6MW 

was able to significantly detect between-group differences in 

EDSS subtypes. In comparison, the T25FW only significantly 

distinguished mild from severe subgroups. Differences were 

further seen in 6MW and T25FW correlations to MSWS-12 

and FAP within EDSS subgroups. Conclusion: The 6MW is 

a meaningful measure of walking function in MS. The 6MW 

again demonstrates increased precision compared with the 

T25FW in defining EDSS subgroups. Further differences in 

6MW and T25FW correlations with other ambulatory and 

balance measures suggest that these measures may have 

different strengths and utility among EDSS subgroups, particularly 

in subjects with mild MS. 

Disclosure: Myla Goldman: Biogen Idec, Novartis (consulting fees). 

Yoojin Suh: Nothing to disclose. Madeline Weikert: Nothing to disclose. 

John Pula: Nothing to disclose. Jacob J. Sosnoff: Nothing to disclose. Robert 

W. Motl: Nothing to disclose. 



6 

SESSION 3: DISEASE MANAGEMENT AND 

THERAPEUTICS 

P13 

EFFICACY OF SUBCUTANEOUS INTERFERON BETA- 

1A IN PATIENTS WITH CLINICALLY ISOLATED 

SYNDROME: THE REFLEX STUDY 

Mark S. Freedman, 1 Giancarlo Comi, 2 Nicola De Stefano, 3 Ludwig Kappos, 4 

Frederik Barkhof, 5 Chris H. Polman, 6 Bernard Uitdehaag, 6 Florence Casset- 

Semanaz, 7 Brian Hennessy, 7 Sanda Rocak, 8 Bettina Stubinski 8 

1 Multiple Sclerosis Research Unit, The Ottawa Hospital–General Campus, 

Ottawa, ON, Canada; 2 Department of Neurology, Ospedale San Raffaele, 

Milan, Italy; 3 Department of Neurological and Behavioral Sciences, University 

of Siena, Siena, Italy; 4 Departments of Neurology and Biomedicine, University 

Hospital Basel, Basel, Switzerland; 5 Diagnostic Radiology, VU University 

Medical Center, Amsterdam, Netherlands; 6 VU University Medical Center, 

Amsterdam, Netherlands; 7 Global Biostatistics, Merck Serono S.A., Geneva, 

Switzerland; 8 Global Clinical Development Unit–Neurodegenerative Diseases, 

Merck Serono S.A., Geneva, Switzerland 

Background: Disease-modifying treatments for multiple 

sclerosis (MS) are most effective when initiated in the early 

stages of the disease. Interferon beta-1a (IFNβ-1a) 44 µg 

subcutaneously (SC) is effective in relapsing forms of MS but 

has not previously been investigated in patients with a first 

demyelinating event. Objectives: The REbif FLEXible dosing 

in early Multiple Sclerosis (REFLEX) study was designed to 

assess the effects of two dosing frequencies of SC IFNβ-1a on 

risk of conversion to MS in patients with a first demyelinating 

event. Methods: Patients with a first demyelinating event 

suggestive of MS and ≥2 clinically silent T2 brain lesions 

on magnetic resonance imaging (MRI) were randomized 

(1:1:1) to the serum-free formulation of SC IFNβ-1a 44 µg, 

3 times weekly (tiw) or once weekly (qw; plus placebo twice 

weekly for blinding), or placebo tiw for ≤24 months. The 

primary endpoint was time to McDonald MS; the main secondary 

endpoint was time to clinically definite MS (CDMS). 

Results: A total of 517 patients were randomized: 171, 

175, and 171 in the tiw, qw, and placebo groups, respectively. 

Mean (SD) age was 30.7 (8.2) years; 64.2% were 

female; baseline characteristics were similar across treatment 

groups. The 2-year cumulative probabilities of McDonald MS 

were 62.5%, 75.5%, and 85.8% in the IFNβ-1a tiw and 

qw, and placebo groups, respectively. Hazard ratios (95% 

confidence interval [CI]) were 0.49 (0.38-0.64) and 0.69 

(0.54-0.87), corresponding to risk reductions versus placebo 

of 51% and 31% for tiw and qw, respectively (P < .000001 

and P = .008), with tiw superior to qw (P = .009). For tiw, 

qw, and placebo, the median times to McDonald MS were 

310, 182, and 97 days, respectively. The 2-year cumulative 

probabilities of conversion to CDMS were 20.6%, 21.6%, 

and 37.5% in the IFNβ-1a tiw, qw, and placebo groups; 

hazard ratios (95% CI) versus placebo: 0.48 (0.31-0.73; P 

= .0004) and 0.53 (0.35-0.79; P = .0023). Adverse events 

were within the established profile of SC IFNβ-1a. No new or 

unexpected adverse events were reported. Conclusion: SC 

IFNβ-1a significantly delayed development of both McDonald 

MS and CDMS compared with placebo; the delay in conversion 

to McDonald MS was more pronounced with 44 µg tiw 

than with qw. 

Disclosure: Mark S. Freedman: Bayer HealthCare, Celgene, Sanofi- 

Aventis, Novartis, Merck Serono, Biogen Idec, Genzyme (consulting fees). 

Giancarlo Comi: Serono Symposia International Foundation, Merck

Serono, Bayer Schering, Biogen Dompè, Sanofi-Aventis, Teva Pharmaceutical 

Industries Ltd, Novartis (honoraria); Merck Serono, Bayer 

Schering, Biogen Dompè, Sanofi-Aventis, Teva Pharmaceutical Industries 

Ltd , Novartis (consulting fees). Nicola De Stefano: Schering, Merck 

Serono, Teva, Biogen Idec (honoraria); Merck Serono (other financial 

benefit). Ludwig Kappos: Acorda Therapeutics, Wyeth, UCB, Teva, 

Roche, Shire, Santhera Pharmaceuticals, Sanofi-Aventis, Novartis, MediciNova, 

Merck Serono, GlaxoSmithKline, Elan, Genmab, Boehringer 

Ingelheim, Biogen Idec, Bayhill, Bayer, Allozyne, Actelion Pharmaceuticals 

(other financial benefits). Frederik Barkhof: Bayer Schering Pharma 

(consulting fee); Serono Symposia Foundation, Roche, Novartis , Merck 

Serono, UCB, Biogen Idec, Sanofi-Aventis, Bayer Schering Pharma 

(honoraria); Roche, Novartis, Merck Serono, UCB, Biogen Idec, Sanofi- 

Aventis (consulting fees). Chris H. Polman: Actelion, Teva, Roche, UCB, 

Novartis, Merck Serono, GlaxoSmithKline, Bayer Schering, Biogen Idec, 

Antisense Therapeutics (other financial benefits). Bernard Uitdehaag: 

Novartis, Danone Research, Synthon, Merck Serono (consulting fees). 

Florence Casset-Semanaz: Merck Serono (salary). Brian Hennessy: Merck 

Serono (salary). Sanda Rocak: Merck Serono (salary). Bettina Stubinski: 

Merck Serono (salary). 


P14 

TERIFLUNOMIDE IN MULTIPLE SCLEROSIS WITH 

RELAPSES: OUTCOMES BY PRIOR THERAPY IN 

TEMSO 

Paul W. O’Connor, 1 Jerry S. Wolinsky, 2 Aaron Miller, 3 Christian Confavreux, 4 

Giancarlo Comi, 5 Ludwig Kappos, 6 Tomas P. Olsson, 7 Hadj Benzerdjeb, 8 

Philippe Truffinet, 8 Lin Wang, 9 Mark S. Freedman 10 

1 University of Toronto, Toronto, ON, Canada; 2 University of Texas Health 

Science Center at Houston, Houston, TX; 3 Mount Sinai School of Medicine, 

New York, NY; 4 Université Claude Bernard Lyon 1, Lyon, France; 5 University 

Vita-Salute San Raffaele, Milano, Italy; 6 University Hospital, Basel, 

Switzerland; 7 Karolinska Institute, Stockholm, Sweden; 8 Sanofi-Aventis, Chilly- 

Mazarin, France; 9 Sanofi-Aventis, Bridgewater, NJ; 10 University of Ottawa, 

Ottawa, ON, Canada 

Background: Teriflunomide is a novel oral disease-modifying 

therapy (DMT) in development for multiple sclerosis with 

relapses (RMS). In the TEMSO phase 3 study, teriflunomide 

significantly reduced annualized relapse rate (ARR), disability 

progression, and magnetic resonance imaging (MRI) activity 

with a favorable safety profile. Objectives: To report 

outcomes from a subgroup analysis of TEMSO according 

to prior DMT exposure. Methods: A total of 1088 RMS 

patients (aged 18–55 years), with Expanded Disability Status 

Scale (EDSS) scores ≤5.5, and ≥1 relapse in the previous 

year or ≥2 in the preceding 2 years, were randomized 

(1:1:1) to placebo (PBO) or teriflunomide, 7 mg or 14 mg, 

once daily for 108 weeks. The primary endpoint was ARR, 

and the key secondary endpoint was 12-week confirmed 

disability progression. Prespecified subgroup analyses were 

conducted according to prior DMT exposure. A generalized 

estimating equation method and Cox regression model 

were used to assess consistency of treatment effects, utilizing 

a treatment-by-subgroup interaction test for each factor 

separately. Results: In the overall TEMSO population, 73% 

of patients were DMT-naive in the 2 years preceding study 

entry. Teriflunomide reduced ARRs among both treatmentnaive 

(0.45, 0.31, and 0.31 for PBO, 7 mg, and 14 mg, 

respectively; relative risk reductions (RRRs) [95% confidence 

interval, CI] of 31.4% [12.1, 46.4%] and 29.8% [8.4, 

46.2%] for 7 mg and 14 mg vs. PBO, respectively) and previously 

treated patients (0.78, 0.50, and 0.47; RRRs [95% 

CI] of 36.3% [11.7, 54.1%] and 39.8% [15.1, 57.3%]). 


7 

Platforms 

The estimated proportion of patients with 12-week-confirmed 

disability progression at week 108 among treatment-naive 

patients was 24.6%, 17.8%, and 20.2% for PBO, 7 mg, and 

14 mg, respectively (RRRs [95% CI] of 30.7% [–3.2, 53.5%] 

and 18.8% [–19.6, 44.9%]). Among previously treated 

patients, the estimated proportions were 35.6%, 32.9%, 

and 20.1% (RRRs [95% CI] of 13.8% [–47.7, 49.7%] and 

50.3% [8.4, 73.0%]). No treatment-by-subgroup interaction 

test reached statistical significance for either evaluation at 

the level of P = .05. Conclusion: Teriflunomide provided 

benefits for relapse rate and disease progression irrespective 

of whether or not patients had been previously exposed to 

other DMTs. 

Supported by: Sanofi-Aventis 

Disclosure: Paul W. O’Connor: Actelion, Bayer, Biogen Idec, BioMS, 

Cognosci, Daiichi Sankyo, EMD Serono, Genentech, Genmab, Novartis, 

Roche, Sanofi-Aventis, Teva, Warburg Pincus (consulting fees). Jerry S. 

Wolinsky: Acorda Therapeutics, Bayer HealthCare, Consortium of MS 

Clinics, Eli Lilly, EMD Serono, Facet Biotech, Johns Hopkins University, 

Medscape CME, Novartis, Peptimmune, Sanofi-Aventis, Serono 

Symposia International Foundation, Teva and Teva Neurosciences, 

National Multiple Sclerosis Society, Northwestern University, University 

of Buffalo, University of South Florida Professionals Conferencing 

and UCB (consulting fees); outlicensed monoclonal antibodies through 

the UTHSCH to Millipore (Chemicon International) Corporation 

since 1993 (royalty); Clayton Foundation for Research, NIH (2 U01 

NS045719-06 [PI of the subcontract to UTHSCH for image analysis], 

2RO1-EB002095-06A1 [Co-I]), Sanofi-Aventis, ACP Medicine, BC 

Decker (other financial benefits). Aaron Miller: Acorda Therapeutics, 

Biogen Idec, Genentech, Genzyme, Sanofi-Aventis, EMD Serono, Pfizer, 

Teva Neuroscience (other financial benefits); Acorda Therapeutics, Biogen 

Idec, BioMarin, Daiichi-Sankyo, EMD Serono, Glaxo Smith Kline, 

Merck Serono, Novartis, ONO, Teva Neuroscience (consulting fees). 

Christian Confavreux: Biogen Idec, Genzyme Corporation, Novartis, 

Merck Serono, Sanofi-Aventis, Teva Pharma, UCB Pharma (consulting 

fees); Bayer-Schering, Biogen Idec, LFB, Merck Serono, Sanofi- 

Aventis, Teva Pharma (other financial benefits). Giancarlo Comi: Bayer 

Schering, Serono Symposia International Foundation, Merck Serono 

International, Sanofi-Aventis, Biogen Dompè, Teva Pharmaceutical 

Ind. Ltd (other financial benefits); Novartis, Bayer Schering, Serono 

Symposia Int. Foundation, Merck Serono International, Sanofi-Aventis, 

Biogen Dompè, Teva Pharmaceutical Ind. Ltd (other financial benefits). 

Ludwig Kappos: Bayer Schering, Biogen Idec, GlaxoSmithKline, Merck- 

Serono, Novartis Pharmaceuticals, Sanofi-Aventis, Teva Pharmaceuticals, 

Wyeth Pharmaceuticals (other financial benefits). Tomas P. Olsson: 

Biogen Idec, Merck Serono, Pfizer, Sanofi-Aventis (consulting fees, other 

financial benefits). Hadj Benzerdjeb: Sanofi-Aventis (salary). Philippe 

Truffinet: Sanofi-Aventis (salary). Lin Wang: Sanofi-Aventis (salary). 

Mark S. Freedman: Genzyme (other financial benefit); Bayer, Biogen 

Idec, Teva, Merck Serono, Novartis, Sanofi-Aventis (consulting fees). 


P15 

NATALIZUMAB-ASSOCIATED PROGRESSIVE 

MULTIFOCAL LEUKOENCEPHALOPATHY OUTCOMES 

John Foley, 1 Patrick Vermersch, 2 Ralf Gold, 3 Ludwig Kappos, 4 Tomas Olsson, 5 

Diego Cadavid, 6 Carmen Bozic, 6 Sandra Richman 6 

1 Rocky Mountain Multiple Sclerosis Clinic, Salt Lake City, UT; 2 University 

of Lille Nord de France, Lille, France; 3 St. Josef-Hospital, Ruhr University– 

Bochum, Bochum, Germany; 4 Neurology and Department of Biomedicine, 

University Hospital, Basel, Switzerland; 5 Center for Molecular Medicine, 

Karolinska Hospital, Stockholm, Sweden; 6 Biogen Idec Inc, Weston, MA 

Background: As of September 2010, 75,500 multiple sclerosis 

(MS) patients have been treated with natalizumab, cor-

Platforms 

responding to 122,900 patient-years. While natalizumab’s 

efficacy is well known, a small number of patients experience 

progressive multifocal leukoencephalopathy (PML), a 

rare opportunistic central nervous system (CNS) infection. 

Objectives: Identify predictors of survival and functional 

status in postmarketing cases of natalizumab-associated 

PML. Methods: Treating physicians provided PML patient 

updates including motor and cognitive function, ability to 

perform daily activities, and Karnofsky Performance Scale 

score. Data were supplemented by the natalizumab global 

safety database, and cases were categorized by survival 

outcome (fatal/nonfatal) and functional status (mild/moderate/severe 

disability). Results: As of November 2010, 60 

of 75 (80%) patients survived. Survival rates in Europe were 

92% (35/38), United States 64% (21/33), and rest of world 

100% (4/4). Analyses of the first 35 cases (25/35, 71% 

survived) revealed nonfatal cases were younger (median, 43 

vs. 51.5 years), had lower disability prior to PML (median 

Expanded Disability Status Scale score, 3.8 vs. 5.5), and 

had shorter time from symptom onset to diagnosis (mean, 37 

vs. 62 days) than fatal cases. Widespread PML on magnetic 

resonance imaging (MRI) was present in most (69%) fatal 

cases. Other factors (eg, gender, MS duration, natalizumab 

exposure, prior immunosuppressant use, cerebrospinal fluid 

(CSF) JC virus DNA load at diagnosis) were generally similar 

between fatal and nonfatal cases. In all 35 cases, natalizumab 

dosing was withheld; most patients were treated by plasma 

exchange or immunoadsorption to rapidly remove natalizumab. 

Immune reconstitution inflammatory syndrome (IRIS) 

was reported in most (91%) cases and was usually treated 

with high-dose corticosteroids. Of the PML survivors with ≥6 

months of follow-up (12/25, 48%) after diagnosis, 33% had 

mild, 33% moderate, and 33% severe disability. Available 

updated outcomes data will be presented. Conclusion: 

Survival in patients with natalizumab-associated PML was 

associated with younger age at diagnosis, less disability prior 

to PML, more localized PML on MRI, and shorter time to PML 

diagnosis. These data suggest that earlier diagnosis through 

enhanced clinical vigilance as well as aggressive management 

of PML and IRIS may improve outcomes. 

Disclosure: John Foley: Biogen Idec, Genzyme,Teva (consulting fees); 

Biogen Idec, Teva (honoraria). Patrick Vermersch: Biogen Idec, Bayer 

Schering, Teva Aventis, Merck Serono, Novartis (honoraria); Biogen 

Idec, Bayer Schering, Teva Aventis, Merck Serono (other financial 

benefits). Ralf Gold: Bayer Health Care, Biogen Idec, Merck Serono, 

Teva Pharma (honoraria); Biogen Idec (royalty); Bayer Health Care, 

Biogen Idec, Merck Serono, Teva Pharma, Novartis (other financial 

benefits). Ludwig Kappos: Acorda, Actelion, Allozyne, BaroFold, Bayer 

HealthCare Pharmaceuticals, Bayer Schering Pharma, Bayhill, Biogen 

Idec, Boehringer Ingelheim, Elan, Genmab, Glenmark, GlaxoSmith- 

Kline, Merck Serono, Medicinova, Novartis, Sanofi-Aventis, Santhera, 

Shire, Roche, Teva, UCB, Wyeth, Swiss MS Society, Swiss National 

Research Foundation, European Union, Gianni Rubatto Foundation, 

Novartis and Roche Research Foundations (other financial benefits). 

Tomas Olsson: Biogen Idec, Merck Serono, Sanofi-Aventis, Novartis, 

Bayer Schering (honoraria); Biogen Idec, Merck Serono, Sanofi-Aventis, 

Bayer Schering (other financial benefits). Diego Cadavid: Biogen Idec 

(salary). Carmen Bozic: Biogen Idec (royalty). Sandra Richman: Biogen 

Idec (salary). 

Keywords: Disease-modifying treatment in MS, Immunology and MS 


8 

P16 

OLIGOCLONAL BANDING AND CEREBROSPINAL 

FLUID MARKERS IN MULTIPLE SCLEROSIS DISEASE 

COURSE AND PROGRESSION 

Pedro Lourenco, 1 Jameelah Saeedi, 1 Afsaneh Shirani, 1 Joel Oger, 1 William 

Schreiber, 2,3 Helen Tremlett 1 

1 Neurology, University of British Columbia, Vancouver, BC, Canada; 

2 Vancouver General Hospital, Vancouver, BC, Canada; 3 Pathology & 

Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada 

Background: Oligoclonal bands (OCBs) and cerebrospinal 

fluid (CSF) markers have been associated with multiple 

sclerosis (MS) disease course, although findings have been 

inconsistent. Reasons might include variation in ethnicity or 

local diagnostic practices. Objectives: To investigate the 

association between OCB/CSF findings, and MS disease 

course and progression, and to examine the impact of ethnicity 

and testing bias on our findings. Methods: In a cohort of 

definite MS patients (Poser or McDonald criteria), registered 

at the British Columbia MS Clinics between 1982 and 2010, 

we retrospectively investigated the association between OCB 

status, IgG index, IgG synthesis rate, total CSF IgG, total CSF 

protein, disease course (relapsing-onset [RO] vs. primary 

progressive [PP]), and disability progression. Disability outcomes 

included time to sustained Expanded Disability Status 

Scale (EDSS) 6 (from MS onset and birth), the proportion of 

patients to reach EDSS 6 within 10 years after onset, and 

progression index. Analysis was repeated in Caucasians only 

(n = 579). Testing bias was examined by comparing patients 

who had OCB/CSF testing done (n = 1120) versus those 

who did not (n = 5815). Results: Of the 1120 patients 

who had their CSF tested, 957 were tested for OCBs. A total 

of 694/957 (72.5%) patients had detectable OCBs. OCB 

presence was higher in PP (107/134; 79.8%) compared 

with RO (587/823; 71.3%) patients (P = .040); this association 

increased when examined in Caucasians only (70/80 

[87.5%] in PP vs. 360/499 [71.9%] in RO; P = .004). Total 

CSF IgG (64.1 ± 44.6 vs. 52.0 ± 37.4 mg/L) and total protein 

(502 ± 276 vs. 418 ± 174 mg/L) levels were higher in 

PP MS patients compared with RO patients, respectively (P < 

.001). Disease progression outcomes were independent of 

OCB status. Patients tested for OCB/CSF markers were more 

likely to be male (32.2% vs. 27.7%), older at symptom onset 

(35.0 ± 10.9 vs. 31.5 ± 10.0 years), and PP MS (14.1% 

vs. 8.9%) than those not tested. Conclusions: Presence of 

OCBs was higher among PP compared with RO patients; this 

association was stronger in Caucasian patients. Higher total 

CSF protein and IgG levels were associated with a PP disease 

course, suggesting different immunologic etiologies for 

RO and PP MS. Disease progression was not associated with 

OCB status. A testing bias was detected. 

Disclosure: Pedro Lourenco: Nothing to disclose. Jameelah Saeedi: 

Nothing to disclose. Afsaneh Shirani: Nothing to disclose. Joel Oger: 

Asprev, Aventis, BioM, Berlex S, Genentech, Serono, Shering, Talecris, 

Teva-neurosciences (honoraria); Bayer, Biogen Idec, Novartis (consulting 

fees). William Schreiber : Nothing to disclose. Helen Tremlett: Nothing 

to disclose. 

Keywords: Natural history of MS, Immunology and MS

P17 

ORAL TERIFLUNOMIDE PLUS GLATIRAMER ACETATE 

IN RELAPSING MULTIPLE SCLEROSIS 

Mark S. Freedman, 1 Jerry S. Wolinsky, 2 Barbara Wamil, 3 Christian 

Confavreux, 4 Giancarlo Comi, 5 Ludwig Kappos, 6 Tomas P. Olsson, 7 Aaron 

Miller, 8 Hadj Benzerdjeb, 9 Huiling Li, 3 Paul W. O’Connor 10 

1 University of Ottawa, Ottawa, ON, Canada; 2 University of Texas Health 

Science Center at Houston, Houston, TX; 3 Sanofi-Aventis, Bridgewater, NJ; 

4 Université Claude Bernard Lyon 1, Lyon, France; 5 University Vita-Salute San 

Raffaele, Milano, Italy; 6 University Hospital, Basel, Switzerland; 7 Karolinska 

Institute, Stockholm, Sweden; 8 Mount Sinai School of Medicine, New York, 

NY; 9 Sanofi-Aventis, Chilly-Mazarin, France; 10 University of Toronto, Toronto, 

ON, Canada 

Background: Teriflunomide is a novel oral disease modifier 

in development for treatment of relapsing forms of multiple 

sclerosis (RMS). Six-month trial data demonstrated that 

teriflunomide had a favorable safety profile and reduced 

magnetic resonance imaging (MRI) disease activity compared 

with placebo (PBO) when added to glatiramer acetate (GA) 

in patients with RMS, supporting its role as an effective oral 

therapy in MS. Objectives: To determine the safety and 

efficacy of teriflunomide added to ongoing GA for 1 year. 

Methods: A total of 123 RMS patients on a stable dose of 

GA were randomized (1:1:1) to treatment (PBO: 41; 7 mg: 

42; 14 mg: 40) for 6 months; 96 entered the 6-month extension 

(PBO: 37; 7 mg: 30; 14 mg: 29). Evaluations included 

treatment-emergent adverse events (TEAEs), laboratory data, 

and brain MRI scans. The number of T1-gadolinium (Gd) 

lesions was estimated using a Poisson model adjusted for 

geographic region and baseline lesion number. Results: 

79% of patients were female, with a mean age of 41.4 

years and mean Expanded Disability Status Scale (EDSS) 

score of 2.5. Patients in the teriflunomide 7 mg group had 

higher baseline MRI disease activity, with a greater proportion 

of patients with ≥1 T1-Gd lesions (29%) compared with 

the 14 mg (13%) or PBO (15%) groups. During 48 weeks of 

treatment, 10 patients had TEAEs leading to treatment discontinuation 

(PBO: 2; 7 mg: 3; 14 mg: 5). Two patients (PBO: 

1; 14 mg: 1) had alanine aminotransferase (ALT) >3× the 

upper limit of normal. One patient (PBO) discontinued treatment 

due to a serious TEAE of herpes zoster. Sixty-six patients 

(PBO: 27; 7 mg: 20; 14 mg: 19) had TEAEs of infections/ 

infestations. The number of T1-Gd lesions over 48 weeks was 

significantly reduced with teriflunomide 7 mg compared with 

PBO, with relative risk reductions (RRRs) of 64% (P = .031) 

and 47% (P = .193) with 7 mg and 14 mg, respectively. 

T1-Gd lesion volume was significantly reduced with 14 mg, 

with RRRs of 40% (P = .134) and 73% (P = .038) with 7 mg 

and 14 mg, respectively. Conclusion: The addition of teriflunomide 

7 mg or 14 mg daily to stable-dosed GA showed 

a favorable safety profile and improved disease control 

(evaluated by MRI activity) beyond GA alone over 1 year 

of treatment. Interpretation is complicated by between-group 

differences in baseline T1-Gd activity. Teriflunomide is an 

effective new oral monotherapy and may be a potential combination 

therapy for RMS. 

Supported by: Sanofi-Aventis 

Disclosure: Mark S. Freedman: Genzyme (other financial benefit); 

Bayer, Biogen Idec, Teva, Merck Serono, Novartis, Sanofi-Aventis (consulting 

fees). Jerry S. Wolinsky: Acorda Therapeutics, Bayer HealthCare, 

Consortium of MS Clinics, Eli Lilly, EMD Serono, Facet Biotech, 


9 

Platforms 

Johns Hopkins University, Medscape CME, Novartis, Peptimmune, 

Sanofi-Aventis, Serono Symposia International Foundation, Teva and 

Teva Neurosciences, National Multiple Sclerosis Society, Northwestern 

University, University of Buffalo, University of South Florida Professionals 

Conferencing, UCB (consulting fees); outlicensed monoclonal antibodies 

through the UTHSCH to Millipore (Chemicon International) 

Corporation since 1993 (royalty); Clayton Foundation for Research, 

NIH (2 U01 NS045719-06 [PI of the subcontract to UTHSCH for 

image analysis], 2RO1-EB002095-06A1 [Co-I]), Sanofi-Aventis, 

ACP Medicine, BC Decker (other financial benefits). Barbara Wamil: 

Sanofi-Aventis (salary). Christian Confavreux: Biogen Idec, Genzyme 

Corporation, Novartis, Merck Serono, Sanofi-Aventis, Teva Pharma, 

UCB Pharma (consulting fees); Bayer-Schering, Biogen Idec, LFB, 

Merck Serono, Sanofi-Aventis, Teva Pharma (other financial benefits). 

Giancarlo Comi: Bayer Schering, Serono Symposia International Foundation, 

Merck Serono International, Sanofi-Aventis, Biogen Dompè, 

Teva Pharmaceutical Ind. Ltd, Novartis (other financial benefits). 

Ludwig Kappos: Bayer Schering, Biogen Idec, GlaxoSmithKline, Merck- 

Serono, Novartis Pharmaceuticals, Sanofi-Aventis, Teva Pharmaceuticals, 

Wyeth Pharmaceuticals (other financial benefits). Tomas P. Olsson: 

Biogen Idec, Merck Serono, Pfizer, Sanofi-Aventis (consulting fees); 

Merck Serono, Biogen Idec, Sanofi-Aventis (other financial benefits). 

Aaron Miller: Acorda Therapeutics, Biogen Idec, Genentech, Genzyme, 

Sanofi-Aventis,Teva Neuroscience (other financial benefits); Acorda 

Therapeutics, Biogen Idec, BioMarin, Daiichi-Sankyo, EMD Serono, 

Glaxo Smith Kline, Merck Serono, Novartis, ONO, Teva Neuroscience 

(consulting fees); Acorda Therapeutics, Biogen Idec, EMD Serono, Pfizer, 

Teva Neuroscience (other financial benefits). Hadj Benzerdjeb: Sanofi- 

Aventis (salary). Huiling Li: Sanofi-Aventis (salary). Paul W. O’Connor: 

Actelion, Bayer, Biogen Idec, BioMS, Cognosci, Daiichi Sankyo, EMD 

Serono, Genentech, Genmab, Novartis, Roche, Sanofi-Aventis, Teva, 

Warburg Pincus (consulting fees). 


P18 

FATIGUE AS A PRECURSOR TO CLINICALLY DEFINITE 


Joseph R. Berger, 1 Susan Boklage, 2 Payal Patel, 2 Gustavo Suarez-Zambrano, 2 

Jennifer Pocoski, 2 Ronald Preblick 2 

1 Department of Neurology, University of Kentucky, Lexington, KY; 2 Medical 

Affairs, Bayer HealthCare Pharmaceuticals, Wayne, NJ 

Background: Fatigue is common in multiple sclerosis (MS) 

and an independent predictor of quality of life. 1 A survey 

through the North American Research Committee on Multiple 

Sclerosis (NARCOMS) registry found that severe fatigue was 

reported by 74% of respondents. 2 The frequency with which 

fatigue heralds MS is unknown. Objectives: To assess 

the prevalence of fatigue prior to the diagnosis of MS in a 

cohort of patients included in a claims database. Methods: 

Patterns of fatigue prior to MS were assessed using the 

MarketScan Database. Patients with clinically definite MS 

(CDMS), defined as ≥2 claims for MS (ICD9 340) or 1 MS 

claim and a disease-modifying therapy (DMT) claim during 

the index period (1/1/2002–9/30/2009) were included. 

Patients were continuously enrolled for ≥3 years before 

(washout) and ≥1 year after (follow-up) the initial claim. 

Analyses for evidence of chronic fatigue syndrome and/or 

fatigue and malaise (ICD9 780.71, ICD9 780.79) prior to 

the initial MS claim were performed. Besides fatigue, selected 

symptoms (ie, dizziness, disturbance of skin sensation) associated 

with MS were evaluated to understand their patterns of 

presentation prior to the diagnosis of CDMS. Additional data 

collected included utilization of fatigue-related prescriptions, 

frequency of fatigue claims, and time from first fatigue claim

Platforms 

to diagnosis of MS. Results: A total of 5305 MS patients 

were identified; 75% were females, and the average age 

was 47 years. At least 1 fatigue diagnosis was identified in 

29% (n = 1534) of patients during the 3-year period prior 

to the diagnosis of MS. Of these 1534 patients, 42% presented 

with ≥2 fatigue claims. In 30% of patients, fatigue 

was the only MS-related symptom preceding a diagnosis of 

MS. The majority of patients presented with some combination 

of fatigue and other precursor MS symptoms. 10.4% of 

patients received treatment for fatigue. Fatigue preceded the 

diagnosis of MS by an average of 501 days. Conclusion: 

This study confirms that fatigue is important in early MS, often 

preceding the MS diagnosis by years. MS should be considered 

in the differential diagnosis of patients presenting with 

unexplained fatigue, and a detailed neurologic history and 

examination are recommended. 

1. Amato et al. Mult Scler. 2001 Oct;7(5):340-4. 

2. Hadjimichael et al. J Neurosci Nurs. 2008 Apr;40(2):72-7. 

Disclosure: Joseph R. Berger: University of Kentucky (salary); Asphelia, 

Astellas, Bayer, Biogen Idec, Genentech, GlaxoSmithKline, Millenium, 

Pfizer, Perseid (consulting fees); Bayer, Biogen Idec, Teva, EMD Serono 

(honoraria); EMD Serono, Bayer, Biogen Idec (other financial benefits). 

Susan Boklage: Nothing to disclose. Payal Patel: Nothing to disclose. 

Gustavo Suarez-Zambrano: Nothing to disclose. Jennifer Pocoski: Nothing 

to disclose. Ronald Preblick: Nothing to disclose. 

SESSION 4: REHABILITATION 

P19 

THE PSYCHOMETRIC PROPERTIES OF THE FOUR 

SQUARE STEP TEST IN PEOPLE WITH MULTIPLE 

SCLEROSIS 

Joanne M. Wagner, 1 Rosemary A. Norris, 1 Linda R. Van Dillen, 2 Amy C. 

Rauchway, 3 Florian P. Thomas, 3,4 Anne H. Cross, 5 Robert T. Naismith 5 

1 Physical Therapy and Athletic Training, Saint Louis University, St. Louis, MO; 

2 Program in Physical Therapy, Washington University School of Medicine, 

St. Louis, MO; 3 Neurology and Psychiatry, Saint Louis University School 

of Medicine, St. Louis, MO; 4 Departments of Molecular Microbiology and 

Immunology, Saint Louis University School of Medicine, St. Louis, MO; 

5 Department of Neurology, Washington University School of Medicine, St. 

Louis, MO 

Background: The Four Square Step Test (FSST) is a standardized 

clinical measure used to assess dynamic standing 

balance during multidirectional stepping and obstacle 

avoidance. Compared with other standardized measures of 

standing balance, the FSST may be advantageous to use with 

individuals with multiple sclerosis (MS) because 1) scoring is 

not dependent on examiner subjectivity, 2) as a timed test, 

the FSST avoids the ceiling effects reported for other commonly 

used clinical measures of standing balance, and 3) the 

FSST requires minimal time, space, and equipment. However, 

the psychometric properties of the FSST have not been established 

in people with MS. Objectives: The purpose of this 

study was to use a comprehensive set of statistical methods to 

assess the reliability, validity, and minimal detectable change 

of the FSST in individuals with MS with mild-to-moderate clinical 

disability. Methods: The FSST was administered on two 

separate occasions (mean interval between assessments, 8.9 

± 3.4 days) to 14 individuals with MS (5 male, 9 female; 

mean age, 39.1 ± 9.5 years) with mild-to-moderate clinical 

disability (median Expanded Disability Status Score [EDSS], 


10 

3.0; range, 0–6). The Berg Balance Scale (BBS), Dynamic 

Gait Index (DGI), and Activities-specific Balance Confidence 

Scale (ABC) were also administered during the first testing 

session. The concurrent validity of the FSST was examined 

by correlating the FSST and the BBS, DGI, ABC, and EDSS. 

Test-retest reliability was examined by the intraclass correlation 

coefficient (ICC), and within-subject variability was evaluated 

using Bland-Altman analyses and the standard error 

of measurement (SEM). The SEM was used to estimate the 

minimal detectable change (MDC). Results: Performance 

on the FSST was related to the BBS (r = –0.85, P < .01), the 

DGI (r = –0.86, P < .01), the ABC (r = –0.65, P < .05), and 

the EDSS (r = 0.84, P < .01). The ICC value for the FSST 

was 0.97. The Bland-Altman analyses revealed no systematic 

error between sessions. The SEM was 11.7% and the MDC 

was 32.4%. Conclusion: The FSST is a valid and reliable 

measure of dynamic standing balance in people with MS 

with minimal-to-moderate clinical disability. A change greater 

than 32% on the FSST would signify a change in individual 

performance over time. 

Disclosure: Joanne M. Wagner: Nothing to disclose. Rosemary A. Norris: 

Nothing to disclose. Linda R. Van Dillen: Nothing to disclose. Amy 

C. Rauchway: Teva Neuroscience Inc (consulting fee). Florian P. Thomas: 

Teva Neuroscience Inc, Novartis, Biogen (consulting fees). Anne H. 

Cross: Bayer HealthCare, Genentech, Inc, Hoffman-La Roche, Eli Lilly, 

Teva Neuroscience, Biogen Idec (consulting fees). Robert T. Naismith: 

Acorda, Teva Neurosciences, EMD Serono, Genzyme, Biogen Idec, Bayer 

(consulting fees). 

Keywords: Rehabilitation strategies and therapy and MS 

P20 

BALANCE TREATMENTS IN MULTIPLE SCLEROSIS 

SUBJECTS: EFFECTS OF PHYSICAL THERAPY 

INTERVENTIONS WITH AND WITHOUT 

BIOFEEDBACK/FORCE PLATE TRAINING 

Giampaolo Brichetto, 1,2 Damiano Costa, 2 Mario Alberto Battaglia, 1 Maria 

Laura L. Lopes de Carvalho 2 

1 Department of Research, Italian Multiple Sclerosis Foundation–FISM, Genova, 

Italy; 2 AISM Rehabilitation Centre, Italian Multiple Sclerosis Society, Genova, 

Genova, Italy 

Background: Balance disorders are frequently observed 

in subjects with multiple sclerosis (MS), leading to impaired 

balance and increased risk of falls. Visual biofeedback/force 

plate systems are often used for treatment of balance disorders. 

Objectives: In this study we investigated the addition 

of visual and biofeedback/force plate training to enhance the 

effects of other physical therapy interventions on balance disorders 

in subjects with MS. Methods: The study included 20 

subjects with MS followed as outpatients at AISM Rehabilitation 

Centre, Italian Multiple Sclerosis Society, Genova, Italy. 

All subjects were evaluated with the Expanded Disability 

Status Scale (EDSS), Modified Fatigue Impact Scale, Berg Balance 

Scale, Equitest (NeuroCom) Sensory Organization Test 

and Motor Control Test, and Balance Master (NeuroCom). 

Subjects were assigned randomly to either an experimental 

group (10 subjects) or a control group (10 subjects). The 

experimental group trained on the NeuroCom Balance Master 

for 45 minutes every session, twice a week for 5 weeks. 

The control group received traditional physical therapy for 45 

minutes every session, twice a week for 5 weeks. Multivariate 

statistical analysis was used in order to assess the effects

of treatment and time and the interaction time × treatment. 

Results: Following intervention, both groups scored higher 

on the Berg Balance Scale, Modified Fatigue Impact Scale, 

and Sensory Organization Test (Equitest NeuroCom), with P 

< .05. Furthermore, multivariate analysis showed a greater 

improvement in the experimental group for the Berg Balance 

Scale and the Sensory Organization Test. Conclusion: Our 

results indicate that physical therapy is helpful for improving 

balance in MS subjects with an additional effect of biofeedback/force 

plate training. Biofeedback/force plate training 

should be part of a multimodal approach to balance disorders 

treatment in MS subjects. 



P21 

BALANCE REHABILITATION IN MULTIPLE SCLEROSIS 

USING NINTENDO WII FIT PLUS 

Erin B. Korsbrek, 1 Daniel McGowan, 2 Neera Garga, 3 Robert W. Motl, 4 

Maureen Odland Dunn 5 

1 Kinesiology, University of Calgary, Calgary, AB, Canada; 2 Clinical 

Neuroscience, University of Calgary, Calgary, AB, Canada; 3 OPTIMUS 

Program, Foothills Medical Centre, Calgary, AB, Canada; 4 Kinesiology and 

Community Health, University of Illinois, Champaign, IL; 5 Kinesiology, Hope 

College, Holland, MI 

Background: Multiple sclerosis (MS) affects sensory reception, 

integration, and motor output, making balance difficult 

to maintain. Objectives: The primary aim of this study 

was to determine if static, dynamic, and functional balance 

assessed by clinical and force plate measures would improve 

for mildly to moderately disabled people with MS following 

regular use of Nintendo Wii Fit Plus compared with a control 

phase. Methods: Eighteen males and females (mean 

age, 49 ± 8.8 years) with a definite diagnosis of MS and a 

baseline Expanded Disability Status Scale score of 2.5–5.0 

(mean, 3.50 ± 0.51) were recruited through the Calgary MS 

Clinic. Participants took part in 6 weeks (three 20- to 30-minute 

sessions/wk) of Nintendo Wii Fit Plus balance game play 

(mean, 19 ± 2 total training days) preceded by 6 weeks of 

habitual activity (mean, 43.4 ± 5.3 days). Assessments were 

performed prior to (T1, 0 weeks) and following the habitual 

activity phase (T2; mean T1-T2 time, 43.4 ± 5.3 days), and 

at the end of 12 weeks (T3; mean T2-T3 time, 46.7 ± 2.5 

days). Primary outcomes were Berg Balance Scale (BBS) 

scores and Accusway balance platform sway data during 

quiet stance and anteroposterior/mediolateral leans. Secondary 

outcomes were the Activities-specific Balance Confidence 

Scale (ABC), Falls Efficacy Scale (FES), Modified Fatigue 

Impact Scale (MFIS), Centre for Epidemiologic Studies 

Depression Scale (CESD), and Timed Up & Go (TUG) test. 

Statistical analysis assessed changes following intervention 

(T2-T3) compared with control (T1-T2). Results: Functional 

balance (BBS) improved (T2: 50.17 ± 3.35; T3: 53.00 ± 

2.87; P < .01) compared with control (T1: 49.36 ± 4.83; 

T2: 50.17 ± 3.35; P = .276). Static and dynamic sway data 

from the force platform were mixed and did not support or 

discredit clinical findings. All secondary indices remained 

stable (T1-T2 and T2-T3). Conclusion: The results suggest 

that 6 weeks of regular balance-promoting game play on 

Nintendo Wii Fit Plus can improve functional balance for 

people with MS without adversely affecting associated physi- 


11 

Platforms 

cal and psychological symptoms. These data may be used to 

guide future research design, sample size calculations, and 

rehabilitation protocols for people with MS. 


Keywords: Rehabilitation strategies and therapy and MS, Complementary/alternative 

therapies in MS 

P22 

COMBINED EXERCISE TRAINING IMPROVES 

WALKING MOBILITY IN MULTIPLE SCLEROSIS 

Madeline L. Weikert, 1 Douglas C. Smith, 2 Jeannette Elliott, 3 Deirdre Dlugonski, 1 

Jacob Sosnoff, 1 Robert W. Motl 1 

1 Kinesiology and Community Health, University of Illinois, Urbana- 

Champaign, Urbana, IL; 2 School of Social Work, University of Illinois, Urbana- 

Champaign, Urbana, IL; 3 Disability Resources and Educational Services, 

University of Illinois, Urbana-Champaign, Champaign, IL 

Background: Previous research shows that physical 

exercise training has been effective for improving walking 

mobility in MS (Reitberg et al., 2000; Snook & Motl, 2009), 

but existing literature has multiple deficiencies. Researchers 

have often included only a single mode of exercise training, 

which does not sufficiently address the physiological dysfunction 

seen with impaired walking in people with MS, such 

as aerobic deconditioning, muscle weakness, and balance 

incoordination (Motl, 2010). Other deficiencies include the 

use of a broad range of mobility outcome measures and the 

recruitment of a more independently ambulatory sample of 

individuals with MS, who have not reached onset of mobility 

disability defined by Expanded Disability Status Scale (EDSS) 

scores. Objectives: This pilot study examined the effect of 

combined exercise training on walking mobility in people 

with MS who have onset of mobility disability based on EDSS 

scores between 4 and 6. Methods: The participants in this 

pilot study (N = 13) completed the Multiple Sclerosis Walking 

Scale–12 (MSWS-12), performed two trials of both the Timed 

25-Foot Walk (T25FW) and Timed Up and Go (TUG) test, 

and completed four walking trials on a 26-foot GAITRite (CIR 

Systems, Inc) electronic walkway before and after an 8-week 

training period. The exercise training program was designed 

by a physical therapist and consisted of nearly equivalent 

amounts of aerobic, resistance, and balance training. The 

program was performed 3 days per week, between 30 and 

60 minutes per session, under the supervision of a trained 

exercise specialist. The data were analyzed using pairedsamples 

t tests in PAWS 18.0. Results: There were statistically 

significant and large improvements in MSWS-12 scores 

(P = .03, d = 0.46), T25FW (P = .004, d = 0.90) and TUG 

(P = .01, d = 0.72) performance, and Functional Ambulatory 

Performance score from the GAITRite (P = .02, d = 0.65). 

Those results were unchanged in nonparametric analyses 

and were not driven by outliers. Conclusion: These findings 

indicate that a combined exercise training stimulus represents 

a comprehensive, physiologically relevant rehabilitation 

strategy that is associated with improved walking mobility in 

people with MS who have onset of gait impairment. 


Keywords: Rehabilitation strategies and therapy and MS

Platforms 

P23 

SELF-MANAGEMENT STRATEGIES AND BARRIERS 

FOR PHYSICAL ACTIVITY IN MULTIPLE SCLEROSIS 

Setareh Ghahari, 1,2 Sue Forwell, 1 Verena Strehlau, 3 Helen Tremlett 4 

1 Occupational Science & Occupational Therapy, University of British 

Columbia, Vancouver, BC, Canada; 2 Occupational Therapy, University of 

Social Welfare and Rehabilitation Sciences, Tehran, Tehran, Iran; 3 Psychiatry, 

University of British Columbia, Vancouver, BC, Canada; 4 Neurology, 

University of British Columbia, Vancouver, BC, Canada 

Background: Physical activity is associated with a better 

quality of life. Studies suggest that people with multiple sclerosis 

(MS) tend to be less active than the general population 

and that physical activity is inversely related to disability in 

MS. However, there is a marked gap in knowledge surrounding 

actual engagement in activity programs and potential 

facilitators and barriers for participation for those with MS. 

Objectives: To describe self-management strategies and 

barriers for activity programs for adults with MS. Methods: 

The self-administered International Physical Activity Questionnaire 

was mailed to patients with definite MS from UBC 

MS clinic in BC between 2006 and 2008. In addition to 

the Likert-scale questions (reported previously), respondents 

added comments regarding their attitude and participation 

in physical activity. These comments were collated, coded, 

categorized, and collapsed into themes. Results: Of the 

2482 questionnaires mailed, 1126 (45.4%) were returned. 

The mean age was 50.8 ± 11.2 years, the mean age at 

disease onset was 38.0 ± 10.5 years, and 76% were 

female. Responders did not differ demographically from nonresponders. 

One-third were employed (either full or part time) 

and 457 (41%) were unemployed due to MS. A total of 534 

(47.4%) responders provided comments, resulting in 136 

pages of data. A variety of activities were reported, ranging 

from 10 minutes of passive range of motion to biking, hiking, 

and running marathons. Hobbies such as dog training or 

playing with grandchildren were reported for staying active. 

Two themes that emerged from this large dataset were a) 

self-management strategies used to adapt activity programs 

(eg, self-pacing, choosing type, time, and venue of programs 

based on abilities and needs); and b) barriers to activity 

grouped as personal (eg, lack of motivation, high disability 

level, work commitments, and financial restrictions) and 

environmental (eg, heat, transportation, lack of appropriate 

programs). Conclusion: The results of this analysis provide 

an in-depth and nuanced understanding of how people with 

MS stay active, self-management strategies used, and barriers 

faced. These findings will be integral for identifying aspects 

to consider when designing and implementing activity programs 

for this population. 




12 

P24 

CORRELATION BETWEEN WALKING SPEED AND 

GAIT PARAMETERS IN PATIENTS WITH MULTIPLE 

SCLEROSIS 

Francois Bethoux, 1 Darlene Stough, 1 Dwyer Conklyn 2 

1 The Mellen Center for MS, The Cleveland Clinic Foundation, Cleveland, OH; 

2 Arts and Medicine Institute, The Cleveland Clinic Foundation, Cleveland, OH 

Background: The Timed 25-Foot Walk (T25FW), a measure 

of maximum walking speed on a short distance, is 

commonly used in the clinical management of patients with 

multiple sclerosis (MS), and has been used as an outcome 

measure in clinical trials of symptomatic and disease-modifying 

therapies, alone or as part of the MS Functional Composite 

(MSFC). However, the clinical significance of the T25FW 

as an indicator of ambulation performance in MS has not 

been fully established. Objectives: To assess the correlation 

between walking speed on the T25FW and spatiotemporal 

gait parameters in patients with MS. Methods: We analyzed 

baseline data from subjects enrolled in two pilot studies 

of the effect of music therapy on gait in MS. The T25FW was 

administered per standard MSFC instructions. Gait parameters 

were measured separately with the GAITRite system, a 

computerized gait analysis system consisting of a 30-foot mat 

with embedded sensors and data acquisition and processing 

software. Descriptive statistics were generated as appropriate. 

Correlations were tested with the nonparametric Spearman 

rho. Results: Data from 22 subjects with MS were 

included in the analysis (mean age, 48.6 ± 6.2 years; 77% 

women; mean disease duration, 14.9 ± 8.5 years; disease 

course, 54% relapsing-remitting). Average walking speed on 

the T25FW was 92.8 ± 36.4 cm/s. There was no significant 

correlation between walking speed and demographic or disease 

characteristics. There was a statistically significant correlation 

between walking speed and gait parameters (cadence 

Spearman rho 0.67, P = .0006; step length 0.75, P < .001; 

stride length 0.74, P < .0001; percent double support –0.53, 

P = .011), as well as the Functional Ambulation Profile score 

calculated by the gait analysis system (0.49, P = .02). Conclusion: 

The strong correlations observed between walking 

speed on the T25FW and gait parameters suggest that it is a 

meaningful measure of gait performance in MS. Similar findings 

were reported in stroke survivors. Further studies should 

be conducted on larger samples, along the entire spectrum of 

MS-related disability, including measures of ambulation in the 

environment, and with longitudinal follow-up to evaluate the 

meaningfulness of changes in walking speed. 

Disclosures: Francois Bethoux: Acorda Therapeutics, Medtronic Inc 

(other financial benefits); Acorda Therapeutics, Allergan, Medtronic Inc 

(honoraria); Acorda Therapeutics, Biogen Idec, Allergan, Medtronic Inc 

(consulting fees). Darlene Stough: Nothing to disclose. Dwyer Conklyn: 

Nothing to disclose. 

Keywords: Rehabilitation strategies and therapy and MS, Complementary/alternative 

therapies in MS

POSTERS 

CATEGORY: BASIC SCIENCE 

S1 

SECRETION OF SOLUBLE-RAGE BY PBMCs ISOLATED 

FROM MULTIPLE SCLEROSIS PATIENTS AND 

CONTROLS IN RESPONSE TO INCUBATION WITH 

THE FLAVONOIDS QUERCETIN AND LUTEOLIN 

Alicia A. Lieberman, 1,2 Zohara Sternberg 1,2 

1 Jacobs Neurological Institute, Buffalo, NY; 2 SUNY at Buffalo School of 

Medicine and Biomedical Sciences, Buffalo, NY 

Background: Flavonoids are immunomodulatory polyphenolic 

compounds found in ubiquity in the diet that are known 

to scavenge free radicals, chelate metal ions, and regulate 

cell signaling pathways involved in inflammation and neurodegeneration. 

These pleiotropic effects of flavonoids could 

beneficially impact multiple sclerosis (MS) disease pathogenesis. 

The flavonoids quercetin and luteolin have both 

been shown to exert immunomodulatory, and specifically 

neuroprotective, effects in both in vivo and in vitro models. 

The receptor for advanced glycation end products (RAGE) 

and its ligands have been established as potential biomarkers 

for both inflammatory and neurodegenerative processes 

known to exist in MS. Unlike the membrane-bound RAGE, the 

soluble isoform, sRAGE, has been shown to have significant 

clinical and therapeutic implications. sRAGE is shed from cell 

membranes into the serum and is believed to act as a decoy, 

blocking RAGE-ligand interactions and subsequent pathologic 

signaling. Previous studies by this group have found sRAGE 

levels significantly lower in MS patients as compared with 

healthy controls. Additionally, an inverse relation between 

sRAGE and Expanded Disability Status Scale (EDSS) score, 

and between sRAGE and rate of clinical relapse, were 

observed. Objectives: 1) To evaluate the dose-dependent 

effects of quercetin and luteolin on sRAGE secretion by 

peripheral blood mononuclear cells (PBMCs). 2) To evaluate 

the differences in sRAGE secretion and response to flavonoids 

between PBMCs isolated from MS patients versus controls. 

Methods: PBMCs from MS patients and healthy adults 

were isolated using the Ficoll-Hypaque isolation technique. 

The cells were cultured for 48 hours with varying concentrations 

of quercetin or luteolin (5–200 µM) in the presence of 

PHA. sRAGE was measured in the culture supernatants using 

commercial enzyme-linked immunosorbent assay (ELISA) kits 

according to manufacturer instructions. Results: Although 

we expected to see increased sRAGE secretion, we observed 

very low concentration of sRAGE in the supernatant derived 

from PHA-stimulated PBMC. The effect of PHA on cells was 

similar between MS patients and controls. Due to the very 

low concentrations of secreted sRAGE, the effect of flavonoids 

could not be assessed. Conclusion: sRAGE secretion 

by PBMCs isolated from MS patients and controls is not 

enhanced by PHA after 48-hour incubation. Therefore, no 

dose-dependent effect of flavonoids could be assessed. 


Keywords: Complementary/alternative therapies in MS, Immunology 

and MS 


13 

S2 

PATHOLOGY OF IRON DEPOSITION IN BASAL 

GANGLIA OF MULTIPLE SCLEROSIS PATIENTS 

Fadi K. Shihadeh, Wei Pei, David Pitt 

Neurology, Ohio State University College of Medicine, Columbus, OH 

Posters 

Background: Magnetic resonance imaging (MRI) studies 

in multiple sclerosis (MS) patients suggest that increased 

iron content in deep gray matter is strongly associated with 

brain atrophy, disease duration, and disability progression. 

Iron accumulation in basal ganglia may therefore constitute 

a biomarker for neurodegeneration; however, it is unclear 

whether excess iron contributes directly to MS pathophysiology. 

Objectives: To determine the localization and pathogenic 

significance of iron deposition in basal ganglia in 

MS. Methods: We used autoptic brain tissue from 17 

MS patients and 10 controls without chronic neurologic 

diseases. Putamen, caudate nucleus, and internal capsule 

were evaluated qualitatively for iron content and localization, 

inflammatory activity, and oxidative tissue damage 

using immunohistochemistry (ferritin, CD68, 4-HNE) and 

histochemistry (DAB-enhanced Perls stain, hematoxylin/eosin, 

oil red O). Results: 1) In nonlesional basal ganglia tissue, 

the predominant iron-containing cells were oligodendrocytes. 

However, the percentage of iron-positive oligodendrocytes in 

putamen/caudate was significantly increased in MS patients 

compared with controls. In the internal capsule, the percentages 

were comparable between both groups. 2) Hemosiderin 

in putamen/caudate was increased in MS patients and did 

not correlate with age as in controls. 3) Iron staining was 

rarely observed in astrocytes and neurons. However, dystrophic, 

iron-positive axons were more frequent in MS than in 

control tissue. 4) Iron-positive microglia as well as oxidative 

tissue damage as indicated by 4-HNE labeling were present 

mostly in inflammatory, demyelinating lesions. Conclusion: 

Basal ganglia excess iron in MS appears to be deposited 

in oligodendrocytes and hemosiderin and is not associated 

with oxidative tissue damage. Therefore, it is unlikely that iron 

mediates neurotoxicity in basal ganglia. 

Disclosure: Fadi K. Shihadeh: Nothing to disclose. Wei Pei: Nothing to 

disclose. David Pitt: Biogen, Teva (honoraria); Five Prime (consulting 

fee). 

Keywords: Glial biology, Immunology and MS 

S3 

IS MULTIPLE SCLEROSIS A HOMOGENEOUS OR 

HETEROGENEOUS DISEASE? INSIGHT FROM TH1 

AND TH17 CYTOKINES IN AUTOIMMUNE AND 

VIRAL MODELS FOR RELAPSING-REMITTING VERSUS 

PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS 

Seiichi Omura, Fumitaka Sato, Nicholas E. Martinez, Ikuo Tsunoda 

Microbiology and Immunology, Louisiana State University Health Sciences 

Center, Shreveport, LA 

Background: Clinically, each case of multiple sclerosis 

(MS) shows a different clinical course, including relapsingremitting 

(RR) and primary progressive (PP) MS. Pathologically, 

some researchers have classified MS lesions into four 

patterns (interindividual heterogeneity) without a pattern 

change during the clinical course in individual patients (intraindividual 

homogeneity), while others showed homogeneity 

of lesions in all patients or overlap of lesion patterns (intrain-

Posters 

dividual heterogeneity). Objectives: We hypothesized that 

the roles of interferon (IFN)-γ-producing Th1 and interleukin 

(IL)-17-producing Th17 cells may differ depending on disease 

courses in autoimmune versus viral models for MS. Methods: 

RR-experimental autoimmune encephalomyelitis (EAE) 

was induced in SJL/J mice with myelin proteolipid protein 

(PLP) 139-151 sensitization. PP-EAE was induced in A.SW mice 

or SJL/J mice with myelin oligodendrocyte glycoprotein 

(MOG) 92-106 sensitization alone or MOG-sensitization with 

injection of curdlan (IL-17 inducer), respectively. Theiler’s 

murine encephalomyelitis virus–induced demyelinating 

disease (TMEV-IDD), a viral model for PPMS, was induced 

in SJL/J mice. Curdlan was injected into mice with EAE or 

TMEV-IDD. IFN-γ and IL-17 mRNA were quantified by realtime 

polymerase chain reaction (PCR). Results: In RR-EAE 

and PP-EAE in SJL/J mice, clinical signs were associated with 

increased levels of IFN-γ (RR-EAE: attack, 55-fold; remission, 

7-fold. PP-EAE: onset, 47-fold; progression, 106-fold) and 

IL-17 (RR-EAE: attack, 407-fold; remission, 29-fold. PP-EAE: 

onset, 123-fold; progression, 174-fold) in the brain. However, 

in PP-EAE in A.SW mice, the levels of cytokines increased 

at the disease onset and declined during the disease progression 

(IFN-γ: onset, 8-fold; progression, 2-fold. IL-17: onset, 

82-fold; progression, 23-fold). Curdlan injection exacerbated 

EAE. In TMEV-IDD, curdlan injection on day 1 suppressed the 

disease, while curdlan injection on day 35 exacerbated the 

disease. Conclusion: The roles of Th1 and Th17 cells can 

be the same or different regardless of or depending on the 

clinical course, mouse strain, etiology (autoimmune vs. virus), 

and stage of disease in animal models for MS. Our results 

will give insight into the controversy of homogeneity versus 

heterogenitiy of MS, clinically and pathologically. 

Supported by: National Institutes of Health (R21NS059724, P20- 

RR018724) 


Keywords: Etiology of MS, Immunology and MS, Genetics and MS 

S4 

REGULATORY T CELLS PLAY A DETRIMENTAL ROLE 

IN A VIRAL MODEL FOR MULTIPLE SCLEROSIS 

Nicholas E. Martinez, Fridrik Karlsson, Fumitaka Sato, Seiichi Omura, 

Mathew B. Grisham, Ikuo Tsunoda 

LSUHSC-S, Shreveport, LA 

Background: Theiler’s murine encephalomyelitis virus– 

induced demyelinating disease (TMEV-IDD) is a viral model 

for multiple sclerosis (MS). TMEV causes neuronal infection 

during the acute phase and an inflammatory demyelinating 

disease during the chronic phase. Regulatory T cells (Tregs) 

can suppress both T helper (Th) 1 and Th17 type immune 

responses, which play a pathogenic role in experimental 

autoimmune encephalomyelitis (EAE), an autoimmune model 

for MS. Thus, Tregs could also be beneficial in MS. Objectives: 

We hypothesized that Tregs can be a double-edged 

sword in TMEV-IDD. In viral infections, although Tregs can 

prevent immune-mediated pathology, Tregs can suppress antiviral 

immune responses leading to more active viral replication 

and/or viral persistence. We tested whether Tregs could 

play a beneficial or detrimental role in TMEV-IDD. Methods: 

Tregs were generated by our novel ex vivo method, 

which generates large numbers of highly pure induced Tregs 

(iTregs; CD4 + CD25 + Foxp3 + T cells), which suppress 


14 

T-cell-dependent colitis in mice. TMEV-IDD was induced in 

SJL/J mice. Mice were injected with iTregs (intraperitoneally) 

on day 0 or during the chronic phase of disease on day 30. 

Clinical signs were assessed daily by weighing and scoring 

of impaired righting reflexes. Results: The iTregs generated 

from SJL/J mice were able to suppress T-cell proliferation in 

vitro by up to 78%. The group injected with iTregs on day 

0 had significant impairment in righting reflex scores (iTregs 

0.7 ± 0.2, control 0; P < .05) and increased weight loss 

(iTregs 1.5 ± 0.3 g, control 0.85 ± 0.1 g; P < .05). Conclusion: 

iTregs worsened acute disease and did not ameliorate 

chronic demyelinating disease; this is most likely due to suppression 

of the antiviral immune response by iTregs, facilitating 

viral replication. In contrast to EAE, iTreg injection did not 

suppress disease. Therefore, administration of iTregs may be 

detrimental in a virus-mediated demyelinating disease. 

Supported by: National Institutes of Health R21NS059724, P20- 

RR018724 


Keywords: Immunology and MS, Disease-modifying treatment in MS 

S5 

DIVERSITY IN THE CLINICAL COURSE OF TH17- 

INDUCED EXPERIMENTAL AUTOIMMUNE 

ENCEPHALITIS 

Heather Walk, 1 Stephen Lalor, 2 Benjamin Segal 2 

1 University of Michigan, Ann Arbor, MI; 2 Neurology, University of Michigan, 

Ann Arbor, MI 

Background: Experimental autoimmune encephalitis (EAE) 

is an inflammatory demyelinating disease of the central nervous 

system that is mediated by myelin-specific T cells. It is 

widely used as an animal model of multiple sclerosis (MS). 

We have previously shown that IFN-γ-producing Th1 and IL- 

17-producing Th17 cells are independently capable of inducing 

acute EAE. However, little is known about the function 

of Th1 and Th17 cells in the context of a relapsing-remitting 

course. Objectives: There is growing evidence that Th17 

cells are plastic. For example, they up-regulate IFN-γ following 

culture with IL-12 in a T-bet dependent manner. We 

questioned whether the plasticity of Th17 cells translates into 

greater diversity in the clinical course. Methods: WT or 

T-bet-deficient C57BL/6 mice were immunized with CFA and 

myelin oligodendrocyte glycoprotein (MOG) 35-55 . Fourteen 

days after immunization, lymph nodes were harvested and 

cultured with MOG 35-55 and IL-23. CD4+ Th17 cells were 

transferred into syngeneic WT hosts 4 days later. T-cell polarization 

was assessed using flow cytometry or ELIspot assays. 

Results: We found that myelin-specific Th17 donor cells 

spontaneously express IFN-γ following adoptive transfer into 

naive hosts. By contrast, Th1 donor cells maintain a stable 

cytokine profile. IL-23 polarized Th17 cells induced a range 

of clinical signs, including ascending paralysis and ataxia, 

that differed between individual hosts and between consecutive 

exacerbations in the same host. In order to limit the 

plasticity of Th17 cells, we used Tbet-/- mice as donors. Compared 

with WT cells, IL-23 polarized Tbet-/- cells were more 

firmly locked into a “pure” Th17 lineage and more likely to 

induce a typical cerebellar syndrome that relapsed with the 

same clinical phenotype. Conclusion: Our data suggest that 

diversity in the clinical course of relapsing-remitting disease 

EAE varies depending on the Th phenotype of the predominant 

effector cell pool and its potential for plasticity.

Supported by: Rackham Merit Fellowship, University of Michigan 

Program in Immunology Training Grant 



S6 

DEFINING THE PROPERTIES OF DENDRITIC CELLS 

CRITICAL FOR PRIMING AUTOIMMUNE EFFECTOR T 

CELLS 

Stephen J. Lalor, Benjamin M. Segal 

Neurology, University of Michigan, Ann Arbor, MI 

Background: Experimental autoimmune encephalomyelitis 

(EAE), an animal model sharing many aspects with multiple 

sclerosis, is a demyelinating disease thought to be mediated 

by myelin antigen-specific Th1 and Th17 cells. Disease is 

induced in susceptible strains by immunization with a variety 

of myelin peptides emulsified in complete Freund’s adjuvant, 

often with coadministration of pertussis toxin (PT). Myelin peptides 

are internalized and processed by antigen-presenting 

cells for major histocompatibility complex (MHC) II–mediated 

presentation in peripheral lymphoid tissues. Although a 

range of different cell types are capable of presenting myelin 

antigens, CD11c + dendritic cells (DC) are believed to be 

critical for priming naive autoreactive T cells during disease 

initiation, as well as epitope spreading. Objectives: The 

specific properties that DC must possess to induce differentiation 

of encephalitogenic T cells are poorly understood. Here 

we describe a model of EAE in C57BL/6 mice induced by 

transfer of bone marrow (BM)–derived DC. Methods: Following 

culture with GM-CSF, CD11+CD11b+ myeloid BMDC 

are matured with Mycobacterium and pulsed with myelin 

oligodendrocyte glycoprotein (MOG) 35-55 before transfer to 

the MOG-specific 2D2 T-cell receptor transgenic strain. Host 

mice are also administered PT. CD45 congenic donor mice 

are used to facilitate the tracking of DC trafficking post transfer. 

Results: Disease onset is typically 8 days following DC 

transfer and proceeds in the form of an ascending paralysis. 

In vitro and ex vivo studies indicate a predominantly Th1-type 

immune response with robust tumor necrosis factor alpha 

(TNF-α) and interferon (IFN)-γ production in the spinal cord 

and peripheral lymphoid tissues. This model is being utilized 

to address questions about the maturation signals and homing 

and effector molecules necessary for the generation, 

trafficking, and function of disease-inducing DC, respectively. 

Different TLR ligands are being compared to Mycobacterium 

for their efficiency in conferring encephalitogenic properties. 

We are also using DC derived from a panel of KO mice to 

interrogate the requirement of candidate molecules in DC 

(including IL-12, IL-23, Tbet, CCR2, and CCR7). Conclusion: 

These studies should increase our understanding of 

how DC contribute to autoimmune pathogenesis and provide 

insights into the development of novel therapeutic agents that 

target molecules on pathogenic DC. 

Supported by: Holtom-Garrett Program in Neuroimmunology 




15 

S7 

RESVERATROL, A RED WINE POLYPHENOL 

COMPOUND, EXACERBATED AUTOIMMUNE 

AND VIRAL MODELS FOR MULTIPLE SCLEROSIS 

WITH INCREASED CENTRAL NERVOUS SYSTEM 

INFLAMMATION 

Posters 

Fumitaka Sato, 1 Nicholas E. Martinez, 1 Seiichi Omura, 1 John W. Rose, 2 Noel 

G. Carlson, 2 Ikuo Tsunoda 1 

1 Microbiology and Immunology, Louisiana State University Health Sciences 

Center, Shreveport, LA; 2 Veterans Affairs Salt Lake City Health Care System, 

Salt Lake City, UT 

Background: Resveratrol is a natural polyphenol compound 

in red wine and has immunosuppressive and antiviral 

properties. Resveratrol has also been reported to prevent 

axonal degeneration via SIRT1 activation, although this has 

become controversial recently. Thus, resveratrol could be 

beneficial in immune-mediated diseases as well as neurologic 

disorders. Objectives: We investigated whether resveratrol 

could be therapeutic for autoimmune and viral models of 

multiple sclerosis (MS): experimental autoimmune encephalomyelitis 

(EAE) and Theiler’s murine encephalomyelitis virus– 

induced demyelinating disease (TMEV-IDD). Methods: EAE 

was induced in C57BL/6 mice with myelin oligodendrocyte 

glycoprotein (MOG) 35-55 peptide. Mice were fed a control 

diet or a diet containing 0.04% resveratrol (20 mg/kg/d) 

during the induction phase or the effector phase or the whole 

course of EAE. SJL/J mice were infected with TMEV and were 

fed a control diet or a diet containing resveratrol during the 

effector phase of TMEV-IDD. Results: In EAE, all the resveratrol 

treatments exacerbated clinical signs. The resveratrol 

treatment during the induction phase resulted in the most 

severe EAE compared with the control (P < .01). Histologically, 

mice fed a resveratrol diet during the induction phase 

developed the most severe inflammatory demyelination and 

meningitis in the central nervous system (CNS). In TMEV-IDD, 

resveratrol treatment exacerbated clinical signs. Resveratrol 

treatment resulted in significantly severe inflammatory demyelination 

(pathology score: control, 50.9 ± 4.5; resveratrol, 

64.3 ± 3.5; P < .05) and meningitis (pathology score: 

control, 55.3 ± 3.4; resveratrol, 69.4 ± 2.3; P < .01) in the 

CNS. Conclusion: No major adverse effects have been 

reported in resveratrol treatment. However, we demonstrated 

that resveratrol treatment exacerbated inflammation of the 

CNS in both EAE and TMEV-IDD. Therefore, resveratrol may 

have detrimental effects in MS. A lack of neuroprotection by 

resveratrol is in accord with recent reports that SIRT1 activation 

by resveratrol is an artifact. 

Supported by: National Institutes of Health R21NS059724, P20- 

RR018724 


Keywords: Complementary/alternative therapies in MS, Etiology of 

MS, Immunology and MS 

CATEGORY: COGNITION, DEPRESSION, AND 

PSYCHOSOCIAL 

S8 

HOW RELATIONSHIP EDUCATION AFFECTS 

COUPLES LIVING WITH MULTIPLE SCLEROSIS 

Kimberly K. Koch, 1 Lara H. Rezzarday, 1 Jessica Roeder, 1 LuAnn Pierce, 1 Sara 

Anne Tompkins 2

Posters 

1 Programs and Services, National Multiple Sclerosis Society, Denver, CO; 

2 Psychology, Colorado State University, Ft. Collins, CO 

Background: Multiple sclerosis (MS) influences both the 

individual diagnosed and his or her family members, who 

often assume caregiving and additional household responsibilities 

(Kouzoupis et al., 2010). MS usually strikes early in 

life, often interfering with the development and maintenance 

of intimate relationships. Specifically, a sixfold increase in the 

risk of divorce is reported when women are diagnosed with 

MS (Glantz et al., 2009). This relationship distress may also 

lead to a poorer course of illness if not dealt with properly 

(Sherman et al., 2007). Objectives: Relationship Matters 

(RM) integrates information and resources of the National 

Multiple Sclerosis Society with empirically based marriage 

education. RM takes couples a few steps beyond general 

knowledge of the disease to a place where they can successfully 

address challenges that MS may bring to their relationship. 

Methods: The program’s baseline sample shows a 

mean age of 47.77 (SD = 11.47) years and 57% women. 

The majority of participants are married (86%) and newly 

diagnosed (40%: 1–5 years; 25%: 6–10 years). Couples 

receive 8 hours of programming via a series of six teleclasses 

or in-person workshops disseminated nationally. Results: 

Repeated-measures analysis of variance was run on data pre 

and 3-month post to determine whether changes were occurring 

over time within participants. RM participants showed 

significant increases in relationship satisfaction (RDAS; F 

[1,184] = 3.10, P < .10), from pre (mean = 48.51, SD = 

10.36) to 3-month post (mean = 49.32, SD = 9.32). This 

is an exciting finding, as a common occurrence with enrichment 

programs over time is that relationship satisfaction goes 

downward for many couples. A comparison group reported 

a decline in relationship satisfaction (F [1,104] = 3.33, P < 

.10), further supporting the idea that RM is increasing relationship 

satisfaction. A clinically significant improvement in 

the mental health domain was also noted in analysis of the 

12-item Short Form Health Status Survey (SF-12), a quality of 

life measurement tool (P < .05). Conclusion: Overall, these 

preliminary findings suggest that RM programming improves 

couple functioning. Additionally, the improvement may be 

linked to psychological health benefits for the individuals with 

MS and their partners. RM is an innovative program that successfully 

addresses how MS impacts one’s life beyond the 

physical. 


Keywords: MS and the caregiver/family, Psychological issues and MS, 

Quality of life in MS 

S9 

LONGITUDINAL CHANGES IN COGNITIVE 

PERFORMANCE IN PEDIATRIC-ONSET MULTIPLE 

SCLEROSIS 

Brenda Banwell, 1 Rezwan Ghessemi, 2 Douglas L. Arnold, 2 Sridar Narayanan, 2 

Christine Till 3 

1 Neurology, The Hospital for Sick Children, Toronto, ON, Canada; 2 McConnell 

Brain Imaging Centre, Montreal Neurological Institute, Montreal, QC, Canada; 

3 Psychology, York University, Toronto, ON, Canada 

Background: Cognitive changes in 28 patients with 

childhood-onset multiple sclerosis (MS) and 16 age-matched 

healthy controls were ascertained through repeat assessment 

conducted on average 13.7 months apart (SD = 3.2). Meth- 


16 

ods: Change was calculated using the Reliable Change 

Index (RCI) for eight neuropsychological (NP) tests commonly 

used in repeat assessment of MS patients. Results: RCI 

analysis using 90% confidence intervals showed statistically 

significant cognitive decline on at least two NP measures in 

17.6% of MS participants, compared with none of the controls. 

Decline was most commonly observed on tests of verbal 

fluency, visuo-perceptual speed, and the delayed recall portion 

of a verbal list learning test, but there was substantial 

variability across patients. Significant improvement on at least 

two NP measures was documented in 28.6% of MS patients, 

compared with 53.3% of controls. Patients who showed 

cognitive improvement had significantly higher T2-weighted 

total brain lesion volume at baseline compared with patients 

who did not improve (P = .03). Conclusion: Consistent with 

a small number of studies examining longitudinal changes in 

pediatric MS, cognitive deterioration may occur early in the 

disease process. Higher T2 lesion load at baseline is associated 

with reduced cognitive impairment, which may relate to 

the active inflammatory process at that time point. Improvement 

over a short time interval may reflect improved disease 

control achieved by MS-related therapies. 


Keywords: Psychological issues and MS, Quality of life in MS 

S10 

REPORT FROM THE FIRST MULTIPLE SCLEROSIS SELF- 

MANAGEMENT RESEARCH CONFERENCE 

Robert T. Fraser, Dawn M. Ehde, Kurt L. Johnson, George H. Kraft, Aimee 

Verrall 

MS Rehabilitation Research and Training Center, Rehabilitation Medicine, 

University of Washington, Seattle, WA 

Background: Health education and disability management 

research supports the efficacy of self-management programs 

related to health outcomes of individuals with chronic illness. 

The emphasis is on actual patient self-management activity 

versus health systems intervention or basic patient education 

(Barlow et al., 2002). The primary tasks in self-management 

are generally threefold: medical symptom management, 

community role management, and emotional management. 

Across a number of studies, the Arthritis Self-Management 

Program (Lorig et al., 2005) and the Chronic Disease Self- 

Management Program (Lorig et al., 2005) have shown significant 

health and disability outcomes within 1 month through 

4 years post-intervention. The self-management research 

in multiple sclerosis (MS), however, has been very limited 

(Devins & Shnek, 2000) and more narrowly focused to a 

degree on health and physical functioning (Stuifbergen et al., 

2003), reduction of depression (Mohr et al., 2000, 2005), 

or energy conservation (Finlayson & Holberg, 2007). Objectives: 

Due to the lack of comprehensive self-management 

research in MS and a number of unanswered questions in the 

generic self-management research, funding was secured from 

the Consortium of Multiple Sclerosis Centers and National 

Institute on Disability and Rehabilitation Research (NIDRR) 

to sponsor an MS self-management research conference 

involving 50 international self-management experts and MS 

psychosocial researchers in November 2010 in Washington, 

DC, in order to set an optimal research agenda. Methods: 

International conference, expert presentations, and workgroups 

format. Results: This presentation initially summa-

izes the “take-home points” from the international speakers 

on generic disability self-management research concerns (eg, 

ethics, measuring program outcomes, consumer-generated 

programs) and the unique concerns and efforts within the MS 

population. Of particular importance are the recommendations 

from the day’s four research workgroup meetings relating 

to self-management techniques, methodologies, impact 

measurement, and translation to consumers. Conclusion: 

Key considerations and innovative research directions are 

summarized in order to move the self-management field forward 

in MS. 


Keywords: Rehabilitation strategies and therapy and MS, Psychosocial 

issues in MS, Management of activities of daily living in MS 

S11 

DISABILITY AND FUNCTIONAL STATUS CHANGE 

AFTER 1 YEAR OF NATALIZUMAB USE 

Judith J. Stephenson, 1 David M. Kern, 1 Sonalee S. Agarwal, 2 Siddhesh A. 

Kamat 1 

1 HealthCore, Inc, Wilmington, DE; 2 Biogen Idec Inc, Weston, MA 

Background: Multiple sclerosis (MS) is a progressive 

debilitating disease in which patients are likely to experience 

symptoms that can impair activities of daily living and 

functional capacity. Natalizumab is effective in reducing 

relapses and slowing the rate of disease progression. Multiple 

observational studies have shown that natalizumab 

also affects other aspects of MS, including fatigue, cognition, 

and quality of life. Objectives: To assess changes in 

patient-reported disability and functional status after 1 year of 

natalizumab treatment. Methods: MS patients newly initiating 

natalizumab reported their disability and functional status 

prior to natalizumab initiation (baseline, BL) and after the 

3rd, 6th, and 12th infusions. Patient-reported disability was 

measured using Hohol’s Disease Steps Scale (0 = normal; 6 

= wheelchair); functional status was measured using a 5-point 

scale (1 = able to do usual daily activities; 5 = required 

assistance). Outcome measures included percentages of 

patients reporting no change (stable) and ≥1-point change 

in disability and functional status. Reported improvement or 

no change in disability or functional status was considered 

a positive outcome. Paired t tests assessed changes from 

baseline. Results: Of 333 patients (mean age, 46.8 ± 10.4 

years; median of 9 years since MS diagnosis) who completed 

all assessments, a significantly greater percentage of 

patients reported improved or stable disability status (82.2%) 

compared with deteriorating disability status (17.8%) after 

1 year of natalizumab treatment (P < .0001). Similar results 

were seen in patient-reported functional status (improved/ 

stable, 85.4%, vs. deteriorated, 15.6%; P < .0001). Of note, 

improvement and stabilization in disability and functional status 

were seen as early as 3 months following treatment initiation. 

Conclusion: The majority of MS patients using natalizumab 

reported improvement or stabilization in disability and 

functional status as early as 3 months that was sustained over 

1 year of treatment. These results provide insights into the 

benefits of natalizumab beyond traditional clinical study outcomes, 

by presenting patients’ perspectives on natalizumab’s 

rapid and continued effect in improving or stabilizing disability 

level and daily functioning. 


17 

Posters 


Keywords: Quality of life in MS, Disease-modifying treatment in MS 

S12 

HEALTH-CARE UTILIZATION AFTER 1 YEAR OF 

NATALIZUMAB TREATMENT 

David M. Kern, 1 Judith J. Stephenson, 1 Sonalee S. Agarwal, 2 Siddhesh A. 

Kamat 1 

1 HealthCore, Inc, Wilmington, DE; 2 Biogen Idec Inc, Weston, MA 

Background: Multiple sclerosis (MS) is a chronic disease 

that imposes a significant economic burden on the health-care 

system and society. Few studies have examined the impact of 

natalizumab on all-cause and MS-related hospitalizations and 

emergency department (ED) visits. Objectives: To assess 

patient-reported all-cause and MS-related hospitalizations 

and ED visits after 1 year of natalizumab treatment. Methods: 

MS patients reported their experiences with natalizumab 

including MS-related and all-cause hospitalizations 

and ED visits during the 3-month period prior to natalizumab 

initiation (baseline, BL) and after the 3rd, 6th, and 12th infusions. 

The percentage of patients with ≥1 utilization (hospital 

or ED) at each time point was calculated; logistic regression 

models (repeated measures) were developed to test for 

changes in resource utilization rates over time adjusting for 

age, disease disability, functional status, years since MS 

diagnosis, number of comorbidities, and number of MS drugs 

used prior to natalizumab. Utilization health-care costs will 

be estimated. Results: A total of 333 patients (mean age, 

46.8 ± 10.4 years; median of 9 years since MS diagnosis) 

completed all four assessments. MS-related hospitalizations 

were highest at BL, and decreased after the 3rd, 6th, and 

12th infusions (BL, 7.6%; 3rd, 4.8%; 6th, 3.2%, 12th, 1.9%; 

adjusted P = .0007). After 1 year of natalizumab treatment, 

patients reported significantly fewer MS-related ED visits 

(BL, 8.9%; 3rd, 7.9%; 6th, 3.2%; 12th, 3.2%; adjusted P 

= .0012). Similar results were observed for all-cause hospitalizations 

(BL, 11.7%; 3rd, 8.5%; 6th, 7.3%; 12th, 6.7%; 

adjusted P = .0178) but not for all-cause ED visits (BL, 13.6%; 

3rd, 14.2%; 6th, 7.0%; 12th, 13.0%; adjusted P = .4945). 

Conclusion: Natalizumab-treated MS patients reported significantly 

fewer MS-related hospitalizations and ED visits over 

1 year of treatment; therefore, natalizumab may reduce the 

economic burden of MS. 

Disclosure: David M. Kern: Nothing to disclose. Judith J. Stephenson: 

Nothing to disclose. Sonalee S. Agarwal: Biogen Idec Inc (salary). Siddhesh 

A. Kamat: Nothing to disclose. 

Keywords: Economic issues and MS, Quality of life in MS, Diseasemodifying 

treatment in MS 

S13 

AGE EFFECTS OF SLEEP PROBLEMS IN INDIVIDUALS 

WITH MULTIPLE SCLEROSIS 

Mark C. Goetz, Mark P. Jensen, Aimee Verrall, Dawn M. Ehde, Alyssa M. 

Bamer, Ivan R. Molton, George H. Kraft 

Department of Rehabilitation Medicine, University of Washington, Seattle, WA 

Background: Sleep disturbances in individuals with multiple 

sclerosis (MS) are relatively common (ie, with many 

studies showing prevalence of approximately 50%), and 

evidence indicates that sleep problems are more common 

in MS samples than in samples of individuals who do not 

have MS. There is also evidence among the general popu

Posters 

lation suggesting that sleep problems increase with age. 

However, previous research suggests that among some disability 

groups (eg, spinal cord injury) there may be a decline 

in sleep problems with age. Objectives: Based on previous 

research, we hypothesized that 1) sleep dysfunction in an MS 

sample would be greater when compared with a normative 

sample and 2) an examination of aging variables (chronological 

age, disability duration, and age at disability onset) 

would show a negative relationship between chronological 

age and the severity of sleep disturbance. Methods: A 

survey was administered to 584 individuals with MS that 

included measures of demographic characteristics and the 

PROMIS Sleep Disturbance Item Bank. The analytic strategy 

was based on a Jensen et al. (2009) paper in which a series 

of multiple regression analyses examined the independent 

contribution of three age-related variables to sleep problems: 

chronological age, disability duration, and age at disability 

onset. Results: Hypothesis 1 was not supported in that 

comparisons of the MS and normative data on the PROMIS 

revealed no differences in sleep disruption. Hypothesis 2 was 

supported in that the findings suggested that younger and 

middle-aged participants reported more sleep disturbance 

than did older participants. When controlling for chronological 

age, disability duration and age at disability onset were 

not significantly associated with sleep difficulties. Conclusion: 

One possible explanation for the age effect found is a 

cohort effect where the older adult groups could potentially 

include participants who are healthier than the younger participants 

(ie, health factors associated with sleep disturbance 

might be related to mortality). It is also possible that age influences 

or is associated with some third variable that influences 

sleep quality (eg, employed vs. retired). Longitudinal research 

following the same group of patients over time is needed to 

help test these possible explanations. 


Keywords: Sleep and MS 

S14 

ASSOCIATIONS BETWEEN ANXIETY AND OTHER 

PATIENT-REPORTED OUTCOMES IN MULTIPLE 

SCLEROSIS 

Line E. Hviid, Bonnie Glanz, Brian Healy, Tanuja Chitnis, Howard Weiner, 

David Rintell 

Partners MS Center, Brookline, MA 

Background: Multiple sclerosis (MS) patients have been 

found to have high levels of anxiety, yet very little has been 

published on the topic. Objectives: To identify correlates of 

anxiety in MS patients, including disease course variables, 

cognition, and patient-reported outcomes. Methods: 157 

CLIMB study participants were administered the State Trait 

Anxiety Inventory for Adults to assess the current temporary 

“state anxiety” and the more general “trait anxiety.” Participants 

also completed the Multiple Sclerosis Quality of Life– 

54, Modified Fatigue Impact Scale, Center for Epidemiologic 

Studies Depression Scale, and the Symbol Digit Modalities 

Test, a brief cognitive screening measure. Finally, participants 

underwent a neurologic examination that included the 

expanded disability status scale (EDSS) and disease category 

ratings. The correlation between anxiety, patient-reported 

outcomes, and cognitive functioning was assessed using 

the Pearson correlation coefficient; the correlation between 


18 

anxiety and EDSS was assessed using the Spearman correlation 

coefficient. Results: In our sample, the mean (SD; 

range) state anxiety score was 30.6 (10.1; 20–64), and 

the mean (SD; range) trait anxiety score was 33.6 (10.9; 

20–68). State and trait anxiety scores were highly correlated 

(r = 0.84, P < .0001). A total of 13.7% (state) and 19.2% 

(trait) patients scored in the moderate to high range of anxiety. 

Moderate to strong negative correlations were observed 

between anxiety and mental quality of life (QOL) (state r = 

–0.62, trait r = –0.64; P < .0001) and physical QOL (state 

r = –0.43, trait r = –0.45; P < .0001). Moderate to strong 

positive correlations were observed between anxiety and 

fatigue scores (state r = 0.49, trait r = 0.54; P < .0001) and 

depression scores (state r = 0.81, trait r = 0.82; P < .0001). 

Weaker but statistically significant correlations were observed 

with EDSS (state r = 0.20, trait r = 0.22; P < .05). There 

were no significant correlations with cognitive functioning or 

disease course. Conclusion: Anxiety is an important feature 

of MS. A total of 19.2% of our population scored in the 

clinically moderate to high anxiety range. Increased anxiety 

correlated with lower mental and physical QOL, as well as 

increased fatigue, depression, and disability. These findings 

highlight the need for identification and treatment of patients 

with anxiety. 

Disclosure: Line E. Hviid: Independent Investigator Award (PI- 

Weiner), EMD Serono (salary). Bonnie Glanz: Investigator Award 

(PI-Weiner), EMD Serono (salary). Brian Healy: Investigator Award 

(PI-Weiner), EMD Serono (salary). Tanuja Chitnis: Investigator Award 

(PI-Weiner), EMD Serono (salary), Biogen Idec (consulting fee). Howard 

Weiner: Nasvax, Biogen, Genentech, Serono, Teva, CE Outcomes, 

LLC (consulting fees); National Multiple Sclerosis Society (honoraria). 

David Rintell: MSAA, Teva Neuroscience, National Multiple Sclerosis 

Society (honoraria); MSAA (consulting fee). 



S15 

CAREGIVING FOR SENIORS WITH MULTIPLE 

SCLEROSIS 

Marijean Buhse, 1 Wendy Zingaro, 2 Lynn Clement, 2 Elizabeth Delia 2 

1 Stony Brook University, Stony Brook, NY; 2 KJT Group, Honeoye Falls, NY 

Background: Multiple sclerosis (MS) is a progressive neurologic 

illness with a typical disease course beginning with 

relapses and remissions (RRMS), later becoming secondary 

progressive (SPMS). Over time, patient ability to perform 

activities decreases and dependence on others increases. 

Caregiving is often informal, provided by family and friends. 

Objectives: Due to limited focus on elderly MS patients, 

this study (in progress) aims to understand who is typically 

providing care for patients aged 60+ and describe the differences 

among patients with and without a caregiver in terms 

of quality of life, neuropsychological impairment, cognition, 

and severity of depression. Methods: Three cross-sectional 

paper-based surveys were administered. The first contains 

basic demographics and the MS Neuropsychological Questionnaire 

(MSNQ); the second has the Multiple Sclerosis 

Quality of Life–54 (MSQOL-54); the third has the Beck 

Depression Inventory (BDI). The Symbol Digit Modalities Test 

(SDMT) was given to all patients upon enrollment. Descriptive 

statistics were used to determine differences between patients 

with and without a caregiver. Results: A total of 152

patients returned their first survey, 126 the second, and 112 

the third. A total of 43% of patients have SPMS, and 37% 

have RRMS. A total of 58% have a caregiver to assist with 

daily activities, and 86% of those patients indicate that their 

caregiver lives with them. Caregivers are most likely to be 

a spouse (65%), paid caregiver (13%), or child (6%) of the 

patient. Those with a caregiver have a higher MSNQ score 

than those without (28.7 ± 9.9 vs. 26.7 ± 8.0, respectively) 

and BDI score (9.0 ± 7.3 vs. 6.1 ± 6.0). Alternatively, those 

with a caregiver have a lower SDMT score than those without 

(31.1 ± 11.1 vs. 34.6 ± 9.2). Patients with a caregiver compared 

with those without have lower mean physical health 

(44.5 ± 20.5 vs. 60.4 ± 18.0) and mental health (60.6 ± 

23.6 vs. 70.8 ± 17.8) MSQOL composite scores. Conclusions: 

This research suggests that patients with poorer health 

and MS disease state require caregiver assistance for daily 

activities. Those with a caregiver have slightly higher levels 

of depression and neuropsychological impairment compared 

with those without. Also, they have lower levels of cognition, 

physical health, and mental health. Both groups score lower 

on the SDMT than average adults aged 65 to 75 years 

(mean, 46). Further analyses are ongoing. 

Supported by: Bayer Pharmaceuticals 

Disclosure: Marijean Buhse: Bayer Pharmaceuticals (consulting fee). 

Wendy Zingaro: Bayer Pharmaceuticals (other financial benefit). Lynn 

Clement: Bayer Pharmaceuticals (other financial benefit). Elizabeth 

Delia: Bayer Pharmaceuticals (other financial benefit). 

Keywords: Psychological issues and MS, Psychosocial issues in MS, 


S16 

EFFECT OF SELF-EFFICACY AND PHYSICAL ACTIVITY 

PARTICIPATION ON QUALITY OF LIFE IN MULTIPLE 

SCLEROSIS 

Cecilie Fjeldstad, Gabriel Pardo 

MS Center of Oklahoma, NeuroScience Institute, Oklahoma City, OK 

Background: Self-efficacy is part of the social-cognitive 

theory that involves beliefs that one can successfully cope 

with challenging situations. It has been suggested that selfefficacy 

can be related to physical activity and quality of life 

(QOL) in individuals with multiple sclerosis (MS). Objectives: 

To examine whether increased self-efficacy and 

increased participation in physical activity have an effect 

on overall QOL in individuals with MS. Methods: A total 

of 110 individuals with MS participated in this study. Each 

individual completed the Multiple Sclerosis Self-Efficacy 

(MSSE) scale, the Multiple Sclerosis Impact Scale (MSIS- 

29), and the Goodin Leisure-Time Exercise Questionnaire 

(GLTEQ). Pearson product moment correlation coefficients 

were computed for self-efficacy, physical activity, and QOL. 

Univariate analysis was used to determine gender differences 

in self-efficacy and QOL, and physical activity and QOL. Further, 

univariate analysis was also used to determine whether 

differences in self-efficacy, physical activity, or QOL existed 

between individuals with different types of MS. Results: 

Cohort (n = 110) characteristics include the following: female 

(75%), relapsing-remitting form of MS (81%), married (68%), 

employed (44%), educated (40% had some college and 38% 

were college graduates). Mean duration since MS diagnosis 

was 7.6 years (SE = 0.62). There were moderately high 

negative correlations between MSSE and QOL, physical com- 


19 

Posters 

ponent (r = –0.65, P < .01), and psychological component (r 

= –0.63, P < .01), indicating that the greater the self-efficacy, 

the fewer psychological issues and the more ability individuals 

have to perform physical tasks. There was a low negative 

but significant correlation between total time spent in leisure 

activity and physical component of QOL (r = –0.21, P < .05), 

but not for psychological component. Further, there was no 

correlation between time spent in leisure time activity and 

self-efficacy in this study, which is in contrast to some other 

studies. Conclusion: The results of this study indicate that 

with increased self-efficacy there is a concomitant increase in 

QOL in both physical and psychological components, which 

is important for overall increased independence and functionality 

in the MS population. 


Keywords: Quality of life in MS, Management of activities of daily living 

in MS 

S17 

EFFECTIVENESS OF A PSYCHOEDUCATIONAL 

WELLNESS GROUP FOR INDIVIDUALS WITH 


Kimberly B. McGuire, 1 Maha Younes, 1 Antoinette Welsh, 2 Megan Castano 2 

1 Psychology and Neuropsychology, Kessler Institute for Rehabilitation, West 

Orange, NJ; 2 Seton Hall University, South Orange, NJ 

Background: Individuals living with multiple sclerosis (MS) 

are faced with the challenge of living with the unpredictable 

process of a neurodegenerative disease. Psychological 

and social adaptation to this process can be optimized with 

adequate resources, support, and education. Objectives: 

To determine the effectiveness of an outpatient psychoeducational 

group/wellness program. Methods: A total of 39 

adults (5 males and 34 females) participated in the program. 

Participants attended an 8-, 10-, or 12-week program (differences 

in program length discussed in poster presentation) 

that focused on enhancing coping strategies for the nonmotor 

aspects of their disease. Each week there was a 30-minute 

educational segment, followed by a 60-minute interactive 

and group process component. Self-report measures, including 

the Multiple Sclerosis Neuropsychological Screening 

Questionnaire (MSNQ) and questionnaires from the MS 

Quality of Life Inventory (MSQLI), along with a qualitative 

assessment of perceived benefits from the program, were 

administered pre and post program and at 3 months after 

completion of the program. Because not all participants 

completed assessments at all time points, data were conservatively 

analyzed with a between-subjects design. Results: 

The intervention produced a robust improvement in anxiety as 

measured by the anxiety subscale of the Mental Health Inventory 

(MHI) from baseline to 3-month follow up (t = –2.189, 

P = .044; Eta squared = 0.23, large effect size) and on 

perceived cognitive deficits (PDQ-5; questionnaire from the 

MSQLI) from baseline to program completion (t = 2.318, 

P = .029; Eta squared = 0.18, large effect size). Additionally, 

there was a trend toward a reduction in symptoms 

reported on the MSNQ from baseline to program completion 

(t = 2.063, P = .058; Eta squared = 0.23, large effect 

size). Qualitative analysis revealed that 91% of participants 

endorsed that their coping skills improved after group participation 

and 70% endorsed that their overall health and wellbeing 

had improved as a result of participating in the group.

Posters 

Conclusion: These results demonstrate that program participation 

decreased anxiety and perceived cognitive deficits 

and improved overall quality of life. Additional results and 

ongoing recommendations for program development with this 

population will be discussed. 


Keywords: Psychosocial issues in MS, Quality of life in MS, Comprehensive 

care and MS 

S18 

LONGITUDINAL STUDY OF COMMUNICATIVE 

PARTICIPATION AND OTHER VARIABLES IN 


Carolyn Baylor, Kathryn Yorkston, Karon Cook, Aimee Verrall 

Rehabilitation Medicine, University of Washington, Seattle, WA 

Background: Communicative participation (CP) is the communication 

that people engage in during everyday activities 

to fulfill life roles including work, home life, social activities, 

community involvement, and personal relationships. Objectives: 

Critical questions include understanding the extent of 

interference in CP associated with health conditions, the influences 

of biopsychosocial variables, and the extent to which 

CP changes over the course of a health condition. We propose 

to look at CP in individuals with multiple sclerosis (MS) 

over time. Methods: Data were used from a longitudinal 

survey of people with MS conducted by the MSRRTC at the 

University of Washington. A total of 391 community-dwelling 

individuals with MS responded to the survey at three time 

points. CP was measured using 10 items from the CP Item 

Bank (CPIB). The CPIB is a new self-report instrument developed 

using Item Response Theory, but has shown strong psychometric 

properties. Other measures utilized included one 

pain intensity question, EDSS, PHQ9, MFIS, and MSPSS. In 

addition, data were collected on other MS symptoms (vision 

loss, slurred speech, problems thinking) and demographic 

information. Results: Participants were divided into five 

groups based on the severity of self-reported speech and cognitive 

symptoms (problems thinking). A 3 × 5 mixed-design 

analysis of variance (ANOVA) was calculated to examine 

the effects of severity group (five levels) and time (three time 

points) on CP scores. No significant main effects for time (P 

= .532) or interactions between time and group (P = .416) 

were found. The main effect for group was significant (P = 

.000). Post hoc tests (Tukey HSD) revealed significant differences 

between the most severe groups and the less severe 

groups. There was greater variability in CP as severity of 

speech or cognitive symptoms increased. Visual inspection 

of graphs of the other constructs included in the study suggest 

relative stability across time. Conclusion: In summary, 

there were no significant changes in CP over the 26 months 

covered in this study. There were differences in participation 

restrictions associated with severity of communication disorders 

with those participants with more severe communication 

symptoms reporting more interference in CP. 


Keywords: Speech/language therapy in MS, Psychosocial issues in MS 


20 

S19 

MULTIPLE SCLEROSIS AND IMAGES OF GOD: THE 

INFLUENCE OF RELIGIOUS BELIEF ON THE QUALITY 

OF LIFE 

Gina Corsi 

Occupational Therapy, Brazilian Multiple Sclerosis Society, Sao Paulo, Brazil 

Background: Multiple sclerosis (MS) is a progressive chronic 

disease of unknown cause. The main role of health professionals 

is to improve the quality of life (QOL) of MS patients 

by relieving their symptoms, improving their emotional wellbeing, 

and helping them find better solutions to adapt to their 

new life. Because of the chronic and progressive nature of 

MS, patients may turn to their religious beliefs to cope with 

MS and find comfort and courage to deal with their impairment. 

Objectives: This study’s objective is to learn about the 

religious beliefs of MS patients and analyze their influence 

on patients’ QOL. Methods: A total of 44 MS patients with 

Expanded Disability Status Scale (EDSS) scores between 1.0 

and 9.0 and a diagnosis of at least 5 years participated 

in this study. We used open interviews to find out about 

patients’ religious beliefs and the Functional Assessment of 

Multiple Sclerosis (FAMS) and the Spiritual/Religious Coping 

(SRC) to measure their QOL and the way they use their faith 

to cope with stress. Results: There is a statistically significant 

relationship between the FAMS and the SRC. The type 

of religious belief had no influence on QOL. Conclusion: 

Religious beliefs among the MS patients included in this study 

were rich, varied, and meaningful. The way patients use their 

faith to cope with stressful situations can influence their QOL. 




S20 

PAIN AND ITS IMPACT ON QUALITY OF LIFE 

AMONG INDIVIDUALS WITH MULTIPLE SCLEROSIS 

Margaret Howlett, M. Jean Turner 

Human Environmental Sciences, University of Arkansas, Fayetteville, AR 

Background: When most people think of multiple sclerosis 

(MS), they think of a disease that causes symptoms of weakness 

and motor problems, not pain. Pain is one of the most 

underrecognized yet pervasive symptoms experienced by 

individuals with MS. One important concern is the degree 

to which pain is problematic in a population that is already 

compromised by disabilities. Little is known about the specific 

influence of pain on the quality of life (QOL) of individuals 

with MS. The scant literature that has investigated the 

effects of pain suggests that individuals with MS are at risk 

for impaired psychological and psychosocial functioning, 

decreased working ability, and poor overall QOL (Douglas 

et al., 2009; Ehde et al., 2003; Grasso et al., 2008). This 

study can facilitate improvement in pain management for 

individuals with MS by exploring more effective treatment 

intervention strategies. Objectives: The purpose of this study 

was to assess the degree to which pain interfered with multiple 

physical and mental QOL domains among individuals 

with MS. Methods: This quantitative, cross-sectional survey 

design compared the impact of pain on the mental and physical 

QOL of individuals with MS. A total of 97 participants, 

ranging in age from 28 to 72 years, were recruited from

three different MS chapters to serve as the study sample. 

All participants completed a questionnaire containing items 

about their demographic and clinical characteristics, validated 

measures of QOL, and the Medical Outcomes Study 

(MOS) Pain Effects Scale, which focused on the prevalence 

and intensity of pain experienced by individuals with MS. 

Results: These findings suggest that pain is a significant 

cause of distress and disability for individuals with MS. Findings 

indicated that prevalence of pain significantly correlated 

with both physical and mental QOL. The outcomes of this 

study supported evidence of the damaging effect of the presence 

of pain on QOL functioning. Conclusion: The findings 

from this study extend our understanding of the relationship 

between pain and QOL among individuals with MS. These 

data support the hypothesis that recognition of pain and 

efficient pain management would enhance the QOL of individuals 

with MS. Further investigation is needed to determine 

the effectiveness of pain management and the impact of pain 

reduction on disability and functioning. 


Keywords: Quality of life in MS, Psychosocial issues in MS 

S21 

PHYSICAL ACTIVITY AND COGNITIVE FUNCTION IN 


Kathryn Nelson, 1 Eduard Gappmaier, 1 Ralph Benedict, 2 Robert Motl 3 

1 Physical Therapy, University of Utah, Salt Lake City, UT; 2 Neurology, State 

University of New York (SUNY) at Buffalo, Buffalo, NY; 3 Kinesiology and 

Community Health, University of Illinois Urbana-Champaign, Urbana, IL 

Background: Cognitive impairment is found by neuropsychological 

(NP) testing in 40% to 60% of people with 

multiple sclerosis (MS). Impairments occur most often in speed 

of information processing and episodic memory. Currently, 

no approved therapies exist for the management of cognitive 

impairment in MS. However, there is some evidence that 

physical activity is associated with better cognitive function 

in older healthy adults, and similar associations may occur 

in people with MS. Objectives: This cross-sectional study 

examined the associations among physical activity, information 

processing speed, and learning and memory tests in 

people with MS. Methods: Twenty-seven people with clinically 

definite MS (11 male, 16 female; mean age, 59.3 ± 

20.3 years; mean Expanded Disability Status Scale [EDSS] 

score, 5.3 ± 2.3; mean years since diagnosis, 16.9 ± 25.1) 

underwent NP assessment including the Selective Reminding 

Test (SRT), Brief Visuospatial Memory Test–Revised (BVMTR), 

Paced Auditory Serial Addition Test (PASAT), and Symbol 

Digit Modalities Test (SDMT). Participants wore a StepWatch 

Activity Monitor (SAM) for a 7-day period as a measure of 

physical activity in average steps per day. Extent of cognitive 

impairment was examined by comparing the scores on the 

neuropsychological assessments with normative data from 

control samples available from other studies. Results: Z 

scores for neuropsychological tests indicated that cognitive 

dysfunction was greatest in the SDMT (2.0 SDs worse than 

normative controls), PASAT (1.3 SDs worse than normative 

controls), and BVMTR (>1.2 SD worse than normative controls), 

and less on the SRT (

Posters 

dent of disability status. This demonstrates the need for future 

research examining the effect of physical activity interventions 

on cognitive dysfunction in MS. 



S23 

PROSPECTIVE MEMORY IN MULTIPLE SCLEROSIS: 

COMPENSATORY STRATEGY IMPLEMENTATION 

Evangelina Cores, 1,2 Sandra Vanotti, 2 Mabel Osorio, 1 Daniel G. Politis, 1 

Orlando Garcea 2 

1 Cognitive Deterioration Laboratory, Eva Peron Hospital, Buenos Aires, 

Argentina; 2 Multiple Sclerosis Unit, Ramos Mejia Hospital, Buenos Aires, 

Argentina 

Background: Prospective memory (PM) allows remembering 

to perform actions in the future. Some studies have indicated 

a PM deterioration in patients with multiple sclerosis 

(MS). Only one previous study had researched the benefits of 

mnemic strategies. Objectives: To analyze MS performance 

in a multi-intentional PM task and the implementation of a 

compensatory strategy. Methods: Twenty-four patients with 

relapsing-remitting MS (mean [SD] Expanded Disability Status 

Scale [EDSS] score, 3.32 [2.9]; age, 41.29 [10.94] years; 

years of education, 11.67 [2.42]) and 31 healthy volunteers 

of similar age and educational status were assessed using a 

battery of neuropsychological tests containing El Cóndor as 

the PM measure and other tests of memory, attention, and 

executive functions. Ten intentions are to be remembered in 

the PM task. During learning of one of these intentions, the 

third one (“In 5 minutes you have to write the date of your 

birth”), the opportunity to write the actual time or the time 

at which the subject should perform the action is given in 

the instructions. In addition, patients were evaluated with 

two measures of physical disability. Results: Significant 

differences were found in mean (SD) El Cóndor total score, 

in favor of the control group (11.75 [6.87] for patients vs. 

6.16 [2.58] for controls; P < .05). The frequency of using a 

compensatory strategy when remembering the third intention 

was higher in the control group than in the patient group 

(Pearson χ 2 : 5.76, P < .05). Also, a tendency was found in 

self-initiation of the third intention in favor of the control group 

(Pearson χ 2 : 3.32, P = 0.06). Conclusion: MS patients had 

worse performance in PM compared with healthy people. 

Patients do not use mnemic compensatory strategies even 

when all conditions are set. This indicates the need to supervise 

patients when a rehabilitation strategy is taught to them. 



S24 

RELATIONSHIP OF EVOLVING COGNITIVE DEFICITS 

TO ACADEMIC FUNCTIONING IN PEDIATRIC-ONSET 


Karen D. Evankovich, 1 Timothy E. Lotze 2 

1 Pediatrics-Neurology/Psychology, Baylor College of Medicine, Houston, TX; 

2 Pediatrics-Neurology, Baylor College of Medicine, Houston, TX 

Background: The cognitive consequences of pediatriconset 

multiple sclerosis (POMS) are just beginning to be 

understood. Even less is known about the evolution of cognitive 

impairments in POMS and their impact on academic 

development. Objectives: To prospectively characterize 


22 

cognitive functioning and the evolution of academic deficits 

in a small cohort of POMS patients during the first 5 years of 

diagnosis. Methods: Nine POMS patients received three 

neuropsychological assessments over 5 years: baseline, 3 

years, and 5 years post diagnosis. Evaluations included 

standardized neuropsychological measures. Group means 

were compared with standardized normative data with mean 

standard scores (SS) of 100 (SD = 15). Disability was measured 

with the Expanded Disability Status Scale (EDSS). The 

cohort was 67% female. Forty-five percent were Hispanic, 

26% African American, and 29% Caucasian. Mean parental 

education was 13.5 years. Mean age at onset was 11 

years. All received immunomodulating therapy. Annualized 

relapse rate was 2.9 at initial evaluation, 1.6 at 3 years, 

and 1 at 5 years. Patients accrued minimal disability, with 

mean EDSS scores of 0.25, 0.33, and 0.4 (ranges, 0–2) 

at initial, 3-year, and 5-year evaluations. Results: Baseline 

findings indicated average intelligence, memory, executive 

functioning, and academic development. Baseline deficits 

were noted in attention (SS = 75), fine motor speed (SS = 

82), and visual-motor integration (SS = 78). These cognitive 

weaknesses persisted at 3 years, with academic underachievement 

emerging in mathematics. At 5 years, additional 

cognitive impairments were detected in processing speed (SS 

= 83) and vulnerability to interference (SS = 78). Multivariate 

repeated-measures analysis indicated declines in mathematics 

over time (Wilks Λ, F = 9.43, P = .03). Declining math scores 

were associated with impairments in attention (r = 0.45, P= 

.01) and visual-motor integration (r = 0.74, P = .03). Conclusion: 

Findings suggest early, persistent problems in sustained 

attention and visual-motor ability with evolving deficits 

in processing speed and executive functioning. Impairments 

in attention and visual-motor integration were associated 

with mounting academic underachievement in mathematics, 

underscoring the functional impact of POMS in the absence 

of physical disability. 


Keywords: Psychological issues and MS 

S25 

SEXUAL SATISFACTION AND MULTIPLE SCLEROSIS: 

FREQUENCY VERSUS QUALITY OF SEXUAL 

COMMUNICATION 

Michael J. Rollock, 1 Lara M. Stepleman, 1,2 William H. Hudson, 3 Marie- 

Christine Rutter Goodworth, 4 Rhonda S. Casillas, 1 Mitzi J. Williams 5 

1 Psychiatry and Health Behavior, Medical College of Georgia, Augusta, GA; 

2 Educational Discovery Institute, Medical College of Georgia, Augusta, GA; 

3 School of Medicine, Medical College of Georgia, Augusta, GA; 4 Graduate 

Department of Clinical Psychology, George Fox University, Newberg, OR; 

5 Department of Neurology, Medical College of Georgia, Augusta, GA 

Background: Sexual satisfaction and functioning have 

been identified as domains of primary concern among individuals 

with multiple sclerosis (MS). Although sexual communication 

has been found to predict higher sexual satisfaction, 

further exploration is needed as to the most beneficial aspects 

of communication. Objectives: The goals of this project 

were to examine and compare the effects of perceived quality 

versus frequency of sexual communication to better inform 

patients with MS, their partners, and practitioners about 

effective sex communication. Methods: Fifty-seven MS clinic 

patients completed a survey packet that included the Dyadic

Sexual Communication Scale (DSCS), frequency of sex-related 

communication and behaviors, the Mental Health Inventory 

(MHI), and the Sexual Satisfaction Scale (SSS). Results: 

Hierarchical linear regression was used to assess the ability 

of the two sex communication measures (frequency of sexual 

communication and the DSCS) to predict levels of sexual satisfaction 

in individuals with MS, after controlling for mental 

health and frequency of sexual behavior. Mental health and 

frequency of sexual behavior were entered in step 1, explaining 

45% of the variance in sexual satisfaction. After entry of 

frequency of sex communication and the DSCS at step 2, 

the total variance explained by the model was 63% (F[4, 

49] = 20.8, P < .0005). The two communication measures 

explained an additional 18.3% of the variance in sexual satisfaction 

(R 2 change = 0.183, F change [2,49] = 12.09, P < 

.001). In the final model, partial correlations show that when 

controlling for all other independent variables, 10.8% of the 

total variance of sexual satisfaction is uniquely explained 

by the DSCS, followed by mental health (7%), frequency of 

sexual behavior (3%), and frequency of sex communication 

(2.9%). Conclusion: The data suggest that for increased 

sexual satisfaction in patients with MS, perceived high quality 

is more important than frequency in sex communication with 

one’s partner. This holds true even when robust predictors of 

sexual satisfaction (mental health and frequency of sexual 

behavior) are taken into account. Future studies should examine 

interventions designed to increase perceived quality of 

sexual communication with one’s partner. 


Keywords: Psychosocial issues in MS, Quality of life in MS, Psychological 


S26 

THE ILLNESS INTRUSIVENESS RATINGS SCALE: NEW 

SUBSCALES, NEW INSIGHTS, AND POSSIBLY NEW 

APPROACHES TO CARE 

Karen Turpin, 1 Walter Hader, 2 Katherine Knox, 2 Sharon Warren, 1 Kenneth 

Warren 1 

1 MS Clinic, University of Alberta, Edmonton, AB, Canada; 2 MS Clinic, 

University of Saskatchewan, Saskatoon, SK, Canada 

Background: The Illness Intrusiveness Ratings Scale (IIRS) 

quantifies the degree of infringement of a disease on subjective 

well-being. Three valid and reliable subscales of the IIRS 

have recently been identified: relationships and personal 

development (ie, family, community involvement), intimacy 

(ie, spousal relationship), and instrumental (ie, health, work, 

active recreation, finances). Objectives: The aim of this 

study was to compare the IIRS scores in people with multiple 

sclerosis (MS) with published IIRS scores reported for several 

other physically disabling chronic diseases: end-stage renal 

disease (ESRD), fibromyalgia (FM), diabetes mellitus type 

2 (DM), osteoarthritis and rheumatoid arthritis (OA/RA), 

systemic lupus erythematosus (SLE), and ulcerative colitis 

(UC). Methods: The IIRS rates the degree to which “illness 

and/or its treatment” interferes with 13 areas important to 

subjective well-being. Total IIRS scores range from 13 to 91; 

subscale scores range from 1 to 7. Higher scores indicate 

increased illness intrusiveness. The IIRS measure was included 

in an MS population-based study evaluating the impact of 

disease-modifying therapies. Baseline IIRS scores from this 

study (N = 196) were compared with published IIRS scores 


23 

Posters 

for the diseases listed above. Results: The MS sample had 

a mild-to-moderate level of intrusiveness (mean = 38.1, SD = 

16.0, range = 13–79). The average subscale scores were as 

follows: relationships and personal development, 2.4 (SD = 

1.7, range = 1–7); intimacy, 2.6 (SD = 1.9, range = 1–7); 

and instrumental, 4.0 (SD = 2.2, range = 1–7). Similar patterns 

were observed in the comparative diseases, with the 

instrumental subscale always reporting the highest scores. 

The DM and UC diseases had the lowest scores overall, while 

ESRD and FM had the highest. The MS scores were most 

similar to those of the SLE, OA, and RA diseases. Conclusion: 

These findings suggest that people with MS experience 

levels of intrusiveness similar to those living with other physically 

disabling chronic diseases. Instrumental factors had the 

greatest influence on illness intrusiveness across all diseases 

examined. Future research should examine common interdisciplinary 

strategies that may be effective in reducing illness 

intrusiveness across multiple chronic diseases, with special 

attention to alleviating barriers related to instrumental intrusiveness. 

Disclosure: Karen Turpin: Nothing to disclose. Walter Hader: Nothing 

to disclose. Katherine Knox: Biogen (consulting fee); Bayer, Teva (other 

financial benefits). Sharon Warren: Nothing to disclose. Kenneth Warren: 


Keywords: Psychosocial issues in MS, Comprehensive care and MS, 


S27 

THE MULTIPLE SCLEROSIS FOUNDATIONS’ CRUISE 

FOR A CAUSE 

Andrea L. Dowdall, 1 Helen Mangan 2 

1 MS Quality of Life Project, Monterey, CA; 2 Multiple Sclerosis Foundation, Fort 

Lauderdale, FL 

Background: The year 2010 marked the ninth annual 

Multiple Sclerosis Foundation (MSF) Cruise for a Cause. Each 

year, the MSF has created an MS Center at Sea. This year, 

over 400 people (those with multiple sclerosis [MS], family 

members, and health-care professionals) came together 

during a 7-night cruise to Alaska. As with previous cruises, 

many opportunities were offered: educational events, support 

groups, social activities for the group as well as other 

onboard activities, and wonderful shore excursions in Alaska. 

This is the first year for which the benefits of this series of 

cruises will be analyzed. Objectives: The aim of this study 

is to evaluate the benefits of the 2010 Cruise for a Cause: 

Were people with MS and their family members motivated 

and empowered by taking this cruise? Were they able to 

improve their quality of life (QOL)? What did they learn 

about themselves, MS, overcoming challenges, and their support 

systems? Methods: Three surveys were administered to 

people with MS and their family members: one at the beginning 

of the cruise, one at the end of the cruise, and one 6 

weeks after the cruise. A modified QOL questionnaire was 

included at the beginning of the cruise and 6 weeks after the 

cruise. Some of the questions to be answered following the 

completion of survey analyis include the following: precruise: 

Was there a need for special planning? What were people’s 

expectations, including any challenges? At cruise end: Were 

any mobility issues experienced? What information was 

learned? What was learned about an individual’s support 

system? Postcruise: Was QOL improved? What new goals

Posters 

were set? What new strategies for symptom management are 

being utilized? Are support groups being attended? Were 

expectations met? Results: Survey analysis to be presented. 

Conclusion: This analysis will demonstrate the multiple benefits 

shared by participants in the 2010 Cruise for a Cause. 


Keywords: MS and the caregiver/family, Quality of life in MS, Psychosocial 

issues in MS 

S28 

THE MULTIPLE SCLEROSIS SOCIAL WORK 

COLLABORATIVE OF WASHINGTON IN ACTION! 

Megan McDaniel, 1 Alicia Sloan, 2 Lisa A. Webb, 3 Jamie Wazenkewitz 4 

1 MS Center, MultiCare Health Systems, Tacoma, WA; 2 Multiple Sclerosis 

Center of Excellence–West, VA Puget Sound Health Care System, Seattle, WA; 

3 Neurology, Virginia Mason Medical Center, Seattle, WA; 4 MS Rehabilitation 

Research and Training Center, University of Washington, Seattle, WA 

Background: Multiple sclerosis (MS) social workers continue 

to make great progress as a united collaborative in 

the Pacific Northwest. The Multiple Sclerosis Social Work 

Collaborative (MSSWC) of Washington was officially established 

in 2009 as a grassroots collaboration of social workers 

and allied health professionals in the Pacific Northwest. 

An initial poster was presented at the Consortium of Multiple 

Sclerosis Centers (CMSC) 2010 Annual Meeting describing 

the evolution of the group’s mission and vision. Objectives: 

This year’s poster presents further progress of the MSSWC 

of Washington. Our overall vision is to provide a model 

for other MS social workers to create their own MSSWC 

groups and encourage networking, resource sharing, and 

collaborations among all groups. Methods: The MSSWC’s 

current infrastructure will allow the group to further implement 

its mission and vision. The typical monthly meeting 

agenda includes professional networking and resource sharing; 

updates on the micro, mezzo, and macro levels of the 

MS community’s needs; information on opportunities in MS 

research studies, agency programs, and projects; MS-focused 

professional education opportunities; and social work clinical 

case presentations. Several guest speakers have presented 

at group meetings on MS social work topics such as social 

work advocacy, MS specialized housing, and other MS 

community developments. Results: After 2 successful years, 

the MSSWC of Washington is thriving and has significantly 

enhanced the individual member’s ability to provide an elevated 

and more informed level of service to people living with 

MS. Since the advent of this collaboration, the MSSWC has 

elected positions, developed bylaws and mission and vision 

statements, created a website, and been profiled in the MS 

Exchange (11/10). The group has worked on developing 

the following focus areas: Outreach and Membership; Funding; 

Web Design and Marketing; Training, Education, and 

Consultation. Further work consists of participation in CMSC 

social work curriculum development and facilitation of conference 

sessions. Conclusion: Future goals include 1) develop 

strategies to enhance the group’s visibility in Washington; 2) 

develop and implement practice-based strategies to enhance 

the value and status of social workers as integral MS care 

team members; 3) share the group’s model and serve as consultants 

to others interested in starting a new MSSWC. 


Keywords: Comprehensive care and MS, Service delivery in MS, Psychosocial 



24 

S29 

UTILITY OF THE MILLON BEHAVIORAL MEDICINE 

DIAGNOSTIC WITH A MULTIPLE SCLEROSIS 

POPULATION 

Kimberly B. McGuire, 1 Megan Castano 2 


Orange, NJ; 2 Seton Hall University, South Orange, NJ 

Background: The Millon Behavioral Medicine Diagnostic 

(MBMD; Millon et al., 2001) is an assessment that assists 

in identifying psychosocial factors that affect the course of 

medical treatment for individuals living with a chronic illness, 

such as multiple sclerosis (MS). In a previous evaluation of 

the MBMD with an MS sample, internal consistency was 

demonstrated with 22 of the 32 subscales. However, there 

is no research regarding the frequencies of and correlations 

between mood symptoms, coping styles, stress moderators, 

and treatment prognostics in an MS population. Objectives: 

To determine whether a common pattern of scores on 

the MBMD exists in an MS population, and to identify correlations 

between mood symptoms, coping styles, and stress 

moderators. Methods: Fifty-six individuals diagnosed with 

MS were referred for neuropsychological assessment, and 

the MBMD was administered as part of a neuropsychological 

assessment. Frequencies and bivariate correlations were conducted 

to identify associations between mood symptoms, coping 

styles, and stress moderators and treatment prognostics. 

Results: The following psychosocial factors were endorsed 

as problematic (>30%) in our sample: anxiety/tension, 

cooperativeness, illness apprehension, functional deficits, 

pain sensitivity, problematic compliance, and adjustment difficulties. 

Participants also endorsed inactivity and eating as 

significant negative health habits (67.9% and 50%, respectively). 

Conversely, information receptivity (67.9%), spiritual 

faith (32.1%), and social support (28.6%) were endorsed 

as potential assets. Bivariate correlation analyses indicated 

that anxiety/tension correlated significantly with introversive 

(r = 0.310, P = .02), inhibited (r = 0.332, P = .01), and 

dejected (r = 0.310, P = .02) coping styles. Furthermore, 

anxiety/tension correlated significantly with stress moderators 

of pain sensitivity (r = 0.343, P = .01) and social isolation (r 

= 0.338, P = .01). Additional results will be discussed. Conclusion: 

Preliminary results indicate that the MBMD demonstrates 

utility in identifying the associations between various 

mood symptoms, coping styles, and stress moderators. This 

information will assist in guiding development of appropriate 

treatment interventions for individuals living with MS. Additional 

research with this population is recommended. 


Keywords: Psychosocial issues in MS, Quality of life in MS 

S30 

PATIENT-REPORTED OUTCOMES IN ADULTS WITH 

PEDIATRIC-ONSET MULTIPLE SCLEROSIS 

Natalie F. Baruch, Bonnie I. Glanz, Brian C. Healy, Line E. Hviid, David J. 

Rintell, Tanuja Chitnis 

Neurology, Brigham and Women’s Hospital, Brookline, MA 

Background: Quality of life (QOL) has been shown to 

be significantly worse in pediatric-onset multiple sclerosis 

(POMS) and adult-onset multiple sclerosis (AOMS) patients 

compared with healthy controls and patients with other auto

immune diseases. Few studies have compared QOL between 

adults in these categories. Objectives: To compare healthrelated 

patient-reported outcomes in adults with POMS and 

AOMS. Methods: Subjects enrolled in the CLIMB (Comprehensive 

Longitudinal Investigation of Multiple Sclerosis at the 

Brigham and Women’s Hospital) at Partners MS Center with 

relapsing-onset MS and age at last visit of

Posters 

Background: Mood disorders are common in patients with 

multiple sclerosis (MS); previous research has focused on the 

prevalence of depression, bipolar, and anxiety disorders, 

but less is known about the prevalence of symptoms without 

a clinical diagnosis. The relationship between a patient’s 

mood and the outcomes of medical treatment and symptom 

management cannot be undermined; however, mood assessment 

is not a routine component of medical management. 

Objectives: To assess “mood” in patients with MS and to 

compare findings with those for patients with other neurologic 

and non-neurologic conditions. Methods: The study design 

is retrospective and cross-sectional. Data were extracted from 

the Uniform Data System for Medical Rehabilitation (UDSMR) 

LIFEwareSM System, an outpatient rehabilitation tracking 

system containing measures of physical and cognitive disability 

as well as health-related quality of life for patients with a 

variety of medical conditions; the years included were 2003 

to 2006. The placid measure, derived from the LIFEware System, 

was used to assess mood; items include loneliness, pessimism, 

tension, panic spells, irritation, blame, and morbid 

thoughts. Items are patient-reported and rated on a 5-level 

scale (1 = extremely; 5 =none/nonbothersome). Patients with 

MS (n = 6178) were compared with patients with Parkinson’s 

disease (n = 431), stroke (n = 6888), head injury (n = 

1919), and other non-neurologic conditions (n = 121,580) 

(mainly orthopedic-related). Results: There were significant 

differences in mean placid ratings (higher ratings are better) 

by condition; patients with MS had significantly lower ratings 

(mean = 80) than those with all other conditions except 

patients with Parkinson’s disease (mean = 81, F = 187.9 [df 

= 4], P < .01). Patients with MS reported significantly more 

loneliness, pessimism, panic, morbid thoughts, and blame 

than patients with non-neurologic conditions, and reported 

the most irritation and feeling uptight of all patient groups. 

Conclusion: Patient-reported symptoms can be useful to 

a clinician in monitoring disease progression and can aid 

in treating the patient with a more holistic, patient-centered 

approach. Additionally, by assessing the patient’s “mood,” 

the clinician may be able to provide a referral for other 

services, such as psychological, biofeedback, or exercise 

therapy. 


Keywords: Quality of life in MS, Psychosocial issues in MS, Comprehensive 


S34 

A FUNCTIONAL LIVING OUTCOME MEASURE FOR 

MULTIPLE SCLEROSIS: COMBINING GPS AND 

ACTIVITY DATA 

Erin Snook, Andrea Morand, Carol Lynn Scott 

Kinesiology, University of Massachusetts Amherst, Amherst, MA 

Background: Understanding and accurately measuring a 

person’s function within their living environment is important 

for determining the effectiveness of multiple sclerosis (MS) 

treatments and disease progression. The World Health Organization 

defines function as a dynamic interaction between a 

person and their environment. Commonly used MS functional 

measures provide limited information about real-world function. 

The Movement and Activity in Physical Space (MAPS) 

measure, a recently developed measure of functional living, 

combines geospatial technologies (Global Positioning 


26 

Systems [GPS], Geographic Information Systems [GIS]) 

and accelerometry data to provide quantitative information 

about when, where, and how a person functions in their 

environment. Data from MAPS provide 14 outcome measures, 

including daily physical activity (PA) and step counts; 

total PA and step counts at home; total PA and step counts 

at locations other than home; time at home, other locations, 

and travel time; number and types of trips (instrumental or discretionary); 

and MAPS intensity (MAPS I ) and MAPS volume 

(MAPS V ) scores, which reflect the PA intensity (MAPS I ) and 

step counts (MAPS V ) at locations other than home. Objectives: 

Establish the feasibility of obtaining GPS and PA data 

across multiple days and provide initial evidence of construct 

validity for the MAPS scores in MS. Methods: Nineteen 

ambulatory MS participants (n = 16 females; mean age, 

47.1 ± 10.6 years; mean MS duration, 7.8 ± 6.5 years) 

completed questionnaires assessing function, symptoms, 

amount of weekly exercise, and the burden of wearing the 

devices. A GPS receiver (Tracking Key Pro) and accelerometer 

(Actigraph GT1M) were worn during the waking hours 

of 5 days, and a daily travel log was completed. Correlations 

were used to examine the relationship among the MAPS 

scores and the measures of function, symptoms, and weekly 

exercise. Results: GPS and PA data were successfully collected, 

and participants reported that the devices were not a 

burden. The MAPS I and MAPS V scores had moderate-to-strong 

correlations with function (r = 0.54; r = 0.66), symptoms (r = 

–0.46; r = –0.51), and exercise (r = 0.70; r = 0.87). Conclusion: 

Initial construct validity of the MAPS scores is supported 

based on the strength and direction of the correlations 

with the function, symptoms, and exercise outcome measures. 

MAPS could be an important new measure of function in MS. 


Keywords: Rehabilitation strategies and therapy and MS, Management 

of activities of daily living in MS 

CATEGORY: DISEASE MEASUREMENT, MECHANISMS, 

AND TREATMENT 

S35 

PATIENT-CENTERED OUTCOMES AND ADHERENCE 

TO DISEASE-MODIFYING AGENTS AMONG 

AFRICAN AMERICAN PATIENTS WITH MULTIPLE 

SCLEROSIS: A 5-YEAR ANALYSIS 

Brian S. Shafa, 1,2 Lonni Schultz, 1,3 Elizabeth Dobie, 4 Ramzi Salloum, 4 Stanton 

Elias, 1 Mirela Cerghet 1 

1 Department of Neurology, Henry Ford Hospital, Detroit, MI; 2 Wayne 

State University School of Medicine, Detroit, MI; 3 Biostatistics and Research 

Epidemiology, Henry Ford Hospital, Detroit, MI; 4 Center for Health Services 

Research, Henry Ford Hospital, Detroit, MI 

Background: Multiple sclerosis (MS) has higher prevalence 

among Caucasians than among other ethnic groups; 

however, studies have shown that African Americans (AAs) 

have a more aggressive and rapidly disabling disease 

course. Disease-modifying agents (DMAs) have been shown 

to reduce relapse rates, magnetic resonance imaging (MRI) 

burden, and short-term disability. Findings from the early 

2-year phase of this study found that mean adherence to 

DMAs was 84%, but that only 68% were continual users 

over the 2-year period. However, knowledge of DMA 

adherence in AA patients and how exposure to DMAs and

patient-centered outcomes including employment, disability, 

and quality of life vary over time in these patients is not well 

known. Objectives: To evaluate the adherence to DMAs 

and patient-centered outcomes over a 5-year period among 

AA patients with relapsing-remitting MS (RRMS). Methods: 

The study population consisted of 156 patients with RRMS 

followed over 5 years (2005–2010) in a large health-care 

system. Automated records were used to compile demographic 

information (age, gender, race, and marital status). 

Measures of disability (Expanded Disability Status Scale 

[EDSS]), quality of life (Multiple Sclerosis Quality of Life Inventory 

[MSQLI]), health status (36-item Short Form Health Status 

Survey [SF-36]), and reported use of and adherence to DMAs 

were obtained using a mailed survey. Generalized estimating 

equation (GEE) methods were used to assess the changes 

in the outcomes of interest over time and test whether these 

changes were similar for Caucasians and AAs. Results: A 

total of 156 patients responded to the survey, of which 128 

had medication coverage for all 5 years. AAs (n = 58) were 

younger (mean age, 46 vs. 51 years), were less likely to be 

married (55% vs. 72%), and had a shorter duration of MS 

(mean, 7.3 vs. 11.9 years). Injectable use and adherence 

rates significantly decreased over time, with higher rates in 

AAs than in Caucasians (P = .046). Significant changes over 

time with worsening of scores were observed for EDSS and 

SF-36 physical functioning in both AAs and Caucasians. 

Conclusion: Racial differences in DMA adherence were 

maintained in a 5-year follow-up. Adherence rates decreased 

significantly over time, and patient-centered outcomes worsened. 

Larger, prospective studies are needed to more fully 

understand the implications of medication adherence for 

patient-centered outcomes among racially diverse populations 

of patients with MS. 


Keywords: Quality of life in MS, Disease-modifying treatment in MS, 

Epidemiology of MS 

S36 

ACCELEROMETRY MEASURES WALKING MOBILITY, 

NOT PHYSICAL ACTIVITY, IN MULTIPLE SCLEROSIS 

Madeline L. Weikert, Deirdre Dlugonski, Yoojin Suh, Brian Sandroff, Robert 

W. Motl 

Kinesiology and Community Health, University of Illinois, Urbana-Champaign, 

Urbana, IL 

Background: An accurate, objective measure of walking 

mobility in real-life settings would be beneficial for determining 

the efficacy of therapeutic programs in people with multiple 

sclerosis (MS). Motion sensors such as accelerometers 

have been deemed the criterion standard because these 

devices capture and quantify a wide range of daily ambulatory 

movements. Previous research has suggested that accelerometers 

are associated with both self-reported physical 

activity and walking mobility in MS. This previous research 

has included neither objective measures of walking mobility 

such as the 6-Minute Walk (6MW) and Timed Up and Go 

(TUG) nor a matched control sample for verifying the specificity 

versus generalizability of the associations. Objectives: 

This study compared the associations among accelerometry, 

walking mobility, and physical activity between people with 

MS and matched controls without a neurologic disorder. 

Methods: The sample included 33 individuals with MS and 


27 

Posters 

33 controls matched in age, race, and gender. Participants 

completed a battery of questionnaires and performed two 

objective mobility measures: the 6MW and TUG. Participants 

then wore an accelerometer (ActiGraph model 7164) 

for 7 days and completed two self-report physical activity 

measures: the Godin Leisure Time Exercise Questionnaire 

(GLTEQ) and International Physical Activity Questionnaire 

(IPAQ). Bivariate correlation and multiple linear regression 

analyses were performed in SPSS, version 18.0 (SPSS Inc, 

Chicago, IL). Results: Accelerometer scores were significantly 

correlated only with the mobility measures (6MW, ρ 

= 0.76; TUG, ρ = –0.68) in those with MS. Accelerometer 

scores were significantly correlated with both the mobility 

(6MW, ρ = 0.57; TUG, ρ = –0.52) and physical activity 

(GLTEQ, ρ = 0.61; IPAQ, ρ = 0.49) measures in the control 

group. The regression analysis with stepwise entry indicated 

that only 6MW explained variance in accelerometry scores 

in those with MS (β = 0.65, R 2 = 0.43), whereas only GLTEQ 

scores explained variance in accelerometry scores in the controls 

(β = 0.62, R 2 = 0.38). 

Conclusion: These findings suggest that accelerometers are 

primarily measuring walking mobility, not physical activity, in 

people with MS, and this differs from healthy controls. 


Keywords: Equipment in MS, Rehabilitation strategies and therapy 


S37 

MOST IN-HOSPITAL DEATHS IN A US MULTIPLE 

SCLEROSIS POPULATION ARE MULTIPLE SCLEROSIS– 

RELATED 

Frank R. Ernst, 1 Jennifer Pocoski, 2 Ronald Preblick, 2 Gary Cutter, 3 David W. 

Kaufman, 4 Howard Golub, 5 Volker Knappertz 2 

1 Premier Healthcare Alliance, Charlotte, NC; 2 Bayer HealthCare 

Pharmaceuticals, Inc, Montville, NJ; 3 Department of Biostatistics, UAB School 

of Public Health, Birmingham, AL; 4 Slone Epidemiology Center, Boston 

University, Boston, MA; 5 Care-Safe LLC, Newton, MA 

Background: A number of prospective and retrospective 

cohort and registry studies have demonstrated differences 

in mortality rates between patients with and without multiple 

sclerosis (MS). Limited evidence exists on primary cause of 

death in patients with MS. Objectives: To examine related 

diagnoses, covariates, and comorbidities among MS patients 

who died in-hospital compared with diabetes mellitus (DM) 

patients and the general hospitalized population (GHP). 

Methods: Retrospective analysis of US hospital-based Premier 

Perspective database was performed for patients at least 

18 years of age who died between January 2007 and September 

2010, with principal or secondary International Classification 

of Diseases (ICD)-9 codes for MS (340). Mutually 

exclusive comparator groups included patients with a DM 

ICD-9 code (250 [all subcodes]) and patients with any other 

ICD-9 code (GHP). Principal diagnoses associated with inhospital 

death were identified and classified into ten categories: 

cardiovascular (CV)/stroke, upper respiratory infection 

(URI), pulmonary infection, urinary tract infection (UTI), other 

infection, septicemia, cancer, accident/suicide, MS, and 

other. Demographic data including age, gender, race, all 

patient-refined diagnosis-related groups, and comorbid conditions 

were collected. All variables were analyzed descriptively. 

Results: Total deceased patients in each cohort were

Posters 

as follows: 818 MS; 78,184 DM; and 185,227 GHP. Septicemia 

was the principal diagnosis among deceased patients 

in the three groups (MS 34.0%, DM 20.0%, GHP 16.9%). 

For deceased MS, DM, and GHP patients, respectively, other 

major diagnostic ICD-9 categories included URI (19.1%, 

14.7%, 13.9%), CV/stroke (12.5%, 26.6%, 23.1%), other 

(10.8%, 18.4%, 18.9%), cancer (6.5%, 7.5%, 12.0%), 

accident/suicide (5.7%, 6.3%, 7.9%), pulmonary infection 

(4.6%, 4.3%, 4.8%), MS (4.3%, 0%, 0%), UTI (1.1%, 0.5%, 

0.5%), and other infection (1.1%, 1.4%, 1.8%). Conclusion: 

This contemporary, large US in-patient sample provides 

cause of death data for hospitalized MS patients. While 

septicemia was the principal diagnosis associated with inhospital 

death in all cohorts, its frequency in MS exceeded 

that in DM and GHP. The relationship between in-hospital 

deaths and all MS deaths remains to be determined for contemporary 

US MS patients. 

Disclosure: Frank R. Ernst: Premier, Inc (salary); Bayer (consulting 

fee). Jennifer Pocoski: Bayer HealthCare Pharmaceuticals (salary). Ronald 

Preblick: Bayer HealthCare Pharmaceuticals (salary). Gary Cutter: 

Sanofi-Aventis, Cleveland Clinic Foundation, Daichi-Sankyo, Glaxo 

Smith Klein Pharmaceuticals, Genmab Biopharmaceuticals, Eli Lilly, 

Medivation, Modigenetech, Ono Pharmaceuticals, PTC Therapeutics, 

Teva, Vivus, University of Pennsylvania, NHLBI, NINDS, NMSS, 

NICHD (other financial benefits); Alexion, Bayhill, Bayer, Novartis, 

Consortium of Multiple Sclerosis Centers, Genzyme, Klein-Buendel 

Incorporated, Nuron Biotech, Peptimmune, Somnus Pharmaceuticals, 

Sandoz, Teva, UT Southwestern Visioneering Technologies, Inc (consulting 

fees). David W. Kaufman: Bayer Healthcare (consulting fee). Howard 

Golub: Bayer HealthCare Pharmaceuticals (consulting fee). Volker 

Knappertz: Bayer HealthCare Pharmaceuticals (salary). 


S38 

NEW DISEASE-MODIFYING THERAPIES IN MULTIPLE 

SCLEROSIS AND PATIENT IMPRESSIONS 

Christina Caon, 1 Anza Memon, 1 Jai Perumal, 2 Omar Khan 1 

1 Neurology, Wayne State University, Detroit, MI; 2 Neurology, New York 

University, New York, NY 

Background: Currently, eight disease-modifying therapies 

(DMTs), including the most recent addition of orally 

administered fingolimod, are available for the treatment of 

relapsing-remitting multiple sclerosis (RRMS) in the United 

States. Anticipating the potential approval of several new 

therapies, including oral ones, we conducted a study seeking 

patient response to the increasing list of new DMTs for MS. 

Objectives: To determine how patients with RRMS respond 

to the availability of new DMTs for MS. Methods: This was 

a cross-sectional, single-clinic, visit-based study questionnaire 

conducted between 2007 and 2009. RRMS patients were 

divided into two groups with disease and therapy duration of 

less than or greater than 5 years. All patients were receiving 

interferon beta or glatiramer acetate and were ambulatory, 

clinically stable, and without significant depression or cognitive 

impairment. A series of standardized questions were 

asked during clinic visits. These included whether patients 

would consider switching to a new therapy with mild risk and 

vigilance (NTMRV), new therapy with significant risk and vigilance 

(NTSRV), new oral therapy with mild risk and vigilance 

(NOTMRV), and new oral therapy with significant risk and 

vigilance (NOTSRV). Results: Group 1 had disease and 

therapy durations of 5 

years and consisted of 100 patients with mean age, disease 

duration, EDSS score, and duration of DMT of 39.7 years, 

9.6 years, 2.7, and 7.3 years, respectively. In Group 2, 

84% responded yes and 16% no to NTMRV; 63% yes and 

37% no to NTSRV; 97% yes and 3% no to NOTMRV; and 

59% yes and 41% no to NOTSRV. The responses to NTSRV 

and NOTSRV were significantly different between Groups 1 

and 2 (P < .0001). Analysis of questions related to risk and 

efficacy as well as correlations is under way. Conclusion: 

Preliminary results show that patients with long-standing disease 

and self-injected DMTs are more inclined to consider 

new therapies despite risk. These data and additional analyses 

may provide insight into patient preferences and assist in 

patient-clinician interaction and education in the era of new 

therapies for MS. 

Disclosure: Christina Caon: Teva Neuroscience, Novartis Pharmaceuticals 

(honoraria); Biogen Idec (consulting fee). Anza Memon: Nothing 

to disclose. Jai Perumal: Nothing to disclose. Omar Khan: Biogen Idec 

(honoraria); Teva Neuroscience, Novartis Pharmaceuticals, Genzyme 

Corporation, Bayer Health (consulting fees). 

Keywords: Disease-modifying treatment in MS, Quality of life in MS 

S39 

A CANADIAN MULTICENTER OBSERVATIONAL 

STUDY OF NATALIZUMAB IN MULTIPLE SCLEROSIS 

Trudy Campbell, 1,2 Virender Bhan, 1,2 Pierre Duquette, 3 Yves Lapierre, 4 

Francois Jacques, 5 Liesly Lee, 6 Marcelo Kremenchutzky, 7 David Howse, 8 Brad 

Stewart, 9 Stanley Hashimoto, 10 Anthony Traboulsee, 10 Galina Vorobeychik, 11 

Paul Giacomini 4 

1 Medicine, Dalhousie University, Halifax, NS, Canada; 2 Dalhousie Multiple 

Sclerosis Research Unit, Capital Health, Halifax, NS, Canada; 3 Medicine, 

Universite de Montreal, Montreal, QC, Canada; 4 Medicine, McGill University, 

Montreal, QC, Canada; 5 Neuro-Outaouais Clinic, Centre Hospitalier des 

Vallées de l’Outaouais, Gatineau, QC, Canada; 6 Medicine, University 

of Toronto, Toronto, ON, Canada; 7 Neurology, University of Western 

Ontario, London, ON, Canada; 8 Neurology, Thunder Bay Regional Health 

Sciences Centre, Thunder Bay, ON, Canada; 9 Neurology, University of 

Alberta, Edmonton, AB, Canada; 10 Medicine, University of British Columbia, 

Vancouver, BC, Canada; 11 Neurology, Fraser Health, Burnaby, BC, Canada 

Background: Natalizumab is indicated in the treatment of 

relapsing multiple sclerosis (MS) with inadequate response 

or intolerance to first-line disease-modifying therapies 

(DMTs) or aggressive-onset MS in therapy-naive patients. 

We studied the pattern of use and effectiveness of natalizumab 

in the “real world” and compared these findings to 

efficacy in randomized controlled trials (RCTs). Objectives: 

To compare the effectiveness of natalizumab in a multicenter 

observational study versus efficacy in the pivotal RCT, and 

to document adherence and discontinuation rates in this 

cohort. Methods: A retrospective observational study of 

266 patients treated with natalizumab for at least 13 consecutive 

infusions between February 2007 and September 

2010 was conducted at 12 Canadian MS centers. Demographic, 

clinical (Expanded Disability Status Scale [EDSS] 

and annualized relapse rate [ARR]) and patient self-report 

quality of life (QOL) were analyzed. Results: Two hundred

sixty-six patients had 13 or more infusions (range, 13–45; 

mean, 27). The mean age was 42 years, 74% were female, 

and 89% had prior DMT use. At natalizumab initiation, 94% 

were classified as relapsing-remitting MS (RRMS) versus 89% 

RRMS at most recent assessment. Pre- and post-treatment 

ARRs were 1.0 and 0.18, respectively (82% reduction, P = 

.0001). Pre- and post-treatment mean EDSS scores were 3.5 

and 3.3, respectively (6% reduction, P = NS). On treatment, 

ARR was greater for patients with previous DMT use than for 

the DMT-naive group (0.21 vs. 0.13; P = .029). ARR was 

similar for the EDSS progression group (n = 109) versus the 

progression-free group (n = 157) (0.24 vs. 0.17; P = .38). 

EDSS progression-free status was seen in 74% and 70% at 

12 and 24 months, respectively. Thirty-two patients (12%) 

discontinued natalizumab, with 34% subsequently being 

treated with another DMT. Discontinuations occurred most 

often between 13 and 20 months. Overall, 191 (72%) had 

complete adherence, while 32 (12%) missed one, 19 (7%) 

missed two, and 21 (8%) missed three or more infusions. 

There were no cases of progressive multifocal leukoencephalopathy 

(PML). Of the 133 patients who completed the QOL 

questionnaire, 82% reported improvement or no change, 

13% had mixed results, and 5% had worsening of physical 

and/or cognitive symptoms. Conclusion: Patients treated 

with natalizumab experienced a major reduction in ARR, with 

stabilization or improvement in EDSS and an improvement in 

QOL. Findings are remarkably similar to the treatment effects 

in the pivotal trial. 

Disclosure: Trudy Campbell: Biogen Idec Canada Inc, EMD Serono 

(honoraria). Virender Bhan: Biogen Idec Canada Inc (honoraria). Pierre 

Duquette: Biogen Idec Canada Inc, Teva, Bayer Health Care, EMD 

Serono, Novartis (honoraria). Yves Lapierre: Biogen Idec Canada Inc 

(honoraria). Francois Jacques: Biogen Idec Canada Inc (honoraria). 

Liesly Lee: Biogen Idec Canada Inc (honoraria). Marcelo Kremenchutzky: 

Biogen Idec Canada Inc, endMS, Teva Neuroscience, Bayer 

Health Care, Boehringer-Ingelheim, Bio-MS, Eli Lilly, Genzyme, GSK, 

GW, Novartis, PDL, Parexcel, Roche, Sanofi-Aventis, Schering, UCB 

Pharma, Bristol-Meyers Squibb, EMD Serono (honoraria). David 

Howse: Biogen Idec Canada Inc (honoraria). Brad Stewart: Biogen Idec 

Canada Inc (honoraria). Stanley Hashimoto: Biogen Idec Canada Inc, 

Novartis (honoraria). Anthony Traboulsee: Biogen Idec Canada Inc 

(honoraria). Galina Vorobeychik: Biogen Idec Canada, Bayer Health 

Care, Teva, EMD Serono, Novartis (honoraria). Paul Giacomini: Biogen 

Idec Canada Inc, Bayer Health Care, EMD Serono, Novartis , Teva 

(honoraria); NeuroRx Research, Elan, Roche-Genentec, Sanofi-Aventis 

(other financial benefits). 


S40 

A CASE OF COMPLETE HEART BLOCK WITH 

FINGOLIMOD 

David E. Jones 

MS Center of the Lehigh Valley, Allentown, PA 

Background: Fingolimod is a sphingosine-1-phosphate 

(S1P) agonist that was recently approved as the first oral 

disease-modifying therapy for relapsing forms of multiple 

sclerosis (MS). Its mechanism of action in MS is thought to 

be sequestration of some lymphocyte subsets in the secondary 

lymphoid tissue by internalization of their S1P receptor. 

S1P receptors are present in many other organ systems (atrial 

myocytes, vascular endothelium, bronchial epithelium, and 

retina), potentially leading to adverse effects. In particular, 


29 

Posters 

several cases of first-dose cardiac rhythm abnormalities 

occurred in the clinical trials of fingolimod, ranging from 

asymptomatic bradycardia to Mobitz II heart block, leading 

the FDA to recommend 6 hours of monitoring after the first 

dose of fingolimod. Objectives: To report a case of thirddegree 

(complete) A-V block with fingolimod. Methods: 

Case presentation and literature review. Results: A 54-yearold 

woman with MS (but otherwise healthy) presented to our 

heart station for 6 hours of cardiac monitoring after her first 

dose of fingolimod. Pretreatment EKG showed sinus bradycardia 

with a heart rate of 55 bpm. She received her first 

dose at 8:55 am. At 11:47, she felt very dizzy and needed 

to lie down; her heart rate at the time was recorded as 19 

bpm. The telemetry strip showed dissociation of P and QRS 

waves, consistent with third-degree heart block, for about 5 

seconds. Subsequent EKG revealed asymptomatic first-degree 

A-V block with a heart rate of 51. The patient was admitted 

for observation; at 14:25, she had another 5-second run of 

third-degree A-V block. At 16:30, her heart rate dropped 

to 34 bpm. She received her second dose of fingolimod the 

next morning at 9:00. At 14:52, she developed a brief run 

of second-degree heart block; this occurred again at 15:43 

with a heart rate of 43. All of these runs were self-limited. 

Conclusion: We present a case of a patient who developed 

brief runs of third-degree A-V block after receiving her 

first dose of fingolimod; she had runs of second-degree A-V 

block after her second dose. First-dose telemetry may be more 

appropriate than hourly vital sign checks in patients starting 

fingolimod. 

Disclosure: Biogen Idec, EMD Serono (consulting fees); Teva Neurosciences, 

Novartis (honoraria) 


S41 

A COMPARISON OF DISEASE-MODIFYING DRUG 

ADHERENCE CALCULATIONS 

Michael Dickson, 1 Chris Kozma, 2 Amy Phillips, 3 Dennis Meletiche 3 

1 College of Pharmacy, University of South Carolina, Columbia, SC; 

2 Independent Consultant, St. Helena Island, SC; 3 Health Outcomes & Market 

Access, EMD Serono, Inc, Rockland, MA 

Background: The medication possession ratio (MPR) is 

often used to describe patient adherence. However, this 

adherence measure can be calculated using different time 

periods in the denominator. Objectives: The objective of 

this analysis was to compare two commonly used adherence 

calculations for multiple sclerosis (MS) patients prescribed 

disease-modifying drugs (DMDs) in a national managed-care 

population. Methods: Patients with pharmacy claims for selfinjectable 

DMDs were selected from 2007–2008 Thomson 

MedStat data. Adherence was calculated across all DMDs 

for 12 months after the first DMD claim (ie, index date) using 

two different adherence calculation methods. The traditional 

medication possession ratio (TMPR) was calculated by summing 

the days’ supply from the first to the last prescription 

and dividing by the time between the last prescription date 

plus the days’ supply on the last prescription and the first 

prescription date. The modified medication possession ratio 

(MMPR) used the same numerator but divided by the 365 

days of the follow-up period. TMPR was calculated based 

on available data (no eligibility requirements), while MMPR 

requires continuous eligibility for the 12-month follow-up

Posters 

period. Results: The mean adherence value for TMPR (n = 

3405) was 90.5%, whereas the mean adherence value for 

MMPR (n = 2145) was 78.0%. Based on TMPR, 82.3% of 

patients were considered adherent (≥80%), while this value 

decreased to 63.7% for MMPR. Conclusion: These results 

demonstrate the importance of understanding the adherence 

calculation method and the population in which the measure 

is generated, and the potential implications for patient care. 

Disclosure: Michael Dickson: EMD Serono, Inc (consulting fee). Chris 

Kozma: EMD Serono, Inc (consulting fee). Amy Phillips: EMD Serono, 

Inc (salary). Dennis Meletiche: EMD Serono, Inc (salary). 

Keywords: Disease-modifying treatment in MS, Comprehensive care 


S42 

A WEB-BASED RESEARCH PROGRAM TO MEASURE 

MULTIPLE SCLEROSIS HEALTH STATUS 

Kathleen Costello, 1 John Foley, 2 Deborah Miller, 3 Katie L. Deering, 4 Sonalee 

Agarwal, 5 Kitty Rajagopalan 5 

1 Multiple Sclerosis Center, The Johns Hopkins Hospital, Baltimore, MD; 2 Rocky 

Mountain Multiple Sclerosis Clinic, Salt Lake City, UT; 3 Mellen Center for 

Multiple Sclerosis Quantitative Health Sciences, Cleveland Clinic, Cleveland, 

OH; 4 EPI-Q, Inc, Oak Brook, IL; 5 Biogen Idec Inc, Wellsley, MA 

Background: Patient-reported outcomes (PROs) can be 

used to monitor patients’ ongoing concerns and priorities and 

highlight frequency and/or severity of problems. Research 

has found that PROs can facilitate patient-clinician communication 

by prompting the patient’s memory, reducing reliance 

on anecdotal information, and improving the patient’s ability 

to describe problems. PRO-derived information can complement 

clinician-derived information if collected in an efficient 

and effective manner for health-care providers (HCPs). 

Objectives: To develop a web-based research program that 

collects standardized PROs and enables multiple sclerosis 

(MS) patients to share and communicate with their HCPs. 

Methods: My MS Health collects and tracks PROs in real 

time, and enrolled patients may elect to give HCPs access to 

their PRO results. My MS Health is being evaluated through 

an institutional review board (IRB)–approved study. Patients 

enroll on a secure website and are prompted to complete a 

series of nine validated PRO surveys that measure symptom 

status, functional status, and quality of life. The survey schedule 

was determined based on the recall periods of the PRO 

instruments and staggered to minimize patient respondent 

burden. Additionally, a program evaluation survey is scheduled 

to be completed every 3 months to measure patient-HCP 

communication and satisfaction with the program. Results: 

At 3 months, 927 patients were enrolled, 122 patients were 

eligible to complete the program evaluation, and 86% reported 

having at least one visit with their MS HCP. The program 

evaluation survey was measured on 5-point Likert scales with 

a range of low agreement (1) to high agreement (5); scores 

of ≥3 signify agreement. Overall, patients felt the My MS 

Health reports and graphs would help their health-care provider 

monitor their quality of life, ability to function, and MS 

symptoms (3.81 ± 1.53, 3.78 ± 1.53, 3.72 ± 1.55, respectively). 

Additionally, 58% of patients felt the My MS Health 

reports and graphs improve how well they discuss different 

aspects of their MS with their HCP (3.31 ± 1.51). Conclusion: 

Preliminary results indicate that patients believe the My 

MS Health reports are helpful for HCPs to monitor their health 


30 

status. In addition, the reports have improved patients’ reported 

ability to communicate the way MS is affecting their lives. 

Disclosure: Kathleen Costello: Biogen Idec (consulting fee). John Foley: 

Biogen Idec (consulting fee). Deborah Miller: Biogen Idec (honoraria). 

Katie L. Deering: Biogen Idec (other financial benefit). Sonalee Agarwal: 

Biogen Idec (salary). Kitty Rajagopalan: Biogen Idec (salary). 

Keywords: Quality of life in MS, Management of activities of daily living 

in MS, Comprehensive care and MS 

S43 

ABSENCE OF EFFECT ON JC VIRUS EXPRESSION BY 

DISEASE-MODIFYING DRUGS 

Craig Miller, 1 Robert Danaher, 1 Sidney Houff, 2 Yushun Lin, 3 Julie Gurwell, 2 

Nubia Vega, 2 Jason Hopper, 2 James Thomas, 4 Joseph R. Berger 2 

1 University of Kentucky College of Dentistry, Lexington, KY; 2 Neurology, 

University of Kentucky College of Medicine, Lexington, KY; 3 Biostatistics, 

University of Kentucky College of Medicine, Lexington, KY; 4 EMD Serono, 

Boston, MA 

Background: The observation of progressive multifocal 

leukoencephalopathy (PML) in patients on natalizumab has 

generated significant interest in the biology of the JC virus 

(JCV). While several studies have addressed the effect of 

natalizumab on JCV expression, none has systematically 

examined the effect of other disease-modifying drugs (DMDs) 

on blood or urine JCV expression. Objectives: To determine 

whether JCV expression in peripheral blood mononuclear 

cells (PBMCs) and urine is altered by DMDs. Methods: 

Real-time polymerase chain reaction was used to detect 

and quantify JCV in the PBMCs and urine of 299 multiple 

sclerosis (MS) patients (214 women, 85 men; mean age, 

39.7 years) on various MS regimens, including interferon 

beta (IFNβ; Avonex, Betaseron, and Rebif)(157), glatiramir 

acetate (Copaxone) (79), other MS regimens (Tysabri, Novantrone, 

or other) (23), or no medication (40). Forty patients 

had blood and urine collection before and 6 months after 

initiation of therapy. A total of 259 patients were on either 

the same DMD or no medication for at least 6 months at the 

time of the study. Results: JCV was detected in the PBMCs 

of only 2 of 299 (

(salary). Joseph R. Berger: Biogen Idec, Bayer (honoraria); Biogen Idec, 

Bayer, EMD Serono (other financial benefits); Bayer, Millenium, Glaxo- 

SmithKline, Genentech, Perseid, Astellas, Asphelia, Eisai, Gilead, Pfizer 

(consulting fees); Teva (honoraria). 


S44 

ALEMTUZUMAB REDUCES RISK OF SUSTAINED 

ACCUMULATION OF DISABILITY AND RELAPSE RATE 

AT YEARS 1 AND 2 IN CAMMS223 

Sibyl Wray, 1 on behalf of the CAMMS223 Study Group 2 

1 Hope Neurology, Knoxville, TN; 2 Genzyme Corporation, Cambridge, MA 

Background: Alemtuzumab demonstrated efficacy superior 

to that of subcutaneous (SC) interferon beta-1a (IFNβ-1a) in a 

3-year, phase 2 safety and efficacy trial with relapsing-remitting 

multiple sclerosis (RRMS) patients, significantly reducing 

relapse rate and risk for 6-month sustained accumulation of 

disability (SAD) (all comparisons, P < .001). Notable alemtuzumab-related 

adverse events included infusion reactions, 

mild-to-moderate infections, and secondary autoimmunity, 

notably thyroid disorders and immune thrombocytopenia. 

Efficacy at earlier time points is reported here. Objectives: 

To evaluate the effect of alemtuzumab on relapse rate and 

SAD at Years 1 and 2 in RRMS patients in a phase 2 study 

(CAMMS223). Methods: A total of 334 patients with early, 

active RRMS were randomized 1:1:1 to IFNβ-1a (44 µg SC 

3 times/wk) or 24 mg/d or 12 mg/d alemtuzumab (intravenously 

[IV] administered, 2 or 3 brief annual cycles). The 

proportion of patients SAD-free and relapse-free was determined 

using Kaplan-Meier estimation. Treatment effects were 

compared for time to SAD using the proportional hazards 

regression model and for rate of relapse using the Andersen- 

Gill model with robust variance estimation. Covariates in 

these models included baseline Expanded Disability Status 

Scale (EDSS) and country. Annualized relapse rate (ARR) was 

estimated using Poisson regression. Results: Risk of SAD 

was reduced by 76% through Year 1 (P = .0024) and 72% 

through Year 2 (P = .0006) among pooled alemtuzumab 

patients compared with IFNβ-1a patients. The proportion of 

patients SAD-free (95% confidence interval [CI]) at Years 1 

and 2 was 0.97 (0.93-0.98) and 0.94 (0.90-0.97) among 

pooled alemtuzumab patients and 0.87 (0.79-0.92) and 

0.81 (0.72-0.88) among IFNβ-1a patients. The rate of 

relapse was reduced by 76% through Year 1 (P < .0001) 

and 79% through Year 2 (P < .0001) among pooled alemtuzumab 

patients compared with IFNβ-1a patients. Among 

pooled alemtuzumab patients, ARR (95% CI) was 0.11 

(0.08-0.17) through Year 1 and 0.08 (0.06-0.12) through 

Year 2; among IFNβ-1a patients, ARR was 0.44 (0.33- 

0.59) through Year 1 and 0.38 (0.30-0.48) through Year 2. 

Conclusion: During the first year after administration and 

throughout the trial, alemtuzumab was effective in reducing 

the risk of SAD and rate of relapse compared with IFNβ-1a 

among RRMS patients. 

Disclosure: Sibyl Wray: Genzyme (other financial benefit); Acorda, 

Bayer, Biogen Idec, EMD Serono, Novartis, Pfizer, Teva (honoraria); 

Biogen Idec, Ono, EMD Serono, Novartis (other financial benefits). On 

behalf of the CAMMS223 Study Group: Genzyme (salary, consulting 

fee, other financial benefit). 



31 

S45 

ANALYSIS OF NATALIZUMAB EFFICACY BY 

BASELINE ANTI-JCV ANTIBODY STATUS 

Christophe Hotermans, Meena Subramanyam, Amy Pace, James Potts 

Biogen Idec Inc, Weston, MA 

Posters 

Background: The efficacy of natalizumab for relapsing 

multiple sclerosis (MS) is well established; however, a small 

number of patients experience progressive multifocal leukoencephalopathy 

(PML), a rare opportunistic central nervous 

system (CNS) infection resulting from JC virus (JCV) infection 

and a complex interaction between host immune and genetic 

factors. Recent studies suggest that anti-JCV antibodies (Ab) 

are a dependable measure of JCV infection and may be useful 

for stratifying PML risk. It is not anticipated that prior JCV 

infection impacts natalizumab efficacy; however, this has 

not been confirmed. Objectives: To evaluate the efficacy 

of natalizumab on clinical and magnetic resonance imaging 

(MRI) measures in anti-JCV Ab negative (ie, undetectable 

in serum) and positive MS patients and confirm a lack of 

interaction between baseline anti-JCV antibody status and efficacy. 

Methods: Patients (n = 417) from the 2-year, pivotal 

AFFIRM trial with baseline anti-JCV Ab status were evaluated. 

Efficacy was assessed using sustained (12- and 24-week) 

progression on the Expanded Disability Status Scale (EDSS), 

annualized relapse rate (ARR), time to first relapse, number 

of new or enlarging T2 lesions, and number of gadoliniumenhancing 

(Gd+) lesions. Interactions between treatment 

effect versus placebo and anti-JCV Ab status were assessed 

with multivariate regression models. Results: At baseline, 

there was no difference between the proportions of placebo- 

(n = 123) and natalizumab-treated (n = 294) patients who 

were anti-JCV Ab+ (49% vs. 52%; P = .544). Baseline characteristics 

were comparable for anti-JCV Ab– and anti-JCV 

Ab+ patients, except a higher proportion of anti-JCV Ab+ 

patients had ≥9 baseline T2 lesions compared with anti-JCV 

Ab– patients (98% vs. 93%; P = .021). Natalizumab treatment 

effect was similar between patients who were anti-JCV 

Ab– and Ab+ at baseline with respect to clinical (12-week 

progression, P = .858, 24-week progression, P = .671; ARR, 

P = .957; time to first relapse, P = .629) and MRI parameters 

(new or enlarging T2 lesions, P = .131; Gd+ lesions, P = 

.883). Conclusion: Natalizumab efficacy in this patient 

subset from the AFFIRM study did not differ by baseline anti- 

JCV status. Large clinical studies are ongoing to assess the 

incidence of PML in anti-JCV Ab– and Ab+ patients and to 

determine the utility of anti-JCV Ab testing in PML risk stratification 

of natalizumab-treated MS patients. 

Disclosure: Christophe Hotermans: Biogen Idec (salary). Meena Subramanyam: 

Biogen Idec (salary). Amy Pace: Biogen Idec (salary). James 

Potts: Biogen Idec (salary). 


S46 

ANATOMICAL SPECIFICITY OF DIFFUSION TENSOR 

IMAGING AND THE TIMED 25-FOOT WALK 

Daniel Ontaneda, 1 Ken Sakaie, 2 Xiaofeng Wang, 3 Jian Lin, 2 Thomas Cronin, 1 

Michael D. Phillips, 2 Mark J. Lowe, 2 Robert J. Fox 1 

1 Mellen Center, Cleveland Clinic, Cleveland, OH; 2 Department of Radiology, 

Cleveland Clinic, Cleveland, OH; 3 Quantitative Health Sciences, Cleveland 

Clinic, Cleveland, OH

Posters 

Background: Diffusion tensor imaging (DTI) is useful in the 

detection of white matter demyelination as well as axon loss 

in patients with multiple sclerosis (MS). The Timed 25-Foot 

Walk (T25FW) has been used as a marker of efficacy in 

clinical trials. The correlation between DTI metrics and clinical 

outcomes is of relevance if DTI is to be used as a surrogate 

marker in clinical trials. Although some studies have evaluated 

the functional relevance of DTI, the anatomical specificity 

of physiological correlates with DTI has received little 

attention. The aim of this study was to correlate neurologic 

function with DTI metrics in directly related and relatively 

less related anatomical regions. Objectives: To correlate 

changes in DTI metrics from different anatomical regions with 

the T25FW over a 1-year period. Methods: Nine patients 

with relapsing-remitting multiple sclerosis (RRMS) underwent 

serial imaging at 0, 6, and 12 months after starting natalizumab 

therapy. T25FW was recorded for each patient within 

±1 month of magnetic resonance imaging (MRI) acquisition. 

Regions of interest (ROIs) were outlined in the physiologically 

relevant corticospinal (CS) tracts. ROIs were also drawn in 

the corpus callosum (CC) and centrum semiovale (CSO) as 

similar highly organized fiber bundles with relatively less 

physiological relationship to ambulation. Average values 

within each anatomical area of interest were derived for fractional 

anisotropy (FA), mean diffusivity (MD), transverse diffusivity 

(TD), and longitudinal diffusivity (LD). Linear regression 

models were obtained using T25FW and DTI metrics from the 

different anatomical regions. Results: Cross-sectional analysis 

showed a statistically significant relationship between 

baseline DTI metrics and T25FW in CS tracts. Slower T25FW 

times were associated with lower FA (P = .001), higher MD 

(P = .003), and higher TD (P < .001). No significant correlations 

were found between T25FW and DTI metrics in the CC 

or CSO. Longitudinal data over 1 year will be presented. 

Conclusion: We observed a significant correlation between 

the T25FW and DTI parameters in the CS tracts, but not 

in the CC or CSO. The results demonstrate the anatomical 

specificity of DTI in relation to neurologic function using an 

established clinical outcome measure. This study supports the 

relevance of DTI as a clinically meaningful surrogate marker 

for clinical trials in MS. 

Disclosure: Daniel Ontaneda: Nothing to disclose. Ken Sakaie: Nothing 

to disclose. Xiaofeng Wang: Nothing to disclose. Jian Lin: Nothing to 

disclose. Thomas Cronin: Nothing to disclose. Michael D. Phillips: Nothing 

to disclose. Mark J. Lowe: Nothing to disclose. Robert J. Fox: Biogen 

Idec, Novartis, Genetech, Teva Neuroscience (consulting fees). 

Keywords: Imaging and MS 

S47 

ANXIETY IN RELAPSING MULTIPLE SCLEROSIS 

AND PATIENTS’ EXPERIENCE WITH A NEW 

AUTOINJECTOR 

Virginia Devonshire, 1 Anthony Feinstein, 2 Patrick Moriarty, 3 Carmen Enciu 3 

1 Department of Neurology, University of British Columbia, Vancouver, BC, 

Canada; 2 Department of Psychiatry, University of Toronto, Sunnybrook 

Health Sciences Centre, Toronto, ON, Canada; 3 Medical Affairs, EMD Serono, 

Mississauga, ON, Canada 

Background: Adherence to medication is critical for optimal 

multiple sclerosis (MS) management. Available diseasemodifying 

drugs require frequent parenteral administration, 

often a challenge for patients. Injection anxiety remains a 


32 

barrier to medication adherence. Objectives: To evaluate 

longitudinal changes in injection anxiety and assess patients’ 

experience with a new electronic device for self-injection 

of subcutaneous (SC) interferon beta-1a (IFNβ-1a), 44 µg 

3 times weekly (tiw), in subjects with relapsing MS (RMS). 

Methods: Interim analysis from an observational, 96-week, 

phase 4 study primarily evaluating treatment adherence 

when using a new electronic device for self-injection of SC 

IFNβ-1a in patients with RMS. We assessed anxiety symptoms 

using the Hospital Anxiety and Depression (HAD) scale 

and State-Trait Inventory (STAI); a 16-item RebiSmart Patient 

Experience Questionnaire (PEQ) evaluated patients’ experience 

with the device. We used continuous descriptives by 

visit (baseline, week 12, week 24) for HAD and STAI scores 

and qualitative assessment of responses to PEQ. Results: A 

total of 91 patients enrolled: 75.6% female, mean (SD) age, 

37.2 (9.8) years; mean (SD) HAD Anxiety subscale score, 

6.8 (3.7), 5.8 (4.1), and 6.5 (4.3) at baseline and weeks 12 

and 24, respectively. The mean (SD) change from baseline 

to week 24 in HAD Anxiety subscale score was –0.5 (4.4); 

median, –1.0. The mean (SD) STAI S-Anxiety score was 

40.3 (11.6), 35.3 (12.2), and 37.6 (13.0) at baseline and 

weeks 12 and 24, respectively. The mean (SD) change in 

STAI S-Anxiety from baseline to week 24 was –3.0 (11.1); 

median, –3.0. The mean baseline anxiety scores were higher 

than norms and decreased by week 24, approaching norm 

values for healthy working adults in their respective age 

groups. Of the 16 questions of the PEQ, the item related to 

injection anxiety showed notable changes: “Fear of self-injection” 

(question 7) decreased over time; the mean (SD) change 

in “fear of self-injection” from baseline to week 24 was –0.7 

(1.3); median, –1.0. Conclusion: Anxiety symptoms in MS 

patients using a new electronic device for self-injection of 

SC IFNβ-1a tiw decreased from baseline over the first 24 

weeks of treatment. Enhanced technology (adjustable comfort 

settings, concealed needle) may aid with injection anxiety, 

improve self-injection experience, and promote better adherence 

to therapy. 

Disclosure: Virginia Devonshire: Nothing to disclose. Anthony Feinstein: 

Nothing to disclose. Carmen Enciu: EMD Serono (salary). 

Keywords: Disease-modifying treatment in MS, Nursing management 

in MS, Quality of life in MS 

S48 

BARIATRIC SURGERY FOR MULTIPLE SCLEROSIS– 

RELATED OBESITY: TWO CASE REPORTS AND 

ANALYSIS OF THE OBESITY BURDEN IN MULTIPLE 

SCLEROSIS 

Heidi Maloni, 1 William J. Culpepper, 2 Christopher Bever, 3 Walter Royal, 3 

Mitchell Wallin 1,3 

1 Neurology, VA MSCoE-East/Georgetown University, Washington, DC; 

2 Pharmacy, VA MSCoE-East/University of Maryland, Baltimore, MD; 

3 Neurology, VA MSCoE-East/University of Maryland, Baltimore, MD 

Background: The obesity epidemic in the United States 

continues to increase, with most states reporting general 

population rates of 20% or more. Mirroring these trends, 

obesity prevalence in patients with multiple sclerosis (MS) 

ranges between 20% and 25%. Approaches to treat MSrelated 

obesity have received limited attention. Objectives: 

1) Evaluate bariatric surgery as an intervention for obesity 

in MS. 2) Examine time trends in obesity in a large national

sample of patients with MS. Methods: Two cases of MSrelated 

obesity successfully treated with bariatric surgery 

are reviewed, and MS-related obesity trends in the Veterans 

Health Administration are examined over time. Results: A 

46-year-old male and a 56-year-old female, both with secondary 

progressive MS and obesity, underwent bariatric surgery 

in 2010 for weight loss. Both patients were wheelchairbound 

(Expanded Disability Status Scale [EDSS] score >7.0) 

and had not responded to traditional weight-loss techniques, 

including exercise programs, over many years. Surgery was 

successful in both patients, with a dramatic loss of weight in 

the initial 3 months and an improvement in comorbid health 

conditions. The burden of increasing weight and obesity is 

examined in the VA MS population over the last decade. 

Conclusion: Bariatric surgery can be successfully utilized 

in patients with MS and obesity. Evaluation of obesity in the 

clinical setting along with risk factors and comorbid disease 

will be discussed. 

Disclosure: Heidi Maloni: North American Association of Medical 

Accreditation Council for Continuing Education, Professional Resources 

in Medical Education (salary); Acorda Pharmaceuticals Medical Advisory 

Board (honoraria). William J. Culpepper: Nothing to disclose. 

Christopher Bever: Hematogenous Stems in Cell Replacement Therapy 

(intellectual property rights). Walter Royal: Biogen Idec, EMD Serono 

(consulting fees); Teva, Novartis, Genzyme, Actilion (other financial 

benefits). Mitchell Wallin: Nothing to disclose. 

Keywords: Comprehensive care and MS, Natural history of MS, Symptomatic 

treatment of MS 

S49 

BENEFITS OF FINGOLIMOD IN PATIENTS WITH 

ACTIVE MULTIPLE SCLEROSIS DESPITE PRIOR 

TREATMENT 

Pierre Duquette, 1 Jeffrey A. Cohen, 2 Ludwig Kappos, 3 Gordon Francis, 4 Dejun 

Tang, 5 Benjamin Eckert 5 

1 CHUM – Hospital Notre-Dame, Montreal, QC, Canada; 2 Neurological 

Institute, Cleveland Clinic Foundation, Cleveland, OH; 3 Neurology and 

Department of Biomedicine, University Hospital, Basel, Switzerland; 4 Novartis 

Pharmaceuticals Corporation, East Hanover, NJ; 5 Novartis Pharma AG, Basel, 

Switzerland 

Background: In the TRANSFORMS phase 3 study, fingolimod 

(FTY720) reduced annualized relapse rate and 

inflammatory magnetic resonance imaging lesion activity at 

1 year versus intramuscular (IM) interferon beta-1a (IFNβ-1a), 

with efficacy in both treatment-naive patients and patients 

previously treated with a disease-modifying therapy (DMT). 

Because treatment options are particularly limited in patients 

with high disease activity despite prior DMT, the efficacy of 

fingolimod in this patient subset was assessed. Objectives: 

To evaluate the efficacy of fingolimod and IFNβ-1a with 

respect to disease activity in patients with highly active multiple 

sclerosis (MS) despite previous DMT. Methods: Patients 

with relapsing-remitting MS were randomized to daily fingolimod 

0.5 mg or 1.25 mg or weekly IM IFNβ-1a 30 µg for 

12 months. In a 12-month extension, patients continued on 

the same dose of fingolimod or were re-randomized from 

IFNβ-1a to fingolimod 0.5 mg or 1.25 mg. The cohort analyzed 

here included patients who received ≥1 DMT (IFNs, 

glatiramer acetate, or natalizumab) in the year prior to study. 

High disease activity was defined as ≥1 relapse in the previous 

year and ≥1 gadolinium-enhancing lesion at the time of 

assessment. Results: At baseline, the proportions of patients 


33 

Posters 

with high disease activity who received DMT in the previous 

year were similar across groups (fingolimod 0.5 mg: 30.4% 

[66/217]; fingolimod 1.25 mg: 25.5% [53/208]; IFNβ- 

1a: 34.1% [72/211]). After 1 year, high disease activity 

persisted for 1.6% [3/191] and 1.2% [2/170] of patients 

treated with fingolimod 0.5 mg and 1.25 mg, respectively, 

and 12.1% (21/173) of patients receiving IFNβ-1a. In the 

extension study, high disease activity rates remained low 

in patients treated with fingolimod for a second year (0.5 

mg: 2.0% [3/152]; 1.25 mg: 1.5% [2/134]). In patients 

changed from IFNβ-1a to fingolimod 0.5 mg, the proportion 

of patients with high disease activity decreased from 

13.7% to 3.0% during the second year, with comparable 

decreases observed with the change to fingolimod 1.25 mg. 

Conclusion: A common reason for changing patients to 

an alternative MS therapy is continued disease activity. In 

TRANSFORMS, fingolimod treatment reduced the proportion 

of patients with high disease activity despite previous DMT. 

Supported by: Novartis Pharma AG, Basel, Switzerland 

Disclosure: Pierre Duquette: Biogen Idec (consulting fee); EMD Serono, 

Teva, Biogen Idec, Novartis, Serono Symposia (honoraria); Teva, 

Biogen Idec (other financial benefits). Jeffrey A. Cohen: Biogen Idec, 

Elan, Lilly, Novartis, Teva (consulting fees). Ludwig Kappos: Actelion, 

Advancell, Allozyne, BaroFold, Bayer Health Care Pharmaceuticals, 

Bayer Schering Pharma, Bayhill, Biogen Idec, BioMarin, CLC Behring, 

Elan, Genmab, Genmark, GeNeuro SA, GlaxoSmithKline, Lilly, Merck 

Serono, MediciNova, Novartis, NovoNordisk, Peptimmune, Sanofi- 

Aventis, Santhera, Roche, Teva, UCB, Wyeth, Swiss MS Society, Swiss 

National Research Foundation, European Union, Gianni Rubatto, 

Novartis and Roche Research Foundations (other financial benefits). 

Gordon Francis: Novartis (salary). Dejun Tang: Novartis (salary). Benjamin 

Eckert: Novartis (salary). 


S50 

CAN ALEFACEPT INDUCE MULTIPLE SCLEROSIS? 

Evanthia Bernitsas 

Neurology, University of Michigan, Ann Arbor, MI 

Background: The correlation of tumor necrosis factor 

(TNF) inhibitors with multiple sclerosis (MS) is well known. 

Alefacept, a biologic response modifier, is highly effective 

in the treatment of psoriasis. Its mechanism of action does 

not involve blockage of TNF. Alefacept is a human receptor– 

antibody fusion protein, which binds to complement domain 

(CD)2 on activated memory T lymphocytes. Objectives: To 

describe the possible induction of MS during use of alefacept 

for severe psoriasis. Methods: Case report. Results: 

A 55-year-old man with history of long-standing psoriasis 

resistant to topical steroids presented with new-onset diplopia 

and difficulty ambulating in November 2009. His psoriasis 

was well controlled with injections of alefacept over the last 2 

years. Neurologic examination was significant for mild weakness 

in the lower extremities. Magnetic resonance imaging 

(MRI) scan of the brain showed T2 and FLAIR hyperintensities 

consistent with MS, including Dawson’s fingers. There was 

one enhancing lesion in the splenium of corpus callosum. 

MRI scans of the spinal cord and cerebrospinal fluid (CSF) 

analysis were negative for demyelination. His symptoms 

improved dramatically after a 5-day course of intravenous steroids. 

At this time, alefacept was discontinued. Baseline MRI 

scan was carried out for evaluation of new-onset headaches

Posters 

in July 2009. It was normal. In April 2010, he developed 

paresthesias in his fingers and toes. Neurologic examination 

showed decreased pinprick and light touch distally. Repeat 

MRI scan of the brain showed progression of the white matter 

disease. No enhancing lesions were identified. Repeat spinal 

MRI scans were normal. Treatment with disease-modifying 

agents was declined. Fourteen months after discontinuation 

of alefacept, the patient remains stable with no relapses. 

Repeat annual MRI scan showed no interval progression. 

Conclusion: This case demonstrates a possible association 

between alefacept and the development of MS, not previously 

described. In order to establish this association, further 

investigation is needed. Although a causal association is not 

conclusive, close monitoring of patients on alefacept is recommended. 

In patients with an established diagnosis of MS, 

discontinuation of alefacept seems reasonable. 

Disclosure: Biogen, Teva (consulting fees); Serono, Novartis (honoraria) 

Keywords: Etiology of MS, Comprehensive care and MS 

S51 

CEREBRAL TOXOPLASMOSIS FOLLOWING 

NATALIZUMAB TREATMENT IN MULTIPLE SCLEROSIS 

Samuel F. Hunter, 1 Joseph R. Berger, 2 Mary Jean Fanelli, 3 Lee Karlsson, 1 Heli 

Hunter, 1 Susanna Hunter, 1 Judith Ann Ferry 4 

1 Advanced Neurosciences Institute, Franklin, TN; 2 Neurology, University of 

Kentucky College of Medicine, Lexington, KY; 3 Biogen Idec, Cambridge, MA; 

4 Hematopathology, Massachusetts General Hospital, Boston, MA 

Background: Central nervous system toxoplasmosis has 

not been previously associated with multiple sclerosis (MS). 

Objectives: Describe an unusual opportunistic brain infection 

following natalizumab administration. Methods: Case 

report. Results: A 42-year-old disabled farmer with severe 

relapsing MS was followed from 2004, with onset of neurologic 

symptoms in 1991 including dysarthria, dysphagia, 

and gait ataxia. In 2006 he underwent a complete resection 

of a squamous cell carcinoma of the lung and received 

one cycle of paclitaxel adjuvant chemotherapy, with no 

evident residual disease and chronic mild thrombocytopenia. 

Despite interferon beta-1a (IFNβ-1a) three times weekly, he 

had marked magnetic resonance imaging (MRI) enhancement 

and three relapses yearly. He started natalizumab 

therapy in March 2008. After a sixth dose of natalizumab, 

he presented with slowly progressive cognitive dysfunction, 

profound fatigue, severe dysphagia, worsening gait 

ataxia, and partial complex seizures. MRI showed a large, 

3 × 4-cm space-occupying, necrotic, ring-enhancing lesion 

of the temporal lobe with extensive right hemisphere edema 

and 20 ring-enhancing cerebral lesions. Cerebrospinal fluid 

(CSF) studies were negative for JC virus by polymerase chain 

reaction (PCR), and protein was 200 mg/dL without pleiocytosis. 

Stereotactic brain biopsy found necrosis and a positive 

immunostain for Toxoplasma. He was treated with plasmapheresis, 

dexamethasone, pyrimethamine, sulfadiazine, 

and oxcarbazepine. Toxoplasma serologies were negative 

several times, and CD4 count exceeded 200/mm 3 . After 1 

month, MRI demonstrated a 75% decrease in enhancement. 

The patient exhibited pseudobulbar affect, severe dysarthria, 

and gait ataxia requiring a walker. MRI showed continual 

improvement, and he started on IFNβ-1b. In March 2009 

a relapse with encephalopathy and apraxia occurred, but 

MRI showed further improvement of toxoplasmosis abscess 


34 

and MS-type ring enhancement. By 1 year afterward, the 

abscess had resolved, and ring-enhancing lesions typical 

of MS showed modest improvement. Conclusion: To our 

knowledge, cerebral toxoplamosis has not previously been 

seen in an immunocompetent person with MS. This extraordinary 

central nervous system infection was likely due in part 

to organ-specific immunocompromise associated with natalizumab 

infusion. 

Disclosure: Samuel F. Hunter: Biogen Idec, Bayer Healthcare, Serono- 

Pfizer, Teva Neuroscience, Acorda Therapeutics (honoraria); Eli Lilly 

(other financial benefit). Joseph R. Berger: Bayer Healthcare, Biogen 

Idec, Teva, EMD Serono, Asphelia, Astellas, Genentech, GlaxoSmith- 

Kline, Millenium, Pfizer, Perseid (consulting fees); EMD Serono, Bayer, 

Biogen Idec (other financial benefits). Mary Jean Fanelli: Biogen Idec 

(salary). Lee Karlsson: Nothing to disclose. Heli Hunter: Bayer Healthcare 

(honoraria). Susanna Hunter: Nothing to disclose. Judith Ann 

Ferry: Nothing to disclose. 

Keywords: Disease-modifying treatment in MS, Imaging and MS, 

Immunology and MS 

S52 

CLINICAL OUTCOMES IN PATIENTS WITH HIGHLY 

ACTIVE MULTIPLE SCLEROSIS TREATED WITH 

FINGOLIMOD 

Marcelo Kremenchutzky, 1 Peter Calabresi, 2 Paul W. O’Connor, 3 Reinhold 

Hohlfeld, 4 Ernst-Wilhelm Radue, 5 Ludwig Kappos, 5 Jeffrey Cohen, 6 Lixin 

Zhang-Auberson, 7 Catherine Agoropoulou, 7 Bingbing Li, 7 Philipp von 

Rosenstiel 7 

1 University of Western Ontario, London, ON, Canada; 2 Johns Hopkins 

Hospital, Baltimore, MD; 3 St. Michael’s Hospital, Toronto, ON, Canada; 

4 Institute für Klinische Neuroimmunologie, Munich, Germany; 5 Neurology 

and Department of Biomedicine, University Hospital, Basel, Switzerland; 

6 Neurological Institute, Cleveland Clinic Foundation, Cleveland, OH; 7 Novartis 

Pharma AG, Basel, Switzerland 

Background: Fingolimod (FYT720) significantly reduced 

annualized relapse rate (ARR) compared with the approved 

first-line therapy intramuscular (IM) interferon beta-1a (IFNβ- 

1a) once weekly and placebo (PBO) in the TRANSFORMS 

and FREEDOMS studies. Objectives: To assess the effects 

of fingolimod on ARR in patients with highly active multiple 

sclerosis (MS) in the TRANSFORMS and FREEDOMS studies. 

Methods: In TRANSFORMS, patients with relapsing-remitting 

multiple sclerosis (RRMS) were randomized to receive 

fingolimod 0.5 mg or 1.25 mg daily or IM IFNβ-1a 30 µg 

weekly for 12 months. In FREEDOMS, patients with RRMS 

were randomized to receive once-daily fingolimod 0.5 mg 

or 1.25 mg or matching PBO for 24 months. Highly active 

MS was defined as ≥2 relapses in the year before study 

and ≥1 gadolinium-enhancing lesion at baseline. ARR was 

analyzed using negative binomial regression models adjusted 

for treatment, the subgroup indicator, and treatment by subgroup 

interaction in the intent-to-treat population. Results: 

TRANSFORMS: Of the 1292 randomized patients, 184 had 

highly active MS at baseline (fingolimod 0.5 mg, n = 56; 

fingolimod 1.25 mg, n = 63; IFNβ-1a, n = 65). In the highly 

active MS subgroup, the ARR at 12 months was 0.27 (95% 

confidence interval [CI], 0.15-0.47) in the fingolimod 0.5 mg 

group and 0.37 (95% CI, 0.23-0.60) in the fingolimod 1.25 

mg group versus 0.56 (95% CI, 0.38-0.83) in the IFNβ-1a 

group, translating to 52% and 34% reductions in ARR versus 

IFNβ-1a for fingolimod 0.5 mg and 1.25 mg, respectively (P 

< .05 for fingolimod 0.5 mg vs. IFNβ-1a). FREEDOMS: Of 

the 1272 randomized patients, 208 had highly active MS at

aseline (fingolimod 0.5 mg, n = 77; fingolimod 1.25 mg, 

n = 68; PBO, n = 63). In the highly active MS subgroup, 

the ARR at 24 months was 0.35 (95% CI, 0.25-0.48) in the 

fingolimod 0.5 mg group and 0.33 (95% CI, 0.23-0.47) in 

the fingolimod 1.25 mg group versus 0.93 (95% CI, 0.70- 

1.23) with PBO, translating to 63% and 65% reductions 

in ARR versus PBO for fingolimod 0.5 mg and 1.25 mg, 

respectively (P < .001 for both comparisons). Conclusion: 

In TRANSFORMS and FREEDOMS, fingolimod consistently 

reduced ARR versus IFNβ-1a and PBO in patients with highly 

active MS. 


Disclosure: Marcelo Kremenchutzky: MS Society of Canada (other 

financial benefit); endMS Research and Training Network, Research 

Scientific Foundation, MS Society of Canada, Bayer, Berles, Bio-MS, 

Biogen Idec, Boehringer-Ingelheim, Bristol-Myers Squibb, Elan, EMD 

Serono, Eli Lilly, Genzyme, GSK, GW, Novartis, PDL, Parexel, Quintiles, 

Roche, Sanofi-Aventis, Schering, Teva, UCB Pharma (consulting 

fees). Peter Calabresi: Teva, EMD Serono, Biogen, Novartis (consulting 

fees); Teva, EMD Serono, Biogen, Novartis, Vertex, Bayer, Abbott (other 

financial benefits). Paul W. O’Connor: Novartis, Sanofi-Aventis, Roche, 

Biogen Idec, Bayer, EMD Serono, Teva Neurosciences, Eli Lilly, Opexa 

Therapeutics, Celgene, Glenmark, Actelion (consulting fees); Biogen 

Idec, EMD Serono, Novartis (honoraria). Reinhold Hohlfeld: Novartis, 

Biogen Idec, Merck Serono, Teva, Sanofi-Aventis, Bayer (consulting fees); 

Novartis, Biogen Idec, Merck Serono, Teva, Sanofi-Aventis (honoraria); 

Novartis, Biogen Idec, Merck-Serono, Teva, Sanofi-Aventis, Bayer (other 

financial benefits). Ernst-Wilhelm Radue: Actelion, Bayer Schering, Biogen 

Idec (other financial benefits). Ludwig Kappos: Actelion, Advancell, 

Allozyne, BaroFold, Bayer HealthCare Pharmaceuticals, Bayer Schering 

Pharma, Bayhill, Biogen Idec, BioMarin, CLC Behring, Elan, Genmab, 

Genmark, GeNeuro SA, GlaxoSmithKline, Lilly, Merck Serono, 

MediciNova, Novartis, Novo Nordisk, Peptimmune, Sanofi-Aventis, 

Santhera, Roche, Teva, UCB, Wyeth, Swiss MS Society, Swiss National 

Research Foundation, European Union, Gianni Rubatto, Novartis and 

Roche Research Foundations (other financial benefits). Jeffrey Cohen: 

Biogen Idec, Elan, Lilly, Novartis, Teva (consulting fees). Lixin Zhang- 

Auberson: Novartis (salary). Catherine Agoropoulou: Novartis (salary). 

Bingbing Li: Novartis (salary). Philipp von Rosenstiel: Novartis (salary). 


S53 

COMORBID ILLNESS AMONG INDIVIDUALS WITH 


Amy Phillips, 1 Michelle Stewart, 2 Natalie Edwards, 3 Shaloo Gupta, 4 Amir 

Goren 4 

1 Health Outcomes and Market Access, EMD Serono, Inc, Rockland, MA; 

2 Outcomes Research, Pfizer, Inc, New London, CT; 3 Health Services Consulting 

Corporation, Boxborough, MA; 4 Health Sciences Practice, Kantar Health, New 

York, NY 

Background: Comorbidities in individuals with multiple 

sclerosis (MS) add to the complexity of disease management. 

A better understanding of the nature and prevalence 

of comorbid illness in MS may improve patient outcomes. 

Objectives: The objective of this research was to gain 

a better understanding of the comorbid illnesses present 

in individuals with MS compared with individuals without 

MS. Methods: The National Health and Wellness Survey 

(NHWS) is an Internet-based annual study of the health-care 

attitudes and behaviors of a US representative adult sample. 

Demographics and comorbidities were compared between 

individuals with diagnosed MS and individuals without MS. 

Results: Compared with subjects without MS, a greater proportion 

of subjects with MS reported being female (64.3% vs. 


35 

Posters 

51.3%; P < .001) and being white (non-Hispanic) (78.7% vs. 

74.0%; P = .006). Subjects with MS reported more comorbidity 

compared with subjects without MS (Charlson Comorbidity 

Index: 0.97 vs. 0.82; P < .001). Neurologic symptoms 

and conditions (pain 56.7% vs. 37.8%, headache 55.8% vs. 

44.6%, migraine 29.5% vs. 16.4%, restless leg syndrome 

18.7% vs. 7.8%, stroke 5.2% vs. 1.4%; P < .001), and 

psychiatric symptoms and conditions (sleep difficulties 43.3% 

vs. 29.6%, depression 39.7% vs. 23.5%, anxiety 33.0% vs. 

22.6%, insomnia 28.5% vs. 17.8%, panic disorder 8.2% 

vs. 3.6%; P < .001) were more common in subjects with 

MS compared with those without MS. Rates for hypertension 

(33.6% vs. 32.8%; P = .968) and high cholesterol (32.3% 

vs. 30.9%; P = .669) were similar, but cardiovascular conditions 

such as angina (4.8% vs. 2.9%; P < .001), arrhythmia 

(4.8% vs. 2.7%; P = .003), and peripheral arterial disease 

(3.7% vs. 1.4%; P < .001) were higher for MS subjects. 

Conclusion: As expected, individuals with MS have significant 

comorbid illness compared with individuals without MS. 

Neurologic and psychiatric conditions and symptoms are 

common and typically more prevalent in MS. Cardiovascular 

risk factors are similar to individuals without MS, but higher 

rates of cardiovascular conditions were observed. 

Disclosure: Amy Phillips: EMD Serono, Inc (salary). Michelle Stewart: 

Pfizer, Inc (salary). Natalie Edwards: EMD Serono, Inc (consulting fee). 

Shaloo Gupta: EMD Serono, Inc, Pfizer, Inc (consulting fees). Amir 


Keywords: Comprehensive care and MS, Epidemiology of MS, Natural 

history of MS 

S54 

CONVENTIONAL BRAIN MAGNETIC RESONANCE 

IMAGING IN NEUROMYELITIS OPTICA 

Jose A. Cabrera-Gomez, 1 Ilya Kister 2 

1 Neurology, Cuban Multiple Sclerosis Society, Havana, Cuba; 2 Neurology, 

NYU Multiple Sclerosis Center, New York, NY 

Background: Numerous case series have demonstrated 

that lesions on brain magnetic resonance imaging (MRI) are 

common in neuromyelitis optica (NMO), but there has not 

yet been an attempt to survey and synthesize the literature on 

neuroradiology of brain findings in NMO. Objectives: To 

review the studies on conventional brain MRI in NMO and to 

propose to incorporate characteristic brain MRI lesions into 

the diagnostic criteria of NMO. Methods: We searched for 

articles on conventional brain MRI in NMO from December 

2004 to 2010 in EBSCO, EMBASE, PubMed/Medline, Science 

Citation Index, and SCOPUS. Results: Brain abnormalities 

are seen in the majority of NMO patients as disease 

duration increases. Brain MRI lesions are rarely symptomatic 

in adults but frequently symptomatic in children. Aquaporin 

4 (AQP4) seropositivity appears to increase the likelihood 

of detecting brain lesions. A significant minority of NMO 

patients meet Barkhof, Paty, or Swanton criteria for multiple 

sclerosis (MS), and these criteria should not be relied on to 

exclude NMO diagnosis. Lesions characteristic of NMO are 

described and catalogued. Conclusions: Brain lesions in 

NMO are a consistent feature of the disease in multiple case 

series. International consensus criteria are needed for brain 

findings in NMO analogous to the existing criteria for MS. 


Keywords: Imaging and MS

Posters 

S55 

CREATING SYNERGY—MATCHING COMMUNITY 

NEED WITH ORGANIZATIONAL DIRECTIONS 

Nigel Cooper 

MS Society of South Australia, Adelaide, SA, Australia; Client Services, MS 

Society of SA and NT, Adelaide, SA, Australia 

Background: The provision of community services to 

people with multiple sclerosis (MS) is based on several factors. 

These include government health policy and planning, 

consumer-perceived need, identified consumer unmet need, 

and finally the vision, barriers, and enablers of the MS Society 

itself. These barriers and enablers can include financial 

restrictions, policy and procedural issues, vision, and mission. 

Creating a synergy of services that meets both consumer and 

organizational needs/requirements can be complex, difficult, 

and controversial but also exciting and innovative. A true synergy 

not only will improve health outcomes for people with 

MS but may also ensure relevance and longevity for the organization 

itself. Objectives: The objectives of this presentation 

are to a) outline the importance and relevance of matching 

organizational outcomes with client need; b) discuss the 

many pressures on an organization to meet the requirements 

of funding bodies, government health policy, and the organization’s 

own policies and beliefs, while at the same time 

managing a budget and meeting client needs; c) stress the 

importance of consumer participation in organizational decision 

making; d) highlight the dangers of a perceived lack of 

relevance by the MS population of a service provider; and 

e) stress the importance for organizations to remain flexible, 

dynamic, and in touch with health policy, research outcomes, 

and MS community issues. Methods: This presentation was 

developed as a thought-provoking and “controversial” session 

for the National Australian MS Conference–MSNA. It 

was well received and was awarded best presentation at 

the conference. Results: As above. Conclusion: Many 

community-based organizations struggle with meeting the 

demand for services placed upon them by people with MS, 

the society’s own belief in where services should be provided, 

and the ever-changing face of MS management and 

research. However, the importance of listening to consumers 

and strategically thinking ahead cannot be understated. With 

the current rapidly changing environment that service providers 

are currently working in, the pressure to meet consumer 

needs/demands and relevance is higher than ever. Synergy 

can be achieved but requires intense organizational reflection, 

sometimes restructuring, but definitely an acceptance of 

the need to be dynamic and ever-evolving. 


Keywords: Service delivery in MS, Economic issues and MS, Comprehensive 


S56 

DECLINE IN MOTOR PREDICTION IN MULTIPLE 

SCLEROSIS SUBJECTS: UPPER-LIMB MENTALLY 

SIMULATED MOTOR ACTIONS AND IMPLICATIONS 

IN PHYSICAL THERAPY 

Giampaolo Brichetto, 1 Ludovico Pedullà, 2 Andrea Tacchino, 2 Mario Alberto 

Battaglia, 1 Marco Bove 2 


Genova, Italy; 2 Department of Experimental Medicine, University of Genova, 

Genova, Italy 


36 

Background: Motor imagery is a state of mental rehearsal 

during which a subject replicates a motor action without 

moving limbs. Internal simulation of single movements has 

been shown to recruit neural networks overlapping with 

those activated during overt movement performance. Multiple 

sclerosis (MS) patients at an early stage of the disease 

could have an impaired motor prediction. Objectives: In 

this study we investigated motor prediction in MS patients 

at a very early stage of the disease in order to compare 

it with that in healthy subjects and explored the implications 

for physical therapy. Methods: We recruited 10 MS 

patients at an early stage of the disease and 10 age-matched 

healthy control subjects. All MS subjects were recruited 

among those followed as outpatients at AISM Rehabilitation 

Centre, Italian Multiple Sclerosis Society, Genova, Italy. The 

experimental protocol took place in a motion-analysis room 

that was sound-attenuated, temperature-regulated, and illuminated 

with homogeneous white light. Upper-limb movements 

were recorded with the motion analyzer system “SMART” 

(Bioengineering Technology and System–BTS, Milan, Italy). 

Subjects had to perform with their upper limbs five cyclical 

pointing movements between targets of different sizes; spatial 

precision of the pointing movements and kinematic analysis 

were measured. For the imagined trials, subjects had to feel 

themselves performing the task. One single pointing movement 

was recorded for covert performance. Results: During 

overt movements healthy controls and MS subjects modulated 

movement duration according to the size of targets, with a 

decreased speed in MS subjects. This observation was also 

valid for the covert performance. Conclusion: This result 

suggests a decline of mental prediction of motor actions in 

MS patients at an early stage of the disease, suggesting that 

motor imagery practice may be effective in enhancing motor 

performance in patients with MS. 



S57 

DEVELOPMENT OF A DISEASE-ORIENTED 

ELECTRONIC FOLDER FOR MULTIPLE SCLEROSIS 

PATIENTS 

Jerry T. Loo, 1 Kevin C. Ma, 2 James F. Fernandez, 3 Lilyana Amezcua, 4 

Margaret Liu, 5 Brent J. Liu 3 

1 Keck School of Medicine, University of Southern California, Los Angeles, CA; 

2 Department of Biomedical Engineering, University of Southern California, Los 

Angeles, CA; 3 Department of Radiology, University of Southern California, Los 

Angeles, CA; 4 Department of Neurology, University of Southern California, 

Los Angeles, CA; 5 University of Southern California, Los Angeles, CA 

Background: The management of multiple sclerosis (MS) 

patients is challenging and complex with regard to medical 

history review and tracking of MS disease progression in 

daily clinical treatment, longitudinal research studies, and 

clinical trials. Current medical record systems lack the ability 

to connect clinical data to radiologic data, which is of utmost 

importance in MS care. Objectives: To develop a diseasecentric 

patient record system (eFolder system) that includes 

a graphical user interface (GUI); a comprehensive database 

that stores patient demographics, clinical data, and magnetic 

resonance imaging (MRI); and MS lesion computer-aided 

detection (CAD), including 3D lesion models. Methods: 

The MS eFolder system database was created using MySQL

(My Structured Query Language) and includes patient history, 

images, and CAD results along with anonymous patient 

demographic data. Detailed medical history, including environmental 

and genetic background, is stored for each patient 

record. A web-based GUI created using PHP: Hypertext 

Preprocessor (PHP) scripting language communicates with the 

database and allows the user to view clinical data, perform 

data mining, input patient records, scroll MR images, and 

view a 3D lesion model based on CAD results. Results: The 

MS eFolder system was successfully developed. Fifty anonymous 

patients have been entered into the database along 

with their imaging and CAD results data. Examples of using 

the eFolder system for tracking MS patients, clinical review, 

and data mining will be discussed and presented. Conclusion: 

The MS eFolder system is a comprehensive informatics 

tool that melds clinical data, imaging, and CAD results in 

order to support clinicians and researchers. As a web-based 

tool, the eFolder system is accessible and implementable in 

any part of the world with Internet access. The eFolder system 

has the potential to generate a personalized database that 

can prove useful in future clinical trials addressing the effect 

of targeted treatment to follow MS progression. 

Disclosure: Jerry T. Loo: Nothing to disclose. Kevin C. Ma: Nothing to 

disclose. James F. Fernandez: Nothing to disclose. Lilyana Amezcua: Biogen, 

Bayer, Teva, Serono (honoraria). Margaret Liu: Nothing to disclose. 

Brent J. Liu: Nothing to disclose. 

Keywords: Imaging and MS, Comprehensive care and MS 

S58 

DISCONTINUATION OF IMMUNOTHERAPIES IN 

MULTIPLE SCLEROSIS PATIENTS: DATA FROM 

NARCOMS 

Denise Campagnolo, 1,2 Tuula Tyry, 3,4 Jennifer Sun, 1 Xiaojun You, 1 Amber R. 

Salter, 4,5 Pamela Foulds 1 

1 Biogen Idec Inc, Weston, MA; 2 University of Arizona College of Medicine, 

Phoenix, AZ; 3 Barrow Neurological Institute, Saint Joseph’s Hospital and 

Medical Center, Phoenix, AZ; 4 CMSC–North American Research Committee on 

Multiple Sclerosis, Birmingham, AL; 5 University of Alabama at Birmingham, 

Birmingham, AL 

Background: Interferon beta (IFNβ) and glatiramer acetate 

(GA) are first-line therapies for the treatment of multiple sclerosis 

(MS) and are widely acknowledged to have similar 

efficacy. Patients discontinue or switch these therapies for 

many reasons, and understanding these behaviors may 

have an impact on informed treatment choices. Objectives: 

To assess the reasons for discontinuation of the following 

disease-modifying therapies (DMTs): intramuscular (IM) IFNβ- 

1a, subcutaneous (SC) IFNβ-1b, SC GA, and SC IFNβ-1a. 

Methods: The spring 2005 update of the North American 

Research Committee on MS (NARCOMS) database provided 

data on reasons for stopping therapy. A cross-sectional analysis 

of discontinuation reasons by category (efficacy, safety, 

tolerability, and burden) with and without adjustment for 

baseline age, disease duration, Patient-Determined Disease 

Steps, and gender was performed. More than one reason 

could be provided for discontinuation. Results: Treatment 

discontinuations were reported by 1956 patients treated with 

IM IFNβ-1a (n = 739), SC IFNβ-1b (n = 460), SC GA (n = 

555), or SC IFNβ-1a (n = 202). GA had the highest rates of 

discontinuation based on efficacy (46%) or burden (24%). 

The tolerability-based discontinuation rate was higher with 

SC IFNβ-1a (43%) than with the other DMTs (31–37%). SC 


37 

Posters 

IFNβ-1b had the highest discontinuation rate based on safety 

(38%), followed by SC IFNβ-1a (36%), GA (25%), and IM 

IFNβ-1a (22%). After adjusting for baseline characteristics, 

GA-treated patients were significantly more likely than IM 

IFNβ-1a-treated patients to discontinue MS therapy for reasons 

of burden (odds ratio [OR], 1.57; 95% confidence 

interval [CI], 1.21-2.05; P < .001) or efficacy (OR, 1.49; 

95% CI, 1.14-1.96; P = .004). Patients were significantly 

more likely to be motivated by safety concerns to discontinue 

SC IFNβ-1a (OR, 2.24; 95% CI, 1.63-3.07; P < .0001) or 

SC IFNβ-1b (OR, 2.10; 95% CI, 1.64-2.68; P < .0001) than 

IM IFNβ-1a. Tolerability was significantly more influential in 

stopping SC IFNβ-1a than IM IFNβ-1a (OR, 1.44; 95% CI, 

1.07-1.92; P = .015). Conclusion: The primary reason for 

MS therapy discontinuation was perceived lack of benefit. 

Unadjusted and adjusted analyses showed that patients who 

discontinued therapy were more likely to stop GA than IM 

IFNβ-1a for efficacy and burden reasons and more likely to 

stop SC IFNβ-1a or IFNβ-1b than IM IFNβ-1a for safety reasons. 

Disclosure: Denise Campagnolo: Biogen Idec (salary). Tuula Tyry: 

Acorda (consulting fee). Jennifer Sun: Biogen Idec (salary). Xiaojun You: 

Biogen Idec (salary). Amber R. Salter: Acorda (consulting fee). Pamela 

Foulds: Biogen Idec (salary). 

Keywords: Comprehensive care and MS, Disease-modifying treatment 

in MS, Quality of life in MS 

S59 

DISEASE COURSE IN HISPANICS WITH RELAPSING- 

REMITTING MULTIPLE SCLEROSIS 

Zulma M. Hernández, Bruce A. Cohen, Joy Derwenskus 

Neurology, Northwestern University, Chicago, IL 

Background: There is little published data characterizing 

relapsing-remitting multiple sclerosis (RRMS) in patients of 

Hispanic origin. Data comparing different ethnic groups has 

shown variation in relapse rate (eg, more active disease in 

African Americans compared with Caucasians). Recently 

published data have shown that pediatric Hispanic patients 

may have breakthrough disease on first-line therapy when 

compared with non-Hispanics, suggesting that the Hispanic 

population may also have more active disease. Objectives: 

To describe the relapse rate of Hispanics with RRMS treated 

with a first-line disease-modifying agent who presented to the 

Northwestern University MS clinic. Methods: A retrospective 

chart review of new patients from May 2005 to January 

2010 was conducted. Patients who self-identified as Hispanic, 

had a diagnosis of RRMS by McDonald criteria, and 

were treated either currently or in the past with any of the 

first-line disease-modifying treatments for at least 12 months 

were included in the study. Results: We identified 12 

patients who fulfilled the inclusion criteria. The female:male 

ratio was 3:1 (9 females and 3 males), with a mean age of 

36.8 years (range, 21–60 years), mean age of disease onset 

of 26 years (range, 14–54 years), mean Expanded Disability 

Status Scale (EDSS) score of 2.2 (range, 1–3.5 years), and 

median disease duration of 10 years (range, 5–42 years). 

There was a mean of 1.3 breakthrough attacks over 42.2 

months on disease-modifying treatment. The mean annual 

relapse rate was 0.54. Two patients in our cohort were 

switched between first-line agents because of a breakthrough 

attack on the first treatment. The mean duration from the first

Posters 

to second clinical event in 11 patients was 2.4 years. Conclusion: 

This study included a small cohort of Hispanics with 

RRMS. Hispanics in this group presented at earlier ages than 

Caucasians and African Americans. Although the numbers 

are small, the Hispanics in this cohort responded to first-line 

therapy. In the future we plan to collect a larger population of 

Hispanic patients with MS in order to better characterize their 

disease course and treatment response. 

Disclosure: Zulma M. Hernández: National Multiple Sclerosis Society 

award CF0060N-1 (other financial benefit). Bruce A. Cohen: Bayer, 

Biogen Idec, EMD Serono, Novartis, Sanofi-Aventis, Teva Neuroscience, 

Acorda, Astellis (consulting fees). Joy Derwenskus: Biogen Idec, Bayer, 

EMD Serono, Novartis, Pfizer, Teva Neurosciences (consulting fees). 

Keywords: Disease-modifying treatment in MS, Epidemiology of MS 

S60 

EARLY INTERFERON BETA-1A RESPONSE PREDICTS 

QUALITY OF LIFE BENEFIT 15 YEARS LATER IN 


Robert Bermel, 1 Bianca Weinstock-Guttman, 2 Dennis Bourdette, 3 Pamela 

Foulds, 4 Xiaojun You, 4 Richard Rudick 1 

1 Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland 

Clinic, Cleveland, OH; 2 Baird Multiple Sclerosis Center, Buffalo, NY; 3 Oregon 

Health & Science University, Portland, OR; 4 Biogen Idec Inc, Weston, MA 

Background: Current first-line disease-modifying therapies 

for multiple sclerosis (MS) are safe but variably effective. 

Rational selection of optimal therapy may be aided by early 

identification of patients more likely to have positive long-term 

outcomes on a given treatment. Objectives: To identify 

early predictors of long-term quality of life (QOL) benefits in 

treatment-naive patients initiated on intramuscular interferon 

beta-1a (IM IFNβ-1a). Methods: ASSURANCE was an 

open-label, multicenter, observational, non-treatment-regulated 

study of patients at 15 years who completed 2 years in 

the MS Collaborative Research Group trial of IM IFNβ-1a for 

relapsing MS. This study enrolled 136 patients: 62 originally 

randomized to IM IFNβ-1a and 57 to placebo completed 

QOL assessments. Criteria for early disease activity during 

the 2-year trial were defined as >1 relapse over 2 years or 

confirmed Expanded Disability Status Scale (EDSS) progression 

over 2 years (>1-point EDSS progression sustained for 

6 months). QOL was determined using the Short Form 36 

(SF-36) and a visual analogue scale (VAS) of self-care. Separate 

analyses were conducted for IM IFNβ-1a and placebo. 

Results: IM IFNβ-1a-treated patients without disability progression 

over the first 2 years (77%) had significantly better 

scores at 15 years on the SF-36 physical component score 

(PCS) (P = .011), SF-36 mental component score (MCS) (P = 

.031), and VAS (P = .009) compared with those experiencing 

early disability progression. IM IFNβ-1a-treated patients 

with ≤1 relapse during the 2-year trial (74%) also had significantly 

higher scores at 15 years than those with >1 relapse 

on the following scales: PCS (P = .004), physical functioning 

subscale (P = .004), role-physical subscale (P < .0001), 

general health subscale (P = .035), and social functioning 

subscale (P = .009). In contrast, for patients initially given 

placebo, relapse rates and progression status did not predict 

long-term QOL benefit. Conclusions: Early suppression of 

clinical disease activity by IM IFNβ-1a constitutes a marker 

of response to treatment that is associated with significant 

long-term QOL benefits. The same trend was not observed in 


38 

placebo patients; therefore, disease severity alone was not 

the driver of long-term QOL differences. These results provide 

supportive evidence that short-term responders to IM IFNβ-1a 

experience beneficial long-term outcomes. 

Disclosure: Robert Bermel: National Multiple Sclerosis Society (other 

financial benefit); Biogen Idec, Teva Neuroscience (consulting fees). 

Bianca Weinstock-Guttman: Biogen Idec, Teva Neuroscience, EMD 

Serono, Pfizer, Novartis (consulting fees); National Multiple Sclerosis 

Society, National Institutes of Health, ITN, Teva Neuroscience, Biogen 

Idec, EMD Serono, Aspreva, Acorda, Cognition (other financial benefits). 

Dennis Bourdette: Biogen Idec, Pfizer, Serono, Teva Neuroscience 

(honoraria); Berlex Laboratories, Biogen Idec, Pfizer, Serono, Teva Neuroscience 

(other financial benefits). Pamela Foulds: Biogen Idec (salary). 

Xiaojun You: Biogen Idec (salary). Richard Rudick: Biogen Idec, Bayhill 

Therapeutics, Millennium, Wyeth, Genzyme-Bayer, Pfizer (consulting 

fees); National Institutes of Health (National Institute of Neurological 

Disorders and Stroke and National Center for Research Resources) (other 

financial benefits); Informa Healthcare (royalty). 

Keywords: Disease-modifying treatment in MS, Quality of life in MS, 

Relapse management in MS 

S61 

EFFICACY OF CLADRIBINE TABLETS ACROSS 

VARIOUS PROGNOSTIC INDICATORS IN 

RELAPSING-REMITTING MULTIPLE SCLEROSIS 

Kottil Rammohan, 1 Giancarlo Comi, 2 Stuart Cook, 3 Gavin Giovannoni, 4 Peter 

Rieckmann, 5 Per Soelberg-Sorensen, 6 Patrick Vermersch, 7 Peter Chang, 8 

Bruno Musch, 8 Vissia Viglietta, 8 Steven Greenberg 8 

1 University of Miami, Miami, FL; 2 Institute of Experimental Neurology, 

University Vita-Salute IRCCS, H San Raffaele, Milan, Italy; 3 University of 

Medicine and Dentistry, New Jersey Medical School, Newark, NJ; 4 Blizard 

Institute of Cell and Molecular Science, Barts and the London School of 

Medicine and Dentistry, London, United Kingdom; 5 Bamberg Hospital, 

University of Erlangen, Bamberg, Germany; 6 Rigshospitalet, Copenhagen 

University Hospital, Copenhagen, Denmark; 7 University of Lille–Nord de 

France, Lille, France; 8 EMD Serono Inc, Rockland, MA 

Background: The CLARITY study showed that short-course 

annual therapy with cladribine tablets in patients with relapsing-remitting 

multiple sclerosis (RRMS) produced significant 

improvements in the annualized relapse rate (ARR), risk of 

sustained 3-month disability progression on the Expanded 

Disability Status Scale (EDSS), and active lesion measures 

assessed by magnetic resonance imaging (MRI). Here we 

report the reduction in ARR for subgroups of patients stratified 

by various baseline criteria known to predict clinical activity 

and disease progression. Methods: Efficacy was analyzed 

for subgroups from the intent-to-treat population of CLAR- 

ITY (437, 433, and 456 patients randomized to placebo or 

cladribine tablets, cumulative doses over 96 weeks of 3.5 or 

5.25 mg/kg, respectively). Stratifications included 1 relapse 

versus ≥2 relapses; 1 relapse plus either: baseline T2 lesion 

volume of ≥5 mL or

Gd+ lesion(s) on MRI (P = .017 and P < .001, respectively); 

44.4% and 48.1% for patients with 1 relapse and an EDSS 

score of ≥2.0 (both P = .002); and 45.0% and 57.5% for 

patients with prior treatment failure and/or intolerability (P = 

.001 and P < .001, respectively). Similarly, cladribine tablets 

therapy produced significant reductions in ARR relative to 

placebo for patients with 3.5), baseline number of gadolinium-enhancing lesions (0,

Posters 

≥1), age (≤40, >40 years), and sex (male, female). Within 

each subgroup, a Cox proportional hazards model, adjusted 

for treatment, country, baseline EDSS, and age, was used to 

compute hazard ratio (HR) and 95% confidence interval (CI). 

Results: In FREEDOMS, fingolimod 0.5 mg reduced the risk 

of disability progression confirmed after 3 months by 30% 

compared with placebo over 2 years (HR, 0.70; P = .024). 

Using the more stringent assessment of disability progression 

confirmed after 6 months, there was a 37% reduction in risk 

over 2 years for fingolimod 0.5 mg versus placebo (HR, 

0.63; P = .012). The risk of 3-month confirmed disability 

progression over 2 years was reduced by fingolimod 0.5 mg 

compared with placebo in previously untreated patients (HR, 

0.63; 95% CI, 0.41-0.95) and in patients who previously 

received a disease-modifying therapy (HR, 0.70; 95% CI, 

0.43-1.14). Fingolimod reduced the risk of disability progression 

regardless of baseline disease activity (ie, prior number 

of relapses, EDSS score, number of magnetic resonance 

imaging [MRI] lesions), age, and sex. Conclusions: In the 

FREEDOMS study, fingolimod reduced disability progression 

as measured using EDSS at 24 months overall as well as in 

patient subgroups according to baseline clinical and MRI disease 

activity and demographics. 


Disclosure: Gordon Francis: Novartis (salary). Peter Calabresi: Teva, 

EMD Serono, Biogen, Novartis (consulting fees); Teva, EMD Serono, 

Biogen, Novartis, Vertex, Bayer, Abbott (other financial benefits). 

Paul O’Connor: Novartis, Sanofi-Aventis, Roche, Biogen Idec, Bayer, 

EMD Serono, Teva Neurosciences, Eli Lilly, Opexa Therapeutics, Celgene, 

Glenmark, Actelion (consulting fees); Biogen Idec, EMD Serono, 

Novartis (honoraria). Reinhard Hohlfeld: Novartis, Biogen Idec, Merck 

Serono, Teva, Sanofi-Aventis, Bayer (consulting fees, honoraria, other 

financial benefits). Ernst-Wilhelm Radue: Actelion, Bayer Schering, Biogen 

Idec (consulting fees). Ludwig Kappos: Actelion, Advancell, Allozyne, 

BaroFold, Bayer HealthCare Pharmaceuticals, Bayer Schering Pharma, 

Bayhill, Biogen Idec, BioMarin, BLC Behring, Elan, Genmab, Genmark, 

GeNeuro SA, GlaxoSmithKline, Lilly, Merck Serono, MediciNova, 

Novartis, Novo Nordisk, Peptimmune, Sanofi-Aventis, Santhera, 

Roche, Teva, UCB, Wyeth, Swiss MS Society, Swiss National Research 

Foundation, European Union, Gianni Rubatto, Novartis and Roche 

Research Foundations (other financial benefits). Lixin Zhang-Auberson: 

Novartis (salary). Catherine Agoropoulou: Novartis (salary). Dieter A. 

Häring: Novartis (salary). Philipp von Rosenstiel: Novartis (salary). 


S64 

FINGOLIMOD REDUCES MULTIPLE SCLEROSIS 

RELAPSE WITH NO REBOUND EFFECT AFTER 

DISCONTINUATION 

Bhupendra Khatri, 1 Ludwig Kappos, 2 Jeffrey A. Cohen, 3 Gordon Francis, 4 Ana 

de Vera, 5 Lixin Zhang-Auberson, 5 Dejun Tang 4 

1 Center for Neurological Disorders, Milwaukee, WI; 2 Neurology and 

Department of Biomedicine, Basel, Switzerland; 3 Neurological Institute, 

Cleveland Clinic Foundation, Cleveland, OH; 4 Novartis Pharmaceuticals 

Corporation, East Hanover, NJ; 5 Novartis Pharma AG, Basel, Switzerland 

Background: Fingolimod (FTY720), a once-daily oral therapy 

for the treatment of relapsing multiple sclerosis (MS), significantly 

reduced annualized relapse rate (ARR) compared 

with the approved first-line therapy intramuscular interferon 

beta-1a (IFNβ-1a) and placebo in the TRANSFORMS and 

FREEDOMS phase 3 studies over 12 and 24 months, respectively. 

Objectives: To report the results of a pooled analysis 

of ARR from TRANSFORMS and FREEDOMS, and to investi- 


40 

gate the potential effect of fingolimod cessation on increases 

in ARR and magnetic resonance imaging (MRI) lesions that 

exceed baseline values. Methods: Data from intent-to-treat 

(ITT) populations in the TRANSFORMS and FREEDOMS studies 

were pooled to assess the ARR associated with fingolimod 

treatment. Disease activity after fingolimod cessation was 

evaluated for all patients who received fingolimod for at least 

3 months and had any data collected for more than 14 days 

after treatment cessation in the 2 phase 3 studies and a placebo-controlled 

phase 2 study (ie, the follow-up population). 

Results: In the pooled ITT population from TRANSFORMS 

and FREEDOMS, ARR was significantly lower (>50%) with 

fingolimod treatment (0.5 mg, 0.21, n = 854; 1.25 mg, 

0.21, n = 849) than with either placebo (0.47, n = 418) 

or IFNβ-1a (0.43, n = 431) (P < .001 for all fingolimod vs. 

control comparisons). In the follow-up population (n = 421), 

median durations of follow-up were 92 to 150 days and 

51% to 80% of patients were observed for ≥90 days after 

treatment cessation. After fingolimod cessation (from last dose 

date plus 15 days to last available assessment), the ARR was 

0.21. The mean number of gadolinium-enhancing T1 lesions 

15 to 90 days after fingolimod cessation was 2.2 (n = 101), 

which was higher than the last on-treatment MRI (0.4 lesions, 

n = 188), but similar to the baseline value (2.1 lesions, n 

= 188). Conclusions: The significant effect of fingolimod 

in reducing ARR was confirmed in the integrated analysis 

of TRANSFORMS and FREEDOMS. ARR remained low and 

MRI lesion activity returned to baseline values in the follow-up 

population, thereby providing no evidence of rebound above 

baseline values after fingolimod cessation to date. Relatively 

short follow-up and small patient numbers limit the interpretability, 

and longer follow-up data are required to confirm 

these findings. 


Disclosure: Bhupendra Khatri: Teva, Bayer, Pfizer, Medtronics, Biogen 

Idec, Serono, Novartis (consulting fees). Ludwig Kappos: Actelion, 

Advancell, Allozyne, BaroFold, Bayer HealthCare Pharmaceuticals, 

Bayer Schering Pharma, Bayhill, Biogen Idec, BioMarin, CLC Behring, 

Elan, Genmab, Genmark, GeNeuro SA, GlaxoSmithKline, Lilly, Merck 

Serono, MediciNova, Novartis, NovoNordisk, Peptimmune, Sanofi- 

Aventis, Sathera, Roche, Teva, UCB, Wyeth, Swiss MS Society, Swiss 

National Research Foundation, European Union, Gianni Rubatto, 

Novartis and Roche Research Foundations (other financial benefits). Jeffrey 

A. Cohen: Biogen Idec, Elan, Lilly, Novartis, Teva (consulting fees). 

Gordon Francis: Novartis (salary). Ana de Vera: Novartis (salary). Lixin 

Zhang-Auberson: Novartis (salary). Dejun Tang: Novartis (salary). 


S65 

FINGOLIMOD TREATMENT EFFECT ON RELAPSE 

RATE: SUBGROUP ANALYSIS OF FREEDOMS 

Marcelo Kremenchutzky, 1 Peter Calabresi, 2 Paul O’Connor, 3 Reinhard 

Hohlfeld, 4 Ernst-Wilhelm Radue, 5 Ludwig Kappos, 5 Lixin Zhang-Auberson, 6 

Catherine Agoropoulou, 6 Dieter A. Häring, 6 Philipp von Rosenstiel 6 

1 London Health Services Centre, London, ON, Canada; 2 Johns Hopkins 

Hospital, Baltimore, MD; 3 St. Michael’s Hospital, Toronto, ON, Canada; 

4 Institute for Klinische Neuroimmunologie, Munich, Germany; 5 Neurology and 

Department of Biomedicine, University Hospital, Basel, Switzerland; 6 Novartis 

Pharma AG, Basel, Switzerland 

Background: Fingolimod (FTY720) is a sphingosine-1phosphate 

receptor modulator for the treatment of relapsing 

multiple sclerosis (MS). At the dose of 0.5 mg daily, it signifi-

cantly reduced annualized relapse rate (ARR) compared with 

the approved first-line therapy interferon beta-1a (IFNβ-1a) 

intramuscularly 30 µg once weekly by 52% at 12 months 

in the TRANSFORMS study. In the FREEDOMS study, ARR 

was reduced by 54% compared with placebo at 24 months. 

Objectives: To evaluate the effect of fingolimod on ARR in 

treatment-naive and previously treated patients and in other 

key patient subgroups based on age, sex, disease history, 

and baseline clinical and magnetic resonance imaging (MRI) 

disease characteristics. Methods: In FREEDOMS, patients 

18 to 55 years of age with an Expanded Disability Status 

Scale (EDSS) score of 0 to 5.5 and ≥1 relapse in the previous 

year (or ≥2 in the previous 2 years) were randomized to 

fingolimod 0.5 mg or 1.25 mg or placebo once daily for 24 

months. The primary efficacy endpoint was ARR at month 24, 

defined as the number of confirmed relapses per year. Supportive 

subgroup analyses were conducted using a negative 

binomial regression model in the intent-to-treat population. 

Results: A total of 1033/1272 patients (81%) completed 

the study, with baseline demographics similar between 

groups. At 24 months, ARR was reduced by 54% with fingolimod 

0.5 mg (0.18) versus placebo (0.40; P < .001). ARR 

treatment ratios (fingolimod 0.5 mg vs. placebo) in the treatment-naive 

(0.36, confidence interval [CI]: 0.27-0.49; n = 

244, fingolimod 0.5 mg; n = 249, placebo) and previously 

treated (0.54, CI: 0.39-0.73; n = 181, fingolimod 0.5 mg; n 

= 169, placebo) subgroups were comparable to that for the 

overall population (0.44, CI: 0.36-0.55). In the previously 

treated subgroup, the ARR treatment ratio favored fingolimod 

regardless of prior therapy type (IFN: 0.53, CI: 0.37-0.77; 

glatiramer acetate: 0.50, CI: 0.26-0.93). Further, fingolimod 

treatment effects on ARR were observed regardless of age, 

sex, relapse history, MS duration, baseline EDSS score, or 

baseline gadolinium-enhancing T1 lesion count. Conclusions: 

In FREEDOMS, fingolimod consistently improved ARR 

regardless of prior treatment, disease history, or baseline 

demographic, clinical, or MRI disease characteristics. 


Disclosure: Marcelo Kremenchutzky: MS Society of Canada (other 

financial benefit); MS Research and Training Network, Research Scientific 

Foundation of the MS Society of Canada, Bayer, Berlex, Bio-MS, 

Biogen Idec, Boehringer-Ingelheim, Bristol-Myers Squibb, Elan, EMD 

Serono, Eli Lilly, Genzyme, GlaxoSmithKline, GW, Novartis, PDL, 

Parexel, Quintiles, Roche, Sanofi-Aventis, Schering, Teva, UCB Pharma 

(consulting fees). Peter Calabresi: Teva, EMD Serono, Biogen, Novartis 

(consulting fees); Teva, EMD Serono, Biogen, Novartis, Vertex, Bayer, 

Abbott (other financial benefits). Paul O’Connor: Novartis, Sanofi- 

Aventis, Roche, Biogen Idec, Bayer, EMD Serono, Teva Neurosciences, 

Eli Lilly, Opexa Therapeutics, Celgene, Glenmark, Actelion (consulting 

fees); Biogen Idec, EMD Serono, Novartis (honoraria). Reinhard 

Hohlfeld: Novartis, Biogen Idec, Merck-Serono, Teva, Sanofi-Aventis, 

Bayer, (consulting fees, other financial benefits). Ernst-Wilhelm Radue: 

Actelion, Bayer Schering, Biogen Idec (other financial benefits). Ludwig 

Kappos: Actelion, Advancell, Allozyne, Biogen Idec, BioMarin, CLC 

Behring, Elan, Genmab, Genmark, BeNeuro SA, GlaxoSmithKline, 

Lilly, Merck Serono, MediciNova, Novartis, NovoNordisk, Peptimmune, 

Sanofi-Aventis, Santhera, Roche, Teva, UCB, Wyeth, Swiss MS 

Society, Swiss National Research Foundation, European Union, Gianni 

Rubatto, Novartis and Roche Research Foundation (other financial benefits). 

Lixin Zhang-Auberson: Novartis (salary). Catherine Agoropoulou: 

Novartis Pharma AG (salary). Dieter A. Häring: Novartis (salary). 

Philipp von Rosenstiel: Novartis (salary). 

Keywords: Disease-modifying treatment in MS, Relapse management 



41 

S66 

FINGOLIMOD TREATMENT EFFECT ON RELAPSE 

RATE: SUBGROUP ANALYSIS OF TRANSFORMS 

Posters 

Bhupendra O. Khatri, 1 Jean Pelletier, 2 Ludwig Kappos, 3 Xavier Montalban, 4 

Hans-Peter Hartung, 5 Giancarlo Comi, 6 Frederik Barkhof, 7 Jeffrey Cohen, 8 

Tracy Stites, 9 James Jin, 9 Shreeram Aradhye, 9 Gordon Francis 9 

1 St. Luke’s Medical Center, Milwaukee, WI; 2 Department of Neurology, CHU 

La Timone, Marseille, France; 3 Neurology and Department of Biomedicine, 

University Hospital, Basel, Switzerland; 4 Clinical Neuroimmunology Unit, Vall 

d’Hebron University Hospital, Barcelona, Spain; 5 Department of Neurology, 

Heinrich-Heine-University, Dusseldorf, Germany; 6 Università Vita-Salute, 

San Raffaele, Milan, Italy; 7 Image Analysis Center, VU Medical Center, 

Amsterdam, Netherlands; 8 Neurological Institute, Cleveland Clinic Foundation, 

Cleveland, OH; 9 Novartis, East Hanover, NJ 

Background: In the phase 3 TRANSFORMS study of 

patients with relapsing-remitting multiple sclerosis (RRMS), 

fingolimod (FTY720) 0.5 mg reduced annualized relapse rate 

(ARR) by 52% compared with interferon beta-1a (IFNβ-1a) 

at 1 year (P < .001). Fingolimod was shown to reduce ARR 

compared with placebo regardless of prior MS treatment in 

the phase 3 FREEDOMS study. In addition, subgroup analyses 

in the FREEDOMS study demonstrated that the effectiveness 

of fingolimod on ARR was not affected by age, sex, 

disease history, or baseline disease characteristics. Objectives: 

To confirm the effectiveness of fingolimod on ARR 

regardless of prior treatment status and additional baseline 

demographics and disease characteristics in TRANSFORMS. 

Methods: Patients with RRMS were randomized to fingolimod 

0.5 mg or 1.25 mg daily or IFNβ-1a intramuscularly 

30 µg weekly for 12 months. Patients were 18 to 55 years of 

age, with an Expanded Disability Status Scale (EDSS) score 

of 0 to 5.5 and ≥1 relapse in the previous year (or ≥2 in the 

previous 2 years). The primary efficacy endpoint was ARR 

at 1 year, defined as the number of relapses per year. Subgroup 

analyses were conducted using a negative binomial 

regression. Results: A total of 1153/1292 patients (89%) 

completed the study, with baseline demographics similar 

between groups. Similar to FREEDOMS, ARR treatment ratios 

(fingolimod 0.5 mg vs. IFNβ-1a) in the treatment-naive (0.45, 

confidence interval [CI]: 0.27-0.75; n = 183, fingolimod 0.5 

mg; n = 183, IFNβ-1a) and previously treated (0.50, CI: 

0.36-0.70; n = 246, fingolimod 0.5 mg; n = 248, IFNβ-1a) 

subgroups were comparable to that of the overall population 

(0.49, CI: 0.37-0.65). In the previously treated subgroup, the 

ARR treatment ratio favored fingolimod regardless of prior 

therapy type (IFN: 0.42, CI: 0.29-0.62; glatiramer acetate: 

0.72, CI: 0.40-1.30). Fingolimod treatment effects on ARR 

were observed regardless of age, sex, relapse history, MS 

duration, baseline EDSS score, or baseline gadoliniumenhancing 

T1 lesion count. Conclusions: In TRANSFORMS, 

fingolimod significantly improved ARR regardless of prior 

treatment, disease history, or baseline demographic and disease 

characteristics. 


Disclosure: Bhupendra O. Khatri: Teva, Bayer, Pfizer, Medtronics, 

Biogen Idec, Serono, Novartis (consulting fees). Jean Pelletier: Novartis, 

Bayer Schering, Merck Serono, Sanofi-Aventis, Teva (consulting fees). 

Ludwig Kappos: Actelion, Advancell, Allozyne, BaroFold, Bayer Health 

Care Pharmaceuticals, Bayer Schering Pharma, Bayhill, Biogen Idec, 

BioMarin, CLC Behring, Elan, Genmab, Genmark, GeNeuro SA, 

GlaxoSmithKline, Lilly, Merck Serono, MediciNova, Novartis, Novo- 

Nordisk, Peptimmune, Sanofi-Aventis, Santhera, Roche, Teva, UCB,

Posters 

Wyeth, Swiss MS Society, Swiss National Research Foundation, European 

Union, Gianni Rubatto, Novartis and Roche Research Foundations 

(other financial benefits). Xavier Montalban: Merck Serono, Bayer 

Schering Pharma, Biogen Idec, Sanofi-Aventis, Teva, Novartis, Almirall 

(honoraria). Hans-Peter Hartung: Bayer HealthCare, Biogen Idec, 

Genzyme, Merck Serono, Novartis, Teva, Sanofi-Aventis (consulting 

fees); Bayer HealthCare, Biogen Idec, Genzyme, Merck Serono, Novartis, 

Roche, Teva, Sanofi-Aventis (honoraria). Giancarlo Comi: Teva, 

Novartis, Biogen, Lilly, Merck Serono, Bayer-Schering (honoraria). 

Frederik Barkhof: Bayer-Schering, Merck Serono, Synthon, Novartis, 

UCB, Biogen Idec, Roche, Sanofi-Aventis, Genzyme, Serono (honoraria). 

Jeffrey Cohen: Biogen Idec, Elan, Lilly, Novartis, Teva (consulting fees). 

Tracy Stites: Novartis (salary). James Jin: Novartis (salary). Shreeram 

Aradhye: Novartis (salary). Gordon Francis: Novartis (salary). 


S67 

GAIT VARIABILITY IN MINIMALLY DISABLING 

MULTIPLE SCLEROSIS USING GAITRITE 

Melanie Flegel, 1 Katherine Knox, 1 Darren Nickel, 1 Kit Beyer, 2 Larry Brawley 2 

1 College of Medicine, University of Saskatchewan, Saskatoon, SK, Canada; 

2 College of Kinesiology, University of Saskatchewan, Saskatoon, SK, Canada 

Background: Gait is affected early in multiple sclerosis 

(MS) and leads to significant disability. Specific gait parameters 

may be useful to detect early disease activity and 

response to treatment or to identify risk of disability progression. 

Kinematic variability measured in a conventional gait 

laboratory is increased in MS (Crenshaw, 2006). Temporalspatial 

abnormalities of gait are correlated with pyramidal 

dysfunction on the Expanded Disability Status Scale (EDSS) 

utilizing the GAITRite (Givon, 2009). The GAITRite measures 

temporal-spatial parameters of gait with a mat that detects 

footfalls using sensors. Objectives: Investigate differences 

in step-length variability between individuals with clinically 

isolated syndrome (CIS) or minimally disabling MS and 

controls using the GAITRite. Methods: Patients with CIS, 

MS, and healthy controls were recruited for enrollment. Inclusion 

criteria for CIS or MS included EDSS score ≤3.0 and a 

diagnosis of CIS or MS. Participants completed three walking 

trials at a self-selected comfortable pace and a fast pace. 

Means of the three trials for each speed were calculated for 

all variables of interest. Independent-samples t tests were used 

to test for between-group differences in velocity, step length, 

double-support time, and single-support time. Also, four 

independent-samples t tests were run to test for differences in 

step-length variability. Results: Eighteen female participants 

(1 CIS, 8 MS, and 9 controls) completed the study. The average 

age was 41.78 years (SD = 9.18) and was similar in 

both groups. Mean EDSS score for the CIS/MS group was 

1.89 (SD = 1.85). The CIS/MS group walked significantly 

more slowly (P = .025) and had longer double-support time 

with one leg (P = .043) in the fast walking trials. In the 

comfortably paced walking trials, although speed between 

groups did not differ significantly, the CIS/MS group had significantly 

greater step-length variability in one leg (P = .043). 

Conclusions: Significant differences between CIS/MS with 

minimal disability and healthy controls were observed in steplength 

variability for comfortably paced walking at similar 

speeds. Exploring temporal-spatial gait variability via GAI- 

TRite in larger samples may reveal more about its viability for 

clinical assessment of MS. 


42 

Disclosure: Melanie Flegel: Nothing to disclose. Katherine Knox: Biogen, 

Bayer HealthCare Pharmaceuticals, Teva (other financial benefits). 

Darren Nickel: Nothing to disclose. Kit Beyer: Nothing to disclose. Larry 

Brawley: Nothing to disclose. 

Keywords: Natural history of MS, Equipment in MS 

S68 

GENETIC ANALYSIS AND NEUROPATHOLOGY 

IN A KINDRED WITH MULTIPLE SCLEROSIS AND 

PARKINSONISM 

Mary L. Filipi, 1 Ekaterina Markopoulou, 2 Ann Bowder, 3 D.W. Dickson, 4 Z.K. 

Wszolek, 5 R. Rademakers, 4 Bruce A. Chase 3 

1 College of Nursing, University of NE Medical Center, Omaha, NE; 

2 Neurology, University of Thessaly Medical School, Larissa, Greece; 

3 Biology, University of NE–Omaha, Omaha, NE; 4 Neuroscience, Mayo Clinic, 

Jacksonville, FL; 5 Neurology, Mayo Clinic, Jacksonville, FL 

Background: The number of genetic risk factors for multiple 

sclerosis (MS) and Parkinson disease (PD) raises the question 

of whether genetic information can predict MS risk and identify 

individuals for interventions that delay or block MS onset. 

A kindred displaying a combination of MS and PD has been 

identified. Genetic evaluation may give insight into predictors 

of a relationship of the two diseases. Objectives: Identify 

genetic factors affecting the dementia/parkinsonism phenotype 

and MS risk. Determine whether interaction between 

the genetic factors increases risk of PD and MS either by 

themselves or in combination. Methods: A 422-member 

kindred (MEN-1)was identified with multiple cases of MS and 

dementia/parkinsonism. Initial screening was performed of 

candidate genes implicated in neurodegeneration. Pathology 

studies have been performed on one individual displaying 

a PD phenotype. Results: Individuals with MS exhibit a 

relapsing-remitting course. Dementia/parkinsonism, an autosomal 

dominant trait with late onset in the 7th decade, presented 

with either dementia or parkinsonism, was responsive 

to levodopa, and includes tremor, rigidity, bradykinesia, and 

postural instability, in varying combinations. Neuropathology 

in one individual displaying dementia but not an MS phenotype 

was consistent with Alzheimer disease Braak stage 

IV, cerebrovascular disease, and optic atrophy with degeneration 

of the lateral geniculate nucleus. The substantia nigra 

showed mild neuronal loss but no Lewy bodies or neurofibrillary 

tangles. Some individuals overlapped in the symptoms of 

MS and dementia/parkinsonism phenotypes. Two individuals 

with MS had resting and postural tremor typical of PD and 

variable bradykinesia but not dementia or rigidity. No mutations 

have been identified in three candidate genes, GRN 

(progranulin), MAPT (tau), and TARDBP (TDP-43), implicated 

in dementia/parkinsonism from sequence analysis of five 

affected kindred members. Conclusion: Identification of the 

genetic factors leading to the dementia/parkinsonism phenotype 

and MS risk will lead to a better understanding of how 

genetic factors can be used to determine MS risk, as well as 

an understanding of whether interaction between the genetic 

factors increases risk of these two diseases. 


Keywords: Genetics and MS, Etiology of MS 

S69 

HEAD TREMOR AS PRESENTING FEATURE IN 


Evanthia Bernitsas 

Neurology, University of Michigan, Ann Arbor, MI

Background: Tremor is an involuntary oscillatory rhythmic 

movement of a body part. Tremor in the arms and hands is 

commonly seen in multiple sclerosis (MS). However, head 

tremor is a rare symptom, especially early in the disease. 

Objectives: To describe a group of MS patients who presented 

with head tremor as an initial symptom. Methods: 

We conducted a retrospective review of the medical records 

of patients seen in the University of Michigan Multiple Sclerosis 

Clinic from January 2008 to December 2010. Information 

regarding the onset, severity, and type of tremor, time of the 

diagnosis of MS, associated symptoms, type of MS, family 

history, and neurologic examination as well as magnetic resonance 

imaging (MRI) findings was collected. Results: Four 

patients with clinically definite multiple sclerosis and head 

tremor were identified. The mean age at the onset of tremor 

was 35.4 years. The mean age at the time of diagnosis of 

MS was 38.2 years. One patient (25%) was African American, 

two Caucasian (50%), and one Hispanic (25%). Three 

patients (75%) had primary progressive MS and one (25%) 

had relapsing-remitting MS. In all but one case, head tremor 

was initially misdiagnosed as essential tremor. Two patients 

(50%) developed intentional tremor of the arms later in their 

disease course. In two patients (50%), dysarthria was also 

present. The severity of the tremor was mild in three cases 

(75%), while one patient had debilitating tremor that interfered 

with activities of daily life. Stress and exercise made 

the tremor worse in all four patients. Neuroimaging showed 

white matter lesions in the cerebellum or brain stem in all 

patients. Conclusion: Head tremor is an underreported 

symptom in MS. It can be the only symptom for a considerable 

period of time, and it may affect the quality of life of 

MS patients. Clinicians should be aware that it may be the 

presenting symptom of this disease. Patients can be wrongly 

labeled as having essential tremor, which may lead to diagnostic 

and therapeutic delay. 

Disclosure: Biogen, Teva (consulting fees); Novartis, Serono (honoraria) 

Keywords: Natural history of MS, Comprehensive care and MS, Quality 

of life in MS 

S70 

IMPACT OF DALFAMPRIDINE ON MSWS-12 SCORE 

CHANGE IN MULTIPLE SCLEROSIS PATIENTS 

Randall T. Schapiro, 1 Theodore R. Brown, 2 Andrew Goodman, 3 Jeremy C. 

Hobart, 4 Lawrence Marinucci, 5 Andrew Blight, 5 on behalf of the MS-F202, 

MS-F203, and MS-F204 study groups 

1 The Schapiro Multiple Sclerosis Advisory Group, Eagle, CO; 2 Evergreen 

Hospital Medical Center, Kirkland, WA; 3 University of Rochester, Rochester, 

NY; 4 Neurology Research Group, Plymouth, United Kingdom; 5 Acorda 

Therapeutics, Inc, Hawthorne, NY 

Background: Three placebo-controlled clinical trials (one 

phase 2, two phase 3) demonstrated that dalfampridine 

extended release (D-ER, fampridine outside the United 

States) 10 mg twice daily improves walking in about onethird 

of people with multiple sclerosis (MS; all forms). D-ER 

responders demonstrated statistically and clinically significant 

improvements in objectively measured walking speed (WS) 

(Timed 25-Foot Walk) in the phase 3 trials, and in subjectively 

reported walking ability (12-Item MS Walking Scale 

[MSWS-12]). A D-ER responder was defined as a person 

who walked faster on at least three of the four on-treatment 

visits than at the fastest of the five off-treatment visits. 


43 

Posters 

Responder status was determined post hoc for the phase 

2 and prospectively for the phase 3 trials. Objectives: 

Determine whether D-ER effects on patient-reported walking 

ability (MSWS-12) are related to baseline walking impairment. 

Methods: Data from the three clinical trials were 

pooled. Expanded Disability Status Scale (EDSS) score was 

measured at screening. WS was measured at four pretreatment 

visits, four on-treatment visits, and one post-treatment 

visit. MSWS-12 scores were collected at two pretreatment 

and four on-treatment visits. The average scores for pre- and 

on-treatment visits for each patient were calculated. Average 

change in MSWS-12 was analyzed by baseline EDSS score 

(≤5.5; =6.0; ≥6.5) and baseline WS stratified by quartile 

Q1 (fastest)–Q4 (slowest). Negative change scores indicate 

improved walking ability. Results: D-ER responder (n = 

147; 37.3% of patients treated) scores changed by an average 

of –7.16 MSWS-12 points. When grouped by baseline 

EDSS score (≤5.5, n = 30; =6.0, n = 56; ≥6.5, n = 61), the 

average MSWS-12 score changes were –12.2, –8.0, and 

–3.9. When grouped by baseline WS quartile, the average 

MSWS-12 change scores were (Q1, n = 36; Q2, n = 

40; Q3, n = 39; Q4, n = 32) –9.7, –7.5, –6.5, and –4.7. 

Floor effects for the MSWS-12 were small or nonexistent in 

all subgroups; thus analyses implied greater self-reported 

improvement in less disabled subgroups. Conclusions: 

Walking benefits from D-ER were experienced in all disability 

levels studied. However, the greatest improvements were 

demonstrated in the least disabled subgroups. This suggests 

that D-ER may be beneficial for people with milder levels of 

walking impairment than included in the trials. This warrants 

further study. 

Disclosure: Randall T. Schapiro: Acorda Therapeutics, Inc, EMD 

Serono (consulting fees); EMD Serono, Bayer, Acorda Therapeutics, Inc, 

Teva (other financial benefits). Theodore R. Brown: Acorda Therapeutics, 

Inc, Serono, Teva, Lilly, Sanofi-Aventis (other financial benefits). 

Andrew Goodman: Acorda Therapeutics, Inc, Actelion Pharmaceuticals 

Ltd, Bayer, Biogen Idec, EMD Serono, Genzyme, Teva Neuroscience 

(consulting fees); Acorda Therapeutics, Inc, Biogen Idec, EMD Serono, 

Genzyme, Teva Neuroscience (other financial benefits). Jeremy C. 

Hobart: Acorda Therapeutics, Inc, Bayer Schering, Biogen Idec, Eisai, 

GlaxoSmithKline, Merck Serono, Pfizer, Teva Neuroscience, Valeant 

(other financial benefits). Lawrence Marinucci: Acorda Therapeutics, Inc 

(salary, ownership interests). Andrew Blight: Acorda Therapeutics, Inc 

(salary, ownership interests). MS-F202, MS-F203, and MS-F204 study 

groups: Nothing to disclose. 

Keywords: Symptomatic treatment of MS, Quality of life in MS 

S71 

IMPACT OF INTRAMUSCULAR INTERFERON BETA- 

1A THERAPY TIMING AFTER CLINICALLY ISOLATED 

SYNDROME ONSET ON QUALITY OF LIFE 10 YEARS 

LATER 

R. Philip Kinkel, 1 Genevieve Laforet, 2 Xiaojun You, 2 Robert Hyde 2 

1 Beth Israel Deaconess Medical Center, Boston, MA; 2 Biogen Idec Inc, Weston, 

MA 

Background: The Controlled High-Risk Subjects Avonex 

Multiple Sclerosis Prevention Study (CHAMPS) demonstrated 

that immediate initiation of intramuscular interferon beta-1a 

(IM IFNβ-1a) after clinically isolated syndrome significantly 

reduced development of clinically definite multiple sclerosis 

(MS) in high-risk patients. This effect remained evident in 

both the CHAMPIONS 5- and 10-year extension studies.

Posters 

Significant beneficial effect on annualized relapse rates 

was also shown at all epochs without significant differential 

effect on standard magnetic resonance imaging (MRI) or 

disability outcomes at 5 and 10 years. Objectives: To 

determine whether timing of treatment at MS onset in the 

CHAMPIONS 10-year extension affected quality of life (QOL) 

between years 5 and 10. Methods: The immediate treatment 

(IT) group initiated treatment at onset of symptoms; the 

delayed treatment (DT) group initiated treatment a median 

of 30 months (25th percentile, 24 months; 75th percentile, 

35 months) after symptom onset. Responses to the Multiple 

Sclerosis Quality of Life Inventory (MSQLI), which covers both 

disease-specific measures and the 36-item Short Form Health 

Status Survey (SF-36), were collected, analyzed, and compared 

between groups at years 5 and 10. Results: A total 

of 155 patients enrolled in CHAMPIONS (IT, n = 81; DT, 

n = 74); 127 patients completed the 10-year examination. 

The majority of QOL measures, particularly disease-specific 

QOL measures, were stable in both groups between years 

5 and 10. The DT group showed significant improvement in 

the Medical Outcomes Study (MOS) Modified Social Support 

Survey (MSSS) total score (P = .004) and the subscales of 

tangible support (P = .037), affectionate support (P = .010), 

and positive social interaction (P = .029) between years 

5 and 10. At year 10, total MSSS score was significantly 

higher in the DT group than in the IT group (87.1 vs. 79.8; 

P = .022), indicating higher perceived social support, and 

the SF-36 role-emotional subscale score was also significantly 

higher (better) in the DT than in the IT group (83.9 vs. 

69.7; P = .027). Conclusion: Disease-specific QOL scores 

remained remarkably robust and stable between years 5 and 

10, with no significant differences identified between the IT 

and DT groups, which is consistent with our previous report of 

a low level of disability in both groups over 10 years. Further 

analyses are required to better understand factors that could 

account for the consistent improvements in perceived social 

support in the DT group between years 5 and 10. 

Disclosure: R. Philip Kinkel: Avanir Pharmaceuticals, Biogen Idec, 

Novartis, Teva Neuroscience (consulting fees); MedReview (honoraria); 

Biogen Idec, National Multiple Sclerosis Society (other financial benefits). 

Genevieve Laforet: Biogen Idec (salary). Xiaojun You: Biogen Idec 

(salary). Robert Hyde: Biogen Idec (salary). 


S72 

IMPACT OF NURSE INTERVENTION ON 

COMPLIANCE WITH INTERFERON BETA-1B (START 

STUDY) 

Suhayl Dhib-Jalbut, 1 Clyde Markowitz, 2 Payal Patel, 3 Francis Boateng, 3 Mark 

Rametta 3 

1 Robert Wood Johnson Medical School, University of Medicine and Dentistry 

of New Jersey, New Brunswick, NJ; 2 Multiple Sclerosis Center, University 

of Pennsylvania, Philadelphia, PA; 3 Bayer HealthCare Pharmaceuticals, 

Wayne, NJ 

Background: A prior study demonstrating high interferon 

beta-1b (IFNβ-1b) compliance allowed for clinical improvement 

in patients with multiple sclerosis (MS). 1 The impact of 

nurse support and adverse event (AE) mitigation techniques 

on patient compliance has not yet been evaluated by a realworld 

study in a US population. Objectives: Primary objective: 

Assess the impact of titration, analgesics, and BETA 

(Betaseron education, training, assistance) nurse support on 


44 

compliance with IFNβ-1b in subjects with early-onset MS. 

Secondary objective: Evaluate safety. Methods: Subjects 

had clinically isolated syndrome (CIS) for

ciation with improved quality of life (QOL). Objectives: To 

evaluate the relationship between sustained changes in disability, 

as measured by MSFC, and sustained QOL changes 

reported by MS patients. Methods: Patient data from the 

AFFIRM study of natalizumab for MS (N = 624) were used 

for post hoc analyses of MSFC components (Timed 25-Foot 

Walk [T25FW] [n = 435], Nine-Hole Peg Test [NHPT, 

dominant hand] [n = 312], and Paced Auditory Serial Addition 

Test [PASAT]) [n = 459]) and patient-reported QOL. 

Disability was categorized as a 15% change (worsened, 

stable, improved) sustained for 12 weeks. Patient-reported 

QOL was evaluated using 36-item Short Form Health Status 

Survey (SF-36) Physical Component Summary (PCS) and 

Mental Component Summary (MCS) scores and visual analogue 

scale (VAS). Results: A 15% sustained improvement 

in disability was significantly associated with QOL improvements 

at 2 years. For patients whose T25FW worsened, 

stabilized, or improved, mean score changes were –1.99, 

–0.25, and 3.09, respectively (P < .0001), for PCS; –2.80, 

2.75, and 5.10, respectively (P < .0001), for MCS; and 

–10.49, –2.59, and 8.01, respectively (P < .0001), for 

VAS. For patients whose NHPT worsened, stabilized, or 

improved, mean score changes were –1.78, 0.22, and 

3.34, respectively (P = .0006), for PCS; 1.38, 0.98, and 

3.26, respectively (P = .326), for MCS; and –6.35, –2.38, 

and 6.61, respectively (P = .001), for VAS. Sustained 15% 

PASAT change was not significantly associated with changes 

in QOL. When MSFC worsening/improvement was defined 

as a 20% change from baseline, results were consistent for 

all variables. Conclusion: Sustained changes in ambulation 

(T25FW) and dexterity (NHPT) but not cognition (PASAT) 

were significantly associated with patient-reported QOL 

changes over 2 years in this post hoc analysis. Findings suggest 

that functional improvements in MSFC components are 

related to patient-reported QOL. 

Disclosure: Deborah Miller: Nothing to disclose. J. Theodore Phillips: 

Biogen Idec, Novartis, Teva (honoraria). Jennifer Sun: Biogen Idec (salary). 

Robert Hyde: Biogen Idec (salary). 

Keywords: Disease-modifying treatment in MS, Management of activities 

of daily living in MS, Quality of life in MS 

S74 

IS THERE AN ASSOCIATION BETWEEN HEPATITIS 

C AND NEUROMYELITIS OPTICA SPECTRUM 

DISORDER? A REPORT OF THREE CASES 

Kristen Babinski, Joseph Herbert, Ilya Kister 

Neurology, NYU Langone Medical Center, New York, NY 

Background: Neuromyelitis optica (NMO) is an idiopathic 

inflammatory demyelinating disease of the central 

nervous system primarily affecting the optic nerves and spinal 

cord. The recently discovered NMO-IgG antibody is a 

highly specific marker of the disease and is thought to play 

a key role in its pathogenesis. NMO has been attributed 

to parainfection in a subset of patients; however, a specific 

association between hepatitis C and NMO has not been 

described previously. Such an association would be biologically 

plausible in view of the well-established role of hepatitis 

C in the emergence of autoimmune diseases (thyroiditis, 

Sjögren’s syndrome, systemic lupus erythematosus), as well 

as its proclivity to neuroinvasion. Objectives: To describe 

three patients with chronic hepatitis C virus infection who 


45 

Posters 

were diagnosed with neuromyelitis optica spectrum disorder 

(NMOsd). Methods: Case series. Results: Three of 24 

patients (13%) with NMOsd followed at the NYU Multiple 

Sclerosis Care Center had an antecedent hepatitis C virus 

infection at the time of NMOsd diagnosis. All three patients 

with hepatitis C and NMOsd were women, of which two 

were of Caribbean descent with African ancestry and one 

was African American. One patient had recurrent optic neuritis, 

another had recurrent longitudinally extensive transverse 

myelitis, and the third had clinically definite NMO. In each 

of the three patients, NMO-IgG antibodies were detected in 

serum. The average age (58 years; range, 54–62 years) of 

NMOsd onset in these patients was higher than the average 

age (37 years; range, 22–56 years) of NMOsd onset in the 

21 patients without the hepatitis C virus, but the difference 

was not statistically significant. In all patients, infection with 

hepatitis C virus was confirmed by the presence of hepatitis 

C virus IgG antibodies. None of the patients were treated for 

hepatitis C. Conclusion: Over 10% of the NMOsd patients 

followed in our clinic had preexisting hepatitis C infection. 

The association between hepatitis C and NMOsd is biologically 

plausible and deserves a systematic investigation. 


S75 

LONG-TERM SAFETY OF FINGOLIMOD IN 

RELAPSING MULTIPLE SCLEROSIS: PHASE 2 AND 3 

ANALYSES 

Pierre Duquette, 1 Ludwig Kappos, 2 Jeffrey A. Cohen, 3 Gordon Francis, 4 

William Collins, 5 Ana de Vera, 5 Lixin Zhang-Auberson, 5 Dejun Tang 4 

1 University of Montreal, Montreal, QC, Canada; 2 Neurology and Department 

of Biomedicine, University Hospital, Basel, Switzerland; 3 Neurological 

Institute, Cleveland Clinic Foundation, Basel, Switzerland; 4 Novartis 

Pharmaceuticals Corporation, East Hanover, NJ; 5 Novartis Pharma AG, Basel, 

Switzerland 

Background: Fingolimod (FTY720) is a sphingosine-1phosphate 

receptor modulator approved in the United States 

for relapsing multiple sclerosis (MS). Objectives: To report 

long-term safety data in patients receiving fingolimod in 

phase 2 and 3 studies. Methods: Overall safety data are 

reported for two populations: Group A (FREEDOMS group; 

n = 1272), patients who received fingolimod 1.25 mg or 

0.5 mg or placebo (PBO), and Group B (all studies; N = 

2615), patients who received once-daily fingolimod in phase 

2 and phase 3 (TRANSFORMS and FREEDOMS) studies 

and ongoing extensions. Pregnancy outcomes are reported 

by trial investigators from all fingolimod studies, including 

core, extensions, and ongoing blinded studies. Results: 

In Group A, the proportions of patients reporting serious 

adverse events (AEs) were 10.1% with fingolimod 0.5 mg, 

11.9% with fingolimod 1.25 mg, and 7.7% with PBO; corresponding 

proportions of patients with AEs leading to study 

discontinuation were 7.5%, 14.2%, and 7.7%, respectively; 

results observed in Group B were similar, with higher rates 

of AEs leading to study discontinuation observed in the fingolimod 

1.25-mg group. Overall infection rates were 68.5% 

to 71.5% in the fingolimod groups versus 72% with PBO in 

Group A; incidences of herpes virus infections were 5.8% to 

9.4% in the fingolimod groups versus 7.9% with PBO. The 

proportions of patients with malignant neoplasms were 0.9% 

in both fingolimod groups versus 2.4% with PBO in Group A

Posters 

and 1.4% with fingolimod 0.5 mg and 1.1% with fingolimod 

1.25 mg in Group B. In Group B, macular edema occurred 

in 0.3% of patients receiving fingolimod 0.5 mg and 1.1% 

of patients receiving fingolimod 1.25 mg. As of December 

2010, 69 pregnancies were reported (fingolimod, n = 42; 

interferon beta-1a [IFNβ-1a], n = 4; PBO, n = 8; treatment 

still blinded, n = 15). Of 42 pregnancies that began while 

on fingolimod, there were 15 normal births, 1 infant with 

unilateral posteromedial bowing of the tibia, 5 spontaneous 

and 10 elective abortions (1 for tetralogy of Fallot), and 11 

ongoing pregnancies (1 with intrauterine detection of acrania). 

Conclusion: The safety profile of fingolimod has been 

well characterized, with comprehensive safety assessments in 

>2600 patients. The overall safety profile of fingolimod 0.5 

mg was better than that of the 1.25-mg dose. 


Disclosure: Pierre Duquette: Biogen Idec (consulting fee); EMD Serono, 

Teva, Biogen Idec, Novartis, Serono Symposia (honoraria); Teva, 

Biogen Idec (other financial benefits). Ludwig Kappos: Actelion, Advancell, 

Allozyne, BaraFold, Bayer HealthCare Pharmaceuticals, Bayer 

Schering Pharma, Bayhill, Biogen Idec, BioMarin, CLC Behring, Elan, 

Genmab, Genmark, GeNeuro SA, GlaxoSmithKline, Lilly, Merck Serono, 

MediciNova, Novartis, Novo Nordisk, Peptimmune, Sanofi-Aventis, 

Santhera, Roche, Teva, UCB, Wyeth, Swiss MS Society, Swiss National 

Research Foundation, European Union, Gianni Rubatto, Novartis and 

Roche Research Foundations (other financial benefits). Jeffrey A. Cohen: 

Biogen Idec, Elan, Lilly, Novartis, Teva (consulting fees). Gordon Francis: 

Novartis (salary). William Collins: Novartis (salary, ownership interests). 

Ana de Vera: Novartis (salary). Lixin Zhang-Auberson: Novartis 

(salary). Dejun Tang: Novartis (salary). 


S76 

MANAGEMENT OF SITE REACTIONS RESULTING 

FROM MULTIPLE SCLEROSIS MEDICATIONS 

Linda A. Moore, 1 Sarah Cashdollar, 2 Cheryl Glenn, 1 Michael Kaufman 1 

1 Multiple Sclerosis Center, Charlotte, NC; 2 NeuroScience and Spine Institute, 

Charlotte, NC 

Background: Multiple sclerosis (MS) patients frequently 

describe concerns about skin site reactions to their health-care 

providers. There is a need for research to identify better methods 

to control reactions to help patients adhere to therapy. 

Objectives: Determine better treatment methods to control 

skin site reactions to injectable MS medications in an effort 

to improve patient adherence. Methods: Patients (N = 60) 

who expressed concern over skin reactions (redness, pain, 

and bruising) that occurred after injections were randomized 

to this crossover, double-blind study and were asked to apply 

to the injection site either placebo cream or an herbal treatment, 

Bach’s Rescue Remedy Cream, for the first part of the 

study and then apply the alternative treatment for the second 

part of the study. Patients recorded size, description, and 

reaction changes in a daily diary. The three current subcutaneous 

medications (interferon beta-1a [IFNβ-1a], interferon 

beta-1b [IFNβ-1b], and glatiramer acetate) were studied. The 

participants indicated that skin site reactions had affected 

their quality of life, such as needing clothing to cover the sites 

or restricting activities such as swimming. Results: Overall 

results indicated a trend of decreasing skin site reactions 

and the tingling, burning, and itching sensation occurring at 

the site of injections. Also noted were trends in pain, size of 

skin site reactions, and degree of coloration. The glatiramer 


46 

acetate responded best to the herbal cream, with statistically 

significant differences from the placebo cream; however, 

the other two MS injectables indicated a trend toward 

reduced skin site reactions. The study is a follow-up of previous 

research conducted with the air-bubble technique that 

decreased many skin site reactions. Additional recommendations 

that were discovered regarding injection techniques 

will be discussed. Conclusion: The herbal cream treatment 

Bach’s Rescue Remedy Cream may provide a treatment for 

patients experiencing skin reactions in response to subcutaneous 

injections of MS therapies. 

Disclosure: Linda A. Moore: Biogen Idec, Bayer, Teva, Serono (consulting 

fees); Bayer, Teva (honoraria); Bayer, Serono, Teva (other financial 

benefits). Sarah Cashdollar: Nothing to disclose. Cheryl Glenn: Nothing 

to disclose. Michael Kaufman: Teva Neuroscience, Genentech, Acorda 

Therapeutics, Serono Inc, Biogen Idec, Berlex (other financial benefits). 


S77 

MEDICARE PART D COVERAGE AND COMPLIANCE 

WITH DISEASE-MODIFYING DRUG THERAPY 

Benjamin F. Banahan, 1,2 Manasi Datar, 1,2 Clive M. Mendonca, 1,2 Zainab 

Shahpurwala, 1,2 John P. Bentley, 1,2 Amy Phillips, 3 Michelle Stewart 4 

1 Center for Pharmaceutical Marketing and Management, University of 

Mississippi, University, MS; 2 Pharmacy Administration, University of 

Mississippi, University, MS, 3 Health Outcomes & Market Access, EMD Serono, 

Inc, Rockland, MA; 4 Health Outcomes Research, Pfizer, Inc, New London, CT 

Background: High out-of-pocket (OOP) burden with 

disease-modifying drugs (DMDs) has been shown to affect 

adherence among commercial patients with multiple sclerosis 

(MS). Objectives: To assess the level of OOP burden 

experienced by Medicare Part D beneficiaries with MS and 

how this burden affects adherence with DMD therapy. Methods: 

A retrospective cohort study was conducted using a 5% 

national sample of Medicare beneficiaries for 2007. Inclusion 

criteria were ambulatory patients diagnosed with MS and 

taking at least one DMD. Adherence was measured using 

proportion of days covered (PDC). Patients were classified 

as discontinuing therapy if the last day of possession was 

more than 60 days before the end of the year. OOP burden 

was classified based on level of low income subsidy (LIS) provided. 

Results: A total of 1439 beneficiaries with MS and 

DMD use were identified. The average age was 58.1 years, 

with 67% Medicare eligible due to disability. A total of 89% 

reached the coverage gap, and 81% reached catastrophic 

coverage. Average time in the gap was 2 to 4 months for the 

different OOP burden groups. Overall PDC measures were 

85.7% pregap, 81.7% during gap, and 87.3% in catastrophic 

coverage. PDC pregap was higher (P < .001) for no-copay 

LIS (88.4%) and full-copay (87.6%) than for reduced-copay 

LIS (78.1%). Full-copay beneficiaries were more likely (P < 

.001) than reduced-copay or no-copay beneficiaries to have 

a drop in PDC during the coverage gap (46.3%, 28.2%, 

18.1%). Full-copay beneficiaries were slightly more likely to 

stop therapy after hitting the gap than were reduced-copay 

or no-copay beneficiaries (17.7%, 15.0%, 10.6%). Conclusion: 

Most beneficiaries with MS reach the coverage gap 

early in the year and fairly quickly move on to catastrophic 

coverage. The average time in the coverage gap is limited 

but significantly reduces adherence. OOP burden appears to 

be associated with an adverse impact on adherence behaviors, 

even for those patients with reduced copay LIS.

Disclosure: Benjamin F. Banahan: Nothing to disclose. Manasi Datar: 

Nothing to disclose. Clive M. Mendonca: Nothing to disclose. Zainab 

Shahpurwala: Nothing to disclose. John P. Bentley: Nothing to disclose. 

Amy Phillips: EMD Serono, Inc (salary). Michelle Stewart: Pfizer, Inc 

(salary). 

Keywords: Economic issues and MS, Disease-modifying treatment in 

MS 

S78 

MENOPAUSE IN WOMEN WITH MULTIPLE 

SCLEROSIS 

Annette Wundes, 1,2 Dagmar Amtmann, 2 Tracy Brown, 2 Silvia Christian 2 

1 Neurology, University of Washington, Seattle, WA; 2 Rehabilitation Medicine, 

University of Washington, Seattle, WA 

Background: Given the predominance of multiple sclerosis 

(MS) in females and reported associations between the 

course of MS and menarche, pregnancy, or the postpartum 

period, a modulating role of sex hormones is assumed. As 

women with MS age, or because of medical interventions 

interfering with ovarian function, they will enter menopause. 

This life stage is marked by changes that affect quality of 

life, such as fatigue, difficulties concentrating, heat intolerance, 

and so on. In women with MS, these may be difficult to 

discriminate from MS-related symptoms. Little is known about 

menopause and effects of hormone replacement therapy 

(HRT) in women with MS. The objective of these studies was, 

therefore, to evaluate such issues. At least two types of impact 

could be hypothesized: Menopause could affect the clinical 

course of MS directly. Alternatively, symptoms of menopause 

could be erroneously attributed to MS. Either scenario could 

be amenable to pharmacologic intervention. A better understanding 

of menopause in MS is needed to evaluate therapeutic 

possibilities. Objectives: To evaluate menopause 

and HRT in women with MS. Methods: Self-reported crosssectional 

survey in women with MS regarding age of onset/ 

cause of menopause and HRT usage and perceived association 

with MS symptoms and course of disease. Results: The 

mail survey (n = 591) included 316 (53%) postmenopausal 

women with MS. They had entered menopause between 

ages 19 and 62 years (median: 46, which is 5 years earlier 

than in the US population per National Institutes of Health 

information); in almost half the respondents, menopause had 

been induced iatrogenically. The majority did not report an 

association between menopause and MS symptoms, but 

those who did were more likely to report worsening. Slightly 

more than half the respondents were ever on HRT, on average 

for 5 years; at least three-quarters felt that HRT had not 

affected MS symptoms or overall course. Conclusion: This 

study represents the largest cohort exploring the relationship 

between menopause, HRT, and MS to date. Data from two 

previous studies (n = 19 and 72), suggesting benefits of HRT 

and worsening of MS with menopause, were not confirmed 

in this sample. However, none of the questionnaires used, 

including our own, study the full complexity of menopausal 

changes, effects of HRT, and natural changes of MS with 

aging. Further studies are warranted. 

Disclosure: Annette Wundes: Biogen, Teva Pharmaceuticals (consulting 

fees). Dagmar Amtmann: Nothing to disclose. Tracy Brown: Nothing to 

disclose. Silvia Christian: Nothing to disclose. 

Keywords: Epidemiology of MS, Quality of life in MS 


47 

S79 

MENTAL COMORBIDITY IS ASSOCIATED WITH 

MORE RAPID DISABILITY PROGRESSION IN 


Ruth Ann Marrie, 1 Gary Cutter, 2 Tuula Tyry 3 

1 Internal Medicine, University of Manitoba, Winnipeg, MB, Canada; 

2 Biostatistics, University of Alabama at Birmingham, Birmingham, AL; 

3 Neurology, Barrow Neurological Institute, Phoenix, AZ 

Posters 

Background: Mental comorbidity is common in multiple 

sclerosis (MS), affecting more than 50% of MS patients at 

some point in their disease course. A prior study suggested 

that psychiatric symptoms not meeting the criteria for a specific 

diagnosis adversely affected disability progression in MS. 

Objectives: We aimed to evaluate the impact of diagnosed 

mental comorbidities on disability progression. Methods: 

A total of 8983 MS patients enrolled in the North American 

Research Committee on Multiple Sclerosis (NARCOMS) Registry 

participated in this study. Time from symptom onset or 

diagnosis until ambulatory disability (cane) was compared 

for patients with or without mental comorbidities, including 

depression, anxiety, bipolar disorder, and psychosis, to 

determine their impact on MS severity. Multivariable proportional 

hazards models were adjusted for sex, race, age 

at symptom onset, year of symptom onset, socioeconomic 

status, and region of residence. Results: After adjustment, 

participants reporting any mental comorbidities at diagnosis 

had an increased risk of ambulatory disability (HR, 1.78; 

95% confidence interval [CI], 1.61-1.96). Mental comorbidity 

developing at any time during the disease course also 

increased the risk of ambulatory disability (adjusted hazard 

ratio for unilateral walking assistance, 1.58; 95% CI, 1.48- 

1.69). The median time between diagnosis and need for 

ambulatory assistance was 19.5 years in patients without, 

and 13.8 years in patients with any mental comorbidity, a 

difference of 5.7 years. We also examined the relationship 

of specific mental comorbidities with disability progression 

among participants reporting only one mental comorbidity. 

Both anxiety (HR, 2.41; 95% CI, 1.77-2.38) and depression 

(HR, 3.35; 95% CI, 2.81-3.99) were associated with an 

increased risk of ambulatory disability, but bipolar disorder 

was not. Insufficient numbers of participants were available 

to examine the impact of psychosis. Conclusion: Mental 

comorbidity, whether present at symptom onset, diagnosis, or 

later in the disease course, is adversely associated with disability 

progression in MS. 

Disclosure: Ruth Ann Marrie: Nothing to disclose. Gary Cutter: 

Sanofi-Aventis, Cleveland Clinic, Daichi-Sankyo, Glaxo Smith Klein 

Pharmaceuticals, Genmab Biopharmaceuticals, Eli Lilly, Medivation, 

Modigenetech, Ono Pharmaceuticals, PTC Therapeutics, Teva, 

Vivus, University of Pennsylvania, NHLBI, NINDS, NMSS Alexion, 

Bayhill, Bayer, Novartis, Genzyme, Klein-Buendel Inc, Nuron Biotech, 

Peptimmune, Somnus Pharmaceuticals, Sandoz, Teva Pharmaceuticals, 

UTSouthwestern Visioneering Technologies, Inc (consulting fees); 

Consortium of Multiple Sclerosis Centers (grant). Tuula Tyry: Acorda 

Therapeutics (consulting fee). 

Keywords: Epidemiology of MS, Psychological issues and MS 

S80 

MOBILITY AND THE MSWS-12 IN THE NARCOMS 

REGISTRY 

Amber R. Salter, 1 Tuula Tyry, 2 Stacey S. Cofield, 1 Gary R. Cutter 1 

1 Biostatistics, University of Alabama at Birmingham, Birmingham, AL; 

2 Barrows Neurological Institute, Phoenix, AZ

Posters 

Background: The assessment of mobility can be captured 

in a multitude of ways. The Multiple Sclerosis Walking 

Scale–12 items (MSWS-12) is a self-report measure used as 

an indicator of walking mobility in multiple sclerosis (MS). 

Objectives: To describe the stability of the MSWS-12 over 

time and the relationship between the MSWS-12 and demographic 

and clinical characteristics in the North American 

Research Committee on Multiple Sclerosis (NARCOMS) Registry. 

Methods: NARCOMS conducted two supplemental 

surveys 6 months apart on a subset of participants with a 

Patient-Determined Disease Steps (PDDS) score of 6 (bilateral 

support) or less. The surveys collected additional information 

on mobility and the treatment of disabilities. Correlation and 

descriptive statistics were obtained for the MSWS-12 (scores 

range from 0 to 100) and mobility performance scale (range, 

0–6), PDDS, age, gender, and disease duration. Results: 

The response rate for the survey was 73.2% (4389/6000 

for the initial survey). The average (SD) age of respondents 

was 55.6 (10.1) years, 80.2% were female, and the average 

disease duration was 17.1 (9.3) years; 2.3% reported 

not walking at the time of the survey. Additionally, for participants 

who had no change in PDDS mobility score, the 

average worsening on the MSWS-12 was 1.36 (12.1, n = 

2148); those who reported improvement in mobility reported 

an increase in MSWS-12 of 0.59 (14.3, n = 409); and those 

who reported a worsening PDDS mobility score reported 

a decline of 3.6 (15.7, n = 547). The correlation between 

the MSWS-12 and the mobility scale was 0.87 (Spearman 

rho) at each survey time point. With each increasing level 

of mobility impairment, a significantly significant increase in 

MSWS-12 score was seen in both time points (normal = 6.3, 

minimal = 24.6, mild = 45.8; occasional use of unilateral 

support = 62.7, frequent use of support = 80.1; severe = 

89.2; values from the first survey). Conclusion: The data 

suggest that the MSWS is sensitive to changes in mobility 

but may also have some reactive effects leading to apparent 

declines. Nevertheless, the impact of factors such as mobility 

aids and therapies can be explored to measure their impact 

on walking mobility while controlling for gender, age, and 

disease duration in NARCOMS participants. 

Disclosure: Amber R. Salter: Acorda Therapeutics (consulting fee). 

Tuula Tyry: Acorda Therapeutics (consulting fee). Stacey S. Cofield: 

Glaxo Smith Kline, American Shoulder and Elbow Society, Teva Neuroscience, 

Department of Defense, Orthotec Biotech (consulting fees). Gary 

R. Cutter: Alexion, Bayhill, Bayer, Novartis, Genzyme, Klein-Buendel 

Inc, Peptimmune, Somnus Pharmaceuticals, Sandoz, Teva Neuroscience, 

UTSouthwestern, Visioneering Technologies, Inc (consulting fees). 

S81 

MORTALITY AND SURVIVAL TRENDS IN MULTIPLE 

SCLEROSIS IN A US COHORT 

Shoshana Reshef, 1 Howard Golub, 2 David W. Kaufman, 3 Gary Cutter, 4 

Andreas Bruckner, 5 Ron Preblick, 1 Volker Knappertz 1 

1 Bayer HealthCare Pharmaceuticals, Inc, Montville, NJ; 2 Care-Safe LLC, 

Newton, MA; 3 Slone Epidemiology Center, Boston University, Boston, MA; 

4 UAB School of Public Health, Birmingham, AL; 5 Bayer Schering Pharma AG, 

Berlin, Germany 

Background: The number of people with multiple sclerosis 

(MS) in the United States is estimated at 400,000, of which 

about 70% are privately insured and included in at least 

one claims database. Despite the importance of this disease, 

epidemiologic studies have been limited, often examining 


48 

small populations within a restricted geography, with a short 

duration of follow-up, and without a comparison group. Due 

to these limitations, important rare events such as mortality 

have been difficult to assess. Objectives: This study attempts 

to assess the current survival patterns in patients with MS 

by utilizing payer data sources. Methods: A longitudinal, 

population-based study of data from a large health plan 

affiliated with i3 was undertaken. This large, US database 

contains 39 million individuals, spanning 1993 to 2008. 

Patients were selected through an algorithm combining ICD-9 

codes and disease-modifying treatment (DMT) information. 

A non-MS comparison cohort from the same population 

pool was identified and matched 3:1 on gender, age, geographic 

residence, and year of first identification of MS in 

the database. To assess mortality/survival, individuals were 

followed through 2008 by linking their data to the National 

Death Index (NDI) and Social Security Administration Data 

Master File (SSA DMF) databases to obtain vital status, date 

of death, and cause of death information by calendar year. 

All cause and cause-specific mortality rates will be described. 

Kaplan-Meier curves since birth (lifespan survival) will compare 

the survival experience of MS and non-MS participants. 

Results: A total of 25,032 participants satisfied the MS 

selection criteria, and 75,096 met the non-MS matching 

criteria. The majority of individuals with MS were women 

(76.9%, 19,242/25,032), resulting in a female-to-male ratio 

of 3.3:1. Most patients with MS were 35 to 54 years of age 

(65.2%, 16,321/25,032). A total of 4515 (18.0%) of the 

MS patients had a follow-up time in the database of at least 

5 years. Additional demographic, socioeconomic, and survival 

information will be presented. Conclusion: The results 

from this study will enhance our understanding of the natural 

history of MS mortality/survival in the United States, with a 

special emphasis on the privately insured, a major subgroup 

of the national US population. 

Disclosure: Shoshana Reshef: Bayer HealthCare Pharmaceuticals, Inc 

(salary). Howard Golub: Bayer HealthCare Pharmaceuticals (consulting 

fee). David W. Kaufman: Bayer HealthCare Pharmaceuticals (consulting 

fee). Gary Cutter: Sanofi-Aventis, Cleveland Clinic Foundation, 

Daichi-Sankyo, Glaxo Smith Klein Pharmaceuticals, Genmab Biopharmaceuticals, 

Eli Lilly, Medivation, Modigenetech, Ono Pharmaceuticals, 

PTC Therapeutics, Teva, Vivus, University of Pennsylvania, NHLBI, 

NINDS, NMSS, NICHD (other financial benefits); Alexion, Bayhill, 

Bayer, Novartis, Consortium of Multiple Sclerosis Centers, Genzyme, 

Klein-Buendel Inc, Nuron Biotech, Peptimmune, Somnus Pharmaceuticals, 

Sandoz, Teva, UTSouthwestern Visioneering Technologies, Inc 

(consulting fees). Andreas Bruckner: Bayer Schering Pharma AG (salary). 

Ron Preblick: Bayer HealthCare Pharmaceuticals (salary). Volker Knappertz: 

Bayer HealthCare Pharmaceuticals (salary). 


S82 

MAGNETIC RESONANCE IMAGING BENEFITS 

WITH CLADRIBINE TABLETS ACROSS A RANGE OF 

PATIENTS WITH RELAPSING-REMITTING MULTIPLE 

SCLEROSIS 

Giancarlo Comi, 1 Stuart Cook, 2 Gavin Giovannoni, 3 Kottil Rammohan, 4 Peter 

Rieckmann, 5 Per Soelberg-Sørensen, 6 Patrick Vermersch, 7 Peter Chang, 8 

Bruno Musch, 8 Vissia Viglietta, 8 Steven Greenberg 8 

1 Institute of Experimental Neurology, University Vita-Salute IRCCS, H San 

Raffaele, Milan, Italy; 2 University of Medicine and Dentistry, New Jersey 

Medical School, Newark, NJ; 3 Blizard Institute of Cell and Molecular Science, 

Barts and the London School of Medicine and Dentistry, London, United

Kingdom; 4 University of Miami, Miami, FL; 5 Bamberg Hospital, University 

of Erlangen, Bamberg, Germany; 6 Rigshospitalet, Copenhagen University 

Hospital, Copenhagen, Denmark; 7 University of Lille–Nord de France, Lille, 

France; 8 EMD Serono, Rockland, MA 

Background: Short-course treatment with cladribine tablets 

over 96 weeks in patients with relapsing-remitting multiple 

sclerosis (RRMS) produced significant improvements in the 

annualized relapse rate, risk of sustained 3-month disability 

progression on the Expanded Disability Status Scale (EDSS), 

and active lesion measures assessed by magnetic resonance 

imaging (MRI) in the CLARITY study. Here we analyzed MRI 

outcomes across subgroups of patients with differing baseline 

characteristics. Objectives: MRI data (number of T1 

Gd-enhancing [Gd+], active T2 and combined unique [CU] 

lesions per patient per scan) were analyzed for subgroups 

of the intent-to-treat population from the CLARITY study (437, 

433, and 456 patients randomized to placebo or cladribine 

tablets, cumulative doses over 96 weeks of 3.5 or 5.25 

mg/kg, respectively). Patients were stratified by various 

baseline criteria including age, gender, disease duration, 

prior therapy, prior relapse rate, disability status (EDSS), 

presence of T1 Gd+ lesions on MRI, and T2 lesion burden. 

Results were previously presented at the 2010 Congress 

of the European Committee for Treatment and Research in 

Multiple Sclerosis. Methods: Treatment with 3.5- or 5.25mg/kg 

cladribine tablets consistently resulted in reductions 

in active lesion counts in each patient subgroup, compared 

with placebo. Relative reductions in CU lesions/patient/scan 

at 96 weeks for patients stratified by prior relapse rate in the 

3.5- and 5.25-mg/kg groups were 74.8% and 75.5% (0 or 

1 relapse), 83.1% and 86.7% (2 relapses), and 76.7% and 

90.0% (>3 relapses), respectively (all P < .001). Similarly, 

relative reductions in CU lesions/patient/scan over 96 weeks 

in the 3.5- and 5.25-mg/kg groups were 73.5% and 75.2% 

for patients with no T1 Gd+ lesions at baseline, and 80.8% 

and 84.9% for patients with T1 Gd+ lesions at baseline, 

respectively (all P < .001). Results: These results indicate 

that short-course treatment with cladribine tablets over 96 

weeks reduced active lesion counts in clinically important 

patient subgroups differing in disease severity or activity. 

Disclosure: Giancarlo Comi: Bayer Schering, Merck Serono, Novartis, 

Sanofi-Aventis, Teva Pharmaceutical (consulting fees); Bayer Schering, 

Biogen Dompè, Merck Serono, Novartis, Sanofi-Aventis, Serono Symposia 

International Foundation, Teva Pharmaceutical (other financial 

benefits). Stuart Cook: Bayer Health Care, Biogen Idec, Merck Serono, 

Sanofi-Aventis (consulting fees); Bayer Health Care, Merck Serono (other 

financial benefits). Gavin Giovannoni: Bayer Schering, Merck Serono 

(consulting fees); Bayer Schering, Biogen Idec, Merck Serono (other 

financial benefits). Kottil Rammohan: Abbott, Acorda, Bayer Health 

Care, Biogen Idec, EMD Serono, Genetech, Teva Pharmaceuticals 

(consulting fees); Acorda, Bayer Health Care, Biogen Idec, EMD Serono, 

Genetech, Genzyme, Teva Pharmaceuticals (other financial benefits). 

Peter Rieckmann: Bayer Schering, Merck Serono, Novartis, Teva (consulting 

fees); Bayer Schering, Biogen Idec, Boehringer Ingelheim, Merck 

Serono, Novartis, Pfizer, Sanofi-Aventis, Teva Pharmaceuticals (other 

financial benefits). Per Soelberg-Sørensen: Biogen Idec, Bayer Schering, 

Elan, Genmab, Merck Serono, Novartis, Sanofi-Aventis, Teva (consulting 

fees); Biogen Idec, Bayer Schering, Elan, Genmab, Merck Serono, 

Novartis, Sanofi-Aventis, Teva (other financial benefits). Patrick Vermersch: 

Bayer Schering, Biogen Idec, Merck Serono, Novartis, Roche, 

Sanofi-Aventis, Teva Pharmaceuticals (consulting fees); Bayer Schering, 

Biogen Idec, GSK, Merck Serono (other financial benefits). Peter Chang: 

EMD Serono (salary). Bruno Musch: EMD Serono (salary). Vissia 


49 

Posters 

Viglietta: EMD Serono (salary). Steven Greenberg: EMD Serono (salary). 

Keywords: Disease-modifying treatment in MS, Imaging and MS 

S83 

MAGNETIC RESONANCE IMAGING 

CHARACTERISTICS OF CENTRAL NERVOUS SYSTEM 

DEMYELINATING DISEASE IN ETHNIC INDIAN 

PATIENTS 

Le H. Hua, Jong-Mi Lee, Jeffrey Dunn 

Department of Neurology and Neuroscience, Stanford University, Stanford, CA 

Background: Central nervous system (CNS) demyelinating 

disease is increasingly recognized as a disorder of worldwide 

prevalence with heterogeneity in clinical presentation 

that varies according to race and ethnicity. Multiple sclerosis 

(MS) in Asia has been characterized by fewer brain lesions 

and involves both the optic nerve and spinal cord more frequently, 

with cord lesions spanning greater than three spinal 

segments, compared with MS described in Western populations. 

This unique radiologic phenotype became known 

as opticospinal MS to emphasize the differences. Most of 

the literature on Asian MS comes from studies performed 

in Japan; only recently have other Asian populations been 

studied. Only a handful of studies have investigated MS 

in those of Indian ethnicity, and the results are mixed as to 

whether Western or Asian MS is more prevalent in the Indian 

population. Objectives: This study aims to help clarify the 

radiologic phenotype of patients of Indian ethnicity through 

a retrospective review. Methods: All patients referred to 

our neuroimmunology clinic who self-identified as ethnic 

Indians were selected for participation. No distinction was 

made regarding clinical diagnosis of MS, clinically isolated 

syndrome (CIS), neuromyelitis optica (NMO), or NMO spectrum 

disorder. Previously acquired magnetic resonance (MR) 

images were anonymized prior to review. Subjects with 

imaging features that met three out of four Barkhof’s criteria 

were considered to meet the Western MS radiologic phenotype. 

The Asian MS radiologic phenotype was defined as 

features not meeting Barkhof’s criteria and the presence of 

cord lesions of greater than three spinal levels. Three independent 

reviewers were blinded to the clinical characteristics 

of patients. Findings were compared and consensus opinion 

formed. Results: Sixteen patients, ages 21 to 58, 5 male, 

were included. All had MR brain images and seven had 

spine images available for review. A total of 81% met three 

of four Barkhof’s criteria for Western MS radiologic phenotype. 

None met criteria for Asian MS radiologic phenotype. 

Conclusion: This small cohort suggests that radiographically, 

CNS demyelinating disease in those of Indian ethnicity 

is of Western MS phenotype based on Barkhof’s criteria. 

Limits of our study include small sample size and referral 

bias to a university setting. Future studies should focus on the 

prevalence of CNS demyelinating disease and comparing 

treatment response, immunologic differences, and biomarkers 

in this minority population. 

Disclosure: Le H. Hua: Nothing to disclose. Jong-Mi Lee: Acorda 

Therapeutics (consulting fee). Jeffrey Dunn: Biogen Idec (consulting fee); 

Teva Neuroscience (honoraria). 

Keywords: Imaging and MS

Posters 

S84 

MULTIPLE SCLEROSIS PATIENT TOLERANCE FOR 

RISKY THERAPIES: SURVEY RESULTS FROM THE 

NARCOMS REGISTRY 

Robert J. Fox, 1 Amber Salter, 2 Joan M. Alster, 3 Neal V. Dawson, 4 Michael 

Kattan, 3 Deborah Miller, 1 Tuula Tyry, 5 Brian Wells, 3 Gary Cutter 2 

1 Mellen Center, Cleveland Clinic, Cleveland, OH; 2 University of Alabama 

at Birmingham, Birmingham, AL; 3 Quantitative Health Sciences, Cleveland 

Clinic, Cleveland, OH; 4 Case Western Reserve University, Metrohealth System, 

Cleveland, OH; 5 Barrow Neurological Institute, Phoenix, AZ 

Background: Multiple sclerosis (MS) therapies have 

potential risks, but little is known about the distribution of MS 

patients’ acceptance of potentially fatal risks related to these 

therapies. Objectives: To determine MS patients’ tolerance 

for risky therapies and identify patient characteristics that correlate 

with risk. Methods: A total of 10,259 MS patients in 

the North American Research Committee on Multiple Sclerosis 

(NARCOMS) Registry’s online cohort were invited to complete 

a web-based questionnaire on treatment decision-making. 

Two standard gamble paradigms were used to evaluate 

risk tolerance (RT): 1) curing MS (CureMS), with permanent 

reversal of all MS symptoms but a risk of immediate painless 

death; and 2) natalizumab (NAT), with benefits defined from 

phase 3 trial results but a variable risk of progressive multifocal 

leukoencephalopathy (PML). The odds of each negative 

outcome were adjusted iteratively to identify the maximum 

RT. We also collected disease and behavior characteristics. 

Analysis used Wilcoxon rank sum and Spearman rank correlation. 

Results: A total of 5446 (53.1%) invitees completed 

the survey. They had a mean age of 52.7 years, a mean disease 

duration of 13.9 years, and a mean Patient-Determined 

Disease Steps (PDDS) score of 3.2; 74% were on MS therapy, 

and 78% were female. Median RT for both scenarios 

was 1:10,000. A total of 34.2% reported RT of 1:1000 or 

higher for NAT, compared with 34.4% for CureMS. A total 

of 21.2% reported RT of 1:500 or higher for NAT. In both 

scenarios, higher RT was associated with greater disability 

(P < .0001) and with male gender (P < .0001). Risk tolerance 

for CureMS was higher in those not on MS therapy (P 

< .01), which may reflect greater disability in that group (P 

< .0001). Factors not associated with RT include smoking, 

education level, self-reported betting behavior, and recent 

relapses. Conclusion: We have identified patient characteristics 

related to increased risk tolerance: increased disability, 

male sex, and not currently on MS treatment. One-third of 

respondents reported an RT that would allow treatment with 

NAT or CureMS. This method may enable health-care providers 

to better identify the appropriate patient populations for 

particular therapies. 

Disclosure: Robert J. Fox: Biogen Idec, Teva Neuroscience, Genentech, 

Novartis (consulting fees). Amber Salter: Acorda Therapeutics Inc (consulting 

fee). Joan M. Alster: Nothing to disclose. Neal V. Dawson: Nothing 

to disclose. Michael Kattan: Sanofi-Aventis, Glaxo Smithkline (consulting 

fees); Oncovance Technology (ownership interests). Deborah Miller: 

Nothing to disclose. Tuula Tyry: Acorda Therapeutics (consulting fee). 

Brian Wells: Nothing to disclose. Gary Cutter: Alexion, Accentia, Barofold, 

Ciba Vision, Biogen Idec, Novartis, Klein-Buendel Inc, Enzo Pharmaceuticals, 

Somnus Pharmaceuticals, Teva Pharmaceuticals, Advanced 

Health Media, EMD Serono Inc, EDJ Associates Inc, Aegis Creative Marketing, 

Eli Lilly, UT Southwestern, University of Illinois, Health Policy 

Center (consulting fees); Antisense Therapeutics Limited, Bayhill Pharmaceuticals, 

BioMS Pharmaceuticals (other financial benefits). 

Keywords: Comprehensive care and MS, Quality of life in MS, Diseasemodifying 

treatment in MS 


50 

S85 

“MUST-TOC”: MULTIPLE SCLEROSIS TEAM FOR 

TRANSITION OF CARE—PEDIATRIC TO ADULT 

SETTING 

Diane Lowden, 1 Amit Bar-Or, 1,2 Marie-Emmanuelle Dilenge, 3,4 Diana 

D’Addio, 1 Heather Davies, 4 Dale Macdonald, 4 Sarah Meffe, 4 Serena Slater, 4 

Genevieve Tousignant 1 

1 Neurosciences Mission, Montreal Neurological Institute & Hospital (MUHC), 

Montreal, QC, Canada; 2 Neurology & Neurosurgery, McGill University, 

Montreal, QC, Canada; 3 Pediatrics and Neurology & Neurosurgery, McGill 

University, Montreal, QC, Canada; 4 Pediatric Mission, McGill University 

Health Centre (MUHC), Montreal, QC, Canada 

Up to 10% of individuals with multiple sclerosis (MS) experience 

their first symptoms before the age of 18. Children 

with MS approaching adulthood need to build skills in selfmanagement 

of symptoms and treatments, achieve developmental 

tasks independently of their parents, and acquire 

expertise within a new health-care system, in preparation for 

their eventual transfer to the adult setting. In our tertiary-care 

health centers, a multidisciplinary, cross-site team of pediatric 

and adult MS specialists have developed a coordinated program 

to transition adolescents from the pediatric to adult MS 

program, with the support of a hospital transition advisor. An 

algorithm detailing age-related actions and responsibilities of 

different team members provides guidance for a consistent 

and coordinated transition plan. Joint MS clinics held on both 

sites, at different points in the transition trajectory, enhance 

the efficacy of information transfer, facilitate the development 

and sharing of individualized care plans or clinical practice 

guidelines, and enable the implementation of new therapeutic 

alliances with adolescents and their families prior to transfer. 

Age-appropriate transition checklists assess the readiness 

for transfer and detail the self-care skills to be developed. 

Transfer summaries and test results are sent in advance to the 

receiving institution. Future initiatives planned with the MUST- 

TOC group include the development of a “Patient Passport” 

of health information and a satisfaction questionnaire based 

on the Fletcher Allen survey. Additional immunologic and biological 

studies are planned as part of an ongoing research 

initiative. This novel program has provided a way to ensure 

that transition occurs by design rather than by default for adolescents 

with MS and their families. 

Disclosure: Diane Lowden: Bayer, Biogen Idec, EMD Serono, Novartis, 

Teva Canada Innovation (honoraria). Amit Bar-Or: Berlex/Bayer, 

Biogen Idec, Novartis, Teva Neuroscience, Eli Lilly, Genentech, Merck 

Serono (honoraria); Biogen Idec, Teva Neuroscience, Bayhill Therapeutics, 

Merck Serono, Genentech (research funding, other financial benefits). 

Marie-Emmanuelle Dilenge: Nothing to disclose. Diana D’Addio: 

Nothing to disclose. Heather Davies: Nothing to disclose. Dale Macdonald: 

Nothing to disclose. Sarah Meffe: Nothing to disclose. Serena Slater: 

Nothing to disclose. Genevieve Tousignant: Bayer, Biogen Idec, EMD 

Serono, Novartis, Teva Canada Innovation (honoraria). 

Keywords: Comprehensive care and MS, Service delivery in MS, MS 

and the caregiver/family 

S86 

NURSING STRATEGIES TO REDUCE ALEMTUZUMAB- 

RELATED INFUSION REACTIONS 

Catherine Meyer 

Consultants in Neurology MS Center, Northbrook, IL 

Background: Alemtuzumab is a humanized monoclonal 

antibody that alters the circulating lymphocyte pool. In a

3-year, phase 2 trial (CAMMS223) in relapsing-remitting 

multiple sclerosis (RRMS) patients, alemtuzumab significantly 

reduced relapse rate and risk for 6-month sustained accumulation 

of disability compared with subcutaneous interferon 

beta-1a (P < .001). A total of 98.6% of alemtuzumab-treated 

patients experienced infusion-associated reactions (IARs). 

Nursing intervention, including close monitoring of hydration 

status and body temperature and early administration of H2 

blockers and antipyretics, ameliorates IARs. Objectives: To 

present a descriptive case study demonstrating how nursing 

strategies reduced IARs in a CAMMS223 patient. Methods: 

The patient received 12 mg/d alemtuzumab at months 0, 

12, and 24. Protocol-defined premedication consisted of 1 

gram intravenous (IV) methylprednisolone on the first 3 days 

of months 0, 12, and 24. Additional daily premedication 

consisted of acetaminophen 500 mg, diphenhydramine 25 

mg, cetirizine hydrochloride 10 mg, and ondansetron 4 mg. 

Seventy-two months after her first dose, the patient received 

another cycle of 12 mg/d alemtuzumab. Premedication at 

this time consisted of famotidine 20 mg twice a day and cetirizine 

hydrochloride 10 mg starting the day before the first 

infusion and acetaminophen 500 mg, diphenhydramine 25 

mg, and ondansetron 4 mg each day of infusion. Results: 

The patient was a 26-year-old female; the first MS symptoms 

occurred 0.7 years prior to randomization, and baseline 

Expanded Disability Status Scale (EDSS) score was 2.0. IARs 

observed at month 0: day 1: mild facial flushing, nausea; 

day 2: moderate facial flushing, nausea, headache; day 3: 

no new events; day 4: facial flushing, chest tightness; day 5: 

nausea, erythema on arms, legs, and chest. IARs at months 

12 and 24 were similar in number and severity except for 

erythema. After an IAR management protocol was implemented 

at month 72, fewer and milder IARs occurred: day 

1: mild headache; day 2: mild abdominal cramping; day 3: 

mild headache, nausea, chest heaviness. The EDSS score at 

month 75 was 1.5. Conclusion: Active nursing monitoring 

of hydration and body temperature and proactive patient 

teaching associated with early use of a combination of H2 

blockers markedly improved IARs. These observations may 

help improve the overall tolerability profile of alemtuzumab in 

the treatment of RRMS. 

Disclosure: Teva, Serono, Novartis (consulting fees) 

Keywords: Nursing management in MS 

S87 

OPTICAL COHERENCE TOMOGRAPHY: USE IN A 

PHASE 3 STUDY OF PEGYLATED INTEFERON BETA- 

1A FOR RELAPSING MULTIPLE SCLEROSIS 

Stephanie Syc, Moira Baynes, Shiv Saidha, E’tona Ford, Peter Calabresi 

Johns Hopkins University, Baltimore, MD 

Background: Optical coherence tomography (OCT) is 

a rapid, noninvasive office-based imaging technique that 

allows objective quantitative evaluation of thickness of the 

retinal axon and neuron layers shown to atrophy in multiple 

sclerosis (MS). OCT outcomes correlate with relapsing MS 

(RMS) measures of disability, brain atrophy, visual function, 

and visual quality of life. Preliminary longitudinal data 

suggest that serial OCT testing may be a useful method for 

tracking RMS progression and, thereby, the efficacy of RMS 

disease-modifying therapies. Objectives: To evaluate lon- 


51 

Posters 

gitudinal changes in retinal nerve fiber layer (RNFL) thickness 

in a clinical study of RMS patients receiving subcutaneous 

PEGylated interferon beta-1a (PEG-IFNβ-1a) or placebo to 

validate the clinical utility of OCT testing as an objective indicator 

of RMS treatment efficacy in a controlled setting. Methods: 

This study is a subcomponent of the ADVANCE study, 

a global, 24-month, randomized, double-blind, placebocontrolled 

phase 3 study evaluating the efficacy and safety of 

subcutaneous PEG-IFNβ-1a 125 µg administered every 2 or 

4 weeks. Eligible ADVANCE participants (men and women 

aged 18–55 years with confirmed RMS [McDonald criteria 

1–4] and baseline Expanded Disability Status Scale score 

≤5) will be randomized 1:1:1 to placebo, PEG-IFNβ-1a every 

2 weeks, or PEG-IFNβ-1a every 4 weeks. Placebo patients 

will be rerandomized to PEG-IFNβ-1a every 2 or 4 weeks 

after 12 months. OCT testing is at baseline and at 3, 12, and 

24 months. Results: Of approximately 1260 ADVANCE 

patients to be randomized, up to 120 will also be enrolled in 

the OCT substudy. OCT testing will be utilized to determine 

the relative proportion of patients in the PEG-IFNβ-1a groups 

versus the placebo group who demonstrate an RNFL thickness 

decrease of ≥5 µm (a “greater-than-minor change”) between 

the baseline and 12- and 24-month visits. Secondary and 

tertiary outcomes include measures of macular pathology and 

validation of the reproducibility of OCT at different international 

study sites. Conclusions: Preliminary evidence supports 

the clinical utility of OCT as an objective tool to monitor 

the effectiveness of RMS therapy. Validating the feasibility 

and utility of OCT in a clinical study will help guide its application 

as an outcome measure in future studies. 

Disclosure: Stephanie Syc: Nothing to disclose. Moira Baynes: Nothing 

to disclose. Shiv Saidha: Nothing to disclose. E’tona Ford: Nothing to 

disclose. Peter Calabresi: Biogen Idec, Teva Neuroscience, EMD Serono, 

Novo Nordisk, Novartis (consulting fees); Biogen Idec, Teva Neuroscience, 

EMD Serono, Vertex, Genentech, Abbott, and Bayer (other financial 

benefits). 

Keywords: Comprehensive care and MS, Disease-modifying treatment 

in MS, Imaging and MS 

S88 

OPTIC RADIATION DIFFUSION TENSOR IMAGING 

CORRELATES WITH ACUITY AND RETINAL NERVE 

FIBER LAYER LOSS IN OPTIC NEURITIS 

Salim Abboud, Mark J. Lowe, Blessy Mathew, Ken Sakaie, Jones E. Stephen, 

Michael D. Phillips, Robert A. Bermel 

Mellen Center for MS, Cleveland Clinic Foundation, Cleveland, OH 

Background: Functional recovery after optic neuritis (ON) 

is variable, and the specific mechanisms underlying differential 

recovery are poorly understood. Transsynaptic degeneration 

may occur in the visual system and may be measured as 

changes in optic radiation (OR) on diffusion tensor imaging 

(DTI). Objectives: To evaluate DTI parameters in OR remote 

to unilateral ON and evaluate their relationship to visual 

function and axon loss in the anterior visual system. Methods: 

Fourteen patients (aged 18–60 years) with remote (>6 

months) ON underwent visual acuity testing, measurement of 

retinal nerve fiber layer (RNFL) thickness (stratus optical coherence 

tomography), and whole-brain DTI at 3T. DTI measurements 

were performed using 71 b = 1000 acquisitions and 

8 b = 0 acquisitions at equally spaced intervals. Regions of 

interest (ROIs) were manually drawn on the lateral geniculate

Posters 

nucleus and occipital cortex, serving as seed points and targets 

for probabilistic OR fiber tracking. Burden of T2 lesions 

in the OR was quantified by an expert rater using an ordinal 

scale. Spearman rho was used to evaluate the relationship 

between visual acuity, RNFL, and OR DTI measures. Results: 

Visual acuity in the ON-affected eye correlated with ipsilateral 

OR fractional anisotropy (FA) (100% contrast: r = 0.525, P 

= .054; 2.5% contrast: r = 0.580, P = .030). Temporal RNFL 

of the ON-affected eye plus nasal RNFL of the unaffected eye 

correlated with synaptically matched OR longitudinal diffusivity 

(LD) (r = –0.538, P = .047) but not transverse diffusivity 

(TD) (r = –0.393, P = .164) or FA (r = 0.226, P = .436). FA 

and TD but not LD were associated with T2 lesion burden 

within the OR. Conclusion: DTI is a valuable tool to assess 

tissue injury in regions and ways that are inaccessible by 

retinal imaging and conventional MRI. FA appears to have 

the strongest functional correlations. LD may be the most sensitive 

measure of transsynaptic changes and may be the least 

impacted by focal demyelinating lesions. 

Disclosure: Salim Abboud: Nothing to disclose. Mark J. Lowe: Nothing 

to disclose. Blessy Mathew: Nothing to disclose. Ken Sakaie: Nothing 

to disclose. Jones E. Stephen: Nothing to disclose. Michael D. Phillips: 

Nothing to disclose. Robert A. Bermel: Biogen Idec, Teva Neuroscience 

(consulting fees). 


S89 

PERCEIVED SEVERITY OF DISEASE IN MULTIPLE 

SCLEROSIS 

Michelle Stewart, 1 Amy Phillips, 2 Natalie Edwards, 3 Shaloo Gupta, 4 Amir 

Goren 4 

1 Outcomes Research, Pfizer, Inc, New London, CT; 2 Health Outcomes & 

Market Access, EMD Serono, Inc, Rockland, MA; 3 Health Services Consulting 

Corporation, Boxborough, MA; 4 Health Sciences Practice, Kantar Health, New 

York, NY 

Background: There is abundant evidence that individuals 

with multiple sclerosis (MS) have compromised quality of 

life (QOL) and work productivity, and increased health-care 

resource use compared with individuals without MS. The 

possible association between subjects’ self-reported severity 

of disease and these variables in an MS population has 

only recently been explored. Patient perceptions of disease 

have been increasingly recognized as an important factor 

in health-care resource use. Objectives: The objective of 

this study was to analyze the association between perceived 

severity of disease (mild, moderate, or severe) and symptoms, 

QOL, work productivity, and health-care resource use 

in individuals with MS. Methods: Data from respondents 

reporting an MS diagnosis were obtained from the 2009 

National Health and Wellness Survey (NHWS), an Internetbased 

annual study of the health-care attitudes and behaviors 

of a US representative adult sample. The survey included 

questions about demographics, disease severity, symptoms, 

quality of life, work productivity, and health-care resource 

use. Results: In the 2009 NHWS study, 536 reported an 

MS diagnosis. MS respondents characterized the severity of 

their disease as follows: mild (n = 206; 38.4%), moderate 

(n = 268; 50%); and severe (n = 62; 11.6%). There were 

no differences in the number of years since diagnosis among 

the groups, but there were significantly more men in the 

severe group. As perceived severity increased among MS 


52 

patients (mild, moderate, severe), symptom severity generally 

increased, QOL decreased (12-item Short Form Health Status 

Survey [SF-12] Physical Component Score), the percentage 

with full-time employment decreased, loss of work productivity 

and presenteeism increased among those reporting employment, 

and health-care resource use increased (emergency 

room visits and hospitalizations). Conclusion: Generally, 

those with more severe illness reported greater impairment. 

However, for many of the variables examined, more significant 

differences were found between patients who perceived 

their disease severity as mild and moderate than between 

those patients reporting moderate and severe disease severity. 

Disclosure: Michelle Stewart: Pfizer, Inc (salary). Amy Phillips: EMD 

Serono, Inc (salary). Natalie Edwards: EMD Serono, Inc (consulting 

fee). Shaloo Gupta: EMD Serono, Inc, Pfizer, Inc (consulting fees). Amir 


Keywords: Natural history of MS, Quality of life in MS, Comprehensive 


S90 

PROVIDER AWARENESS OF COMPLEMENTARY AND 

ALTERNATIVE MEDICINE USE BY THEIR MULTIPLE 

SCLEROSIS PATIENTS 

Sierra C. Ford, 1,2 Joanna A. Cooper 2 

1 College of Osteopathic Medicine, Touro University, Vallejo, CA; 2 Division of 

Neurology, East Bay Physicians Medical Group, Berkeley, CA 

Background: Olsen found that complementary and alternative 

medicine (CAM) is used by 27% to 100% of multiple 

sclerosis (MS) patients, 1 but Rosenbaum et al. felt that physicians 

believe that 25% MS) were significantly more aware of CAM 

use, believing that 40% to 50% of their MS patients currently 

use and 50% to 60% have tried CAM; and 2) those who are 

more aware of CAM use counsel their patients more regularly, 

with providers who think that >40% of their patients are 

using CAM being more likely to ask often or always. Conclusion: 

Vickrey et al. found that approximately half of MS 

patients in the United States are treated by general neurolo

gists rather than at MS-dedicated clinics. 3 In order to facilitate 

improved MS patient satisfaction and safety, it is vital that 

all neurologists become more knowledgeable about CAM. 

As two-thirds of respondents were not very comfortable with 

CAM, more education for neurologists is needed. Future studies 

in this area may need to include provider/patient pairs to 

assess neurologists’ awareness and comfort with the patientspecific 

use of CAM. 

1. Olsen, Occup Ther Int. 2009; 16(1):57-70. 

2. Rosenbaum et al., Am J Med Qual. 2002; 17(1):3-9. 

3. Vickrey et al., Neurology. 1999; 53:1190-97. 

Disclosure: Sierra C. Ford: Foundation of the Consortium of Multiple 

Sclerosis Centers: MS Workforce of the Future program (other financial 

benefit). Joanna A. Cooper: Nothing to disclose. 

Keywords: Complementary/alternative therapies in MS 

S91 

PSYCHOSOCIAL FACTORS RELATED TO CIGARETTE 

SMOKING BEHAVIOR AND DISABILITY OF 

PATIENTS WITH MULTIPLE SCLEROSIS 

Joseph H. Ostroff, 1,2 Katherine A. Barker, 1 Bianca Weinstock-Guttman, 1,3 

Barbara E. Teter 1,2 

1 New York State Multiple Sclerosis Consortium, Buffalo, NY; 2 SUNY Buffalo, 

Buffalo, NY; 3 Jacobs Neurological Institute, Buffalo, NY 

Background: Multiple sclerosis (MS) is a neurodegenerative 

disease characterized by chronic inflammation of central 

nervous system (CNS) tissue, and it has been proposed that 

the biological mechanism NNK, a known carcinogen in 

cigarette smoke, can directly damage neurons in the CNS. 

Cigarette smokers with MS typically experience higher rates 

of disability, and smoking has also been recently associated 

with the progression of relapsing-remitting MS to a secondary 

progressive form of the disease. Objectives: To investigate 

sociodemographic, psychosocial, and clinical factors related 

to differences between MS patient smokers and nonsmokers. 

Methods: Analysis was based on a cross-sectional subset of 

data from the New York State Multiple Sclerosis Consortium 

(NYSMSC) registry. The sample included 1300 MS patients 

who reported ever or never smoking between the years of 

2006 and 2009. Demographic, psychosocial, and clinical 

data extracted from the registry included sex, age, marital 

status, education level, social isolation, stress, mood, satisfaction 

with life, pain, fatigability, Expanded Disability Status 

Scale (EDSS) score, MS type, and years from symptom onset. 

Results: The prevalence of smokers in this sample population 

of MS patients was 35.5%. Of those, 33.5% reported 

smoking cigarettes for a period of greater than 20 years. A 

total of 77.8% of the studied patients were female. A total 

of 15.8% of smokers had an EDSS score of 6.0 or greater 

at registration, compared with 11.2% of nonsmokers. For 

smokers, 78.2% had relapsing-remitting MS (RRMS) and 

12.6% had secondary progressive MS (SPMS), which was 

significantly different from the proportion for nonsmokers at 

82.7% and 9.95% for RRMS and SPMS, respectively. A total 

of 20.9% of smokers reported “distressing pain,” compared 

with 17.0% of nonsmokers. Smokers were significantly more 

likely to be single or divorced and to experience higher levels 

of pain, fatigue, tension, and loneliness. Conclusion: 

Cigarette smoking is known to influence the development, 

progression, and severity of MS. It is important for patients 


53 

Posters 

and clinicians to be better informed regarding the potential 

associations between psychosocial factors and MS disability. 

Our study suggests that MS is negatively associated with 

cigarette smoking behavior. 

Disclosure: Joseph H. Ostroff: Nothing to disclose. Katherine A. Barker: 

Nothing to disclose. Bianca Weinstock-Guttman: Biogen Idec, Teva 

Neuroscience, EMD Serono, Pfizer, Novartis, Apreva, Acorda, Cognition, 

National Multiple Sclerosis Society, National Institutes of Health 

(other financial benefits). Barbara E. Teter: Biogen Idec, EMD Serono, 

Teva (other financial benefits). 

Keywords: Psychosocial issues in MS 

S92 

RISK OF NATALIZUMAB-ASSOCIATED PROGRESSIVE 

MULTIFOCAL LEUKOENCEPHALOPATHY 

Alfred W. Sandrock, Christophe Hotermans, Sandra Richman, Amy Natarajan, 

Sophia Lee, Tatiana Plavina, Gary Bloomgren, Meena Subramanyam, Carmen 

Bozic 

Biogen Idec Inc, Weston, MA 

Background: Progressive multifocal leukoencephalopathy 

(PML) is a rare, demyelinating central nervous system 

disease caused by JC virus (JCV) and a complex interaction 

between host immune and genetic factors. Data from 75,500 

natalizumab-treated patients (29,400 treated for ≥2 years as 

of September 2010) worldwide indicated that prior immunosuppressant 

(IS) use and natalizumab treatment duration are 

independently associated with increased risk of PML. Anti-JCV 

antibody positive status, a potential risk factor for PML, is currently 

being studied. Objectives: To assess risk stratification 

for natalizumab-associated PML by prior IS use, natalizumab 

treatment duration, and anti-JCV antibody status. Methods: 

PML incidence calculations by prior IS use and natalizumab 

duration were based on 70 confirmed cases as of November 

2010. Frequency of IS use was based on reported use in 

the TYGRIS observational study. The potential utility for risk 

stratification by anti-JCV antibody status was evaluated by 

determination of antibody status in sera archived prior to 

PML diagnosis from 21 natalizumab-treated multiple sclerosis 

(MS) PML patients. Results: At the time of analysis, the 

estimated PML risk for patients without prior IS use was 0.19 

per 1000 patients (95% confidence interval [CI], 0.10-0.33) 

with ≤2 years’ natalizumab, and 1.13 per 1000 patients 

(95% CI, 0.75-1.65) with >2 years’ natalizumab. PML risk 

for patients with prior IS exposure was 0.42 per 1000 

patients (95% CI, 0.16-0.92) with ≤2 years’ natalizumab, 

and 4.35 per 1000 patients (95% CI, 2.82-6.42) with >2 

years’ natalizumab. Pre-PML sera from 21 MS patients with 

PML (prior IS use [9/21, 43%], median natalizumab doses 

[31, range 17–49]) consistently tested positive for anti-JCV 

antibodies. The observed 100% anti-JCV antibody positivity 

in these 21 PML cases is significantly different from the 54% 

seroprevalence observed in natalizumab-treated patients from 

the STRATA study (P < .0001). Conclusions: PML risk may 

be stratified by prior IS use and increased natalizumab treatment 

duration. The 100% anti-JCV antibody positivity in pre- 

PML sera from 21 PML patients supports the hypothesis that 

anti-JCV antibody testing using a two-step ELISA can stratify 

subpopulations of patients for lower or higher risk of developing 

PML. This hypothesis is being further evaluated in large 

clinical studies.

Posters 

Disclosure: Alfred W. Sandrock: Biogen Idec (salary). Christophe 

Hotermans: Biogen Idec (salary). Sandra Richman: Biogen Idec (salary). 

Amy Natarajan: Biogen Idec (salary). Sophia Lee: Biogen Idec (salary). 

Tatiana Plavina: Biogen Idec (salary). Gary Bloomgren: Biogen Idec 

(salary). Meena Subramanyam: Biogen Idec (salary). Carmen Bozic: 

Biogen Idec (salary). 


S93 

SAFE AND EFFECTIVE USE OF AN AUTOINJECTOR 

FOR INTRAMUSCULAR INTERFERON BETA-1A IN 

MULTIPLE SCLEROSIS PATIENTS 

J. Theodore Phillips, 1 Dianne Tuccillo, 2 Shifang Liu, 2 Kathleen Curnow, 2 Aaron 

Deykin 2 

1 MS Center at Texas Neurology, Dallas, TX; 2 Biogen Idec Inc, Weston, MA 

Background: Patients with multiple sclerosis (MS) may 

have difficulty self-administering parenteral treatments 

because of fear of injections and impaired motor function. 

Autoinjectors may improve patients’ self-administration ability 

and provide benefits including enhanced convenience, 

increased adherence, and improved quality of life. Objectives: 

To assess the safety, effective use, and pharmacodynamic 

effects of a single-use autoinjector for administration of 

intramuscular interferon beta-1a (IM IFNβ-1a) in patients with 

MS. In addition, to evaluate ease of autoinjector use, clarity 

of instructions, and preferences for device type. Methods: 

The study was an open-label, single-country, multicenter trial 

in MS patients who had used IM IFNβ-1a (30 µg/wk) prefilled 

syringes for ≥12 weeks prior to enrollment. On day 1, 

patients self-administered a prefilled syringe of IM IFNβ-1a 

in the clinic. Patients returned on day 8 for their first dose 

of IM IFNβ-1a using the autoinjector. On day 15, patients 

administered IM IFNβ-1a with the autoinjector at home, 

returning on day 22 for the study staff observation of the final 

self-administered dose. All doses of IM IFNβ-1a during the 

study were self-administered. Patients completed a preference 

questionnaire on day 23, and injection sites were assessed at 

a final clinic visit. Serum samples for neopterin were collected 

1 hour before and 24 and 48 hours after injection on days 

1 and 8. Adverse events (AEs) were monitored throughout. 

Results: Most patients (96%; n = 71) completed the study. 

Most completing patients (89%) used the autoinjector successfully 

as prespecified in the protocol; 99% used it without 

injury or incomplete dosing. No autoinjector malfunctions 

occurred. One unsuccessful dosing occurred due to patient 

error. Patients gave the autoinjector high ratings (8.7–9.3) on 

a 10-point scale for ease of use (0 = extremely difficult, 10 

= extremely easy). The majority of patients (94%) preferred 

the autoinjector over manual injection. Serum neopterin levels 

were comparable to those of the prefilled syringe. The most 

commonly reported AE was injection-site pain (reported in 

7% of patients; n = 5). Conclusions: Study results indicate 

that the single-use IM IFNβ-1a autoinjector is safe and well 

tolerated and that patients prefer the autoinjector over manual 

injection. 

Disclosure: J. Theodore Phillips: Biogen Idec, Novartis, Teva (honoraria). 

Dianne Tuccillo: Biogen Idec (salary). Shifang Liu: Biogen Idec 

(salary). Kathleen Curnow: Biogen Idec (salary). Aaron Deykin: Biogen 

Idec (salary). 



54 

S94 

SAFETY OF SUBCUTANEOUS INTERFERON BETA- 

1A IN PATIENTS WITH CLINICALLY ISOLATED 

SYNDROME: THE REFLEX STUDY 

Mark S. Freedman, 1 Ludwig Kappos, 2 Nicola De Stefano, 3 Giancarlo Comi, 4 

Florence Casset-Semanaz, 5 Brian Hennessy, 5 Sanda Rocak, 6 Lorenz Lehr, 7 

Margot Stam Moraga 8 

1 Multiple Sclerosis Research Unit, The Ottawa Hospital–General Campus, 

Ottawa, ON, Canada; 2 Departments of Neurology and Biomedicine, 

University Hospital Basel, Basel, Switzerland; 3 Department of Neurological 

and Behavioral Sciences, University of Siena, Siena, Italy; 4 Department 

of Neurology, Ospedale San Raffaele, Milan, Italy; 5 Global Biostatistics, 

Merck Serono S.A., Geneva, Switzerland; 6 Global Clinical Development 

Unit–Neurodegenerative Diseases, Merck Serono S.A., Geneva, Switzerland; 

7 Global Medical Affairs, Merck Serono S.A., Geneva, Switzerland; 8 Drug 

Safety, Merck Serono S.A., Geneva, Switzerland 

Background: The benefits of subcutaneous (SC) interferon 

beta-1a (IFNβ-1a) in patients with relapsing multiple sclerosis 

(MS) have been demonstrated, with best outcomes achieved 

with early treatment. Objectives: To report the safety findings 

of the REFLEX (REbif FLEXible dosing in early Multiple 

Sclerosis) trial, in which two dosing frequencies (once weekly 

[qw] or three times weekly [tiw]) of the serum-free formulation 

of SC IFNβ-1a were studied in patients with clinically isolated 

syndrome. Methods: Patients, aged 18 to 50 years, with 

a first demyelinating event, considered to be at high risk of 

converting to MS (exclusion of alternative diagnoses and ≥2 

clinically silent T2 brain lesions on magnetic resonance imaging) 

were randomized (1:1:1) to the serum-free formulation 

of IFNβ-1a, 44 µg SC tiw or qw (plus placebo twice weekly 

for blinding), or placebo tiw, for up to 24 months. Upon conversion 

to clinically definite MS, patients were treated with 

open-label IFNβ-1a, 44 µg SC tiw. Safety endpoints included 

adverse events (AEs), focusing on typical IFNβ-related AEs. 

Results: A total of 517 patients were randomized (mean 

[SD] age: 30.7 [8.2] years; 64.2% women); 515 were 

treated. During the double-blind period, 440/515 patients 

(85.4%) experienced ≥1 prespecified AE: 148/171 (86.5%) 

in the IFNβ-1a tiw group, 158/173 (91.3%) in the IFNβ-1a 

qw group, and 134/171 (78.4%) in the placebo group. Incidences 

of these AEs by treatment arm (IFNβ-1a tiw, IFNβ-1a 

qw, and placebo, respectively), were as follows: for injectionsite 

reactions, 35.7%, 24.3%, 7.0%; for flu-like syndrome, 

54.4%, 70.5%, 19.9%; for hepatic disorders, 11.1%, 9.2%, 

4.7%; for cytopenia, 11.1%, 5.2%, 2.3%; for depression 

and suicidal ideation, 8.2%, 6.4%, 8.2%. No unexpected 

serious adverse drug reactions were reported during the 

trial. In the 2-year period, 22 patients withdrew due to AEs: 

7 (4.1%) from the IFNβ-1a tiw group, 5 (2.9%) from the 

IFNβ-1a qw group, and 10 (5.8%) in the placebo group. 

Conclusions: The safety profile of the serum-free formulation 

of IFNβ-1a, 44 µg SC tiw or qw, in a population of patients 

with early MS was in line with that established in relapsing 

MS, and no new safety issues were revealed. 

Disclosure: Mark S. Freedman: Bayer HealthCare,Celgene, Sanofi- 

Aventis, Merck Serono, Novartis, Biogen Idec, Genzyme (other financial 

benefits). Ludwig Kappos: Acorda Therapeutics, Wyeth, UCB, Teva, 

Roche, Shire, Santhera Pharmaceuticals, Sanofi-Aventis, MediciNova, 

Novartis, Merck Serono, GlaxoSmithKline, Elan, Genmab, Boehringer 

Ingelheim, Biogen Idec, Bayhill, Bayer, Allozyne, Actelion Pharmaceuticals 

(other financial benefits). Nicola De Stefano: Schering, Biogen 

Idec, Teva, Merck Serono (honoraria); Merck Serono (other financial

enefits). Giancarlo Comi: Serono Symposia International Foundation, 

Biogen Dompè, Bayer Schering, Sanofi-Aventis, Teva Pharmaceutical 

Industries Ltd, Merck Serono, Novartis (honoraria); Biogen Dompè, 

Bayer Schering, Sanofi-Aventis, Teva Pharmaceutical Industries Ltd, 

Merck Serono, Novartis (consulting fees). Florence Casset-Semanaz: 

Merck Serono (salary). Brian Hennessy: Merck Serono (salary). Sanda 

Rocak: Merck Serono (salary). Lorenz Lehr: Merck Serono (salary). Margot 

Stam Moraga: Merck Serono (salary). 


S95 

START-UP AND RECRUITMENT IN ACADEMIC 

CENTERS AND PRIVATE PRACTICES IN COMBIRX 

C. Steveson Powell, 1 Tarah Gustafson Herrmann, 2 Gary R. Cutter, 1 Jerry S. 

Wolinsky, 3 Robin Conwit, 4 Fred D. Lublin, 2 Stacey S. Cofield 1 

1 Biostatistics, The University of Alabama at Birmingham, Birmingham, AL; 

2 Neurology, Mount Sinai School of Medicine, New York, NY; 3 Neurology, The 

University of Texas Health Science Center at Houston, Houston, TX; 4 Clinical 

Research, NIH/NINDS, Bethesda, MD 

Background: The CombiRx trial is a double-blind, multicenter 

randomized clinical trial studying relapsing-remitting 

multiple sclerosis (RRMS), comparing participants on combined 

interferon beta-1a and glatiramer acetate versus singleagent 

arms with matching placebo for a minimum of 3 years. 

Entry criteria include the following: Expanded Disability 

Status Scale (EDSS) score of ≤5.5, RRMS diagnosed by Poser 

or McDonald criteria, age from 18 to 60 years, ≥2 relapses 

in the prior 3 years, and no prior use of either medication. 

CombiRx centers include private practice and academic centers, 

which allows for description and comparison of start-up 

times, screening, and recruitment numbers in a large clinical 

trial. Objectives: Compare administrative, regulatory, and 

recruitment benchmarks between academic centers and private 

practices during start-up in CombiRx. Methods: Both 

academic centers (ACs) and private practice centers (PPs) 

were eligible to participate as study centers in the CombiRx 

trial. All centers were required to have institutional review 

board (IRB) approval, local or central IRB; an executed fiscal 

contract; protocol training; data entry system (DES) training 

and certification; and magnetic resonance imaging (MRI) certification 

and approval prior to recruitment. Dates of initiation 

and completion were collected for all regulatory steps from all 

centers. Results: Of the 68 centers that randomized at least 

1 participant, 57% (39) were ACs and 43% (29) were considered 

PPs. For ACs compared with PPs, there were nominal 

differences in the median number of screened (15 vs. 12) 

and randomized (13 vs. 11) participants, as well as the 

number of screen failures (2 vs. 1) and the number of months 

of open recruiting (36.9 vs. 35.5). There was a statistically 

longer median time from the initiation of DES certification to 

completion for ACs compared with PPs (46 vs. 17 days, P 

= .0004) and a nominally larger number of AC compared 

with PPs utilizing remote desktop access rather than a site 

application-based system (67 vs. 55%). Conclusions: 

Although there does not appear to be a large difference in 

the number of participants recruited between ACs and PPs, 

the time to complete data training, a surrogate for Internet, 

firewall, and data access issues, was significantly longer in 

ACs. Additional benchmark results for other administrative 

and regulatory issues, such as contracting and IRB approval 

times, will also be presented. 

Supported by: NIH/NINDS 1 U01 NS 45719-01 


55 

Posters 

Disclosure: C. Steveson Powell: Nothing to disclose. Tarah Gustafson 

Herrmann: Nothing to disclose. Gary R. Cutter: Sanofi-Aventis, 

Cleveland Clinic, Daichi-Sankyo, GlaxoSmithKline Pharmaceuticals, 

Genmab Biopharmaceuticals, Eli Lilly, Medivation, Ono Pharmaceuticals, 

PTC Therapeutics, Teva Neuroscience, Inc, Vivus, University of 

Pennsylvania, NIH/NHLBI/NINDS, National Multiple Sclerosis Society 

(consulting fees); Alexion, Klein-Buendel Inc, Bayhill, Peptimmune, 

Bayer, Novartis, UT Southwestern, Somnus, Sandoz, Visioneering Technologies 

(honoraria); Consortium of Multiple Sclerosis Centers (other 

financial benefit). Jerry S. Wolinsky: Acorda Therapeutics, Inc, Acetilion, 

Antisense Therapeutics, Bayer, Consortium of Multiple Sclerosis Centers, 

Facet Biotech, Eli Lilly, EMD Serono, Genentech Inc, National Multiple 

Sclerosis Society, Novartis Pharmaceuticals, Sanofi-Aventis, Teva 

Pharmaceuticals, UCB, University of South Florida, University of Texas 

Medical Branch, ACP Medicine, Clayton Foundation for Research, BC 

Decker (other financial benefits); Millipore (Chemicon International) 

(royalty). Robin Conwit: Nothing to disclose. Fred D. Lublin: Acorda 

Therapeutics, Inc, Biogen Idec, Genentech, Inc, Novartis Pharmaceuticals 

Corp, Teva Neuroscience, Inc, Genzyme, Sanofi-Aventis, NIH, 

National Multiple Sclerosis Society (other financial benefits); Bayer 

Health Care, Questcor, BioMS Medical Corp, EMD Serono, Avanir, 

Novartis, Pfizer, Genmab, Medicinova, Actelion, Roche, Celgene, Allozyne, 

Abbott, MorphoSys (consulting fees). Stacey S. Cofield: Teva Neuroscience, 

Inc (consulting fee); NIH, Consortium of Multiple Sclerosis 

Centers, Amercian Shoulder and Elbow Society (other financial benefits); 

American Institute of Biological Sciences, Centocor Ortho-Biotech Services 

LLC, GlaxoSmithKline Pharmaceuticals (consulting fees). 

S96 

SUBCUTANEOUS DACLIZUMAB, INJECTION-SITE 

REACTIONS, AND ANTIDRUG ANTIBODIES 

Jake Elkins, 1 Chungchi Wang, 2 Lauri Neyer, 2 Katherine Riester 1 

1 Biogen Idec Inc, Weston, MA; 2 Abbott Biotherapeutics Corp, Redwood City, CA 

Background: The phase 2 CHOICE trial was conducted 

to assess the safety and efficacy of daclizumab (DAC) in 

patients with active relapsing forms of multiple sclerosis (MS) 

concurrently receiving interferon beta (IFNβ) therapy. Objectives: 

Evaluate the incidence of injection-site reactions (ISRs) 

with subcutaneous (SC) administration of DAC in MS patients 

and any potential association of ISRs with the presence of 

antidrug antibodies. Methods: We searched the safety 

database for adverse events related to ISRs to determine 

event frequency. Incidence by treatment group (DAC/IFNβ 

vs. placebo/IFNβ), treatment duration (first 3 months vs. last 

3 months), and DAC antidrug antibody status (any antidrug 

antibody vs. any neutralizing antidrug antibody vs. no antibody) 

was compared using a Fisher exact test. A McNemar 

test was used to compare incidence during the first 3 months 

of treatment with incidence during the last 3 months of treatment. 

Results: All recorded ISRs (as defined by the Medical 

Dictionary for Regulatory Activities [MedDRA] term) were 

considered nonserious. A total of 5.9% (n = 153) of DAC/ 

IFNβ subjects versus 6.5% (n = 77) of placebo/IFNβ subjects 

(P > .999) reported ISRs. When injection-site pain, irritation, 

discomfort, and erythema were included in the definition of 

ISR, the incidence was 32.7% (n = 50/153) in DAC/IFNβ 

subjects versus 39.0% (n = 30/77) in placebo/IFNβ subjects 

(P = .615). In DAC/IFNβ subjects, injection-site adverse 

events were more common during the first 3 months of treatment 

than during the last 3 months (P = .019) and DAC antidrug 

antibody status was not associated with the occurrence 

of ISRs (P = .389). Conclusion: The incidence of ISRs during 

SC DAC dosing was low; they did not appear to represent a

Posters 

specific reaction to DAC, given the similar incidence seen in 

the placebo/IFNβ group, and were not associated with DAC 

antidrug antibody status. These findings should be confirmed 

in long-term studies. 

Disclosure: Jake Elkins: Biogen Idec (salary). Chungchi Wang: Abbott 

Biotherapeutics (salary). Lauri Neyer: Abbott Biotherapeutics (salary). 

Katherine Riester: Biogen Idec (salary). 


S97 

SURVIVAL IN MULTIPLE SCLEROSIS FROM THE 

NARCOMS REGISTRY 

Gary R. Cutter, 1 Amber R. Salter, 1 Tuula Tyry, 2 Ruth Ann Marrie, 3 Robert J. 

Fox, 4 Rachel L. Moreau, 1 Stacey S. Cofield 1 

1 Biostatistics, University of Alabama at Birmingham, Birmingham, AL; 2 Barrow 

Neurological Institute, Phoenix, AZ; 3 University of Manitoba, Winnipeg, MB, 

Canada; 4 Neurology, Cleveland Clinic, Cleveland, OH 

Background: To date, mortality data reported for multiple 

sclerosis (MS) were based on national registries, clinical trials, 

or population studies. One United States–based study 

suggested that mortality rates from MS are increasing (Redelings 

2006), which seems inconsistent with worldwide drops 

in adult mortality rates. The North American Research Committee 

on Multiple Sclerosis (NARCOMS) Registry offers an 

opportunity to evaluate mortality trends in participants with 

varying dates of disease onset and diagnosis, and age at 

death. NARCOMS is a long-term effort with semi-annual 

updates via patient self-report using validated, standardized 

instruments and targeted questions. The data are obtained 

using web- or paper-based data collection. Objectives: This 

study has four major objectives: 1) to assess mortality in MS 

patients from disease diagnosis; 2) to assess age at death 

among MS patients; 3) to assess underlying causes of death; 

and 4) to perform a comparison of temporal trends to assess 

whether general worldwide reductions in mortality are seen 

among MS populations. Methods: NARCOMS registrants 

(n > 35,000) who had not responded to the spring 2010 

update (n = 20,861) were compared with the US National 

Death Index (NDI) to obtain data on dates of death and 

underlying causes of death through 2008. Life tables will 

be constructed and cohorts will be compared by age, index 

year of onset, and/or diagnosis. Results: Among the nearly 

35,000 participants registered in NARCOMS, over 1280 

have been identified as deceased via passive surveillance. 

Of these, 1038 were matched to the NDI, of whom 52.2% 

were male participants. The average age of a NARCOMS 

participant at death was 61.2 years (SD 12.4), and the average 

duration of MS from diagnosis until death was 22 years 

(SD 12.2). The mortality rates by age and disability level 

appear to behave as expected, with mortality rates rising 

exponentially by age, females having lower mortality than 

males, and increasing degree of disability. Underlying causes 

of death and the impact of other covariates on mortality, such 

as use of immunologic therapies, will be examined. Conclusion: 

Results of the mortality analyses will be presented and 

assessments against primary objectives made. 

Disclosure: Gary R. Cutter: Alexion, Bayhill, Bayer, Novartis, Genzyme, 

Klein-Buendel Inc, Peptimmune, Somnus Pharmaceuticals, Sandoz, 

Teva Neuroscience, UT Southwestern, Visioneering Technologies, 

Inc (consulting fees). Amber R. Salter: Acorda Therapeutics (consulting 

fee). Tuula Tyry: Acorda Therapeutics (consulting fee). Ruth Ann Mar- 


56 

rie: Nothing to disclose. Robert J. Fox: Biogen Idec, Genentech, Teva 

Neuroscience, Novartis (consulting fees). Rachel L. Moreau: Nothing to 

disclose. Stacey S. Cofield: Glaxo Smith Kline, Orthotec Biotech, Teva 

Neuroscience, American Shoulder and Elbow Society, Department of 

Defense (consulting fees). 

Keywords: Natural history of MS, Epidemiology of MS 

S98 

THE DANGERS OF RELYING ON RADIOLOGY 

REPORTS FOR MULTIPLE SCLEROSIS MAGNETIC 

RESONANCE IMAGING FINDINGS RATHER THAN 

THE NEUROLOGIST READING/INTERPRETING THE 

FILMS 

Daniel Kantor 

Neurologique, Ponte Vedra, FL 

Background: Modern medicine has divided the roles of 

specialists, such as neurologists and radiologists. It is increasingly 

difficult for the neurologist to obtain and interpret their 

multiple sclerosis (MS) patients’ magnetic resonance imaging 

(MRI) scans. It is important to educate neurologists on the 

need to personally interpret MRI scans of their MS patients. 

Objectives: To demonstrate the dangers of relying on radiology 

reports rather than interpreting MRI scans personally. 

Methods: Case report. Results: A 53-year-old woman with 

stable relapsing-remitting MS (RRMS) developed subacute 

headaches, imbalance, and falling to the right. An inner 

ear infection was suspected, but her neurologist ordered a 

brain MRI scan, and the radiologist documented “a small 

amount of new enhancement adjacent to the frontal horns of 

both lateral ventricles with no brainstem lesions.” Intravenous 

SoluMedrol was initiated, but she was then referred to an 

MS specialist because of incomplete recovery. She also had 

horizontal diplopia and tongue hypoesthesia. On neurologic 

examination, she had horizontal nystagmus, mild bilateral 

intranuclear ophthalmoplegia, and overshooting on pursuit. 

She was hyperreflexic. Sensory examination revealed right 

> left reduction to all sensory modalities and a T2 spinal 

sensory level. She had right > left dysmetria and was unable 

to perform tandem gait; she needed a cane and walked 

unsteadily (previously she walked unaided). Romberg testing 

was positive. On reading the MRI scan, the MS specialist 

found right (1.6 cm) and left (1 cm) brachium pontis gadolinium-enhancing 

lesions. Conclusion: Neurologists need 

to interpret MRI scans without simply relying on reports. Had 

this patient not also had other gadolinium-enhancing lesions, 

the radiologist would have read the MRI scan as “stable compared 

with previous examination.” Her primary neurologist 

may then have doubted that she was having an MS relapse, 

and instead have suspected an inner ear infection. There is 

a risk of accumulating disability with each MS relapse, and 

untreated relapses may have potentially detrimental effects on 

patient well-being; with the reliance on MRI findings, neurologists 

should be educated on the need to interpret MRI films 

independently from radiologists. Despite increasing barriers 

to neurologists’ interpreting MRI films on their own, it is important 

for patient safety and management. 


Keywords: Comprehensive care and MS, Imaging and MS

S99 

DISABILITY OUTCOMES OF DISEASE-MODIFYING 

DRUGS IN MULTIPLE SCLEROSIS 

Walter J. Hader 

Physical Medicine, University of Saskatchewan, Saskatoon, SK, Canada 

Background: The beneficial effects of disease-modifying 

drugs (DMDs) in decreasing attacks and reducing cerebral 

lesions in relapsing-remitting multiple sclerosis (RRMS) have 

been previously reported. However, the results related to disability 

outcomes and the reduction of disease progression in 

the shorter-term pivotal trials, and the few longer studies are 

variable and inconclusive. Objectives: To determine the 

utilization and compare the disability outcomes of DMDs in 

RRMS over 10 years. Methods: A prospective open-label 

cohort of 262 patients with clinically definite MS, 78 men 

and 184 women, with two attacks in the past 2 years and 

a disability level as measured by the Disability Status Scale 

(DSS) of ≤5.5, were enrolled consecutively from December 

1997 to November 1999 and followed for 12 years. This 

study had ethics committee approval, and informed consent 

was obtained from participants. A baseline questionnaire 

and database were completed, and annual neurologic 

evaluations (DSS) were recorded. The drug chosen for treatment 

was at the discretion of the patient and physician. 

The reasons for drug switching and discontinuation were 

tabulated. A descriptive analysis of the cohort and individual 

drug outcomes and switches was performed. The results were 

compared with studies of the natural history of MS. Results: 

At 10 years, 72/262 participants (27.5%) remained on the 

initial prescription, and 64/72 (88.9%) had a DSS level of 

≤3.0. A total of 126/262 (48.1%) had continued on a drug 

(including 54 switches), and 136 (51.9%) had discontinued 

at a mean duration of 55.5 months. At baseline, 232/262 

(88.5%) had a DSS level of ≤3.5, decreasing to 43.5% 

including switched prescriptions. A total of 59/262 (22.5%) 

who started and stopped therapy had a DSS level of ≤3, 

24/262 (9.2%) had a DSS level of 3.5 to 5.5, and 37/262 

(14.1%) had a DSS level of ≥6. Three patients have died. 

The DSS levels of the individual DMDs were recorded. A 

total of 30/131 patients (26.9%) taking Betaseron, 28/102 

(30.4%) taking copaxone, and 14/28 (50%) taking Rebif 

remained on the initial prescription. Conclusions: This study 

does not support a beneficial impact of DMDs on the reduction 

of disease progression in MS in the longer term. 



S100 

EFFECTS OF FINGOLIMOD ON DISABILITY 

PROGRESSION USING THE MULTIPLE SCLEROSIS 

FUNCTIONAL COMPOSITE 

Gordon Francis, 1 Peter Calabresi, 2 Paul O’Connor, 3 Reinhard Hohlfeld, 4 Ernst- 

Wilhelm Radue, 5 Jean Pelletier, 6 Xavier Montalban, 7 Hans-Peter Hartung, 8 

Giancarlo Comi, 9 Bhupendra O. Khatri, 10 Frederik Barkhof, 11 Ludwig Kappos, 5 

Jeffrey A. Cohen, 12 Lixin Zhang-Auberson, 13 Catherine Agoropoulou, 13 

Dieter A. Häring, 13 Tracy Stites, 1 James Jin, 1 Shreeram Aradhye, 1 Philipp von 

Rosenstiel 13 

1 Novartis Pharmaceuticals, East Hanover, NJ; 2 Johns Hopkins Hospital, 

Baltimore, MD; 3 St. Michael’s Hospital, Toronto, ON, Canada; 4 Institut 

für Klinische Neuroimmunologie, Munich, Germany; 5 Neurology and 

Department of Biomedicine, University Hospital, Basel, Switzerland; 6 CHU 


57 

Posters 

Timone, Marseille, France; 7 Neuroimmunology Unit, Hospital Vall d’Hebron, 

Barcelona, Spain; 8 Department of Neurology, Heinrich-Heine University, 

Dusseldorf, Germany; 9 Università Vita-Salute, San Raffaele, Milan, Italy; 

10 Regional MS Center, Center for Neurological Disorders, Milwaukee, WI; 

11 VU University Medical Center, Amsterdam, Netherlands; 12 Mellen Center, 

Cleveland Clinic Foundation, Cleveland, OH; 13 Novartis Pharma AG, Basel, 

Switzerland 

Background: In the phase 3 FREEDOMS study, fingolimod 

(FTY720) 0.5 mg reduced the risk of 3-month confirmed disability 

progression on the Expanded Disability Status Scale 

(EDSS) by 30% compared with placebo over 2 years (hazard 

ratio, 0.70; P = .024). In the 12-month TRANSFORMS study, 

reduction in the risk of disability progression with fingolimod 

versus intramuscular (IM) interferon beta-1a (IFNβ-1a) did not 

reach statistical significance. The Multiple Sclerosis Functional 

Composite (MSFC) is a 3-part quantitative tool that measures 

arm/hand dexterity (Nine-Hole Peg Test [NHPT]), leg function 

(Timed 25-Foot Walk [T25FW]), and cognition (3-second 

Paced Auditory Serial Addition Test [PASAT3]). Objectives: 

To evaluate the efficacy of fingolimod in patients with 

relapsing-remitting multiple sclerosis (RRMS) in the TRANS- 

FORMS and FREEDOMS studies using the MSFC. Methods: 

In TRANSFORMS, patients received daily fingolimod 0.5 mg 

(n = 429) or 1.25 mg (n = 420) or weekly IM IFNβ-1a 30 µg 

(n = 431) for 12 months. In FREEDOMS, patients received 

daily fingolimod 0.5 mg (n = 425) or 1.25 mg (n = 429) 

or placebo (n = 418) for 24 months. Average scores on the 

MSFC and its subscales were converted to z scores using the 

combined population at baseline as the reference population 

for each study. Higher z scores represent improvement. Positive 

changes in the T25FW and NHPT signify deterioration, 

and in the PASAT3 indicate improvement. MSFC data were 

also evaluated by change in MSFC and subscales by various 

thresholds (≥30%, ≥20%, ≥10 improvement, any improvement, 

≤10%, ≤20%, and ≤30% worsening). Results: Mean 

MSFC z scores improved from baseline with fingolimod 0.5 

mg, but slightly deteriorated with IFNβ-1a in TRANSFORMS 

at 12 months (0.04 ± 0.42 vs. –0.03 ± 0.48, P = .02) 

and with placebo in FREEDOMS at 2 years (0.03 ± 0.39 

vs. –0.06 ± 0.57, P = .01). In FREEDOMS, change from 

baseline in the fingolimod 0.5 mg and placebo groups at 2 

years on the MSFC subscales were as follows: T25FW (0.32 

± 2.07 vs. 0.66 ± 3.33, P = .005), NHPT (0.36 ± 9.10 vs. 

0.61 ± 7.44, P < .001), and PASAT3 (2.3 ± 7.71 vs. 1.5 ± 

6.81, P = .252). Data on proportions of patients with various 

thresholds of improvement, which favored fingolimod, will 

also be presented. Conclusions: Fingolimod has beneficial 

effects on disability progression as demonstrated by the 

MSFC. 


Disclosure: Gordon Francis: Novartis (salary). Peter Calabresi: Teva, 

EMD Serono, Biogen, Novartis (consulting fees); Teva, EMD Serono, 

Biogen, Novartis, Vertex, Bayer, Abbott (other financial benefits). 

Paul O’Connor: Novartis, Sanofi-Aventis, Roche, Biogen Idec, Bayer, 

EMD Serono, Teva Neurosciences, Eli Lilly, Opexa Therapeutics, Celgene, 

Glenmark, Actelion (consulting fees); Biogen Idec, EMD Serono, 

Novartis (honoraria). Reinhard Hohlfeld: Novartis, Biogen Idec, Merck 

Serono, Teva, Sanofi-Aventis, Bayer (consulting fees, honoraria, other 

financial benefits). Ernst-Wilhelm Radue: Actelion, Bayer Schering, 

Biogen Idec (other financial benefits). Jean Pelletier: Novartis, Bayer 

Schering, Merck Serono, Sanofi-Aventis, Teva (consulting fees). Xavier 

Montalban: Merck Serono, Bayer Schering Pharma, Biogen Idec, Sanofi- 

Aventis, Teva, Novartis, Almirall (honoraria). Hans-Peter Hartung:

Posters 

Bayer HealthCare, Biogen Idec, Genzyme, Merck Serono, Novartis, 

Teva, Sanofi-Aventis (consulting fees); Bayer HealthCare, Biogen Idec, 

Genzyme, Merck Serono, Novartis, Roche, Teva, Sanofi-Aventis (honoraria). 

Giancarlo Comi: Teva, Novartis, Biogen, Lilly, Merck Serono, 

Bayer Schering (honoraria). Bhupendra O. Khatri: Teva, Bayer, Pfizer, 

Medtronics, Biogen Idec, Serono, Novartis (consulting fees). Frederik 

Barkhof: Bayer Schering, Merck Serono, Synthon, Novartis, UCB, 

Biogen Idec, Roche (consulting fees); Sanofi-Aventis, Genzyme, Serono 

Symposia (honoraria). Ludwig Kappos: Actelion, Advancell, Allozyne, 

BaroFold, Bayer HealthCare Pharmaceuticals, Bayer Schering Pharma, 

Bayhill, Biogen Idec, BioMarin, CLC Behring, Elan, Genmab, Genmark, 

GeNeuro SA, GlaxoSmithKline, Lilly, Merck Serono, MediciNova, 

Novartis, NovoNordisk, Peptimmune, Sanofi-Aventis, Santhera, 

Roche, Teva, UCB, Wyeth, Swiss MS Society, Swiss National Research 

Foundation, European Union, Gianni Rubatto, Novartis and Roche 

Research Foundations (other financial benefits). Jeffrey A. Cohen: Biogen 

Idec, Elan, Lilly, Novartis, Teva (consulting fees). Lixin Zhang-Auberson: 

Novartis (salary). Catherine Agoropoulou: Novartis (salary). Dieter 

A. Häring: Novartis (salary). Tracy Stites: Novartis (salary). James Jin: 

Novartis (salary). Shreeram Aradhye: Novartis (salary). Philipp von 

Rosenstiel: Novartis (salary). 


S101 

THE INTERNET AND TREATMENT INFORMATION- 

SEEKING BY PEOPLE WITH MULTIPLE SCLEROSIS 

Anneliese J. Synnot, 1 Sophie Hill, 1 Deidre Beecher, 2 Cinzia Colombo, 3 

Graziella Filippini, 2 Paola Mosconi, 3 Richard Osborne, 4 Sue Shapland, 5 

Michael Summers 6 

1 Centre for Health Communication and Participation, La Trobe University, 

Melbourne, VIC, Australia; 2 Cochrane Multiple Sclerosis Review Group, 

Fondazione IRCCS Istituto Neurologico “Carlo Besta,” Milan, Italy; 3 Istituto di 

Ricerche Farmacologiche, Mario Negri, Milan, Italy; 4 Public Health Innovation, 

Deakin University, Melbourne, VIC, Australia; 5 MS Australia, Perth, WA, 

Australia; 6 MS Australia, Melbourne, VIC, Australia 

Background: Access to accurate, relevant, and easily 

understood health information facilitates informed decision 

making for people with multiple sclerosis (MS). Within the 

context of disease self-management models, people with 

MS not only need high-quality health information, but they 

need to know how to assess its relevance and examine 

how it relates to them personally. The Internet is increasingly 

being used by people with MS and their families to access 

such health information. A collaborative project with MS 

Australia and researchers in Australia and Italy is under way 

to develop a new Internet-based model for developing highquality 

treatment information for people with MS and their 

families, using systematic reviews from The Cochrane Library. 

The first stage of the project is described below. Objectives: 

To document and analyze the experiences of people with 

MS in finding, assessing, and integrating research-based 

health information from the Internet along with personal 

preferences and values to make decisions and manage their 

health. Methods: Three focus groups have been conducted 

with people with MS and their families to explore their 

experiences finding and integrating information about MS 

treatments, with a particular focus on the Internet. Purposive 

sampling is being used to recruit participants from metropolitan 

and regional areas in two Australian states. Three 

more focus groups and an online forum are planned for 

completion by April 2010. A phenomenological framework 

and grounded theory method are being used to underpin the 

analysis. Results: Themes generated from the focus groups 

will be presented. Information is being gathered around four 


58 

main topics: 1) Where do you get reliable information on the 

evidence of treatments for MS? 2) What kinds of information 

do you need, and how do these needs change over time? 

3) How do you use the Internet to access information about 

treatments for MS? 4) How do you assess the quality and 

usefulness of this information? Conclusion: Conclusions and 

the relevance of the findings to subsequent project stages will 

be discussed. 


Keywords: Psychosocial issues in MS, MS and the caregiver/family, 

Comprehensive care and MS 

S102 

THE THERAPY OPTIMIZATION IN MS STUDY: 

BASELINE DEMOGRAPHIC CHARACTERISTICS 

Patricia Coyle, 1 Bruce Cohen, 2 Howard Zwibel, 3 Mary D. Hughes, 4 Thomas 

Leist, 5 MerriKay Oleen-Burkey 6 

1 Neurology, SUNY at Stony Brook, Stony Brook, NY; 2 Neurology, 

Northwestern University, Chicago, IL; 3 Neuroscience Consultants, 

Comprehensive Multiple Sclerosis Center, Coral Gables, FL; 4 Neurology, 

University Medical Group Neuroscience Associates, Greenville, SC; 

5 Neurology, Thomas Jefferson University, Philadelphia, PA; 6 Medical Affairs, 

Teva Pharmaceuticals, Kansas City, MO 

Background: A number of specialty pharmacies have 

implemented medication therapy management (MTM) 

programs for multiple sclerosis (MS). They can go beyond 

monitoring therapy adherence to assess patient self-reported 

health outcomes. Objectives: To evaluate baseline characteristics 

in a large phase 4 study (TOP MS; Therapy Optimization 

in MS) involving MS patients in MTM programs. 

Methods: Potential participants for TOP MS, a prospective, 

open-label parallel group study, were identified at specialty 

pharmacies with MTM programs. Signed informed consent 

forms were returned to the pharmacies, and study enrollment 

produced log-on instructions for the study website. Beginning 

at baseline and at regular intervals over 24 months, enrolled 

participants receive reminders to respond to survey questions. 

Self-reported responses are entered directly into the study 

database. Results: Of the 2901 participants who have 

completed their TOP MS baseline surveys, 80.4% are female; 

89.9% are Caucasian and 5.8% are black/African American. 

The mean age is 49.0 years (range, 18–78 years). At 

baseline, the average time since MS diagnosis is 9.4 years 

(range, less than 1 year to 47 years). Nearly 56% of the participants 

report being employed full or part time at baseline; 

8.5% are retired; 23.5% are not employed due to MS-related 

disability; and 4.7% are unemployed for other reasons. A 

known family history of MS is reported by 21.2% of the participants. 

The most commonly reported comorbidities among 

the Caucasian subset are thyroid disease (10.4%), psychiatric 

disorders (8.3%), osteoporosis (5.6%), and diabetes 

(5.2%). Diabetes (8.4%) and psychiatric disorders (8.4%) 

are the most prevalent in the black/African American subset. 

Overall, the prevalence of current smokers (17.5%) is below 

the US prevalence of 21%, with no statistically significant 

difference between ethnic groups. However, smoking prevalence 

is higher than the US rate among those who are retired 

(24.3%) or unemployed due to MS-related disability (27.2%). 

Conclusion: TOP MS is the largest prospective phase 4 

study conducted in MS. It characterizes the MS population 

receiving treatment and MTM from specialty pharmacies. The 

eventual study outcome will provide insight into the benefits of

adherence to therapy on MS patients’ health outcomes. 

Disclosure: Patricia Coyle: Acorda Therapeutics, Biogen Idec, Bayer 

Healthcare, EMD Serono, Novartis, Pfizer, Sanofi-Aventis, Teva Neuroscience/Teva 

Pharmaceuticals (consulting fees); Bayer Healthcare, 

Biogen Idec, EMD Serono, Teva Neuroscience/Teva Pharmaceuticals 

(honoraria); Novartis, Sanofi-Aventis (other financial benefits). Bruce 

Cohen: Acorda, Biogen Idec, EMD Serono, Genzyme, Novartis, Pfizer, 

Sanofi-Aventis, Teva Neuroscience (consulting fees); Bayer, EMD 

Serono, Pfizer, Teva Neuroscience (honoraria); NINDS, Biogen Idec, 

EMD Serono, Novartis, Pfizer, Teva Neuroscience (other financial 

benefits). Howard Zwibel: Acorda Therapeutics, Teva Neuroscience, 

EMD Serono, Bayer Pharmaceuticals (honoraria); Teva Neuroscience, 

EMD Serono, Bayer Pharmaceuticals, Medscape (WebMD) (consulting 

fees). Mary D. Hughes: Medtronic, Teva Pharmaceutical Industries, 

Ltd (consulting fees); Bayer, Biogen Idec, EMD Serono, Teva Pharmaceutical 

Industries, Ltd (honoraria); Biogen Idec, Genentech, Novartis 

Pharmaceuticals, Teva Pharmaceutical Industries, Ltd (other financial 

benefits). Thomas Leist: Biogen Idec, EMD Serono, Novartis, Pfizer, 

Teva Neuroscience (consulting fees); Acorda, Biogen Idec, EMD Serono, 

Novartis, Pfizer, Teva Neuroscience (honoraria); Acorda, Biogen Idec, 

Daichi, EMD Serono, Novartis, Pfizer (other financial benefits). MerriKay 

Oleen-Burkey: Teva Pharmaceuticals (salary, ownership interests). 

Keywords: Comprehensive care and MS, Service delivery in MS 

S103 


CHARACTERISTICS OF EARLY DISEASE 

Mary D. Hughes, 1 Patricia Coyle, 2 Howard Zwibel, 3 Bruce Cohen, 4 Thomas 

Leist, 5 MerriKay Oleen-Burkey 6 

1 Neurology, University Medical Group Neuroscience Associates, Greenville, 

SC; 2 Neurology, SUNY at Stony Brook, Stony Brook, NY; 3 Neuroscience 

Consultants, Comprehensive Multiple Sclerosis Center, Coral Gables, FL; 

4 Neurology, Northwestern University, Chicago, IL; 5 Neurology, Thomas 

Jefferson University, Philadelphia, PA; 6 Medical Affairs, Teva Pharmaceuticals, 

Kansas City, MO 

Background: The Therapy Optimization in MS Study 

(TOP MS) participants responded to baseline surveys that 

reviewed features of their early disease and diagnosis. 

Objectives: To evaluate the characteristics of early MS as 

reported by participants in a large phase 4 study (TOP MS) 

involving patients participating in specialty pharmacy medication 

therapy management (MTM) programs. Methods: 

Potential participants for TOP MS, a prospective, open-label 

parallel group study, were identified at specialty pharmacies 

with MTM programs. Signed informed consent forms 

were returned to the pharmacies, and study enrollment produced 

log-on instructions for the study website. Beginning at 

baseline and at regular intervals over 24 months, enrolled 

participants receive reminders to respond to survey questions. 

Self-reported responses are entered directly into the study 

database. Results: The 2901 TOP MS baseline participants 

reported a mean time since diagnosis of 9.4 years (range, 

0.0–47 years). The most commonly reported first symptoms 

of MS were numbness and tingling (67.1%) or visual symptoms 

(45.6%); these were typically of sudden onset. Fatigue 

(44.4%) and impaired coordination or balance (40.5%) were 

more often reported as of gradual onset. First disease symptoms 

that were least likely to improve were sexual dysfunction 

(56.8%), fatigue (43.2%), and bladder problems (41.8%). 

With regard to initial diagnostic tests, 69.0% had brain 

magnetic resonance imaging (MRI), 46.5% had a spinal 

tap, and 42.3% had spinal cord MRI. Compared with those 

>50 years old, participants aged 50 years or younger were 


59 

Posters 

significantly more likely to undergo brain and spinal cord 

MRI (P < .0001). Initial treatment involved corticosteroids in 

39.1%; 22.1% were started on disease-modifying therapy. 

Approximately 85% of patients reported that their physicians’ 

assessments and MRI were the basis for diagnosis. The 

primary treating physician was an MS specialist neurologist 

for 74.6% and a general neurologist for 23.5% of the participants. 

Conclusion: TOP MS is characterizing a large and 

modern population of MS patients in MTM programs from 

specialty pharmacies. Although initial symptoms of their disease 

were variable, management of early disease was fairly 

uniform and provided consistently by neurologists. 

Disclosure: Mary D. Hughes: Medtronic, Teva Pharmaceutical Industries, 

Ltd (consulting fees); Bayer, Biogen Idec, EMD Serono, Teva 

Pharmaceutical Industries, Ltd (honoraria); Biogen Idec, Genentech, 

Novartis Pharmaceuticals, Teva Pharmaceutical Industries, Ltd (other 

financial benefits). Patricia Coyle: Acorda Therapeutics, Biogen Idec, 

Bayer Healthcare, EMD Serono, Novartis, Pfizer, Sanofi-Aventis, Teva 

Neuroscience/Teva Pharmaceutical Industries (consulting fees); Bayer 

Healthcare, Biogen Idec, EMD Serono, Teva Neuroscience/Teva Pharmaceutical 

Industries (honoraria); Novartis, Sanofi-Aventis (other financial 


EMD Serono, Bayer Healthcare, Medscape (WebMD) (consulting fees); 

Acorda Therapeutics, Teva Neuroscience, EMD Serono, Bayer Healthcare 

(honoraria). Bruce Cohen: Acorda, Biogen Idec, EMD Serono, 

Genzyme, Novartis, Pfizer, Sanofi-Aventis, Teva Neuroscience (consulting 

fees); Bayer, EMD Serono, Pfizer, Teva Neuroscience (honoraria); 

NINDS, Biogen Idec, EMD Serono, Novartis, Pfizer, Teva Neuroscience 

(other financial benefits). Thomas Leist: Biogen Idec, EMD Serono, 

Novartis, Pfizer, Teva Neuroscience (consulting fees); Acorda, Biogen 

Idec, EMD Serono, Novartis, Pfizer, Teva Neuroscience (honoraria); 

Acorda, Biogen Idec, Daichi, EMD Serono, Novartis, Pfizer (other 

financial benefits). MerriKay Oleen-Burkey: Teva Pharmaceuticals (salary, 

ownership interests). 

Keywords: Comprehensive care and MS, Natural history of MS 

S104 


DISEASE-MODIFYING THERAPY HISTORY 

Thomas Leist, 1 Howard Zwibel, 2 Bruce Cohen, 3 Patricia Coyle, 4 Mary D. 

Hughes, 5 MerriKay Oleen-Burkey 6 

1 Neurology, Thomas Jefferson University, Philadelphia, PA; 2 Neuroscience 

Consultants, Comprehensive Multiple Sclerosis Center, Coral Gables, FL; 

3 Neurology, Northwestern University, Chicago, IL; 4 Neurology, SUNY at Stony 

Brook, Stony Brook, NY; 5 Neurology, University Medical Group Neuroscience 

Associates, Greenville, SC; 6 Medical Affairs, Teva Pharmaceuticals, Kansas 

City, MO 

Background: The Therapy Optimization in MS Study (TOP 

MS) enrolled participants using a first-line disease-modifying 

therapy (DMT). On baseline surveys they were asked to 

provide a chronological history of their DMT. Objectives: 

To evaluate the history of DMT as reported by participants 

in a large phase 4 study (TOP MS) designed to assess the 

benefits of adherence to MS therapy in specialty pharmacy 

medication therapy management (MTM) programs. Methods: 

Potential participants for TOP MS, a prospective, 

open-label parallel group study, were identified at specialty 

pharmacies that had shown a commitment to MTM. Signed 

informed consent forms were returned to the pharmacies, 

and study enrollment produced log-on instructions for the 

study website. Beginning at baseline and at regular intervals 

over 24 months, enrolled participants receive reminders to 

respond to survey questions. Self-reported responses are

Posters 

entered directly into the study database. Results: Of the 

2901 TOP MS baseline participants, 1048 (36.1%) reported 

using prior DMT, with a mean number of 1.4 therapies; 74% 

had used one other DMT; 19.4% used two DMTs; and 6.6% 

used three or more therapies. There were no differences in 

number of prior therapies by age or ethnic group, gender, 

smoking history, or primary treating physician (PTP; general 

neurologist vs. MS specialist). The most common reasons for 

stopping previous DMT included therapy ineffectiveness 

(31.3%), intolerable flu-like symptoms (30.5%), and physician 

preference (24.2%), with no statistically significant differences 

by age or ethnic group, gender, smoking history, or 

PTP. However, compared with other employment categories, 

significantly more (50.0%) participants disabled due to MS 

had used prior DMT, and significantly more changed DMT 

due to physician preference (P < .0001). Longer durations of 

disease were also associated with more prior DMT. Physician 

preference as a reason for stopping prior DMT was more 

likely when duration of disease exceeded 10 years. Conclusion: 

Approximately one-third of the TOP MS participants, a 

prevalent sample of MS patients receiving therapy and MTM 

from specialty pharmacies, had used prior DMT. Longer duration 

of disease and greater disability were associated with 

more prior DMT. 

Disclosure: Thomas Leist: Biogen Idec, EMD Serono, Novartis, 

Pfizer, Teva Neuroscience (consulting fees); Acorda, Biogen Idec, EMD 

Serono, Novartis, Pfizer, Teva Neuroscience (honoraria); Acorda, 

Biogen Idec, EMD Serono, Novartis, Pfizer, Daichi (other financial 


EMD Serono, Bayer Healthcare, Medscape (WebMD) (consulting fees); 

Acorda Therapeutics, Teva Neuroscience, EMD Serono, Bayer Healthcare 

(honoraria). Bruce Cohen: Acorda, Biogen Idec, EMD Serono, 

Genzyme, Novartis, Pfizer, Sanofi-Aventis, Teva Neuroscience (consulting 



(other financial benefits). Patricia Coyle: Acorda Therapeutics, Biogen 

Idec, Bayer Healthcare, EMD Serono, Novartis, Pfizer, Sanofi-Aventis, 

Teva Neuroscience/Teva Pharmaceutical Industries (consulting fees); 

Bayer Healthcare, Biogen Idec, EMD Serono, Teva Neuroscience/Teva 

Pharmaceutical Industries (honoraria); Novartis, Sanofi-Aventis (other 

financial benefits). Mary D. Hughes: Medtronic, Teva Pharmaceutical 

Industries, Ltd (consulting fees); Bayer, Biogen Idec, EMD Serono, Teva 


Novartis Pharmaceuticals, Teva Pharmacutical Industries, Ltd (other 



Keywords: Disease-modifying treatment in MS, Comprehensive care 


S105 


PERSISTENT DISEASE SYMPTOMS 

Bruce Cohen, 1 Howard Zwibel, 2 Patricia Coyle, 3 Thomas Leist, 4 Mary D. 

Hughes, 5 MerriKay Oleen-Burkey 6 

1 Neurology, Northwestern University, Chicago, IL; 2 Neuroscience Consultants, 

Comprehensive Multiple Sclerosis Center, Coral Gables, FL; 3 Neurology, SUNY 

at Stony Brook, Stony Brook, NY; 4 Neurology, Thomas Jefferson University, 

Philadelphia, PA; 5 Neurology, University Medical Group Neuroscience 

Associates, Greenville, SC; 6 Medical Affairs, Teva Pharmaceuticals, Kansas 

City, MO 

Background: The Therapy Optimization in MS Study (TOP 

MS) participants responded to baseline surveys that reviewed 

characteristics of initial MS symptoms as well as any other 


60 

symptoms they have experienced. Objectives: To evaluate 

the characteristics of persistent MS symptoms as reported 

by participants in a large phase 4 study (TOP MS) involving 

patients participating in medication therapy management 

(MTM) programs. Methods: Potential participants for TOP 

MS, a prospective, open-label parallel group study, were 

identified at specialty pharmacies with MTM programs. 

Signed informed consent forms were returned to the pharmacies, 

and study enrollment produced log-on instructions for a 

study website. Beginning at baseline and at regular intervals 

over 24 months, enrolled participants receive reminders to 

respond to survey questions. Self-reported responses are 

entered directly into the study database. Results: The TOP 

MS baseline participants (n = 2901) reported that the most 

prevalent first disease symptoms were numbness and tingling 

(67.1%), visual symptoms (45.6%), fatigue (44.4%), and 

impaired coordination or balance (40.5%). These symptoms 

persisted for 71.0%, 39.4%, 92.7%, and 82.0% of participants, 

respectively. TOP MS participants were also asked to 

report on additional symptoms, exclusive of the first they had 

experienced. Fatigue (37.7%), impaired coordination or balance 

(35.6%), and problems with thinking, memory, or concentration 

(31.1%) were most commonly reported, and these 

symptoms persisted for 89.4%, 80.7%, and 90.6% of participants. 

There were no significant differences when these additional 

symptoms were examined by gender, ethnic group, 

smoking history, or type of treating physician. However, the 

persistence of first and additional symptoms were significantly 

associated with being unemployed due to MS disability or 

any reason (P < .0001). Additionally, smoking history and 

disease duration longer than 15 years were associated with 

the persistence of some MS symptoms. Conclusion: TOP 

MS participants represent a sample of MS patients receiving 

therapy and MTM from specialty pharmacies. The results 

reflect clinical experience in confirming high symptom prevalence, 

both first disease symptoms as well as additional symptoms, 

with relatively little complete symptom relief. 

Disclosure: Bruce Cohen: Acorda, Biogen Idec, EMD Serono, Genzyme, 

Novartis, Pfizer, Sanofi-Aventis, Teva Neuroscience (consulting 



(other financial benefits). Howard Zwibel: Acorda Therapeutics, Teva 

Neuroscience, EMD Serono, Bayer Healthcare, Medscape (WebMD) 

(consulting fees); Acorda Therapeutics, Teva Neuroscience, EMD Serono, 

Bayer Healthcare (honoraria). Patricia Coyle: Acorda Therapeutics, 

Biogen Idec, Bayer Healthcare, EMD Serono, Novartis, Pfizer, Sanofi- 

Aventis, Teva Neuroscience/Teva Pharmaceutical Industries (consulting 

fees); Bayer Healthcare, Biogen Idec, EMD Serono, Teva Neuroscience/ 

Teva Pharmaceutical Industries (honoraria); Novartis, Sanofi-Aventis 

(other financial benefits). Thomas Leist: Biogen Idec, EMD Serono, 

Novartis, Pfizer, Teva Neuroscience (consulting fees); Acorda, Biogen 

Idec, EMD Serono, Novartis, Pfizer, Teva Neuroscience (honoraria); 

Acorda, Biogen Idec, Daichi, EMD Serono, Novartis, Pfizer (other 

financial benefits). Mary D. Hughes: Medtronic, Teva Pharmaceutical 

Industries, Ltd (consulting fees); Bayer, Biogen Idec, EMD Serono, Teva 


Novartis Pharmaceuticals, Teva Pharmaceutical Industries, Ltd (other 



Keywords: Natural history of MS, Symptomatic treatment of MS

S106 

THE TORONTO EDSS CALCULATOR: AN 

APPLICATION FOR MULTIPLE SCLEROSIS HEALTH- 

CARE PROVIDERS 

Jeff E. Alfonsi, Liesly Lee 

Neurology, Sunnybrook Health Sciences Centre, Toronto, ON, Canada 

Background: The Kurtzke Expanded Disability Status Scale 

(EDSS) is an important metric that can be used to assess a 

multiple sclerosis (MS) patient’s disability and the progression 

of their disease. However, the EDSS algorithm can be timeconsuming 

to calculate, and individual interpretations can 

lead to interobserver variability. Objectives: To develop an 

application to reliably and quickly calculate the Kurtzke EDSS 

score using a handheld device. Methods: An application 

was designed and coded for all Apple handheld devices 

using Apple’s iOS 4.0 at the Sunnybrook Health Sciences 

Centre in Toronto, Canada. The assigned functional impairments 

were scored according to the papers published by 

Kurtzke. To improve reliability of scoring, written instructions 

and video examples of disabilities were included to demonstrate 

physical findings corresponding to various levels of 

functional impairment. Consensus of the video impairments 

was reached among the MS neurologists at the University 

of Toronto MS program. Results: The application, entitled 

EDSS Calculator, is currently available for download from the 

Apple store. A patient’s EDSS score can be rapidly computed 

using handheld devices (Apple iPhone, iPod Touch, iPad). A 

summary of the patient’s score in each functional system as 

well as their total EDSS score can be readily saved electronically 

and easily printed. Conclusion: This is the first application 

that has been developed to enable a rapid and accurate 

calculation of the EDSS score using Kurtzke’s algorithm with a 

simple handheld device. Reliability of the scoring is facilitated 

by the accompanying written instructions and videos. This 

allows MS health-care workers to document patient disability 

scores electronically and facilitate the long-term monitoring of 

MS patients’ disabilities. 

Disclosure: Jeff E. Alfonsi: EMD Serono Canada (honoraria). Liesly 

Lee: EMD Serono Canada (honoraria). 

Keywords: Service delivery in MS, Equipment in MS 

S107 

TOLERABILITY AND RETENTION WITH CLADRIBINE 

TABLETS FOR RELAPSING-REMITTING MULTIPLE 

SCLEROSIS OVER 96 WEEKS 

Stuart Cook, 1 Giancarlo Comi, 2 Patrick Vermersch, 3 Gavin Giovannoni, 4 

Kottil Rammohan, 5 Peter Rieckmann, 6 Per Soelberg-Sorensen, 7 Peter Chang, 8 

Anthony Hamlett, 8 Bruno Musch, 8 Jonathan Weiner, 8 Vissia Viglietta, 8 Steven 

Greenberg 8 

1 University of Medicine and Dentistry, New Jersey Medical School, Newark, 

NJ; 2 Institute of Experimental Neurology, University Vita-Salute IRCCS, H 

San Raffaele, Milan, Italy; 3 University of Lille–Nord de France, Lille, France; 

4 Blizard Institute of Cell and Molecular Science, Barts and the London School 

of Medicine and Dentistry, London, United Kingdom; 5 University of Miami, 

Miami, FL; 6 Bamberg Hospital, University of Erlangen, Bamberg, Germany; 

7 Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; 

8 EMD Sorono, Inc, Rockland, MA 

Background: In the CLARITY study, cladribine tablets 

therapy in patients with relapsing-remitting multiple sclerosis 

(RRMS) produced significant improvements in key outcomes, 

meeting its primary and all secondary endpoints, with high 

study and treatment completion rates. Here we examine fac- 


61 

Posters 

tors that contribute to patient retention in CLARITY, based on 

tolerability data and the use of rescue therapy. Methods: 

Patients with RRMS were randomized (1:1:1) to cladribine 

tablets, cumulative doses of 3.5 or 5.25 mg/kg or matching 

placebo. Cladribine was administered in short courses (once 

daily for the first 4 to 5 days of a 28-day period) for 2 or 4 

consecutive months in the first 48 weeks, then 2 short courses 

at the beginning (weeks 48 and 52) of the second 48-week 

period. Data were analyzed for early treatment discontinuations 

and use of rescue therapy (IFN beta-1a [IFNβ-1a] 44 

µg subcutaneously, 3 times per week, permitted from week 

24). Results were previously presented at the 2010 Congress 

of the European Committee for Treatment and Research in 

Multiple Sclerosis. Results: Of 456, 433, and 437 patients 

randomized to 5.25- or 3.5-mg/kg cladribine tablets or placebo, 

89.0%, 91.9%, and 87.0% completed the 96-week 

study; 86.2%, 91.2%, and 86.3% completed full-course treatment 

(week 52); mean treatment compliance was 99.7%, 

99.9%, and 99.8%, respectively. A dose response was seen 

in adverse events (AEs) leading to treatment delay/interruption 

(9.5%, 5.6%, and 3.2% of patients) or study discontinuation 

(2.0%, 1.2%, and 1.1%), with 7.9%, 3.5%, and 2.1% 

discontinuing treatment due to AEs (4.2%, 0.9%, and 0% 

lymphopenia/leukopenia), respectively. Few patients given 

cladribine tablets 5.25 or 3.5 mg/kg discontinued treatment 

due to a perceived lack of efficacy (0.9% and 1.2% vs. 4.8% 

for placebo) or received rescue therapy (2.0% [P = .003] 

and 2.5% [P = .011] vs. 6.2%, respectively). Time from 

last dose administered to rescue therapy was similar across 

groups. Median time on study for patients who discontinued 

the study was longer with cladribine 5.25 or 3.5 mg/kg than 

placebo (41.2 and 43.0 vs. 36.1 weeks, respectively). Conclusions: 

Retention of patients on cladribine tablets in CLAR- 

ITY was approximately the same across the drug and placebo 

groups, with a higher frequency of AEs leading to delay/ 

interruption or study discontinuation in the cladribine groups. 

Disclosure: Stuart Cook: Bayer Health Care, Biogen Idec, Merck Serono, 

Sanofi-Aventis (consulting fees); Bayer Health Care, Merck Serono 

(other financial benefits). Giancarlo Comi: Bayer Schering, Merck 

Serono, Novartis, Sanofi-Aventis, Teva Pharmaceutical (consulting fees); 

Bayer Schering, Biogen Dompè, Merck Serono, Novartis, Sanofi-Aventis, 

Serono Symposia International Foundation, Teva Pharmaceutical (other 

financial benefits). Patrick Vermersch: Bayer Schering, Biogen Idec, 

Merck Serono, Novartis, Roche, Sanofi-Aventis, Teva Pharmaceuticals 

(consulting fees); Bayer Schering, Biogen Idec, GSK, Merck Serono (other 

financial benefit). Gavin Giovannoni: Bayer Schering, Merck Serono 

(consulting fees); Bayer Schering, Biogen Idec, Merck Serono (other 

financial benefits). Kottil Rammohan: Abbott, Acorda, Bayer Health 

Care, Biogen Idec, EMD Serono, Genetech, Teva Pharmaceuticals 

(consulting fees); Acorda, Bayer Health Care, Biogen Idec, EMD Serono, 

Genetech, Genzyme, Teva Pharmaceuticals (other financial benefits). 

Peter Rieckmann: Bayer Schering, Merck Serono, Novartis, Teva (consulting 

fees); Bayer Schering, Biogen Idec, Boehringer Ingelheim, Merck 

Serono, Novartis, Pfizer, Sanofi-Aventis, Teva Pharmaceuticals (other 

financial benefits). Per Soelberg-Sorensen: Biogen Idec, Bayer Schering, 

Elan, Genmab, Merck Serono, Novartis, Sanofi-Aventis, Teva (consulting 

fees); Biogen Idec, Bayer Schering, Elan, Genmab, Merck Serono, 

Novartis, Sanofi-Aventis, Teva (other financial benefits). Peter Chang: 

EMD Serono (salary). Anthony Hamlett: EMD Serono (salary). Bruno 

Musch: EMD Serono (salary). Jonathan Weiner: EMD Serono (salary). 

Vissia Viglietta: EMD Serono (salary). Steven Greenberg: EMD Serono 

(salary). 

Keywords: Disease-modifying treatment in MS

Posters 

S108 

TREATMENT CHOICES IN MULTIPLE SCLEROSIS: 

PATIENT AND PHYSICIAN VIEWPOINTS 

Kathy Fortin, 1 Elisabetta Verdun, 2 Alberto Riñòn, 2 Mandy Buch, 3 Derek Holley 3 

1 EMD Serono Canada, Mississauga, ON, Canada; 2 Merck Serono S.A.– 

Geneva, Geneva, Switzerland; 3 GfKNOP Healthcare, London, United 

Kingdom 

Background: Based on the presumed mechanism of 

action of disease-modifying drugs (DMDs) and the etiology 

of multiple sclerosis (MS), long-term adherence may be an 

important factor in determining a patient’s prognosis. With 

new treatments on the horizon, it is increasingly important 

to understand the factors motivating treatment selection and 

motivating patients to take their treatments in the long term. 

The Global MS Choices Survey investigated patient and 

physician viewpoints on key aspects of MS diagnosis and 

therapy. Objectives: To evaluate motivating factors that 

influence treatment selection and adherence to therapy, from 

the MS Choices Survey. Methods: The survey was completed 

by 331 patients (MS for ≥1 year; receiving DMD therapy) 

and 280 neurologists (treating patients with MS in ≥60% 

of their clinical consultations) from 7 countries. Results: 

When considering their current therapy, the most commonly 

reported difficulty faced by patients (29%) was fitting treatment 

around their lifestyle, with 69% believing that their 

quality of life (QOL) would be improved by an injection-free 

alternative treatment. “No more injections” was also rated the 

factor most likely to improve compliance with therapy, with 

49% of patients considering the most beneficial innovation 

to be oral therapy. In addition, 41% of patients reported less 

frequent dosing as an important factor for improving QOL. 

These findings were mirrored by physician responses, with 

85% viewing oral therapy as the innovation most likely to 

benefit their patients, 88% indicating that they would change 

their patient’s MS therapy to a different mode of administration 

to improve compliance, and 94% reporting that 

compliance would be increased by less frequent treatment. 

Conclusions: Patient preferences and motivations should be 

considered when selecting treatment for lifelong conditions. 

The MS Choices Survey results indicate that patients feel their 

QOL would be improved by taking oral therapy in place 

of injections. In addition, less frequent dosing could help to 

reduce the impact of treatment on patients’ lifestyles. These 

findings may have important implications for long-term treatment 

adherence. 

Supported by: Merck Serono S.A.–Geneva, Switzerland, an affiliate of 

Merck KGaA, Darmstadt, Germany 

Disclosure: Kathy Fortin: EMD Serono Canada (salary). Elisabetta 

Verdun: Merck Serono S.A. (salary). Alberto Riñòn: Merck Serono S.A. 

(salary). Mandy Buch: Nothing to disclose. Derek Holley: Nothing to 

disclose. 

Keywords: Disease-modifying treatment in MS, Management of activities 

of daily living in MS, Nursing management in MS 

S109 

UK PATIENTS’ RATING OF AN ELECTRONIC DEVICE 

FOR SUBCUTANEOUS INJECTION OF INTERFERON 

BETA-1A 

Caroline D’Arcy, 1 Shannon Gaughan, 2 Dee Stoneman 3 

1 West London Neuroscience Centre, Charing Cross Hospital, London, United 


62 

Kingdom; 2 Department of Neurology, United Lincolnshire Hospitals NHS Trust, 

Lincoln, United Kingdom; 3 Merck Serono Ltd, Feltham, Middlesex, United 

Kingdom 

Background: Most first-line multiple sclerosis (MS) therapies 

require regular self-injection, which can be challenging for 

some patients. Developments in injection-device technology 

designed to improve ease of use and comfort may encourage 

treatment adherence and thus potentially improve clinical 

outcomes. RebiSmart is an electronic, multidose autoinjector 

developed for the subcutaneous (SC) administration of interferon 

beta-1a (IFNβ-1a). RebiSmart is approved in Canada 

but is not yet approved in the United States. Objectives: To 

determine the percentage of patients with relapsing-remitting 

MS (RRMS) who liked using RebiSmart; the percentage of 

patients who found RebiSmart “easy” or “very easy” to use; 

and the top three device functions that patients found most 

useful. Methods: This open-label, single-arm, 12-week, 

phase 4, observational study (NCT01195870) enrolled 

patients from 10 sites in the United Kingdom and Ireland. 

Eligible patients were aged 18 to 65 years, had RRMS, 

and had been prescribed SC IFNβ-1a for the first time. 

During the study, patients self-injected SC IFNβ-1a using 

RebiSmart. At week 12, patients were assessed in the MS 

clinic and completed a questionnaire to rate their experience 

with RebiSmart. Primary endpoint: patients (%) who gave a 

score of ≥6 on a 0 to 10 visual analogue scale (VAS; 0 = 

dislike, 10 = like) when asked how much they liked using 

RebiSmart. Patients also rated ease of use, and ranked 10 

device functions in order of usefulness (1 = most useful, 10 = 

least useful). Results: In total, 63 patients were enrolled and 

59 (93.7%) completed the study. Of the 59 who completed 

the VAS, 54 (91.5%; 95% confidence interval, 81.3-97.2%) 

gave a score of ≥6/10, indicating that they liked using 

RebiSmart. RebiSmart was rated as “easy” or “very easy” to 

use by 57/59 (96.6%) patients. The device feature ranked 

as most useful was the hidden needle (mean [SD] score 3.3 

[3.01]), followed by the confirmation sound (3.9 [2.45]), and 

having three doses in a single cartridge (4.6 [2.32]). Conclusions: 

The electronic autoinjection device was liked by 

>90% of patients who completed the study. Concealment of 

the needle throughout the injection process was rated as the 

most useful feature. 

Disclosure: Caroline D’Arcy: Merck Serono, Biogen Idec, Novartis, 

Bayer Schering (honoraria); Teva (other financial benefit). Shannon 

Gaughan: Novartis, Merck Serono, Teva (honoraria). Dee Stoneman: 

Merck Serono Ltd (salary). 

Keywords: Disease-modifying treatment in MS, Equipment in MS 

S110 

UNIFYING INTERPRETATION OF MEASURES OF 

MULTIPLE SCLEROSIS PROGRESSION IN CLINICAL 

TRIALS 

Eric Chamot, 1 Ilya Kister, 2 Joseph Herbert, 2 Gary Cutter 3 

1 Department of Epidemiology, University of Alabama at Birmingham, 

Birmingham, AL; 2 Multiple Sclerosis Center, NYU Hospital for Joint Diseases, 

New York, NY; 3 Biostatistics, University of Alabama at Birmingham, 


Background: There is a debate about the relative merits 

of Kurtzke’s Expanded Disability Status Scale (EDSS) and the 

Multiple Sclerosis Functional Composite (MSFC) as clinical 

outcome measures for assessing the short-term impact of inter-

ventions on the progression of neurologic disability in multiple 

sclerosis (MS) clinical trials. The EDSS has some well-known 

limitations in this role, whereas the MSFC is not currently 

accepted as a primary outcome measure by the FDA, in part 

because changes are not seen as clinically interpretable. 

Objectives: We hypothesize that it is possible to report 

both MSFC scores and EDSS scores on a common normal 

standard scale of general disease progression. Methods: 

The models for the development of this scale are successful 

attempts to employ Item Response Theory (IRT) and other 

modern measurement methods to refine composite instruments 

of neurodevelopment assessment in children. Each of these 

instruments reports scores from heterogeneous functional 

measures on a common linear scale. IRT is the most powerful 

framework for documenting and solving problems with how 

multi-item measures perform. IRT also proposes especially 

rigorous approaches to link related scales; improve score 

reporting; and assess measurement bias. Data for the initial 

analysis will be the original pooled dataset assembled by 

the National Multiple Sclerosis Society (NMSS) Task Force 

on Clinical Outcomes Assessments for the development of 

the MSFC. Results: We will report preliminary results on the 

feasibility of using IRT methods to calibrate on a common IRT 

scale scores from the three subscales of the MSFC, the EDSS, 

and a range of other functional measures available in the 

“Task Force” dataset. Conclusion: As a result of this calibration 

process, several convenient options might become available 

to interpret changes in the MSFC in terms of clinically 

meaningful changes in the EDSS, facilitating the use of the 

MSFC in trials and thus potentially shortening development 

time by using reduced sample sizes. Should the calibration 

process be unsatisfactory, IRT modeling would still provide 

a wealth of new information about the circumstances and 

extent to which assessing disease progression with the MSFC 

(or the EDSS) might result in substantial measurement bias. 

Disclosure: Eric Chamot: Nothing to disclose. Ilya Kister: Nothing to 

disclose. Joseph Herbert: Nothing to disclose. Gary Cutter: Sanofi-Aventis, 

Cleveland Clinic, Daichi-Sanky, Glaxo Smith Klein Pharmaceuticals, 

Genmab Biopharmaceuticals, Eli Lilly, Medivation, Modigenetech, 

Ono Pharmaceuticals, PTC Therapeutics, Teva, Vivus, Alexion, Bayhill, 

Bayer, Novartis, Genzyme, Klein-Buendel Inc, Peptimmune, Somnus 

Pharmaceuticals (consulting fees). 


S111 

UPDATE ON CHANGE IN LONGITUDINAL CD4 AND 

CD8 COUNTS IN MULTIPLE SCLEROSIS PATIENTS 

RECEIVING NATALIZUMAB THERAPY 

Erica Tomas, 1 Derek Eng, 1 Kate Kennedy, 1 Lily Jung Henson 1,2 

1 Swedish Neuroscience Institute, Swedish Medical Center, Seattle, WA; 

2 Department of Neurology, University of Washington, Seattle, WA 

Background: Previously, our center had studied the change 

in CD4 and CD8 cells in patients receiving natalizumab 

therapy, a monoclonal antibody that blocks the migration 

of lymphocytes into the central nervous system. Because of 

concern over the risk of progressive multifocal leukoencephalopathy 

(PML) associated with natalizumab therapy, we have 

continued to monitor the cell counts of our patients over the 

past year. Objectives: To assess the degree of immunomodulation 

or immunocompromise in patients treated with 

natalizumab. Methods: The CD4 and CD8 percent cell 


63 

Posters 

counts as well as CD4/CD8 ratios of 75 patients (19 males, 

56 females) were measured from monthly blood draws taken 

before infusion of natalizumab at a tertiary multiple sclerosis 

(MS) center from January 2008 through October 2010. 

Exposure to natalizumab prior to the start of the study was 

varied among patients, from the very beginning of treatment 

(zero prior infusions) to 26 months of therapy, with a maximum 

of 51 months of therapy at the end of the study. Data 

were analyzed by one-way repeated-measures analysis of 

variance (ANOVA). Results: Statistical analysis of one-way 

repeated-measures ANOVA (df = 50,85; F = 1.4290 for α 

= .05) for CD4 and CD8 cell counts and CD4/CD8 ratios 

showed significance of P = .00976 for CD4 cells, and P = 

.00001 for CD8 cells and CD4/CD8 ratios. Conclusions: 

Our data show that there is a statistically significant change 

in the CD cell counts of patients receiving natalizumab 

therapy, with a drop in CD4 cells and CD4/CD8 ratios over 

time and a rise in CD8 cells, which becomes apparent after 

about 30 months of therapy, similar to the timeline seen of 

PML cases starting to arise. While there are no current cases 

of PML seen at our MS center, this information may be of use 

in determining those at risk for developing the disease. 

Disclosure: Erica Tomas: Nothing to disclose. Derek Eng: Nothing to 

disclose. Kate Kennedy: Teva, Biogen, Projects in Knowledge (consulting 

fees); Biogen, Projects in Knowledge (honoraria). Lily Jung Henson: Biogen, 

Teva, Novartis, Serono (honoraria); National Institutes of Health, 

Biogen, Novartis, Genzyme, Sanofi-Aventis (salary). 

Keywords: Immunology and MS, Disease-modifying treatment in MS 

S112 

MONITORING MY MULTIPLE SCLEROSIS: A PATIENT- 

ADMINISTERED HEALTH ASSESSMENT SCALE 

Elsie E. Gulick, 1 Marie Namey, 2 June Halper 3 

1 College of Nursing, Rutgers, the State University of New Jersey, Newark, NJ; 

2 Mellon Center for MS Treatment & Research, Cleveland Clinic, Cleveland, OH; 

3 Executive Director, Consortium of Multiple Sclerosis Centers, Hackensack, NJ 

Background: Promoting optimal health of multiple sclerosis 

(MS) patients is facilitated by sharing patient self-assessed 

health information through periodic monitoring with healthcare 

providers. Self-monitoring by MS patients who share 

their health-related conditions with health-care providers holds 

promise for initiating treatment/interventions aimed at controlling 

and/or alleviating symptoms that result in improved 

health, activity levels, and quality of life. Objectives: Develop 

a reliable and valid scale for use by MS patients to monitor 

their MS health-related conditions together with the impact 

on the MS patient’s everyday activities. Methods: One 

hundred seventy-one MS patients were recruited from several 

MS outpatient clinics. Their mean (SD) age was 47.05 

(10.98) years, mean MS duration was 11.69 (7.82) years, 

79.5% were female, 79.3% had relapsing-remitting MS 

(RRMS), and 20.7% had secondary progressive MS (SPMS). 

Participants completed the Monitoring My Multiple Sclerosis 

(MMMS) scale, Patient-Determined Disease Steps (PPDS), and 

demographic form. Results: Factor analysis of the 26-item 

MMMS scale resulted in four factors with satisfactory alpha 

reliability coefficients for the total scale (0.90) and subscales: 

0.85 (Physical), 0.80 (Relationships), 0.70 (Energy), and 

0.67 (Cognitive/Mental). Test-retest reliability for the MMMS 

scale determined by intraclass correlation coefficients for 23 

patients was 0.94 for the total scale and for subscales was

Posters 

0.96 (Physical), 0.91 (Relationships), 0.92 (Energy), and 

0.87 (Cognitive/Mental). Analysis of variance demonstrated 

that the total scale and factored subscales Physical, Energy, 

and Cognitive/Mental but not Relationships demonstrated significantly 

lower scores for MS patients with severe disability 

measured by the PDDS scale compared with MS patients with 

mild disability (P < .001). Independent t tests demonstrated 

that patients classified as having SPMS had significantly 

lower scores on the total MMMS scale (P < .05) and Physical 

subscale (P < .001) than those with RRMS. Conclusion: The 

MMMS scale demonstrated satisfactory reliability and validity 

and is recommended for use for MS patients and their healthcare 

providers as a mechanism to promote shared information 

for the welfare of the patient and provider. 

Disclosure: Elsie E. Gulick: Nothing to disclose. Marie Namey: Biogen 

Idec, Teva Neuroscience, EMD Serono, Acorda Therapeutics, Pfizer, 

Questcor Pharmaceuticals, Novartis Pharmaceuticals (consulting fees). 

June Halper: Questcor Pharmaceuticals, Biogen Idec, Acorda Therapeutics, 

Novartis Pharmaceuticals (consulting fees). 

Keywords: Nursing management in MS, MS and the caregiver/family 

S113 

RELIABILITY OF CLASSIFYING MULTIPLE SCLEROSIS 

DISEASE ACTIVITY USING MAGNETIC RESONANCE 

IMAGING IN A CLINIC SETTING 

Ebru Erbayat Altay, 1 Elizabeth Fisher, 2 Jar-Chi Lee, 1 Clair Hara-Cleaver, 1 

Stephen Jones, 3 Richard A. Rudick 1 

1 Neurology, Cleveland Clinic, Cleveland, OH; 2 Biomedical Engineering, 

Cleveland Clinic, Cleveland, OH; 3 Radiology, Cleveland Clinic, Cleveland, OH 

Background: New/enlarging magnetic resonance imaging 

(MRI) lesions are a standard metric for multiple sclerosis 

(MS) trials. MRI lesion activity is also measured in the clinic 

setting, but the reliability of this practice has not been rigorously 

evaluated. Objectives: To assess interrater reliability 

in quantifying MRI disease activity in an MS clinic setting. 

Methods: Eighty-five clinically isolated syndrome (CIS) or 

relapsing-remitting MS (RRMS) patients (30 male, 55 female; 

mean ± SD age, 35.7 ± 9.8 years) participating in a longitudinal 

study were analyzed. Patients were imaged with a standardized 

MRI protocol at baseline and 6 months. The number 

of new T2 lesions or enlarging T2 lesions and the number of 

gadolinium-enhancing (Gd+) lesions at 6 months were determined 

using image analysis software based on registration 

and subtraction. To assess reliability in the clinic setting, four 

raters evaluated the MRI scans: a neurologist, a neurology 

resident, a nurse practitioner, and a neuroradiologist with MS 

expertise. Each rater counted the number of new or enlarging 

lesions and the number of Gd+ lesions. Counts were compared 

between raters using Lin’s concordance correlations. 

The proportion of cases with >3 new/enlarging lesions was 

determined and compared across raters using kappa statistics. 

Results: Concordance correlation was high (0.8–0.96) 

for Gd+ lesions but intermediate (0.6–0.8) for new T2 lesions 

and very poor (0.0–0.14) for enlarging lesions. According 

to the image analysis software, 18% of the patients had >3 

new/enlarging lesions, compared with 15% as assessed by 

the neuroradiologist and 14% to 31% by the clinical raters. 

There was considerable nonoverlap in patients classified as 

having >3 new/enlarging lesions; agreement for classifying 

disease activity was low to moderate (kappa levels, 0.17– 

0.57). Conclusion: This study documents poor interrater 


64 

reliability for quantifying lesion activity in an MS clinic. Lesion 

activity is used widely for decision-making in the clinic setting, 

but this study raises concerns about reliability in the absence 

of standardized methodology that reduces variability. 



S114 

OPTICAL COHERENCE TOMOGRAPHY REVEALS 

GANGLION CELL LAYER PATHOLOGY AFTER 

OPTIC NEURITIS IN MULTIPLE SCLEROSIS AND 

NEUROMYELITIS OPTICA 

Stephanie B. Syc, 1 Shiv Saidha, 1 Scott D. Newsome, 1 John N. Ratchford, 1 

Jonathan D. Oakley, 2 Mary K. Durbin, 2 Scott A. Meyer, 2 Elliot M. Frohman, 3 

Laura J. Balcer, 4 Peter A. Calabresi 1 

1 Neurology, Johns Hopkins University, Baltimore, MD; 2 Carl Zeiss Meditec, 

Inc, Dublin, CA; 3 Neurology and Ophthalmology, University of Texas 

Southwestern, Dallas, TX; 4 Neurology and Ophthalmology, University of 

Pennsylvania, Philadelphia, PA 

Background: Retinal nerve fiber layer (RNFL) degeneration 

and macular volume loss occur as sequelae of acute optic 

neuritis (ON) in multiple sclerosis (MS) and neuromyelitis 

optica (NMO). Retinal ganglion cell layer (GCL) dropout 

has been observed in MS eyeballs at postmortem; however, 

an in vivo comparison of the GCL following ON in MS and 

NMO patients has not been performed. Objectives: To 

determine whether MS and NMO patients develop GCL 

pathology following ON and to compare, characterize, 

and quantify such changes in vivo. Methods: Cirrus-HD 

optical coherence tomography (OCT) imaging with automated 

retinal layer segmentation of the ganglion cell inner 

plexiform complex (GCIP, GCL thickness plus inner plexiform 

layer thickness) was performed at least 6 months after ON. 

OCT imaging was performed on NMO patients (NMO and 

NMO spectrum as defined by the Wingerchuk criteria), MS 

patients with a history of unilateral ON, and healthy controls 

(HCs). Results: Twenty NMO patients (4 NMO, 16 NMO 

spectrum; mean ± SD age, 48.6 ± 9.9 years; 17 females; 

16 NMO-IgG positive), 20 MS patients (mean ± SD age, 

41.8 ± 11.1 years; 12 females), and 20 HCs (mean ± SD 

age, 42.9 ± 5.9 years; 16 females) were assessed. GCIP 

thickness of NMO ON eyes (n = 16, 55.2 ± 8.5 µm) was 

reduced compared with non-ON NMO eyes (n = 24, 71.8 

± 11.8 µm, P < .001), MS ON eyes (n = 20, 62.3 ± 7.2 

µm, P = .01), non-ON MS eyes (n = 20, 68.6 ± 7.6 µm, P < 

.001), and HC eyes (n = 20, 83.4 ± 5.6 µm, P < .001). No 

difference was observed between non-ON MS and non-ON 

NMO eyes; however, both were reduced compared with 

HC eyes (P < .001 for each comparison). Conclusion: In 

vivo retinal ganglion neuronal layer thinning occurs following 

ON in both NMO and MS, and although less pronounced 

also occurs subclinically in non-ON eyes in both disease 

processes. OCT segmentation reveals more severe GCIP loss 

in NMO patients, extending previous work utilizing conventional 

OCT metrics (RNFL and average macular volume) that 

demonstrated greater RNFL loss in NMO ON eyes than MS 

ON eyes. It is possible that NMO patients may have subclinical 

disease activity similar to MS patients, which may be 

detected by OCT.

Supported by: National Multiple Sclerosis Society grant TR-3760-A-3, 

National Eye Institute, Braxton Debbie Angela Dillon and Skip 

(DADS) Donor Advisor Fund 

Disclosure: Stephanie B. Syc: Nothing to disclose. Shiv Saidha: Nothing 

to disclose. Scott D. Newsome: Biogen Idec (honoraria); Biogen Idec 

(consulting fee). John N. Ratchford: Sun Pharmaceutical (consulting fee). 

Jonathan D. Oakley: Carl Zeiss Meditec, Inc (salary). Mary K. Durbin: 

Carl Zeiss Meditec, Inc (salary). Scott A. Meyer: Carl Zeiss Meditec, Inc 

(salary). Elliot M. Frohman: Biogen Idec, Teva, Athena (honoraria); 

Abbott Laboratories, Biogen Idec, Teva, Athena (consulting fees). Laura 

J. Balcer: Biogen Idec (consulting fee, honoraria). Peter A. Calabresi: 

Novartis, EMD Serono, Teva, Biogen Idec, Vertex, Amplimmune, Centocor, 

Genentech, Novonordisk (honoraria); Bayer, Abbott Laboratories 

(other financial benefits). 


S115 

THE MOLECULAR MECHANISMS OF DIMETHYL 

FUMARATE IN MULTIPLE SCLEROSIS 

Haiyan Peng, 1 Elif Akyol, 1 Mireia Guerau, 1 David J. Huss, 2 David Pitt, 1 Amy E. 

Lovett-Racke, 2 Michael K. Racke 1 

1 Neurology Department, The Ohio State University, Columbus, OH; 2 Molecular 

Virology, Immunology, and Medical Genetics, The Ohio State University, 

Columbus, OH 

Background: Two clinical trials showed that dimethyl 

fumarate (DMF), a novel treatment for multiple sclerosis 

(MS), significantly reduced gadolinium-enhancing lesions 

in relapsing-remitting MS (RRMS). However, the molecular 

mechanisms of DMF have not been fully investigated. Objectives: 

To determine whether DMF exerts its therapeutic 

effects in both the immune system and central nervous system 

(CNS) through HO-1 induction. Methods: In order to study 

the immunoregulatory effects of DMF, bone-marrow-derived 

dendritic cells (BMDCs) were stimulated with LPS/IFN-γ (10 

ng/mL each) in the presence or absence of DMF (70 µM), 

and cytokine profile was analyzed 24 hours after stimulation. 

To further determine whether DMF-treated DCs can 

subsequently alter T-cell activation, a co-culture system was 

utilized. Stimulatory DCs were treated with DMF or vehicle for 

24 hours and supernatants were washed out. DCs were then 

co-cultured with naive myelin-specific T-cell receptor (TCR) 

transgenic T cells in the presence of MBP Ac1-11 (2 µg/mL) 

for 72 hours. The activation and proliferation of T cells were 

then evaluated. In addition to the immunoregulatory effects of 

DMF, possible neuroprotective effects were investigated using 

an excitotoxic model induced by AMPA microinjection. Mice 

were pretreated with DMF (200 mg/kg) or vehicle for 3 days 

followed by AMPA injection into the spinal cord. Neuronal 

damage and behavioral outcomes were then examined. To 

determine whether HO-1 is the molecular target of DMF, 

HO-1 protein expression after DMF treatment was analyzed 

in immune cells and the CNS. Results: DMF significantly 

reduced proinflammatory cytokines (IL-12 and IL-6) produced 

by DCs after stimulation. Subsequently, DMF treatment suppressed 

myelin-specific T-cell activation as demonstrated by 

less IFN-γ and T-bet expression. Additionally, our neuroprotective 

study showed that DMF pretreatment reduced neuronal 

damage by 30% and improved behavioral outcomes as 

compared with vehicle-treated mice. We also demonstrated 

that HO-1 protein expression in both DCs and the CNS was 

significantly up-regulated by DMF treatment. Conclusion: 

Our data suggest that DMF inhibits T-cell encephalitogenicity 

and protects neuronal damage caused by excitotoxicity, 

potentially through HO-1 induction. 


65 

Supported by: National Multiple Sclerosis Society 


Keywords: CNS repair, Disease-modifying treatment in MS 

S158 

ADVANCED MAGNETIC RESONANCE IMAGING 

TECHNIQUES TO EVALUATE SUBCUTANEOUS 

INTERFERON BETA-1A IN SUBJECTS WITH 

RELAPSING-REMITTING MULTIPLE SCLEROSIS 

Posters 

Robert Zivadinov, 1 Silva Markovic-Plese, 2 Kara Patrick, 1 Xin Zhang, 2 Yazhong 

Tao, 2 Cheryl Kennedy, 1 Eric Watsky, 3 Fernando Dangond, 4 Bianca Weinstock- 

Guttman 1 

1 The Jacobs Neurological Institute, State University of New York at Buffalo, 

Buffalo, NY; 2 Department of Neurology, University of North Carolina, Chapel 

Hill, NC; 3 Specialty Neuroscience Disease Area, Specialty Care Business Unit, 

Pfizer Inc, New London, CT; 4 Medical Affairs, EMD Serono, Inc, Rockland, MA 

Background: While it is known that interferon beta-1a 

(IFNβ-1a) 44 µg administered subcutaneously (SC) three 

times weekly reduces relapse rates and slows the progression 

of disability in subjects with relapsing forms of multiple 

sclerosis (MS), its potential effects on remyelination are 

unknown. Objectives: To evaluate the effects of IFNβ-1a 44 

µg SC three times weekly on remyelination/demyelination, 

central nervous system (CNS) iron deposition, and immune 

status in subjects with relapsing-remitting MS (RRMS) via 

several magnetic resonance imaging (MRI) techniques and 

immunologic assessments. Methods: This is a 24-week, 

open-label, single-center, pilot trial (no. 29665; ClinicalTrials. 

gov identifier: NCT01085318; sponsored by EMD Serono, 

Inc) in subjects with RRMS compared with healthy controls 

(HCs). The primary objective is to characterize the effects of 

treatment for 6 months with IFNβ-1a 44 µg SC three times 

weekly on remyelination/demyelination using a voxel-wise 

magnetization transfer ratio (VW-MTR) dynamic mapping of 

normal appearing brain tissue (NABT) in subjects with RRMS 

compared with HCs. The study will enroll 25 eligible subjects 

and 15 HCs. Eligible subjects will be male or female, aged 

18 to 65 years, treatment-naive or currently treated (excluding 

IFNβ-1a SC), with a disease duration of

Posters 

Yazhong Tao: Nothing to disclose. Cheryl Kennedy: Nothing to disclose. 

Eric Watsky: Pfizer Inc (salary). Fernando Dangond: EMD Serono, 

Inc (salary). Bianca Weinstock-Guttman: Biogen Idec, Pfizer, Novartis, 

EMD Serono, Teva Neuroscience, Acorda (consulting fees, honoraria); 

Biogen Idec, Pfizer, Novartis, EMD Serono, Shire, Questcor, Teva Neuroscience, 

Acorda (other financial benefits). 

Keywords: CNS repair, Imaging and MS, Immunology and MS 

CATEGORY: REHABILITATION 

S116 

FUNCTIONAL ELECTRICAL STIMULATION FOR 

PEOPLE WITH MULTIPLE SCLEROSIS: CLINICAL 

GUIDELINES FOR PATIENT ASSESSMENT, DEVICE 

FITTING, AND FOLLOW-UP OF A DROPPED FOOT 

STIMULATOR 

Maura Whittaker, 1 Christine Singleton 1,2 

1 PT Private Practitioner, West Vancouver, BC, Canada; 2 West Midlands 

Rehabilitation Centre, Birmingham Community Health Care NHS Trust, 

Birmingham, West Midlands, United Kingdom 

Background: Studies on dropped foot stimulation for walking 

have shown improved mobility and quality of life (QOL) 

for people with multiple sclerosis (MS). Increased walking 

speed, walking endurance, and range of walking were seen 

in this population. Additional findings included reduced falls 

and greater walking confidence. As application of dropped 

foot stimulation becomes more universal, protocols for assessing, 

fitting, and providing follow-up to patients should ensure 

beneficial outcomes and appropriate deployment of the technology 

for the population of people with MS. Objectives: 

Provide an overview of the technology and its application in 

MS gait; describe the clinical pathway for fitting a dropped 

foot stimulator on people with MS; discuss clinical considerations 

and efficacy of the technology, delineate patient 

goals and therapeutic objectives in fitting the technology. 

Methods: A clinical pathway model based on protocols 

developed at the National Clinical FES Centre, Salisbury, 

United Kingdom, will be described and will include pertinent 

aspects of MS patient assessment, stimulator technology and 

setup, single- and dual-channel stimulation, gait training, 

gait analysis, and outcome measures for a diverse range of 

people with MS. Results: In people with MS, studies have 

shown an immediate orthotic effect with the use of a dropped 

foot stimulator, measured by an average increased walking 

speed of 20% (10-m walk test) and a reduced walking effort 

of 29% (Physiological Cost Index [PCI]). A positive impact on 

QOL (Psychosocial Impact of Assistive Devices [PIADS]), a 

positive impact on activities of daily living (ADLs) (Canadian 

Occupational Performance Measurement [COPM]), and a 

72% reduction in recorded falls over an 18-week period 

were seen in long-term follow-up of patients using the devices. 

Conclusion: A dropped foot stimulator can provide people 

with MS a unique opportunity to improve walking mobility, 

endurance, and QOL. The orthotic effect addressing foot 

drop and providing improved limb excursion during walking 

is one of the principal and immediate benefits that patients 

experience. Both patients who have severe walking difficulty 

and those with less severe disease progression can benefit 

from use of dropped foot stimulation. To ensure optimal 

results from the technology, a clinical care pathway involving 

a comprehensive assessment, walking trials, gait analysis, 

and long-term follow-up is necessary. 


66 

Disclosure: Maura Whittaker: Odstock Medical Limited (other financial 

benefit). Christine Singleton: Odstock Medical Ltd (other financial 

benefit). 

Keywords: Rehabilitation strategies and therapy and MS, Quality of life 

in MS, Equipment in MS 

S117 

INCREASING PHYSICAL ACTIVITY BEHAVIOR IN 

PEOPLE WITH MULTIPLE SCLEROSIS: RESULTS OF A 

BEHAVIORAL INTERVENTION 

Robert W. Motl, 1 Deirdre Dlugonski, 1 Brian Sandroff, 1 Edward McAuley, 1 

David Mohr 2 


Champaign, Urbana, IL; 2 Preventive Medicine, Northwestern University, 

Chicago, IL 

Background: Physical activity has been positively associated 

with meaningful outcomes among people with multiple 

sclerosis (MS), and yet this population is largely sedentary 

compared with the general population. Objectives: We 

conducted a pilot randomized controlled trial (RCT) to 

examine the effect of a behavioral intervention for increasing 

physical activity among individuals with MS. We further 

conducted a formative evaluation of the intervention program 

and its administration. Methods: We randomly allocated 

46 individuals with MS to either behavioral intervention (n 

= 23) or wait-list control (n = 23) conditions. The behavioral 

intervention involved the dissemination of information 

on skills, techniques, and resources for becoming more 

physically active with MS through an Internet website. The 

participants completed measures of physical activity, selfefficacy, 

outcome expectations, functional limitations, and 

goal setting before and after a 12-week period. Results: 

The intervention group reported a statistically significant (P = 

.0001) and large increase in physical activity over time (d = 

0.98), whereas the control group had a small (d = 0.06) and 

nonsignificant change in physical activity (P = .78). The intervention 

group further reported statistically significant improvements 

in goal setting (P = .0001, d = 0.98), self-evaluative 

outcome expectations (P = .035, d = 0.40), and functional 

limitations over time (P = .015, d = 0.50), whereas the control 

group had nonsignificant changes in goal setting (P = 

.20, d = 0.18) and self-evaluative outcome expectations (P = 

.22, d = 0.17) as well as a worsening of function (P = .02, d 

= –0.46). The formative analysis (0–5 scale) indicated strong 

overall satisfaction with the behavioral intervention (mean 

4.8, SD 0.4), website (mean 4.1, SD 0.9), and project staff 

(mean 4.9, SD 0.2). We further note that 91% of participants 

endorsed “strongly recommending” the behavioral intervention 

to others with MS (mean 4.9, SD 0.3). Conclusion: This 

pilot study sets the stage for a subsequent RCT that includes 

a larger sample of individuals with MS, longer intervention 

period along with a follow-up, objective measure of physical 

activity, and secondary outcomes. 



S118 

EFFICACY OF CYCLE ERGOMETER REHABILITATION 

TREATMENTS IN AMBULATORY MULTIPLE 

SCLEROSIS SUBJECTS: A PILOT STUDY 

Maria Laura Lopes de Carvalho, 1 Mauro Di Santi, 1 Mario Alberto Battaglia, 2 

Giampaolo Brichetto 2

1 AISM Rehabilitation Centre, Italian Multiple Sclerosis Society, Genova, Italy; 


Italy 

Background: People with multiple sclerosis (MS) tend to be 

less physically active than members of the general population 

even when their MS has caused minimal disability. One of 

the most frequently reported symptoms is primary fatigue. 

Randomized controlled trials have demonstrated that aerobic 

exercise training can improve fatigue and endurance in MS 

subjects. Objectives: The aim of our study was to evaluate 

the efficacy of cycle ergometer aerobic training in a group 

of MS subjects. Methods: We recruited 57 MS subjects 

among those followed as outpatients at AISM Rehabilitation 

Centre, Italian Multiple Sclerosis Society, Genova, Italy. All 

subjects were ambulatory, and they were trained on a cycle 

ergometer (TheraVital, Medica, Germany) with antispasm 

control and visual feedback. All subjects were evaluated 

with the Expanded Disability Status Scale (EDSS), Modified 

Fatigue Impact Scale (MFIS), Ambulation Index, and time 

to walk 7.5 m at the start and at the end of treatment. All 

subjects were treated for 20 sessions, two to three times 

per week, 45 minutes per session. Results: Of 57 MS 

subjects, 38 were female and 19 male, the mean age was 

54 years, and the mean EDSS score was 5.26. The distribution 

of disease types was primary progressive MS, 10.3%; 

relapsing-remitting MS, 48.3%; and secondary progressive 

MS, 41.4%. Data analysis showed an improvement for MFIS 

total score and time to walk 7.5 m, with P < .05, while the 

Ambulation Index score showed no improvement. Conclusion: 

Our data, consistent with previous studies on aerobic 

exercise in MS subjects, underlined the efficacy of rehabilitation 

treatment with a cycle ergometer in improving fatigue in 

people with MS. Furthermore, the lack of dropouts during the 

training program showed that MS subjects can safely conduct 

cycle-ergometer aerobic training, which could be considered 

a part of a multimodal approach to treating fatigue in MS 

subjects. 



S119 

A CASE COMPARISON STUDY OF ENERGY USE 

DURING ACTIVITIES OF DAILY LIVING 

Christina Machaby, Erin Snook 

Kinesiology, University of Massachusetts Amherst, Amherst, MA 

Background: Research has shown that individuals with 

multiple sclerosis (MS) expend more energy than healthy controls 

during walking on a treadmill and over flat ground, and 

that several MS symptoms may be associated with increased 

energy expenditure (EE). However, little is known about EE 

during activities of daily living (ADLs) in MS. Objectives: 

To compare EE during seven ADLs in a person with MS and 

a matched (age, sex, height, weight, physical activity level) 

control. Methods: Participants completed a treadmill graded 

exercise test and seven ADLs (treadmill walking at 1.5 

and 3.0 mph, computer work, washing dishes, carrying a 

load [5 lbs each arm], stationary cycling, vacuuming) on two 

separate occasions. Peak oxygen consumption (VO 2peak , mL/ 

kg/min) and VO 2 during the ADLs were measured using an 

Oxycon Mobile indirect calorimeter. The percent difference 

between the participants in VO 2 during each ADL was cal- 


67 

Posters 

culated as follows: (MS VO 2 ÷ Control VO 2 ) × 100; values 

>100% indicate higher EE in the MS participant. Results: 

The MS participant had a higher absolute VO 2 during five 

of seven activities (1.5-mph walk, 108%; 3.0-mph walk, 

128%; washing dishes, 101%; computer work, 109%; and 

carrying a load, 136%). To determine the relative intensity 

of each activity, VO 2 during the ADLs was also expressed 

as a percentage of each participant’s VO 2peak . The MS participant 

had a higher relative VO 2 for all seven ADLs (range, 

107–181%). Conclusion: These results provide important 

initial data suggesting that individuals with MS may have 

higher EE during ADLs compared with healthy adults. Relative 

intensity might provide a more appropriate measure of EE in 

people with MS because it accounts for the low levels of fitness 

often seen in this population. Although these results are 

not generalizable, further study with a larger sample clearly 

is warranted. 


Keywords: Management of activities of daily living in MS 

S120 

STANDING, WALKING, AND THINKING IN 


Morgan K. Boes, 1 Jacob J. Sosnoff, 1,2 John H. Pula, 3,4 Brian M. Sandroff, 2 

Robert W. Motl 2 

1 Bioengineering, University of Illinois at Urbana-Champaign, Urbana, 

IL; 2 Kinesiology and Community Health, University of Illinois at Urbana- 

Champaign, Urbana, IL; 3 College of Medicine, University of Illinois, Peoria, IL; 

4 Illinois Neurologic Institute, Peoria, IL 

Background: People with multiple sclerosis (MS) may have 

both balance and walking dysfunction. There is growing 

evidence that balance and walking in individuals with MS 

are further impaired with performance of a simultaneous 

cognitive task. To date, there is no information concerning 

the association between so-called dual task cost (DTC) 

in walking and balance. Objectives: This investigation 

examined the association between DTC in a static balance 

task and a walking task in individuals with MS. Methods: 

Twenty-three ambulatory individuals with MS (9 males, 14 

females) participated in this investigation. Participants underwent 

a neurologic examination for generating an Expanded 

Disability Status Scale (EDSS) score, and then completed a 

static balance and walking task with and without a wordgeneration 

task. The balance task involved standing on a 

force platform for 30 seconds. The walking task involved 

walking at a self-selected pace across a 26-foot electronic 

pathway that recorded spatiotemporal patterns of gait. The 

word-generation task involved stating as many words as possible 

in a given category (eg, animals or words starting with 

the letter “H”). The effect of the cognitive task (eg, dual task 

cost) on balance performance was quantified as the percent 

change in postural sway area and both anteroposterier (AP) 

and mediolateral (ML) sway velocity. The effect of the cognitive 

task on walking was quantified as the percent change in 

cadence and normalized walking velocity. The association 

between balance and gait DTC as well as EDSS score was 

determined using Spearman rho (ρ) correlation analysis. 

Results: The EDSS score ranged from 2.0 to 6.5, with a 

median of 4.5. Average DTC for postural sway area and ML 

and AP sway velocity were –89.2%, –41.2%, and –19.9%, 

respectively. Average DTC for cadence and normalized walk-

Posters 

ing velocity was 5.8% and –10.2%. No significant associations 

were observed between DTC in the balance or gait task 

(P > .05). EDSS scores were associated with DTC for postural 

sway area (ρ = 0.45) and normalized walking velocity (ρ = 

0.42). Conclusion: The observations confirm that there are 

significant DTCs for both balance and walking in individuals 

with MS. DTC in a static balance task is unrelated to DTC in 

walking, but DTCs in balance and walking tasks were moderately 

related to disability level. 



S121 

TRACKING QUANTITATIVE SENSORY AND MOTOR 

IMPAIRMENTS IN MULTIPLE SCLEROSIS 

Scott Newsome, 1 Joseph Wang, 2 John Mcgready, 3 Peter A. Calabresi, 1 

Kathleen M. Zackowski 2,4 

1 Neurology, Johns Hopkins University School of Medicine, Baltimore, MD; 

2 Motion Analysis Laboratory, Kennedy Krieger Institute, Baltimore, MD; 

3 Biostatistics, Johns Hopkins School of Public Health, Baltimore, MD; 4 Physical 

Medicine and Rehabilitation, Johns Hopkins University School of Medicine, 

Baltimore, MD 

Background: Tracking changes in sensation and strength 

in clinical studies of multiple sclerosis (MS) is done using 

rating scales. These scales rely heavily on a tester’s experience 

and clinical judgment and do not detect subtle changes 

over time. Use of quantitative tools that provide linear data 

may be a more objective way to evaluate specific and 

subtle impairments compared with categorical rating scales. 

Objectives: To track the relationship of quantitative linear 

measures of sensation and strength in comparison with the 

Functional System Score (FSS) of the Expanded Disability 

Status Scale (EDSS) in individuals with MS over 2 years. 

Methods: Longitudinal analyses of sensorimotor deficits in 

76 MS subjects (not all have complete data sets). EDSS score 

and FSS were collected at baseline and 2 years. Vibration 

threshold at the toe was quantified using a Vibratron II. Hip 

and ankle strength were quantified using a Microfet2 handheld 

dynamometer, and grip strength using a Jamar grip 

dynamometer. Baseline correlations were determined using 

Spearman rank correlation coefficients. Significant individual 

changes over time were determined using the t test. Results: 

Our cohort’s median EDSS score was 3.0 (range, 0–7); 63% 

were females. Vibration sensation correlated with the EDSS 

and sensory FSS (SFSS) score; r = 0.48, P < .0001. A subgroup 

of 19 subjects showed no change in SFSS; however, 

there were significant changes in quantitative sensation for all 

individuals (≥10% change). Similarly, hip and ankle strength 

correlated with the EDSS and the pyramidal FSS (PFSS) score; 

r = –0.40 to –0.64, P < .001. A subgroup of 24 showed no 

change in PFSS. However, there were significant changes 

(P < .05) in quantitative strength for 12/21 measured for 

ankle, 10/23 for hip, and 5/12 for grip strength. Conclusion: 

Quantitative measures of vibration sensation and 

strength detect changes over time and may improve the 

ability to detect disability in MS. Clinical “gold standard” 

categorical rating scales are less sensitive to subtle changes 

in strength or sensation. More precise quantification of motor 

and sensory loss is important for a more timely and accurate 

means of detecting functional improvement or decline. These 

quantitative devices could be used to test the effectiveness of 


68 

neuroreparative agents and to guide choices of rehabilitation 

interventions. 

Disclosure: Scott Newsome: Biogen Idec (honoraria, consulting fee). 

Joseph Wang: Nothing to disclose. John Mcgready: Nothing to disclose. 

Peter A. Calabresi: Biogen Idec, Teva, Merck Serono, Vertex, Genentech, 

Novonordisk (consulting fees); Biogen Idec, Teva, Merck Serono, Vertex, 

Genentech, Bayer (other financial benefits). Kathleen M. Zackowski: 


Keywords: Natural history of MS, Equipment in MS, Rehabilitation 

strategies and therapy and MS 

S122 

NUMBER OF DAYS NEEDED FOR RELIABLE 

FUNCTIONAL LIVING OUTCOME SCORES FOR 


CaraLynn Scott, 1 Erin Snook, 1 Andrea Morand, 1 Brian G. Ragan 2 

1 Kinesiology, University of Massachusetts Amherst, Amherst, MA; 2 School of 

Applied Health Sciences and Wellness, Ohio University, Athens, OH 

Background: Function is defined as the interaction of a 

person with their environment. The Movement and Activity 

in Physical Space (MAPS) measure is a new assessment of 

real-world functional living that combines geospatial (Global 

Positioning System [GPS] and Geographic Information 

System [GIS]) and physical activity (PA) data (intensity and 

steps) to provide quantitative measures of function. The MAPS 

volume score (MAPS V ) reflects steps taken at locations other 

than home, and the MAPS intensity (MAPS I ) score reflects PA 

intensity at locations other than home. A person’s daily movement 

within their environment and their physical activity can 

vary greatly. Because of the this high intraindividual variability, 

the number of days of monitoring needed to produce a 

reliable estimate of the person’s function must be adequately 

addressed. Objectives: To determine the number of days 

needed to produce acceptable levels of reliability for MAPS V 

and MAPS I scores. Methods: Nineteen ambulatory multiple 

sclerosis (MS) participants (mean ± SD age, 47.1 ± 10.6 

years; mean ± SD MS duration, 7.8 ± 6.5 years) wore a 

GPS receiver (Tracking Key Pro) and accelerometer (Actigraph 

GT1M) during the waking hours of 3 days. Generalizability 

theory analyses were performed through a G-study to 

calculate the variance associated with the components of the 

measurement procedure and follow-up D-studies to estimate 

reliability coefficients (G-coefficients) for various measurement 

models (different number of days of monitoring). A reliability 

coefficient of 0.70 was considered acceptable, and 0.80 or 

greater desired. The facets included were person (P) and 

days (D). Results: The G-study for the MAPS V score revealed 

that the P facet accounted for 49.38% of the variance, D 

accounted for 0.74%, and the interaction between P and D 

was responsible for 49.87%. The measurement model that 

met the desired reliability was 4 days (coefficient = 0.8). 

The MAPS I G-study revealed that the P facet accounted for 

0.00047% of the variance, D accounted for 99.999%, 

and the interaction between P and D was responsible for 

0.00053%. The measurement model that met the desired 

reliability was 3 days (coefficient = 0.79). Conclusion: Reliable 

estimates of MAPS V and MAPS I scores can be obtained 

from 3 to 4 days of GPS and accelerometer data. More days 

of monitoring do not yield great increases in the reliability 

estimates. 



S123 

COMPUTER-ASSISTED COGNITIVE REHABILITATION 

FOR MULTIPLE SCLEROSIS: UPDATED FINDINGS 

Brittany Thorne, Francisco I. Perez, Victor M. Rivera, George J. Hutton 

NeuroScience, Baylor College of Medicine, Houston, TX 

Background: This clinic presented preliminary data that 

was encouraging for the cognitive rehabilitation of people 

with multiple sclerosis (MS). Since then, we have recruited 

additional participants, and the data lend conclusive evidence 

to our hypotheses. This intervention been shown to not 

only improve cognitive processes (Thorne et al., 2010), but 

also increase quality of life. Cognitive deficits are common in 

individuals with MS, occurring in 50% to 60% of this population. 

At the present time, there are limited options for its 

treatment (Sullivan, 2004). Objectives: We are evaluating 

the effectiveness of a computer-assisted cognitive rehabilitation 

(CACR) program. This intervention has been shown to 

improve neuropsychological (NP) processes in those with 

cognitive deficits unrelated to MS, thus providing promise for 

this study (Bennet et al., 1991). We are now able to evaluate 

pre-post statistical changes. Methods: To this date we 

have studied 17 individuals with MS, demonstrating mild-tomoderate 

cognitive deficits on formal NP testing. They were 

recruited to participate in a 30-week study. Subjects completed 

1 hour of CACR 5 days a week at home, and their progress 

was monitored using a log and recorded data. Patients 

completed pre and post MicroCog, Paced Auditory Serial 

Addition Test (PASAT), and Controlled Oral Word Association 

(COWA) NP assessments (Powell et al., 2004), as well 

as Multiple Sclerosis Quality of Life (MSQOL) assessments 

(Vickrey et al., 1997). Results: The COWA, PASAT, and 

pre-post MicroCog t-test analyses demonstrated statistically 

significant changes in General Cognitive Functioning and 

Proficiency, Attention and Mental Control, Memory, Reasoning, 

Spatial Processing, and Reaction Time. In addition, the 

quality of life measures Multiple Sclerosis Neuropsychological 

Screening Questionnaire (MSNQ) and MSQOL-54 showed 

significant improvement in life enjoyment. Conclusion: This 

is an ongoing study. In general, these preliminary results suggest 

that participating in this online cognitive rehabilitation 

program produced improvements in cognitive functioning and 

improved life enjoyment. Practice on cognitive tasks over time 

demonstrates statistically significant changes. Future studies 

should include a control group and evaluate generalization 

and maintenance of cognitive rehabilitation gains to everyday 

cognitive functional abilities as well as life enjoyment. 



in MS, Symptomatic treatment of MS 

S124 

AIR TRAVEL ACCESSIBILITY FOR INDIVIDUALS WITH 

MULTIPLE SCLEROSIS AND OTHER DISABILITIES 

Florian P. Thomas, 1,2 Stanley D. Brown, 3 Whitney A. Cadagin, 1 Laura M. 

Huff, 4 Robert Huskey, 3,5 Stacy R. Kinstler, 1 Matthew D. Luitjohan, 1 David J. 

Newburger 6 

1 Spinal Cord Injury and Multiple Sclerosis Center, St. Louis VA Medical Center, 

St. Louis, MO; 2 Neurology & Psychiatry, St. Louis University, St. Louis, MO; 

3 Gateway Chapter, Paralyzed Veterans of America, St. Louis, MO; 4 Child and 

Adolescent Services, Saint Louis Behavioral Medicine Institute, St. Louis, MO; 

5 Paraquad, St. Louis, MO; 6 Office on the Disabled, City of St. Louis, St. Louis, MO 


69 

Posters 

Background: Air travel with a disability presents challenges. 

Some are inevitable; others result from lack of 

knowledge and sensitivity on the part of airport, airline, 

and Transportation Security Administration (TSA) staff and 

of appropriate assistive equipment. Avoidable confusion, 

hardship, and damage to travelers’ equipment are common 

outcomes. Objectives: Facilitate air travel accessibility for 

individuals with disabilities. Methods: The St. Louis VA MS 

Center and Spinal Cord Injury Service teamed with travelers 

with disabilities, National Multiple Sclerosis Society (NMSS) 

St. Louis, Paralyzed Veterans of America (PVA), the St. Louis 

Americans with Disabilities Act (ADA) coordinator, and 

airport, airline, and TSA staff to effect change in policies, 

routines, and attitudes. Results: Following focus groups 

with travelers and trips to the local airport, several targets for 

accessibility improvement were identified. General: Disability 

awareness training, soliciting/respecting input from travelers, 

communication with destination airport re: individual needs, 

assistance to travelers re: exiting the airport, accessible restrooms, 

restaurants, and other services for wheelchair users 

and service dogs, opportunities for “dry runs” for travelers 

with disabilities in order to increase familiarity, design and 

renovate airports to current accessibility standards. Mobility 

disability: Continuous education of staff re: attitudes, 

transfers between wheelchairs, aisle chairs, and plane seats, 

wheelchair management and storage, availability of lift kits 

and aisle chairs at each airport and gate, training of staff 

re: wheelchair mechanics and batteries, designation/deployment 

of trained/certified ground crews with each airline, 

improved signage/directions to indicate accessible routes to 

baggage claim, etc. Hearing disability: Lack of appropriate 

information, need for traveler to request alerts to announcements. 

Visual disability: Provision for service dogs to relieve 

themselves without leaving the Security Area, availability of 

menus in Braille. Behavioral disability: Need to bypass lines 

and for a calming attitude from staff. Conclusion: Lacking 

familiarity with people with disabilities, airport service providers 

often make uninformed, wrong assumptions about what 

the disabled can and cannot do. Sustained and sophisticated 

training is required. Airports must be (re)designed with disability 

awareness. Airport, TSA, and airline staff must have 

access to appropriate equipment. 

Disclosure: Florian P. Thomas: Teva (consulting fee); Novartis, Biogen, 

Serono (honoraria). Stanley D. Brown: Nothing to disclose. Whitney 

A. Cadagin: Nothing to disclose. Laura M. Huff: Nothing to disclose. 

Robert Huskey: Nothing to disclose. Stacy R. Kinstler: Nothing to disclose. 

Matthew D. Luitjohan: Nothing to disclose. David J. Newburger: Nothing 

to disclose. 

Keywords: Quality of life in MS, Equipment in MS, Rehabilitation 

strategies and therapy and MS 

S125 

AMBULATORY MOBILITY MONITORING IN PEOPLE 


Jacob J. Sosnoff, 1,2 Michael J. Socie, 3 Morgan K. Boes, 2 Brian M. Sandroff, 1 

Yoojin Suh, 1 Robert W. Motl 1 


Champaign, Urbana, IL; 2 Bioengineering, University of Illinois at Urbana- 

Champaign, Urbana, IL; 3 Mechanical Sciences and Engineering, University of 

Illinois at Urbana-Champaign, Urbana, IL 

Background: There are data indicating that accelerometry 

is a valid objective marker of free-living walking impairment

Posters 

in people with multiple sclerosis (MS). Nevertheless, there 

are several untested assumptions for this application, including 

that walking itself serves as a major contributor to the 

accelerometer signal. Objectives: The purpose of this 

investigation was to test the assumption that a waist-worn 

accelerometer captures walking behavior in a free-living 

environment. Methods: Eleven ambulatory individuals (3 

males, 8 females) with MS participated in this investigation. 

Participants wore a triaxial accelerometer (Actigraph GT3X) 

at the waist as well as an IDEEA system over the course of a 

single day. The IDEEA system consists of five uniaxial accelerometers 

with one placed on the plantar surface of each foot, 

on the anterior portion of each thigh, and on the sternum. 

Outcome measures for the accelerometer included movement 

counts per hour for the vertical, anteroposterior, and 

mediolateral axes. Outcomes for the IDEEA system included 

percent time walking, sitting, and standing as well as walking 

speed (m/min). Nonparametric bivariate correlations (ρ) 

were used to examine the association between movement 

counts and walking behavior. Results: Wear time ranged 

from 6.1 to 10.1 hours across participants, with a mean of 

7.7 hours. Mean (SD) movement counts per hour along the 

vertical, anteroposterior, and mediolateral axis were 15,541 

(8745), 14,384 (7828), and 15,934 (6888), respectively. 

On average (SD), participants sat 68.1% (11.5%), stood 

21.1% (8.9%), and walked 6.1% (4.6%) of the time. Mean 

(SD) walking speed was 60.0 m/s (13.5 m/s). Significant 

correlations were observed between percent walking time 

and vertical (ρ = 0.78) and anteroposterior (ρ = 0.65) accelerations. 

Significant correlations were further noted between 

walking speed and vertical (ρ = 0.57) and mediolateral (ρ 

= –0.77) accelerations. Conclusions: Such observations 

further support accelerometry as an objective marker of freeliving 

walking in individuals with MS. Further work is needed 

to determine whether accelerometry is sensitive to alterations 

in walking impairment over time in individuals with MS. 


Keywords: Rehabilitation strategies and therapy and MS, Equipment 


S126 

ASSISTIVE TECHNOLOGIES FOR MULTIPLE 

SCLEROSIS RESIDENTS IN A LONG-TERM-CARE 

ENVIRONMENT 

MaryJane Frick, Wanda M. Kolipinski 

Assistive Technology, Good Shepherd Rehabilitation Network, Allentown, PA 

Background: Technological advances throughout the past 

10 years have greatly enhanced the lives of those individuals 

with multiple sclerosis (MS) who experience deficits in the 

areas of cognition, vision, and physical functioning. This is 

particularly true with those experiencing severe MS deficits 

who live in long-term-care (LTC) facilities. The use of assistive 

technologies (ATs) in the LTC setting has allowed residents to 

participate in functional daily life tasks using low and high 

technological adaptations. The use of power wheelchairs, 

environmental management equipment, and computer 

hardware and software allows those individuals with severe 

disabilities the opportunity to maintain the highest levels of 

independence possible. This specialized equipment that 

promotes optimal quality of life allows individuals to continue 

to read, write, and participate in mobility, leisure, and envi- 


70 

ronmental management tasks despite their deficits. Providing 

a thorough evaluation is important to determine the correct 

AT equipment. Objectives: 1) Describe the use of low and 

high technological adaptations for residents with progressed 

MS in the LTC environment. 2) Illustrate the specialized equipment 

that allows individuals to continue to read, write, and 

participate in mobility, leisure, and environmental management 

tasks within their environment. 3) Provide information on 

the evaluative process to determine equipment and training 

needs of residents. 4) Highlight how utilizing AT with residents 

with MS improves the quality for life of those individuals. 

Methods: Case studies will be presented to illustrate the 

process of evaluation and recommendation of technologies 

that improve life participation and quality of life of individuals 

with MS who experience cognitive, visual, and physical challenges. 

Results: Proper evaluation and tailoring specific AT 

equipment for each resident allows those residents the opportunity 

to live more independently, feel a sense of self-efficacy 

in managing their environment, and participate in functional 

tasks that the MS disease process had previously prevented. 

Conclusion: Utilizing AT within the LTC setting is an important 

intervention for residents with MS, allowing them to 

participate in functionally based tasks and maximizing their 

quality of life and overall independence. 



S127 

CALIBRATION OF ACCELEROMETER OUTPUT IN 

PEOPLE WITH MULTIPLE SCLEROSIS AND HEALTHY 

CONTROLS 

Brian M. Sandroff, Robert W. Motl, Yoojin Suh, Swathi Balantrapu 

Department of Kinesiology and Community Health, University of Illinois, 

Urbana, IL 

Background: Accelerometry has been recognized as a 

valid and reliable objective measure of physical activity. 

This is based on a strong association between accelerometer 

activity counts and energy expenditure during dynamic 

activity in adults without a chronic disease. Objectives: 

This study examined the association between the rates of 

accelerometer activity counts and energy expenditure during 

walking and generated cutpoints based on activity counts 

per minute that represented moderate-to-vigorous physical 

activity (MVPA) in individuals with multiple sclerosis (MS) and 

controls. Methods: The sample included 43 people with 

MS and 43 age-, sex-, height-, weight-, exercise history–, 

and ambulatory ability–matched controls. The participants 

undertook up to five 6-minute periods of walking at speeds of 

54, 67, 80, 94, and 107 m/min on a motor-driven treadmill 

while wearing an ActiGraph accelerometer and mouthpiece 

in line with an open-circuit spirometry system for measuring 

energy expenditure (VO 2 ). We estimated the intercept, slope, 

and strength of the linear association between activity counts 

per minute and VO 2 and then the MVPA cutpoint for each 

participant using Microsoft Excel. The data were analyzed 

with independent-samples t tests using PASW 18.0. Results: 

There was a strong linear association between accelerometer 

activity counts and energy expenditure that did not differ (t 

= 0.97, P = .33) between individuals with MS (average R 2 

= 0.90 ± 0.02) and controls (average R 2 = 0.91 ± 0.01). 

The mean slope (t = 1.97, P = .025), but not intercept (t =

0.06, P = .48), of the linear relationship was steeper in those 

with MS (0.003891 ± 0.0001) than in controls (0.003136 

± 0.0003). This difference in slope resulted in distinct cutpoints 

for MVPA based on accelerometer counts for MS 

(1723 counts/minute) and controls (2001 counts/minute). 

Conclusion: There was a strong linear relationship between 

accelerometer activity counts and energy expenditure during 

walking in both samples, but the slope of the relationship was 

steeper in individuals with MS than in controls. This resulted 

in a lower cutpoint for MVPA in individuals with MS. Such a 

finding has implications for quantifying physical activity and 

its predictors and consequences in those with MS. 



S128 

CHANGES IN SPATIOTEMPORAL PARAMETERS OF 

GAIT DURING THE 6-MINUTE WALK IN PEOPLE 


Michael J. Socie, 1 Morgan K. Boes, 2 Robert W. Motl, 3 Jacob J. Sosnoff 2,3 

1 Mechanical Sciences and Engineering, University of Illinois at Urbana- 

Champaign, Urbana, IL; 2 Bioengineering, University of Illinois at Urbana- 

Champaign, Urbana, IL; 3 Kinesiology and Community Health, University of 

Illinois at Urbana-Champaign, Urbana, IL 

Background: The 6-Minute Walk (6MW) test is a valid 

marker of walking performance in individuals with multiple 

sclerosis (MS). Performance on the 6MW test is determined 

by the distance walked in a 6-minute period. There is no 

information concerning the spatiotemporal parameters of gait 

during the 6MW. Objectives: This investigation examined 

spatiotemporal parameters of gait during the 6MW in individuals 

with MS. Methods: Eight ambulatory individuals 

with MS (Expanded Disability Status Scale [EDSS] score, 

0–6) completed the 6MW while wearing the IDEEA system. 

The IDEEA system consists of five uniaxial accelerometers 

with one attached to each foot, each thigh, and the sternum. 

Gait speed, cadence, stride length, and single- and doublesupport 

time were calculated for each minute of the 6MW. 

Results: Distance walked ranged from 116.1 to 724.5 m 

and averaged 479.8 m (SD 194.8). There were no changes 

in gait speed (87.1 [SD 33.0] m/min) or time in double support 

during the 6MW. However, there was a decrease in 

cadence from the first minute to the last of 3 steps per minute 

(118.6 vs. 115.8 steps/min) coinciding with an increase in 

stride length (1.3 m vs. 1.4 m) and an increase in the amount 

of time spent in single support (352.6 ms vs. 362.7 ms). 

Conclusion: Spatiotemporal parameters are not constant 

throughout the 6MW test. Future research should investigate 

the impact of disability level on changes in spatiotemporal 

parameters of gait during the 6MW test. 




S129 

CUSTOM OPTIONS FOR FUNCTIONAL WHEELCHAIR 

MOBILITY AND POSITIONING 

Nicole Marie Pruitt, Carmel Levine 

Rehabilitation, Inglis House, Philadelphia, PA 

Background: As therapists with 26 years of combined 

experience at a residential facility for wheelchair-bound 


71 

Posters 

adults, the presenters are familiar with a wide variety of 

mobility variations and options to maximize function through 

positioning. Because wheelchairs are expensive, the ability 

to accommodate unpredictable disease progression will 

be highlighted. Unique and custom modifications are often 

needed to maximize the functional benefits of wheelchair 

mobility in the MS population. Learning how to problemsolve 

requires exceptional skills that the presenters will share. 

Objectives: Our poster will showcase many of the mobility 

options available commercially, as well as customized solutions 

to complex problems typical for people with multiple 

sclerosis (MS). Enhancing quality of life by transitioning to a 

wheelchair is often viewed with skepticism by a person with 

MS. Mobility can be more acceptable and valuable in a 

wheelchair when the “get up and go has got up and went.” 

Methods: With the overriding goal of maximizing independence, 

considerations for using a wheelchair include energy 

conservation, preservation of muscle control, the impact of 

distance and environment, and caregiver abilities. Choices 

for wheelchairs, both manual and motorized, are many. 

Trunk stability and balance, the necessity for weight shifts, the 

need for pressure relief, fatigue, tone, and varying strength 

issues will be addressed. Each of these areas will be highlighted 

by showcasing people with MS living enriched lives 

with custom modifications. Results: Freedom of movement 

enhances the opportunity for social interaction and broadens 

the view of the world beyond the Lazyboy recliner in front of 

the television. Optimal wheelchair positioning can prevent 

deformities, preserve skin integrity, diminish neurologic pain, 

enhance respiration, coordinate movements, normalize tone, 

and facilitate elimination functions. Problem solving outside 

of the box enhances lives for people with MS. Conclusion: 

Quality of life is enhanced with wheelchair mobility when the 

“get up and go got up and went.” Sharing years of knowledge 

and expertise will further educate the MS population 

and dedicated professionals in the field. There are countless 

custom modifications for mobility that can be provided with a 

creative approach. 



in MS, Equipment in MS 

S130 

DIAPHRAGM PACING MAY PROMOTE VENTILATOR 

WEANING IN NEUROMYELITIS OPTICA 

Megan Rahmlow, William D. Freeman 

Neurology, Mayo Clinic Florida, Jacksonville, FL 

Background: Neuromyelitis optica (NMO) is an immunemediated 

demyelinating disorder characterized by severe 

optic neuritis and longitudinally extensive transverse myelitis. 

In some cases there may be involvement of the cervicomedullary 

junction with edema, resulting in life-threatening 

complications. In patients with NMO, neurogenic respiratory 

failure remains the leading cause of death. Objectives: To 

describe the first case of diaphragm pacing in a patient 

with neuromyelitis optica. Methods: Case report. Results: 

A 43-year-old African American woman with NMO was 

transferred to our hospital with progressive tetraplegia and 

respiratory failure requiring intubation and mechanical ventilation. 

Her past history was notable for bilateral, severe optic

Posters 

neuritis. Cerebrospinal fluid (CSF) evaluation demonstrated 

a mild lymphocytic pleocytosis with normal protein and 

glucose and two oligoclonal bands. Serum NMO IgG was 

positive. Physical examination revealed a flaccid, areflexic 

tetraplegia, bilateral afferent pupillary defects with no light 

perception, bilateral cranial nerve VI palsies, and loss of 

all sensory modalities in the limbs with a C4 sensory level. 

Magnetic resonance imaging (MRI) demonstrated characteristic 

T2/FLAIR hyperintensities with edema of the cervical and 

thoracic cords and lower medulla. Despite multiple courses 

of intravenous steroids and plasma exchange, the patient 

remained ventilator-dependent at 1 month. She did not tolerate 

pressure support trials secondary to low tidal volumes 

and frequent apnea. At that point, institutional review board 

approval and patient consent were obtained for off-label use 

of a diaphragm pacemaker with the hope that this would 

facilitate ventilator weaning. The device was inserted laparoscopically 

without complications. Over the subsequent 2 

days she was progressively weaned off pressure-regulated 

volume control mode entirely and progressed to pressure support 

ventilation with continuous pacemaker support. She was 

discharged back to the referring hospital for further weaning. 

Conclusion: In patients with neurogenic respiratory failure 

secondary to demyelinating disease, diaphragm pacing may 

be a means to facilitate ventilator weaning and could potentially 

extend periods of ventilator independence. Diaphragmatic 

pacemakers are FDA-approved under investigational 

device exemption for traumatic spinal cord injury, but further 

research is needed to evaluate the safety and efficacy for 

other types of spinal cord injury. 




S131 

EFFECTIVENESS OF BOWEL REHABILITATION IN 

MULTIPLE SCLEROSIS PATIENTS 

Maria Laura Lopes De Carvalho, 1 Giampaolo Brichetto, 1,2 Roberta Motta, 1 

Giorgia Cancellieri, 1 Marina Causa, 1 Mario Alberto Battaglia 2 

1 AISM Rehabilitation Centre, Italian Multiple Sclerosis Society, Genova, Italy; 


Italy 

Background: Over 75% of multiple sclerosis (MS) patients 

have symptoms of bowel disorders during the disease course. 

Bowel disorders can have a significant impact on patient 

quality of life. Comprehensive evaluation is essential for 

MS specialists to effectively manage these potentially lifedisrupting 

symptoms. Objectives: This study evaluated the 

effectiveness of a rehabilitation program for MS patients with 

bowel disorders being followed in a specialized rehabilitation 

center. Methods: Twenty-four MS patients with bowel 

disorders were enrolled in the study. Data collected at pretreatment 

(T0) included age, Expanded Disability Status Scale 

(EDSS) score, course and duration of disease, mobility status, 

bowel symptoms, and results of pelvic floor muscle evaluation. 

Patients also completed a 1-week bowel diary. An individualized 

rehabilitation program was developed based on 

patient evaluation. At the end of the rehabilitation program 

(T1) (mean duration, 20 sessions), all patients repeated the 

same evaluation as was conducted at T0. Primary outcomes 


72 

included Wexner scale (incontinence and constipation score); 

mean number of episodes of incontinence and fecal urgency 

and number of evacuations in a week; and strength, coordination, 

and tonus of external sphincter and pubo-rectalis muscles. 

Results: Of 24 subjects enrolled in the study, 19 were 

female and 5 were male. The mean ± SD age was 46.17 ± 

14.44 years. The mean time since disease onset was 12.52 

± 9.66 years. The mean time since symptom onset was 5.25 

± 4.90 years. The mean EDSS score was 4.12 ± 1.12. Fourteen 

subjects had constipation; 6 subjects had incontinence; 

and 4 subjects had both bowel disorders. Statistical analysis 

showed statistically significant differences at T0 and at T1 for 

bowel diary (P < 0.05) and strength, coordination, and tonus 

of external sphincter and pubo-rectalis muscles (P < .05). No 

statistically significant differences were found for Wexner 

scale. Conclusion: Statistical analysis showed that rehabilitation 

of bowel disorders in MS can be effective. The study is 

based on preliminary results and is still in course to increase 

the number of subjects. 



S132 

EVALUATION OF A MULTIPLE SCLEROSIS 

EDUCATIONAL TRACK FOR PHYSICAL THERAPY 

STUDENTS 

Angela Rosenberg, 1 Diane Meyer, 2 Cari Eicher, 3,1 April Fay, 1,3 Erica Byrne 

Gaskins, 3,4 Kasey Gore, 1,3 Melissa Mahon, 3,5 Kelly Thomas, 1,3 Kaye Gooch, 6 

Lisa Johnston 1 

1 Physical Therapy, School of Medicine, University of North Carolina at 

Chapel Hill, Chapel Hill, NC; 2 Outpatient Neuro/Vestibular Physical Therapy, 

UNC Hospitals, Chapel Hill, NC; 3 MS Scholar, University of North Carolina 

at Chapel Hill, Chapel Hill, NC; 4 Department of Physical Therapy, Raleigh 

Neurology, Chapel Hill, NC; 5 University Physical Therapy, Chapel Hill, NC; 

6 Programs and Services, National Multiple Sclerosis Society Eastern North 

Carolina Chapter, Raleigh, NC 

Background: The Education and Scholarship Track in Multiple 

Sclerosis is a unique collaboration between the University 

of North Carolina (UNC), Division of Physical Therapy, 

and the Eastern North Carolina Chapter of the National 

Multiple Sclerosis Society. The curriculum was created in 

response to a local need for physical therapists (PTs) who 

have expertise in the management of the neurologic and psychosocial 

needs of patients living with multiple sclerosis (MS). 

Objectives: The goal is to enhance the MS-related competencies 

of an annual cohort of Doctor of Physical Therapy 

(DPT) students. The desired outcome is to graduate DPT students 

who have a skill competency base specific to MS and 

to expand the current evaluation format to include a report of 

an advanced outreach level of scholarship-related activities. 

Methods: This 2-year track focuses on five elements: didactic 

learning, clinical experiences, service, advocacy, and 

education/training instruction. Scholars tailor class projects 

and readings to focus on MS. Clinical experiences provide 

opportunities to work with PTs, neurologists, and researchers 

who have a focus on this population. Scholars participate 

in community service opportunities, including MS Society 

events, board meetings, and educational presentations for 

support groups. The track is evaluated using qualitative and 

quantitative measures, including the MS Competencies Rating

Scale,* MS Activity Tracking Form, and qualitative feedback 

from MS/DPT scholars and graduates, patients, and interdisciplinary 

preceptors. Results: Evaluation outcomes indicate 

increased student competencies in MS-specific knowledge 

and skills. Student competencies indicate a change from 

a pre-program Likert scale rating of “below average” to a 

mid-program rating of “average” to “above average” in several 

domains. Evaluation findings reflect program expansion 

beyond eastern North Carolina, as evidenced through scholar 

and graduate delivery of web-based modules, teleconferences, 

and workshops. Conclusion: It is our goal that this 

curriculum will serve as a national education model for other 

universities seeking to advance the competencies of DPTs to 

provide services for individuals with MS. 

*Adapted from the Maternal and Child Health Bureau Leadership Development 

in Neurodevelopmental Disabilities Competencies Rating Scale, 2009 



S133 

EXERCISE REDUCES BRAIN IRON CONTENT IN 

PROGRESSIVE MULTIPLE SCLEROSIS: A PILOT TRIAL 

Lara A. Pilutti, 1 Michael D. Noseworthy, 2 John E. Paulseth, 3 Danny A. Lelli, 3 

Shucui Jiang, 4 Michel P. Rathbone, 3 Audrey L. Hicks 1 

1 Kinesiology, McMaster University, Hamilton, ON, Canada; 2 Biomedical 

Engineering, Electrical and Computer Engineering and Medical Physics, 

McMaster University, Hamilton, ON, Canada; 3 Medicine, McMaster 

University, Hamilton, ON, Canada; 4 Surgery, McMaster University, Hamilton, 

ON, Canada 

Background: Elevated brain iron content has been 

observed in many neurodegenerative conditions, including 

multiple sclerosis (MS). Although the exact role of iron in 

MS pathology remains unclear, accumulated iron may exert 

effects through free radical–mediated damage. Development 

of advanced brain magnetic resonance imaging (MRI) 

sequences, such as susceptibility weighted imaging (SWI), 

has made it possible to quantify brain iron with a high 

degree of sensitivity. Objectives: A pilot trial was undertaken 

to determine the effect of 24 weeks of aerobic treadmill 

exercise on regional brain iron content as measured by SWI 

in progressive MS patients of high disability. Methods: Six 

patients with progressive MS (mean ± SD Expanded Disability 

Status Scale [EDSS] score, 6.9 ± 1.07) participated in 24 

weeks of body-weight-supported treadmill training (BWSTT; 

30 min, 3 times/wk). Using a GE 3T Signa HD MRI system 

and 8-channel phased array coil, a fully flow compensated 

SWI sequence (TE/TR/flip = 20 ms/30 ms/15°, 40-kHz 

bandwidth, 512 × 256, 24-cm field of view [FOV], 2 mm 

thick [0 skip], ASSET = 2) was used to collect magnitude 

and phase images at baseline and following 24 weeks of 

exercise. Phase images were high-pass filtered to remove 

aliasing, and iron was quantified bilaterally in the following 

brain regions: motor cortex, caudate nucleus, globus 

pallidus, putamen, and thalamus. Results: All participants 

completed the exercise regimen and imaging assessments. A 

significant decrease in iron content was observed in all deep 

brain regions—caudate nucleus (P = .01), globus pallidus (P 

= .003), putamen (P = .03), and thalamus (P = .047)—following 

24 weeks of exercise. The highest iron content was 

observed in the caudate nucleus at baseline and follow-up. 


73 

Posters 

Conclusion: Pilot data suggests 24 weeks of weightsupported 

treadmill exercise reduces iron content in deep 

brain structures as assessed by SWI in people with progressive 

MS. Larger, randomized controlled trials are required to 

determine the relationship between exercise and brain iron 

deposition in MS. 

Supported by: Multiple Sclerosis Society of Canada Pilot grant 


Keywords: Complementary/alternative therapies in MS, Imaging and 


S134 

INSTRUMENTED MEASURES OF LOWER-EXTREMITY 

VIBRATION ARE CORRELATED WITH AMBULATION 

IN MULTIPLE SCLEROSIS 

Elissa C. Held Bradford, 1 Robert T. Naismith, 2 Joanne M. Wagner 1 

1 Program in Physical Therapy, Saint Louis University, Saint Louis, MO; 

2 Department of Neurology, Washington University School of Medicine, Saint 

Louis, MO 

Background: Somatosensory loss has been associated 

with impaired balance and abnormal gait in multiple sclerosis 

(MS). Vibration perception threshold (VPT) is a common 

measure of somatosensation and a proposed surrogate 

marker of dorsal column pathology. The relationship between 

lower-limb vibratory loss and ambulation is unclear in MS. 

Objectives: Determine whether two different methods of 

VPT testing correlate with objective and self-reported measures 

of ambulation. Determine whether these two different 

validated VPT methods would yield similar results. Methods: 

Fifteen adults with MS (10 female, 5 male; mean ± SD age, 

36.1 ± 10.0 years) with minimal-to-moderate clinical disability 

(Expanded Disability Status Scale [EDSS] score, 0–6.0; 

mean, 3.4) participated in this study. VPT at the interphalangeal 

joint of each great toe was assessed using a 128-Hz 

Rydel-Seiffer tuning fork (VPT-TF), and also the Computer 

Aided Sensory Evaluator (CASE) System IV (VPT-CASE). The 

average VPT between left and right lower extremities was 

used for comparison. Ambulation was assessed with the 

Timed 25-Foot Walk (T25FW) test, the distance walked during 

the 6-Minute Walk (6MW) test, and the self-report Multiple 

Sclerosis Walking Scale–12 (MSWS-12). Results: VPT- 

CASE correlated with all measures of ambulation (T25FW: 

r = 0.57; 6MW: r = –0.54; MSWS-12: r = 0.70, P < .05). 

In contrast, no significant correlations between VPT-TF and 

the three measures of ambulation were observed (T25FW: r 

= –0.17; 6MW: r = 0.24; MSWS-12: r = –0.43, P > .05). 

Conclusion: Detailed instrumented assessment of VPT with 

the CASE System IV demonstrated a correlation with ambulation 

not seen with clinical testing using the Rydel-Seiffer tuning 

fork. This suggests that the strength of VPT correlation with 

ambulation depends on the method of testing. VPT quantification 

by the Case IV System may be an important component 

in explaining impaired ambulation in MS. 

Disclosure: Elissa C. Held Bradford: Nothing to disclose. Robert T. 

Naismith: Acorda, Bayer, Biogen Idec, Genzyme, EMD Serono, Teva 

Neurosciences (consulting fees). Joanne M. Wagner: Nothing to disclose. 


Posters 

S135 

MULTIPLE SCLEROSIS AND GARDENING: A 

BENEFICIAL LEISURE ACTIVITY 

Tricia L. Grady 

Occupational Therapy, Good Shepherd Rehabilitation Network, Bethlehem, PA 

Background: A reality for many people living with multiple 

sclerosis (MS) is the detrimental effects of disease progression 

that may lead to living in a long-term-care (LTC) facility, 

sometimes at a relatively young age. Most people with 

MS can expect a near-normal life expectancy; therefore, a 

person with MS can live many years within this custodial 

level of care. For optimal quality of life, it is important that 

the staff develop appropriate programs and support systems 

and offer leisure activities for people with MS. High-quality 

and individually tailored leisure programs provide a sense of 

meaning and purpose to life. Objectives: There are many 

challenges and adjustments people experience when transitioning 

into LTC. Occupational therapy practitioners play an 

important role in exploring the residents’ leisure interests and 

then helping them to engage in these leisure activities using 

activity analysis and adaptation. Because of the progressive 

nature of MS, people can experience profound loss of function. 

However, providing appropriate leisure activities can 

help residents redirect their focus to productive and meaningful 

projects. Understanding each resident’s individual leisure 

interests or creating new interests is beneficial to the MS 

population in LTC. Methods: Horticulture is an activity that 

has been shown to improve cognitive, physical, and psychological 

deficits of MS residents in the LTC environment. Gardening 

and horticulture activities can be adapted to fit a multitude 

of functional deficits through adaptive gardening tools 

and supplies and accessible gardens. Using the therapeutic 

group format involves the MS residents in planning, educational 

sessions, and various gardening activities throughout 

the growing season. Results: Harvesting produce can lend 

fresh supplies for cooking groups, which provides residents a 

great sense of accomplishment, especially when they participate 

in the entire process from planting the seeds to harvest. 

Socialization and various group discussion topics, based on 

memories of past gardening experiences, enhance the group 

camaraderie. Conclusion: The many benefits of horticulture 

as a leisure activity for the MS resident can help develop 

valued leisure interests that provide meaning and purpose to 

those who live in the LTC environment. 


Keywords: Quality of life in MS, Rehabilitation strategies and therapy 

and MS, Complementary/alternative therapies in MS 

S136 

ORTHOPEDIC MANAGEMENT OF CHRONIC 

PAIN RESULTS IN IMPROVED REHABILITATION 

OUTCOMES IN A 69-YEAR-OLD FEMALE WITH 


Herbert I. Karpatkin, 1 Emil Euaparadorn, 2 Robert Schreyer 2 

1 Physical Therapy, Hunter College, New York, NY; 2 Physical Therapy, Touro 

College, New York, NY 

Background: Physical therapy (PT) management of multiple 

sclerosis (MS) usually focuses on neurologic impairments. 


74 

However, a significant amount of the disability experienced 

by those with MS is orthopedic, resulting from movement 

compensations adopted to adjust to changes in gait and 

posture caused by neurologic weakness, spasticity, or sensory 

loss. Physical therapists who work with people with 

MS must therefore have orthopedic skills needed to address 

these issues. Objectives: The purpose of this case report 

is to describe orthopedic management of a patient with MS 

who presented with chronic low back pain (LBP) of more 

than 1 year’s duration, which was severe enough to prevent 

addressing balance and gait impairments in PT. Methods: 

The patient was a 69-year-old woman with an Expanded 

Disability Status Scale (EDSS) score of 5.0. She had been 

receiving regular PT to address gait and balance impairments 

until she began experiencing right-sided LBP of sufficient 

intensity to disrupt her ability to continue therapy. Pain medication 

was of limited effectiveness. Her physical therapist 

referred her to a second therapist with specialized training 

in LBP. Orthopedic examination revealed point tenderness at 

the right sacroiliac (SI) joint and diminished trunk flexion and 

right-side bending. Right-side bending reproduced her pain 

symptoms. Provocative testing for the SI joint was positive. 

Based on these findings, the pain was deemed to be musculoskeletal 

as opposed to neurogenic in nature. The findings 

of right SI hypermobility and point tenderness, coupled with 

right-hip hypomobility, were strongly suggestive of SI joint 

dysfunction. Treatment was instituted, including patient education 

to decrease excessive active hip motion, core training to 

strengthen the hypermobile SI joint, and mobilization of the 

lumbar spine and hip joint. Results: Within four visits over 

1 month, the patient reported absence of pain on movement 

and during walking, and minimal pain with palpation. At 

this time she was able to resume therapy that addressed her 

neurologic impairments. At 4-month follow-up, she continued 

to report no symptoms of LBP. Conclusion: MS clinicians 

should recognize that pain in MS can be orthopedic rather 

than neurogenic in nature, and that as a result, physical therapists 

who work with individuals with MS should be adept in 

orthopedic as well as neurologic treatment techniques. 



S137 

PHYSICAL ACTIVITY IS ASSOCIATED WITH 

DECREASED AXONAL LOSS IN PEOPLE WITH 


Brian M. Sandroff, 1 Jason P. Kam, 2 John H. Pula, 2 Robert W. Motl 1 

1 Department of Kinesiology and Community Health, University of Illinois, 

Urbana, IL; 2 College of Medicine, University of Illinois at Peoria, Peoria, IL 

Background: Physical activity behavior (ie, bodily movement 

produced by the contraction of skeletal muscle) may 

have neuroprotective effects in people with multiple sclerosis 

(MS). There is evidence that cardiorespiratory fitness (ie, 

characteristic of an individual related to aerobic capacity) is 

associated with brain white and gray matter integrity in this 

population, but we are unaware of research linking physical 

activity behavior with axonal loss in individuals with MS. 

Objectives: This study examined the relationship between 

physical activity behavior and axonal loss, measured by opti-

cal coherence tomography (OCT) using retinal nerve fiber 

layer (RNFL) thickness, after accounting for disability status. 

Methods: Thirty-eight participants with MS underwent a 

neurologic examination for Expanded Disability Status Scale 

(EDSS) scoring, followed by RNFL thickness measurement on 

a Stratus OCT scanner. Only eyes without prior optic neuritis 

or other ocular disease were scanned. Participants then 

completed the Godin Leisure-Time Exercise Questionnaire 

(GLTEQ), a valid, self-report measure of physical activity in 

individuals with MS. The data were analyzed using bivariate 

correlations and multiple linear regression in PASW 18.0. 

Results: The mean (SD) GLTEQ score was 21.6 (21.5) 

MET min/wk, mean (SD) RNFL thickness was 90.3 (15.4) 

µm, and the mean (SD) and median EDSS scores were 4.8 

(1.3) and 4.75 (range, 2–6.50), respectively. GLTEQ scores 

were significantly correlated with both RNFL thickness (r = 

0.37, P = .01) and EDSS scores (r = –0.30, P = .03). RNFL 

thickness was further correlated with EDSS scores (r = –0.27, 

P = .05). GLTEQ scores remained significantly associated 

with RNFL thickness (pr = 0.32, P = .03) after controlling for 

EDSS scores. Multiple linear regression analysis indicated 

that GLTEQ scores explained a significant portion of variance 

(ΔR² = 0.11) in RNFL thickness (β = 0.31, P < .05), after controlling 

for EDSS scores (β = –0.17, P > .05). Conclusions: 

Physical activity is associated with less RNFL loss in people 

with MS, and therefore may have neuroprotective effects. 

Such a possibility could be examined in the context of a 

behavioral intervention for increasing physical activity. 


Keywords: Rehabilitation strategies and therapy and MS, Imaging and 


S138 

PULMONARY FUNCTION AND RESPONSE TO LUNG 

VOLUME RECRUITMENT IN MULTIPLE SCLEROSIS 

PATIENTS 

Douglas McKim, 1 Carole LeBlanc, 2 Judy King, 3 Andrew Woolnough 4 

1 Medicine, The Ottawa Hospital Rehabilitation Centre, Ottawa, ON, Canada; 

2 Respiratory Therapy, Ottawa Hospital Rehabilitation Centre, Ottawa, ON, 

Canada; 3 Physiotherapy, University of Ottawa, Ottawa, ON, Canada; 

4 Institute for Rehabilitation Research Development, The Rehabilitation Centre, 

Ottawa, ON, Canada 

Background: Multiple sclerosis (MS) patients with respiratory 

muscle weakness may have significant pulmonary function 

impairment. Impaired cough capacity results in retained 

secretions and risk of pneumonia due to infection or aspiration. 

Noninvasive airway clearance including lung volume 

recruitment (LVR) may effectively increase cough peak flows 

(CPF) and forced vital capacity (FVC). LVR is the use of a 

resuscitation bag and mouthpiece to provide breaths, stacked 

to achieve a maximum capacity (maximum insufflation capacity, 

MIC). Survival in some neuromuscular diseases is related 

to ability to increase FVC, achieving a MIC (MIC-FVC difference). 

The regular use of LVR may improve airway clearance, 

respiratory mechanics, and survival. Objectives: Present 

pulmonary function of MS patients referred to a rehabilitation 

center respiratory program, determine the proportion who 

benefit from LVR, and measure their response to LVR in terms 

of increases in CPF and MIC. Methods: All MS patients 

referred to the program completed neuromuscular pulmonary 


75 

Posters 

functions, including FVC; CPF, both spontaneous and with 

LVR; and MIC. Statistical analysis was performed using a 

paired t test in Microsoft Excel 2003. Results: Pulmonary 

function was available for 86 patients with MS. The average 

age was 55 years; there were 39 males and 47 females. The 

average FVC and CPF were 2.12 L (55% pred) and 3.47 

L/s; 47 (55%) patients were impaired sufficiently to initiate 

LVR, with a significant increase (P < .001) in CPF of 2.76 to 

3.59 L/s and in FVC of 1.76 to 2.43 L (MIC), but not all 47 

responded. Of the positive responders, 41% (n = 35) demonstrated 

a significant increase (P < .001) in CPF from 2.48 

to 3.78 L/s and in FVC from 1.56 (41% pred) to 2.4 L (MIC- 

FVC = 0.84 L). Conclusion: Moderate-to-severe impairment 

of pulmonary function is present in patients referred to a 

rehabilitation center respiratory program. At least 55% of 

these patients have sufficient impairment to indicate the need 

for airway clearance techniques and demonstrate increases 

in CPF and MIC with LVR. The most impaired patients demonstrated 

the greatest response to LVR in both CPF and MIC. 

Regular use of LVR may improve respiratory mechanics and 

increase effective airway clearance, thereby reducing hospital 

admissions and possibly improving survival. 



S139 

REASONABLE ACCOMMODATION OUTCOMES IN 

THE WORKPLACE FOR EMPLOYED PEOPLE WITH 


Phillip D. Rumrill, 1 Richard Roessler 2 

1 Lifespan Development and Educational Sciences, Kent State University, Kent, 

OH; 2 University of Arkansas, Fayetteville, AR 

Background: This study is a follow-up with 41 adults with 

multiple sclerosis (MS) who participated in a telephonic and 

web-based employment assistance service at Kent State University 

in Ohio. The follow-up survey examined the outcomes 

of the accommodation-related assistance participants sought 

from the service. Objectives: 1) Identify the effectiveness 

of consultation provided regarding reasonable accommodations. 

2) Examine the outcomes of the accommodation 

process. 3) Investigate the types of accommodations used by 

employed participants. Methods: A telephone survey was 

conducted with 41 people with MS who had participated in 

the MS Employment Asssistance Service 4 to 7 years prior to 

the follow-up. Open- and closed-ended questions were used 

to elicit information about participants’ employment situations 

and accommodation usage. Results: Results indicated that 

the majority of respondents were still employed at follow-up, 

that a wide range of accommodations in the workplace were 

reported, and that communication between the employee and 

employer was described as the most important aspect of successful 

accommodation outcomes. Other important issues in 

the accommodation process included disclosure of disability, 

understanding of assistive technology, and consideration of 

scheduling modifications. Conclusion: People with MS 

desire and need timely and responsive interventions to aid 

in implementing reasonable accommodations as a means of 

maintaining employment. Telephonic and web-based interventions 

of this kind are cost-effective strategies for promoting 

on-the-job accommodations.

Posters 


Keywords: Employment in MS, Quality of life in MS, Economic issues 


S140 

SLEEP PROBLEMS IN MULTIPLE SCLEROSIS: 

CONFLICTING RESULTS FROM TWO PATIENT- 

REPORTED OUTCOME MEASURES 

Alyssa M. Bamer, Dagmar Amtmann, Karon Cook, Kurt Johnson 


Background: Our prior research, along with other published 

studies, suggests that individuals with multiple sclerosis 

(MS) have significantly more problems sleeping than the 

general population. The PROMIS network recently released a 

set of patient-reported outcome measures that included shortform 

measures of both sleep and wake disturbance. Objectives: 

To compare levels of sleep difficulties in people with 

MS as measured by the newly developed PROMIS scales 

and by the older Medical Outcomes Study Sleep Scales 

(MOSSS). Methods: Community-dwelling individuals with 

MS (N = 461) involved in an ongoing longitudinal study of 

outcomes completed a self-report mail survey. Included in the 

survey were the PROMIS sleep and wake dysfunction short 

forms, as well as MOSSS. All measures were scored based 

on recommendations of scale developers, and summary 

statistics (mean ± SD) were calculated. The PROMIS scales 

were developed such that the general US population mean is 

centered at 50 with a standard deviation of 10. Comparison 

population data for the MOSSS were reported by Hays and 

Spritzer in the MOS manual and original publication, and 

included chronically ill patients and the general US population. 

Results: Using the MOSSS, study participants reported 

more difficulties with sleep disturbance (33.1 ± 25.2), sleep 

adequacy (48.7 ± 27.5), daytime somnolence (37.3 ± 

23.7), and overall sleep problems (36.2 ± 19.1) than the 

comparison populations published by Hays and Spritzer. 

Using the PROMIS scale, participants reported similar levels 

of sleep (50.8 ± 10.1) and wake (52.6 ± 9.2) disturbance 

as the general US population. Conclusion: Summary results 

of the PROMIS sleep scales suggest that levels of sleep problems 

in individuals with MS may actually be similar to those 

of the general US population. Content analyses of the scales 

suggested that there is significant overlap in item and content 

coverage between the MOSS and PROMIS scales. Results 

from the different scales suggest substantially different conclusions 

about difficulties with sleep in people with MS. Additional 

research needs to be done to examine the properties 

of both scales in this population and identify which scale(s) 

should be used to measures sleep in individuals with MS. 


Keywords: Sleep and MS 

S159 

THE ROLE OF NEUROMUSCULAR ELECTRICAL 

STIMULATION IN DYSPHAGIA MANAGEMENT FOR 

INDIVIDUALS WITH MULTIPLE SCLEROSIS 

Marissa A. Barrera, Barbara O’ Connor-Wells 

Raymond Naftali Center for Rehabilitation, New York, NY 


76 

Background: Neuromuscular electrical stimulation (NMES) 

is a noninvasive form of muscle rehabilitation. For nearly 2 

decades, physical therapists (PTs) have used NMES to treat 

patients with a wide range of diagnoses, including multiple 

sclerosis (MS). In 2002, the US Food and Drug Administration 

cleared the use of NMES for the treatment of dysphagia, 

introducing speech-language pathologists to the modality 

of electrical stimulation. When applied to the exterior neck, 

NMES can reeducate the pharyngeal muscles to initiate 

swallowing. With nearly 45% of MS patients developing dysphagia 

and the high incidence of aspiration pneumonia (AP) 

deaths, utilizing NMES for the treatment of dysphagia may 

reduce MS mortality. Objectives: To assess the impact of 

NMES swallowing therapy on oropharyngeal dysphagia in 

individuals with relapsing-remitting multiple sclerosis (RRMS). 

Methods: Eight individuals with RRMS with an MS duration 

ranging from 4 to 16 years participated. All patients were 

referred for a swallowing evaluation by their neurologist 

because of risk of developing AP and documented complaints 

of “coughing 4+ times/meal,” “shortness of breath during 

mealtime,” “fatigue when eating/drinking,” and “globus 

sensation.” These symptoms were chronically present. All 

participants received a swallowing evaluation prior to and at 

the end of treatment. Three participants also received videofluoroscopic 

swallowing studies before and after treatment. 

All participants received 24 1-hour NMES sessions over 3 to 

4 months. Results: Improvement from pretreatment to posttreatment 

was observed in oropharyngeal transit time (18 vs. 

10 seconds). Via palpation of the thyroid cartilage, hyolaryngeal 

excursion was noted to improve. A total of 88% of participants 

reported “coughing 2 times or less during a meal,” 

compared with 100% of participants reporting “coughing 4+ 

times/meal” at baseline. Interpretation of videofluoroscopic 

studies after treatment revealed reduced saliva pooling and 

improved base-of-tongue propulsion. Lastly, upon completion, 

all participants reported “less fear when eating,” and no one 

developed AP despite their “high risk” status prior to participation. 

Conclusion: The present findings support the use of 

NMES for the treatment of oropharyngeal dysphagia due to 

RRMS. Wide implementation of NMES swallowing therapy 

could reduce social stigma associated with dysphagia, eliminate 

the need for costly modified diets, and most importantly, 

reduce harmful respiratory infections. 


Keywords: Speech/language therapy for MS, Rehabilitation strategies 

and therapy for MS, Quality of life and MS 

CATEGORY: SYMPTOMS MANAGEMENT 

S141 

PHYSICAL ACTIVITY AND CARDIOVASCULAR 

COMORBIDITIES IN PEOPLE WITH MULTIPLE 

SCLEROSIS: EVIDENCE FROM A CROSS-SECTIONAL 

ANALYSIS 

Robert W. Motl, 1 Bo Fernhall, 1 Edward McAuley, 1 Gary Cutter 2 


Champaign, Urbana, IL; 2 Biostatistics, Universty of Alabama, Birmingham, AL

Background: There is evidence of a linear, inverse association 

between physical activity and cardiovascular comorbidities 

in the general population that has not yet been examined 

in individuals with multiple sclerosis (MS). Objectives: The 

present study examined the possibility of a linear, inverse 

association between objectively measured and self-reported 

physical activity and number of cardiovascular comorbidities 

in individuals with MS, controlling for confounding variables. 

Methods: The sample included 561 individuals with MS 

who completed a battery of questionnaires that included 

demographic information, cardiovascular comorbidities, 

disability status, and physical activity assessments, and then 

wore an accelerometer for 7 days. The data were analyzed 

using bivariate correlation and multiple linear regression. 

Results: Bivariate correlation analysis indicated that there 

were statistically significant and inverse associations between 

number of cardiovascular comorbidities and objectively measured 

(r = –0.192, P = .0001) and self-reported (r = –0.151, 

P = .0001) physical activity. The first multiple linear regression 

indicated that objectively measured physical activity was 

significantly associated with the number of cardiovascular 

comorbidities (B = –0.003, SE B = 0.001, β = –0.128), 

even after controlling for confounding variables. The second 

multiple linear regression indicated that self-reported physical 

activity too was significantly associated with the number of 

cardiovascular comorbidities (B = –0.011, SE B = 0.004, β 

= –0.114), even after controlling for confounding variables. 

Conclusion: Physical activity was linearly and inversely 

associated with the number of cardiovascular comorbidities, 

independent of disability status and other possible confounding 

variables, in individuals with MS. Such a result provides 

initial evidence that even small increases in physical activity 

may be associated with a reduction in cardiovascular comorbidities 

in MS as in the general population. 



S142 

TREATMENT OF SLEEP DISORDERS IN MULTIPLE 

SCLEROSIS PATIENTS 

Ann Robinson, 1 John Kimoff, 2 Isabelle Cote, 2 Marta Kaminska, 2 Andrea 

Benedetti, 3 Mauro Cardoso, 1 Amit Bar-Or, 1 Yves Lapierre, 1 Douglas L. 

Arnold, 1 Daria A. Trojan 1 

1 Neurology and Neurosurgery, Montreal Neurological Institute and Hospital, 

McGill University, Montreal, QC, Canada; 2 Respiratory Division and Sleep 

Laboratory, McGill University Health Centre, Montreal, QC, Canada; 

3 Respiratory Division and Respiratory Epidemiology and Clinical Research 

Unit, McGill University Health Centre, Montreal, QC, Canada 

Background: Fatigue is a common and disabling symptom 

of multiple sclerosis (MS). We have found that sleep disorders, 

especially obstructive sleep apnea-hypopnea (OSAH), 

are common in MS patients. OSAH was also common in 

our normal controls. OSAH was significantly associated with 

fatigue in MS patients, but not in controls. These results raise 

the possibility that treatment of sleep disorders may reduce 

fatigue in MS. Objectives: To evaluate the effects of treatment 

of sleep disorders on fatigue, somnolence, and quality 

of life in MS patients. Methods: We studied 62 ambulatory 

MS patients without known sleep disorders. Patients 

completed study questionnaires and underwent complete 


77 

Posters 

overnight in-laboratory polysomnography (PSG). Standardized 

questionnaires were used to assess fatigue (Fatigue 

Severity Scale; FSS), somnolence (Epworth Sleepiness Scale; 

ESS), and health-related quality of life (36-item Short Form 

Health Status Survey; SF-36). Patients were referred to a sleep 

physician and offered treatment as clinically necessary. All 

patients were asked to return for a second assessment to complete 

questionnaires >3 months after the first, whether or not 

they were being treated. Patients treated for sleep disorders 

were compared with all others using multivariate analyses, 

correcting for age, gender, disability, body-mass index, MS 

exacerbation, and baseline outcome measure. Results: Fiftysix 

of 62 MS patients returned for a second study assessment. 

Twenty-one patients were treated for sleep disorders (17 for 

OSAH, 3 for restless legs syndrome, 1 for insomnia). Eighteen 

patients had sleep disorders but were not treated. Seventeen 

patients did not have sleep disorders. In unadjusted 

analyses, in treated patients, FSS scores decreased from 5.1 

± 1.6 to 4.5 ± 1.6, and ESS scores decreased from 9.6 ± 

3.8 to 6.1 ± 3.7 (P < .05). In multivariate analyses, treatment 

of sleep disorders produced a significant reduction in fatigue 

and somnolence (P < .05), but not in quality of life in MS. 

Conclusion: In this preliminary, prospective, nonrandomized 

study, we found that treatment of sleep disorders in MS 

patients produces an improvement of subjective fatigue and 

somnolence. Our results emphasize the importance of identifying 

sleep disorders, especially OSAH, in MS patients, as 

treatment may produce a reduction in the disabling symptom 

of fatigue. 


Keywords: Sleep and MS, Symptomatic treatment of MS 

S143 

A PILOT STUDY OF THE EFFECTS OF MAGNESIUM 

SUPPLEMENTS ON FATIGUE IN MULTIPLE SCLEROSIS 

PATIENTS 

James Gill, Marketa van den Elzen, Galina Vorobeychik 

Fraser Health Multiple Sclerosis Clinic, Burnaby, BC, Canada 

Background: Fatigue is a common, multifactorial symptom 

experienced by patients with multiple sclerosis (MS). The current 

pharmacological fatigue management therapies include 

regimens with disputed efficacy. Levels of magnesium have 

been shown to be lower in central nervous system (CNS) tissues 

of MS patients, which may be an unexplored factor in 

MS-related fatigue. Objectives: The proposed research will 

attempt to determine the effect of magnesium oxide supplementation 

on fatigue in MS patients in a randomized, doubleblind, 

sham-controlled study. The primary endpoint of the 

study was a mean decrease in total raw score of the Modified 

Fatigue Impact Scale (MFIS). Methods: The effect on 

fatigue will be measured through subjective means using the 

MFIS before and after the treatment. The treatment consisted 

of 250 mg magnesium oxide twice a day for 30 days. Vitamin 

C has shown no efficacy in fatigue in MS patients, making 

it an ideal sham treatment, which consisted of 500 mg 

of vitamin C twice a day. Results: Preliminary results of the 

MFIS indicate magnesium’s efficacy in decreasing fatigue. 

Final analysis of data will be presented at the conference. 

Conclusion: Results of this study will provide a basic level

Posters 

of evidence on the use of magnesium in MS clinical care. We 

hope that the results of the study will add to the existing therapies 

provided for MS-related fatigue. 


Keywords: Symptomatic treatment of MS, Quality of life in MS 

S144 

CMSC CONSENSUS CONFERENCE: COMPREHENSIVE 

MULTIPLE SCLEROSIS SYMPTOMATIC 

MANAGEMENT 

Randall T. Schapiro 

The Schapiro Multiple Sclerosis Advisory Group, Eagle, CO; Clinical Professor 

of Neurology, University of Minnesota, Minneapolis, MN 

Background: Chaired by Dr. Randall T. Schapiro and held 

on December 10-12, 2010, this conference convened an 

expert multidisciplinary panel of experts to examine evidencebased 

knowledge and current practice, and to explore best 

practices in comprehensive management in multiple sclerosis 

(MS) symptomatic care. The result of this multidisciplinary 

conference is to develop evidence-based consensus statements 

about best practices in multiple sclerosis. Objectives: 

Learning objectives of the Consensus Conference: Participants 

were able to 1) describe the symptom chain in MS and their 

interlinking consequences in patient function and quality of 

life; 2) develop a schema of best practices that will address 

and control primary symptoms such as fatigue, elimination 

dysfunction, pain, and movement changes with discussion 

of other confounding MS symptoms; and 3) discuss both 

pharmacological and nonpharmacological Best Practices in 

Comprehensive Symptomatic Management in MS. Results: 

Outcomes: Needs assessments and surveys were used to 

establish a baseline for our current understanding and unmet 

educational needs. The projected outcomes will include 1) 

development of consensus statements summarizing best practices 

in symptomatic management in MS; and 2) access to 

consistent and validated evidence-based best practice information 

for all members of the multidisciplinary MS health-care 

team through various dissemination measures. Conclusions: 

This poster will present details of the conference agenda, 

case studies, and outcomes of group interaction, and will 

premiere the consensus statements developed by conference 

attendees. This information will be further disseminated 

through conferences, publications, and web postings. A 

3-hour symposium on best practices is planned for the 2012 

CMSC Annual Meeting. Conference participants: Pat Bednarik; 

Francois Bethoux; Patty Bobryk; Brenda Brelje; Susan 

Forwell; June Halper; Colleen Harris; Rock Heyman; Cinda 

Hugos; Rosalind Kalb; Marie Namey; Christine Smith; Matthew 

Sutliff; Ben Thrower; Roberta Winter. 

Supported by: Acorda Therapeutics, Inc, XenoPort, Inc 

Disclosure: Acorda Therapeutics, Inc, EMD Serono, Inc, Pfizer Inc 

(consulting fees) 

Keywords: Symptomatic treatment of MS, Comprehensive care and 

MS, Economic issues and MS 

S145 

WITHDRAWN 


78 

S146 

FACILITATING MULTIPLE SCLEROSIS PATIENT SELF- 

MANAGEMENT 

Cinda Hugos, Lois Copperman 

Neurology, Oregon Health & Science University, Portland, OR 

Background: Approximately 400,000 Americans and 2 

million people worldwide have multiple sclerosis (MS). MS 

has a wide variety of significant symptoms, including fatigue, 

spasticity, gait and mobility problems, cognitive problems, 

tremor, balance problems, bowel and bladder problems, 

dizziness, pain, vision loss, sensory loss, and weakness that 

may result in mild to severe disabilities. It is recognized that 

there is considerable interaction between the symptoms, 

and the overall complexity of symptom management can be 

overwhelming to the person with MS. Objectives: To help 

people with MS manage their symptoms to improve their 

quality of life. To educate people with MS about the interaction 

of MS symptoms. To develop an effective program that 

enhances personal success in daily symptom management. 

To increase self-efficacy of people with MS. Methods: The 

authors have developed methods that enhance the ability of 

individuals with MS to identify, measure, and analyze their 

symptoms and symptom interactions. These methods have 

been successful in helping people with MS deal with complicated 

symptoms such as fatigue and spasticity. The authors 

have created self-management programs for these common 

and disabling symptoms. Fatigue: Take Control continues to 

be used nationwide in chapters of the National Multiple Sclerosis 

Society and the VA system. MS Spasticity: Take Control 

was launched at the 2010 Consortium of Multiple Sclerosis 

Centers (CMSC) meeting. Results: A 2010 article published 

in the peer-reviewed journal Multiple Sclerosis confirmed the 

efficacy of the authors’ approach to management of fatigue. 

MS Spasticity: Take Control was enthusiastically received 

and will be posted on the websites of Paralyzed Veterans 

of America, the CMSC and the VA MS Center of Excellence 

West. The Cleveland Clinic has requested copies for distribution 

to their patients with MS. Conclusion: Training in effective 

self-management is increasingly recognized as one of the 

most important ways to help people with MS manage their 

symptoms. Ultimately, learning techniques for self-management 

helps people with MS continue to lead productive lives 

and increases their quality of life. The present status of methods 

and techniques in process will be shared at the meeting. 


Keywords: Symptomatic treatment of MS, Rehabilitation strategies and 

therapy and MS, Quality of life in MS 

S147 

OCCURRENCE OF A RELAPSE DOES NOT INFLUENCE 

PHYSICAL ACTIVITY IN EARLY RELAPSING- 

REMITTING MULTIPLE SCLEROSIS 

Madeline L. Weikert, Robert W. Motl 

Kinesiology and Community Health, University of Illinois, Urbana-Champaign, 

Urbana, IL 

Background: Relapses are a defining feature of multiple 

sclerosis (MS) and reflect underlying inflammatory activity 

in the early phase of the disease. The occurrence of each

elapse may impart some degree of functional impairment 

that accumulates over time. Thus the occurrence of a relapse 

may be a contributing factor in the rate of physical inactivity 

in individuals with MS. Objectives: This study examined the 

effect of relapse occurrence on change in physical activity in 

individuals with relapsing-remitting multiple sclerosis (RRMS). 

Methods: The sample included 28 females with a definite 

diagnosis of RRMS and disease duration of less than 5 years 

who were ambulatory without assistance and between the 

ages of 18 and 40 years. The participants wore a Yamax 

SW-200 pedometer for 7 days and reported whether a 

relapse occurred, every month over a 12-month period. If 

a participant reported a relapse during the month, then the 

project coordinator conducted a recall evaluation of that 

specific relapse over the phone for confirmation. There were 

14 participants who experienced a relapse during the year 

of data collection and 14 individuals who did not experience 

a relapse who were matched on baseline physical activity 

levels. The pedometer steps for the month before, during, 

and after the relapse were entered into a database for both 

groups. Data analysis was performed using SPSS, version 

18.0 (SPSS Inc, Chicago, IL). Results: There was no significant 

difference in baseline pedometer step counts between 

the two groups (t[26] = 0.10, P = .92), with average baseline 

values for the relapse and no relapse groups of 5486 ± 

2456 and 5396 ± 2504 steps per week, respectively. The 

occurrence of a relapse had no significant influence on the 

monthly pedometer step counts based on a 2 (group) × 3 

(time) mixed-model analysis of variance (ANOVA) (F[2,52] = 

1.25, P = .29, eta-squared = 0.05). The mean ± SD pedometer 

step counts per week for the relapse group, in particular, 

from before, during, and after the relapse were 6175 ± 618, 

6553 ± 830, and 6646 ± 619, respectively. Conclusion: 

The occurrence of a relapse does not influence physical activity 

in ambulatory females with early RRMS. 


Keywords: Relapse management in MS 

S148 

OVERACTIVE BLADDER IN MULTIPLE SCLEROSIS: 

DEVELOPMENT OF A SCREENING TOOL 

Jack Burks, 1 Michael Chancellor, 2 Manuel Signori, 3 Marcy Fitz-Randolph, 4 

Denise Globe 5 

1 Chief Medical Officer, Multiple Sclerosis Association of America, Cherry 

Hill, NJ; 2 William Beaumont School of Medicine, Oakland University, Royal 

Oak, MI; 3 Global Strategic Marketing, Allergan, Irvine, CA; 4 Patient-Reported 

Outcomes, Mapi Values, Boston, MA; 5 Global Health Economics Strategy and 

Research, Allergan, Irvine, CA 

Background: Neurogenic detrussor overactivity (NDO) is 

a common problem in patients with multiple sclerosis (MS), 

but may be underrecognized, underreported, and undertreated. 

There currently exists no screening tool for bladder 

overactivity specifically for the MS population, which already 

suffers from numerous complex and varied symptoms that can 

change over the course of the disease. A tool to help identify 

NDO patients who could benefit from both neurologic and 

possible urologic treatments may increase their quality of 

life. Objectives: To develop a patient-completed screening 

tool for MS health-care professionals to identify MS patients 


79 

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who could benefit from NDO treatments. Methods: The 

screening tool was developed using three sources of information. 

First, a review of existing instruments was completed. 

Next, expert clinician input was gathered from urologists, 

neurologists, physiatrists, and MS nurse specialists, first with 

telephone interviews (n = 15) reflecting on the existing instruments, 

then through two semi-structured focus groups, one 

held in Amsterdam with European clinicians (n = 5) and one 

held in New York (n = 6). After clinician input was obtained, 

20 semi-structured patient interviews were conducted with 

male and female MS patients with and without urologic 

symptoms to gather information on symptoms of urinary 

incontinence, impacts of incontinence, and coping strategies. 

Results: The patient-completed screening tool was developed 

using information from three sources: review of existing 

instruments, clinician interviews and focus groups, and 

individual patient interviews. These processes identified three 

general categories with items in several domains including 

symptoms (urinary urgency, nocturia, leakage, and incontinence), 

impacts (emotional, friends and family, work, travel, 

and sleep), and coping strategies (bathroom mapping, bladder 

protection, fluid restriction). Conclusion: The screening 

tool is currently undergoing further refinement through cognitive 

interviews with patients and psychometric validation. 

Disclosure: Jack Burks: Allergan, Acorda, Avanir, Bayer, Novartis, 

Serono, Biogen (consulting fees). Michael Chancellor: Allergan (honoraria). 

Manuel Signori: Allergan (salary). Marcy Fitz-Randolph: Allergan 

(consulting fee). Denise Globe: Allergan (salary). 

Keywords: Quality of life in MS 

S149 

PHYSICAL ACTIVITY AND AGING IN PEOPLE WITH 

LONG-STANDING MULTIPLE SCLEROSIS 

Janet D. Morrison, Alexa K. Stuifbergen 

School of Nursing, The University of Texas at Austin, Austin, TX 

Background: A variety of research studies suggest that 

physical activity (PA) may have a positive influence on anxiety, 

depression, fatigue, cognition, and disease progression 

in people with multiple sclerosis (MS). Although people 

with MS may derive great benefits from PA, many lead a 

progressively sedentary lifestyle as they age. Little is known 

about PA in individuals with long-standing MS and aging. 

Objectives: The purpose of this study was to describe PA 

in individuals with long-standing MS (12- to 54-year history) 

participating in a longitudinal wellness study of people 

with MS. Methods: A sample of 363 (52 men and 311 

women; mean ± SD age, 60.5 ± 9.4 years; mean time since 

diagnosis, 23.5 ± 6.8 years) completed the Health Promoting 

Lifestyle II as part of an ongoing longitudinal survey of 

health promotion and quality of life. The PA subscale (α = 

.87) addresses how often individuals engage in PA ranging 

in intensity level from vigorous to leisure-time. Descriptive 

statistics (frequencies, percentages, and Pearson correlations) 

were used to explore the relationship of PA to demographic 

and illness variables. Participation was defined as sometimes, 

often, or routinely engaging in PA at three different levels: 1) 

exercise vigorously for 20 or more minutes at least three times 

a week, 2) take part in light-to-moderate PA, and 3) take part 

in leisure-time PA. Results: There were no significant rela

Posters 

tionships between PA subscale scores and age, gender, or 

time since diagnosis. Men reported slightly higher participation 

than women, and more than 50% of the sample reported 

participating in PA up to the age of 80. Over 50% reported 

continued PA participation as their years since diagnosis 

increased. Notably, there was a decrease in leisure-time PA 

in individuals with a 40+ year history of MS. Conclusions: 

Further research is needed to determine whether continued 

PA participation despite increasing age and time since diagnosis 

is unique to this sample that has participated in a longitudinal 

study for 14 years. 

Supported by: National Institute of Nursing Research, National Institutes 

of Health, R01NR003195 



of activities of daily living in MS, Nursing management in MS 

S150 

PREVALENCE OF SELF-REPORTED DYSPHAGIA IN 

OUTPATIENTS WITH MULTIPLE SCLEROSIS 

Gathline Etienne, 1 Parker Freels, 2 Michael Crary, 3 Giselle Carnaby-Mann, 3 

Scott Silliman 1 

1 Neurology, University of Florida Jacksonville, Jacksonville, FL; 

2 Undergraduate, Wofford College, Spartanburg, SC; 3 College of Public Health 

& Health Professions, University of Florida, Gainesville, FL 

Background: Complications of dysphagia are common 

causes of morbidity and mortality in patients with multiple 

sclerosis (MS). Observational studies have reported a broad 

prevalence of dysphagia in MS, ranging from 3% to 43%. 

These studies have been limited by small sample size, 

population bias, and the use of nonvalidated questionnaires. 

Objectives: The purpose of this study was to estimate the 

prevalence of self-reported dysphagia via use of validated 

questionnaires in outpatients with MS. Methods: A crosssectional 

study was conducted at the University of Florida– 

Jacksonville Multiple Sclerosis Comprehensive Center, where 

consecutive patients (N = 101) seen in an outpatient clinic 

from July 15, 2010, to September 27, 2010, were enrolled 

with consent. The participants completed two validated questionnaires, 

the Sydney Swallow Questionnaire (SSQ) and the 

EAT-10. The Functional Oral Intake Scale (FOIS) was completed 

via patient interview to evaluate functional eating ability. 

The scores were correlated with race, gender, MS type, disease 

duration, and degree of disability using the Expanded 

Disability Status Scale (EDSS) score. Results: The mean age 

was 45.3 years; 82.4% were women; 23.8% were African 

American (AA); the mean disease duration was 9.7 years; 

and the mean EDSS score was 3.8. Based on the EAT-10, 

which classifies dysphagia as a score of >3, the prevalence 

of self-reported dysphagia in the 101 patients was 38%. 

There was a good Pearson correlation of 0.92 (P = .0001) 

between the EAT-10 and SSQ, which showed corresponding 

high values for the SSQ. Similarly, this was reflected in 

the FOIS, with a Pearson correlation of –0.60, where the 

degree of dysphagia identified on EAT-10 significantly correlated 

with modification of oral intake. Subgroup analysis 

showed that AAs had higher EAT-10 and SSQ scores than 

Caucasians and also were more likely to have a progressive 

form of MS and greater disability based on their EDSS score. 


80 

Conclusion: The prevalence of self-reported dysphagia in 

MS outpatients was found to be 38%. Clinicians caring for 

outpatients with MS should be aware of this relatively high 

prevalence of self-reported dysphagia. Also, AAs with MS 

may be at particularly high risk for developing dysphagia. 

Early detection of dysphagia followed by appropriate interventions 

for dysphagia may help to reduce morbidity and 

mortality associated with MS. 


Keywords: Comprehensive care and MS 

S151 

PROMOTING SELF-MANAGEMENT FOR PEOPLE 

WITH MULTIPLE SCLEROSIS AND PAIN 

Robyn M. Smith, 1 Megan Varlow, 2 Erika Coxhead 2 

1 Client Services, MS Australia–ACT/NSW/VIC, Sydney, NSW, Australia; 

2 Programs Office, MS Australia–ACT/NSW/VIC, Sydney, NSW, Australia 

Background: Pain is a significant problem for people with 

multiple sclerosis (MS), with prevalence estimated at between 

48% and 66% and constant pain reported by 40% to 57% 

of people with MS (Ehde et al., 2006; Khan et al., 2007; 

O’Connor et al., 2007; Hadjimichael et al., 2007). There 

is good evidence in the general population for the effectiveness 

of multidisciplinary cognitive-behavioral programs that 

promote the use of active strategies to improve pain management. 

Although these programs can be very effective in the 

management of chronic pain (Morley et al., 1999; Guzman 

et al., 2001; Turk & Burwinkle, 2005), in Australia they 

are often not available or not suitable for people with MS. 

Objectives: This project aimed to determine protocols and 

strategies supported by scientific research to facilitate the 

self-management of pain in people with MS. It also aimed 

to locate or develop resources to support people with MS to 

effectively manage their pain and to inform health and medical 

professionals about this strategy. Methods: A literature 

review examined the evidence of efficacy for pain management 

strategies in the general population and people with 

MS. The search identified strategies in four main categories: 

physical, psychological, medical/pharmacological, and 

surgical. The evidence from the literature review was used to 

develop a pilot pain management program specifically for 

people with MS and pain. The program was interdisciplinary, 

based on clinical expertise, developed with consumer consultation, 

and granted ethics approval. Simultaneously, health literature 

was developed to provide information on pain in MS 

and evidence-based pain management strategies. Training 

was conducted for MS Australia client service staff. Results: 

Results from the small pilot program (N = 9) were promising. 

There were no significant overall group effects; however, 

trends in depression (pre to follow-up t[3] = 3.236, P = .048) 

and self-efficacy (pre to post t[5] = –2.374, P = .064) were 

evident. The health literature is available on the MS Australia 

website. MS Australia staff are better informed on pain and 

MS. Conclusion: People living with MS and pain are able 

to achieve successful outcomes in pain management by participating 

in a customized pain program. Health literature is 

now available to promote self-management specifically for 

people with MS and pain. 


Keywords: Symptomatic treatment of MS, Quality of life in MS

S152 

RETINAL PATHOLOGY MIMICKING DEMYELINATING 

EVENTS IN MULTIPLE SCLEROSIS 

Pilar Prieto, 1 Rosa A. Tang, 1 Jade S. Schiffman 1,2 

1 Neuro-Ophthalmology, University of Houston MS Eye Care Center, Houston, 

TX; 2 Neuro-Ophthalmology, The University of Texas MD Anderson Cancer 

Center, Houston, TX 

Background: Optic neuritis (ON) is the most common 

neuro-ophthalmologic manifestation in patients with multiple 

sclerosis (MS). It usually presents as a relatively sudden onset 

of monocular vision loss along with pain upon eye movement. 

These symptoms are shared by other ophthalmologic 

conditions such as macular lesions and corneal and retinal 

pathologies, which can be confused with ON. Objectives: 

To differentiate between various retinal pathologies of ON 

caused by MS based on history, evolution, and clinical 

presentation. Methods: This is a case review of patients 

from our center encompassing both MS and non-MS patients 

initially evaluated for ON with symptoms of decreased visual 

acuity and blurred vision with or without pain. Results: A 

30-year-old man was evaluated for multiple falls and paresthesias. 

Brain magnetic resonance imaging (MRI) showed 

multiple periventricular white matter lesions, one of which 

was enhancing. He received two doses of oral methylprednisolone, 

after which he developed central vision loss in his 

right eye along with mild pain. It was initially diagnosed 

as ON. He stopped the steroid treatment and was sent to 

our clinic for neuro-ophthalmologic evaluation. Upon the 

discontinuation of steroids, his vision gradually improved. 

Optical coherence tomography (OCT) revealed normal nerve 

fiber layer thickness in both eyes. The right macula showed 

central serous retinopathy (CSR). Electrophysiologic studies 

(visual evoked potential, multifocal visual evoked potential) 

failed to demonstrate a delay, and multifocal electroretinography 

demonstrated decreased amplitude in the right eye 

consistent with maculopathy. Central serous retinopathy can 

be easily confused with ON because it typically occurs in 

young patients. Both entities can be triggered by stress, are 

usually monocular, and present a sudden onset similar to 

ON. CSR worsens with the use of steroids. Despite the lack 

of demyelinating evidence on his visual pathway, the patient 

met the diagnostic criteria for MS. His vision loss was due to 

CSR and not ON. Conclusion: Some retinal entities such as 

CSR can be confusing when they appear in the context of a 

potential demyelinating disease and can be easily confused 

with ON. One difference is that CSR is induced or worsened 

by steroid therapy. 

Disclosure: Pilar Prieto: Nothing to disclose. Rosa A. Tang: Bayer, 

EMD Serono (honoraria). Jade S. Schiffman: Nothing to disclose. 

Keywords: Comprehensive care and MS, Symptomatic treatment of MS 

S153 

SELF-EFFICACY IN MULTIPLE SCLEROSIS 

Dagmar Amtmann, Alyssa M. Bamer, Joanne Brockway, Karon Cook, Kurt 

Johnson 


Background: Multiple sclerosis (MS) is a complex disease. 

Health management in the context of MS presents a considerable 

challenge, especially in combination with the complexity 

of the US health-care system. People with MS who develop 


81 

Posters 

confidence in their ability to manage the disease often have 

better health outcomes and quality of life. Objectives: The 

objective of our study was to examine self-efficacy and its 

impact on emotional well-being and quality of life using two 

self-efficacy scales. The Disability Management Self Efficacy 

Scale (DMSES) is a new scale developed with and validated 

for people with MS. The Stanford Self-efficacy (SSE) scale 

was developed for general self-management in chronic disease 

and has not been validated in people with MS. Methods: 

Short versions of both scales consist of six items. The 

DMSES was developed using Item Response Theory scoring, 

with the range from 0 to 100. The summary score on the SSE 

scale ranges from 0 to 10. Data were collected via surveys of 

community-dwelling individuals with MS (N = 473) enrolled 

in an ongoing longitudinal survey study. Results: The average 

age of the sample was 52.3 years, the mean duration of 

MS was 14.9 years, and the sample was 82.7% female. On 

the DMSES the sample had a mean (SD) of 50.1 (9.3), and 

on the SSE scale a mean (SD) of 7.1 (2.0). Published studies 

on the SSE scale for other populations reported a mean 

(SD) of 5.53 (2.2) based on 175 participants with arthritis 

and a mean (SD) of 6.87 (1.76) based on the sample of 

186 people with diabetes. Both scales were most highly correlated 

with scores from the Modified Fatigue Impact Scale 

(MFIS) (DMSES r = –0.72, SSE r = –0.69), followed by the 

Perceived Stress Scale (DMSES r = –0.67, SSE r = –0.65). In 

the regression model, self-efficacy measured by either scale 

was most predictive of MFIS scores 8 months later (DMSES r 2 

= 0.46, SSE r 2 = 0.43). Conclusion: Self-efficacy in this MS 

sample appears higher than that in other populations with 

chronic diseases. People with MS with higher self-efficacy 

scores reported better overall health as well as less pain interference, 

fatigue, depression, perceived stress, and interference 

with participation in valued activities. 


Keywords: Quality of life in MS 

S154 

SELF-REPORTED IMPACT OF SPASTICITY IS 

ASSOCIATED WITH SPATIOTEMPORAL PARAMETERS 

OF GAIT 

Swathi Balantrapu, Brian Sandroff, Jacob Sosnoff, Robert W. Motl 

Kinesiology, University of Illinois, Urbana-Champaign, Urbana, IL 

Background: Spasticity is prevalent in multiple sclerosis 

(MS) and represents a burdensome symptom that may affect 

ambulation. People with spasticity experience muscle weakness, 

stiffness, pain, fatigue, tremor and apprehension of 

falling, resulting in difficulty with walking and management 

of spasticity itself. Objectives: This study examines the 

association between the self-reported impact of spasticity and 

spatiotemporal parameters of gait in MS. Methods: The 

sample included 44 adults with MS who completed a battery 

of questionnaires, including the Multiple Sclerosis Spasticity 

Scale–88 (MSSS-88). The participants further performed four 

trials on a 26-foot GAITRite electronic walkway for measurement 

of spatiotemporal gait components including velocity, 

cadence, base of support, step time, single support, double 

support, and swing phase. Results: The overall MSSS-88 

score was significantly associated with velocity (P = .007; r = 

–0.371), cadence (P = .022; r = –0.306), base of support (P

Posters 

= .009; r = 0.357), step time (P = .022; r = 0.305), singleleg 

support (P = .005, r = –0.388), double-leg support (P = 

.006; r = 0.379), and swing phase (P = .005, r = –0.386). 

Conclusion: The results suggest that the overall perceived 

burden of spasticity coincides with alterations of the spatiotemporal 

parameters of gait. Subsequent interventions that 

decrease spasticity or its perceived impact might consider 

further focusing on mobility as an outcome. 



S155 

SLEEP DISORDERED BREATHING IN MULTIPLE 

SCLEROSIS 

Tiffany Braley 

University of Michigan, Ann Arbor, MI 

Background: Sleep disordered breathing (SDB), a term 

used to describe disorders of respiration during sleep, 

includes obstructive sleep apnea (OSA) and central sleep 

apnea (CSA). Untreated SDB affects quality of life and is 

a known contributor to fatigue in the general population. 

Yet there is a dearth of information about the relationship 

between SDB and multiple sclerosis (MS). Objectives: 1) 

To explore differences between apnea-hypopnea and central 

apnea indices (measures of sleep apnea severity) in subjects 

with and without MS referred for polysomnography (PSG); 

and 2) to explore subjective symptoms among MS patients 

with SDB. Methods: PSG data from MS cases and controls 

were retrospectively reviewed. Demographic and PSG data 

including the apnea-hypopnea index (AHI) and central apnea 

index (CAI) were collected for 48 subjects with clinically 

definite MS; 84 controls matched by body-mass index (BMI), 

age, and gender; and 48 randomly selected controls. Mean 

AHI and CAI were compared among MS cases and matched 

controls using paired t tests. Multiple linear regression, 

adjusted for age, gender, and BMI, was used to analyze differences 

between mean AHI and CAI among MS cases and 

randomly selected controls. Extant data regarding subjective 

daytime symptoms were also assessed. Results: Mean 

± SD AHI was greater among MS cases (18.73 ± 22.1) 

than among matched (9.38 ± 8.9, P = .0114) or randomly 

selected controls (9.95 ± 9.81, P = .0050). Mean CAI also 

was greater among cases (3.47 ± 8.1) than among matched 

(0.37 ± 1.1, P = .0178) or randomly selected controls (0.42 

± 1.23, P = .0173). Among cases, n = 37 had available 

data to determine the presence or absence of radiographic 

and/or clinical brainstem involvement. Of the 22 MS subjects 

with brainstem involvement, differences from controls in AHI 

and CAI became more robust, while among the 15 MS subjects 

without brainstem involvement, these differences became 

nonsignificant. Of those with available subjective data, 22 of 

23 cases with SDB reported fatigue, lack of energy, or tiredness 

to be their most problematic symptom, as opposed to 

excessive daytime sleepiness. Conclusion: These data suggest 

a predisposition for central and obstructive apneic events 

in a subset of MS patients, which may in part be secondary 

to brainstem involvement. This study also sheds light on the 

potential contributions of SDB to MS-related fatigue. 


82 

Supported by: Supported in part by a Sylvia Lawry Physician Fellowship 

from the National Multiple Sclerosis Society 

Disclosure: Teva Pharmaceuticals, Pfizer Pharmaceuticals, Serono Inc 

(honoraria) 

Keywords: Sleep and MS, Imaging and MS 

S156 

SPASTICITY OF THE LEGS AND ITS EFFECT ON 

MEASURES OF AMBULATION AND GAIT 

Swathi Balantrapu, 1 Jacob Sosnoff, 1 John Pula, 2 Madeline Weikert, 1 Yoojin 

Suh, 1 Morgan Boes, 1 Brian Sandroff, 1 Robert W. Motl 1 

1 Kinesiology, University of Illinois, Urbana-Champaign, Urbana, IL; 

2 Neurology, University of Illinois, Peoria, IL 

Background: Spasticity of the limbs is a common and 

seemingly incapacitating symptom experienced by people 

with MS. Spasticity of the legs is seemingly associated with 

walking impairments in people with MS, but there has been 

limited research conducted on spasticity using objective 

measures of mobility and gait. Objectives: This study examined 

the effect of spasticity of the legs on the performance of 

mobility and gait assessments in individuals with MS. Methods: 

The sample included 42 patients with a definite diagnosis 

of MS. Spasticity of the legs was measured by a qualified 

neurologist using a 4-point rating scale ranging between 0 

(normal) and 4 (most severe and contracted spastic tonus). 

Patients then completed a battery of objective walking tests, 

namely the 6-Minute Walk (6MW), Timed 25-Foot Walk 

(T25FW), and Timed Up and Go (TUG) test. The patients 

undertook four walking trials on a GAITRite (CIR Systems, 

Inc) electronic mat used for measuring gait dysfunction based 

on a Functional Ambulatory Performance (FAP) score. The 

patients further completed a self-report questionnaire on 

mobility, namely the Multiple Sclerosis Walking Scale–12 

(MSWS-12). Results: Twenty-two participants, 52% of the 

sample, presented with spasticity in the legs. Those with leg 

spasticity had moderate-to-large ambulatory impairments on 

the 6MW (Cohen’s d = 0.45), T25FW (Cohen’s d = 0.46), 

TUG (Cohen’s d = 0.39), and MSWS-12 (Cohen’s d = 0.79) 

compared with those without spasticity. Those with spasticity 

of the legs further had moderate gait impairments with low 

FAP scores (Cohen’s d = 0.45) compared with those who 

did not have spasticity. Conclusion: Spasticity was present 

in more than half of the MS sample and was associated 

with greater walking impairment using both self-report and 

objective measures. This underscores the importance of its 

management, particularly given the prevalence and impact in 

individuals with MS. 



S157 

URINARY TRACT INFECTION INCIDENCE AMONG 

MULTIPLE SCLEROSIS PATIENTS TREATED WITH 

DALFAMPRIDINE 10 MG TWICE DAILY 

Patti Snyder, Thomas Wessel, Adrian Rabinowicz, Douglas Kargman, Herbert 

R. Henney III, Andrew Blight 

Acorda Therapeutics, Inc, Hawthorne, NY 

Background: Urinary tract infection (UTI) is the most frequent 

urinary complication in multiple sclerosis (MS) patients;

ladder dysfunction occurs in 75% of women with MS. 

Dalfampridine (D-ER, fampridine outside the United States) 

trial data have shown that in healthy volunteers the mean 

D-ER urine concentration at 2 to 4 hours post dose is 5110 

ng/mL (54.4 µM) with a maximum of 12,200 ng/mL (130 

µM), compared with a maximum plasma concentration 

of about 34 ng/mL (0.36 µM). D-ER elimination is nearly 

complete after 24 hours; 95.9% of the dose is recovered in 

urine. Objectives: Examine patient reports of symptoms 

consistent with UTI among MS patients treated with D-ER 

10 mg twice daily in double-blind and extension studies, 

as well as postmarket safety reports. D-ER is indicated to 

improve walking in MS as demonstrated by an increase in 

walking speed. Methods: A review of pooled trial data and 

postmarket safety reports was performed to assess reports 

of adverse events (AEs) termed UTI and laboratory tests performed 

in response to patient-reported symptoms. Results: 

In controlled clinical trials, AEs of UTI were reported more frequently 

in D-ER-treated patients (14.5%, 0.5% serious) than in 

placebo (9.2%, 0.4% serious). No discontinuations were due 

to UTI. With the exception of UTI, there was no difference 

in AEs related to infection rates between drug and placebo 

groups in the controlled trials. In open-label extension studies, 

30.6% of patients experienced a UTI event. However, urinal- 


83 

Posters 

ysis or culture was not required to diagnose UTI in the clinical 

trials. Individual postmarket safety reports of UTI in which 

laboratory analysis results were reported will be described in 

the poster presentation. Urinalysis in a number of these cases 

did not support the presence of UTI, or urine cultures were 

negative. Conclusion: A higher rate of symptoms consistent 

with UTI was reported in MS patients treated with D-ER relative 

to placebo in clinical trials. From postmarket surveillance, 

urinalysis or culture, when available, often revealed negative 

results. A potential explanatory hypothesis is that high D-ER 

concentrations in the urine may have an excitatory effect on 

the mucosal lining of the ureters, bladder, and urethra, or 

may enhance neuronal transmission, which may mimic symptoms 

of UTI. 

Supported by: Acorda Therapeutics, Inc 

Disclosure: Patti Snyder: Acorda Therapeutics, Inc (salary, ownership 

interests). Thomas Wessel: Acorda Therapeutics, Inc (salary, ownership 

interests). Adrian Rabinowicz: Acorda Therapeutics, Inc (salary, ownership 

interests). Douglas Kargman: Acorda Therapeutics, Inc (salary, 

ownership interests). Herbert R. Henney III: Acorda Therapeutics, Inc 

(salary, ownership interests). Andrew Blight: Acorda Therapeutics, Inc 

(salary, ownership interests). 

Keywords: Symptomatic treatment of MS, Quality of life in MS

Whitaker Research Track 

WHITAKER RESEARCH TRACK 

Dr. John N. Whitaker was a world-famous researcher in multiple 

sclerosis. Not only did Dr. Whitaker engage in research 

himself, he encouraged budding scientists to enter the field 

and develop their skills and talents in this important work. The 

Consortium of Multiple Sclerosis Centers is proud to honor 

Dr. Whitaker’s memory by presenting the Whitaker Research 

Track each year as part of its annual meeting. 

GRANULOCYTE COLONY-STIMULATING FACTOR 

PLAYS A CRITICAL ROLE IN EXPERIMENTAL 

AUTOIMMUNE ENCEPHALOMYELITIS BY 

DRIVING GRANULOCYTE EXPANSION IN THE 

BONE MARROW AND MOBILIZATION INTO THE 

CIRCULATION 

Julie Rumble, 1,2 Praveen Rao, 1,2 Benjamin M. Segal 1,2 

1 Holtom-Garrett Program in Neuroimmunology, University of Michigan, Ann 

Arbor, MI; 2 Department of Neurology, University of Michigan, Ann Arbor, MI 

Background: Experimental autoimmune encephalomyelitis 

(EAE) is a murine model of neuroinflammatory demyelination 

that is frequently used as a model for multiple sclerosis (MS). 

We have previously shown that CXCR2+ granulocytes are 

critical for blood-brain-barrier (BBB) breakdown and the 

development of neurologic deficits in myelin oligodendrocyte 

glycoprotein (MOG)–immunized mice. However, pathways 

controlling the mobilization and recruitment of granulocytes 

to the central nervous system (CNS) remain unclear. Objectives: 

In the current study we investigated the mechanisms 

by which granulocytes are regulated during EAE. Methods: 

EAE is induced in C57BL/6 mice by active immunization 

with an epitope of MOG combined with adjuvants. Bordetella 

pertussis toxin (PT) administration at days 0 and 2 

postimmunization (pi) is required for clinical manifestation of 

disease. Serum levels of granulocyte colony-stimulating factor 

(G-CSF), a granulocyte growth and mobilization factor, were 

measured by enzyme-linked immunosorbent assay (ELISA), 

and cell numbers in blood and bone marrow were assessed 

by flow cytometry. Results: We found that granulocytes 

expanded dramatically in the bone marrow and bloodstream 

by day 3 pi, which was preceded by a spike in systemic levels 

of G-CSF. Sustained expression of G-CSF and accumulation 

of circulating monocytes and granulocytes only occurred 

in mice given PT, suggesting that this accumulation was mechanistically 

linked to disease. In addition, treatment of actively 

immunized mice with an antagonistic G-CSF receptor-Fc 

fusion protein prevented clinical EAE. Conclusion: We postulate 

that induction of G-CSF by active immunization drives 

the expansion and mobilization of bone marrow–derived 

granulocytes that ultimately mediate BBB breakdown, thereby 

facilitating CNS infiltration by leukocytes. Our findings are 

consistent with the observation that individuals with MS 

experienced severe exacerbations upon the administration of 

recombinant G-CSF following bone marrow transplantation. 

Furthermore, this suggests that granulocyte growth and mobilization 

factors may be novel therapeutic targets in autoimmune 

demyelinating disease. 



84 

ANTERIOR AND POSTERIOR VISUAL PATHWAY 

DEGENERATION CORRELATE IN MULTIPLE 

SCLEROSIS 

Aleksandra M. Stankiewicz, 1 John N. Ratchford, 1 Shiv Saidha, 1 Navid Shiee, 2 

Stephanie B. Syc, 1 Pierre-Louis Bazin, 3 Dzung L. Pham, 4 Daniel S. Reich, 3,5 

Peter A. Calabresi 1 

1 Neurology, Johns Hopkins University School of Medicine, Baltimore, MD; 

2 Electrical Engineering, Johns Hopkins University, Baltimore, MD; 3 Radiology- 

Neuroradiology, Johns Hopkins University School of Medicine, Baltimore, 

MD; 4 Center for Neuroscience and Regenerative Medicine, Henry Jackson 

Foundation, Bethesda, MD; 5 Translational Neuroradiology Unit, National 

Institute of Neurological Disorders and Stroke, Bethesda, MD 

Background: Optical coherence tomography (OCT) is an 

imaging technique allowing objective quantitative evaluation 

of retinal structures. OCT-derived measures of axonal retinal 

nerve fiber layer (RNFL) thickness correlate with brain atrophy, 

visual function, and disability in multiple sclerosis (MS). 

Neuronal pathology in MS may in part result from retrograde 

or anterograde transynaptic degeneration. Objectives: 

To determine and characterize the relationships between 

magnetic resonance imaging (MRI)–derived estimates of 

cortical thickness and OCT-derived measures of RNFL thickness. 

Methods: Twenty-nine MS patients underwent MRI 

brain and OCT imaging within a 30-day interval. MRI data 

were obtained on a Philips 3T magnet, and OCT data were 

obtained with Cirrus-HD OCT model 4000. Occipital and 

frontal lobe average cortical thickness was calculated from 

T1-weighted and FLAIR scans utilizing TOADS-CRUISE brain 

segmentation tools (www.nitrc.org/projects/toads-cruise). 

Peripapillary RNFL thickness and total macular volume (TMV) 

were determined using the Optic Disc Cube 200X200 and 

Macular Cube 512X128 Cirrus-HD OCT protocols, respectively. 

OCT measures in each subject’s worse eye (eye with 

the lower RNFL thickness) were regressed against average 

cortical thickness, history of optic neuritis, age, sex, and disease 

duration. Results: Mean age was 39.7 ± 12.9 years 

and mean disease duration was 7.4 ± 7.3 years. A total of 

59% of the subjects were female. A total of 38% of eyes studied 

had a history of optic neuritis, and mean RNFL thickness 

was 81.5 ± 13.0 µm. Average occipital cortical thickness 

correlated more significantly with RNFL thickness (r = 0.59, P 

= .002) than TMV (r = 0.43, P = .03). Conversely, average 

frontal cortical thickness did not correlate significantly with 

OCT metrics. Conclusion: RNFL thickness correlates strongly 

with occipital but not frontal lobe cortical thickness in MS, 

suggesting that degeneration in the anterior and posterior 

visual pathways may be specifically related. Future studies 

utilizing OCT segmentation (which facilitates the quantitative 

assessment of retinal neuronal layer thicknesses) may allow 

further characterization of the relationships between retinal 

neuronal integrity and cortical gray matter volumes. 

Supported by: NMSS Tissue Repair grant, Intramural Research Program 

of the National Institute of Neurological Disorders and Stroke, 

National Multiple Sclerosis Society 

Disclosure: Aleksandra M. Stankiewicz: Nothing to disclose. John N. 

Ratchford: Sun Pharmaceuticals (consulting fee); Novartis, University 

of California–Los Angeles (other financial benefits). Shiv Saidha: 

Nothing to disclose. Navid Shiee: Nothing to disclose. Stephanie B. Syc: 

Nothing to disclose. Pierre-Louis Bazin: Nothing to disclose. Dzung L. 

Pham: Nothing to disclose. Daniel S. Reich: Nothing to disclose. Peter 

A. Calabresi: Biogen Idec, Teva Neuroscience, EMD Serono, Novo Nordisk, 

Novartis (consulting fees); Biogen Idec, Teva Neuroscience, EMD 

Serono, Vertex, Genentech, Abbott, Bayer (other financial benefits).

WHOLE-EXOME SEQUENCING OF A 

MULTIGENERATIONAL FAMILY WITH MULTIPLE 

SCLEROSIS 

Sreeram Ramagopalan, David Dymen, George Ebers 

University of Oxford, Oxford, United Kingdom 

Background: We have previously reported a family with 

19 individuals affected with multiple sclerosis (MS) present in 

four generations. The segregation of MS within this pedigree 

is consistent with an autosomal dominant mode of inheritance 

with reduced penetrance. The clinical characteristics of the 

affected individuals are indistinguishable from those seen in 

sporadic MS with respect to sex ratio, age at onset, onset 

symptoms, magnetic resonance imaging (MRI) findings, and 

clinical course. Linkage analysis was performed, but positional 

cloning was unable to identify any convincing candidate 

locus. Objectives: To further understand the heightened 

prevalence of MS in this family using whole-exome sequencing. 

Methods: Exon-enriched DNA using Agilent SureSelect 

was sequenced using the Illumina Genome Analyser II platform. 

Raw image files were processed by the Illumina pipeline 

for base calling. The sequencing reads were aligned to 

the NCBI human reference genome using the program Bowtie. 

Single nucleotide polymorphisms (SNPs) were subsequently 

called using the program SAMTools. We used the software 

PolyPhen2 to assess nonsynonymous variants for a likely functional 

impact. Insertion deletion polymorphisms (indels) were 

called using the programs BWA and SAMTools. Results: 

On average, 3.1 gigabases of mappable sequence was 

generated per individual and 85% of reads were mapped. 

The average fold-coverage of each exome was 100 fold. On 

average, 57,750 SNPs were called per individual, of which 

64% were already annotated in a public database (dbSNP 

v131). A total of 19,743 SNPs were in common between all 

four patients, and 7701 of these were novel to this family. 

A total of 396 were predicted to be damaging (ie, a loss of 

function mutation) by Polyphen, and 156 were novel to this 

family. On average, 5038 indels were called per individual, 

of which 13.5% were previously annotated in dbSNP v131. 

A total of 1840 indel locations were in common between all 

four patients, 1562 were novel, and 267 were frameshift 

mutations. Conclusion: By looking at SNPs and indels present 

in regions of linkage in this family, plausible novel MS 

causative variants have been highlighted, and the study illustrates 

the usefulness of rare multigenerational MS families to 

identify large effects in individual genes predisposing to MS. 


85 

Whitaker Research Track 

Supported by: Multiple Sclerosis Society of Canada Scientific Research 

Foundation, Multiple Sclerosis Society of Great Britain and Northern 

Ireland 


MIRNA BIOMARKERS MODULATE T-CELL 

DIFFERENTIATION IN MULTIPLE SCLEROSIS 

Mireia Guerau-de-Arellano, 1 Kristen Marie Smith, 2 Jakub Godlewski, 3 Sean 

Lawler, 3 Caroline Whitacre, 2 Michael K. Racke, 1 Amy E. Lovett-Racke 2 

1 Neurology, The Ohio State University, Columbus, OH; 2 Molecular Virology, 

Immunology, and Medical Genetics, The Ohio State University, Columbus, 

OH; 3 Neurological Surgery, The Ohio State University, Columbus, OH 

Background: In multiple sclerosis (MS) patients, myelinspecific 

T cells acquire pathogenic Th1/Th17 phenotypes. 

However, the factors that drive this pathogenic differentiation 

are unclear. miRNAs have been recently described as posttranscriptional 

regulators of gene expression that regulate cellular 

processes. Objectives: We investigated whether miR- 

NAs are differentially expressed in MS patients as potential 

disease biomarkers. In addition, we explored whether and 

how miRNAs contribute to pathogenic T-cell differentiation 

in MS. Methods: We profiled miRNA expression in naive 

CD4+CD45RA+T cells of healthy (n = 8) and untreated MS 

(n = 22) donors. Specific miRNAs were transfected into T 

cells to evaluate their effects on proinflammatory Th1 versus 

more benign Th2 cell differentiation and effector cytokine 

production, as well as their encephalitogenic potential in 

experimental autoimmune encephalomyelitis (EAE). Results: 

miR-128, miR-27a/b, and miR-340 were significantly 

increased in naive CD4+T cells from MS patients. miR-128, 

-27a/b, and -340 directly and specifically suppressed the 

pro-Th2 factor Bmi1, resulting in decreased GATA-3 expression 

in T cells. In addition, miR-340 directly and specifically 

suppressed the Th2 cytokine IL-4. Moreover, when transfected 

into myelin-specific T cells, these miRNAs worsened EAE. 

Overall, these miRNAs suppressed Th2 and enhanced pathogenic 

proinflammatory Th1 responses. In contrast, treatment 

of MS patient cells with miRNA inhibitors led to the restoration 

of more benign Th2 responses. Conclusion: These 

findings link miR-128, -27ab, and -340 overexpression in 

MS patients’ naive CD4+ T cells to the proinflammatory T-cell 

differentiation observed in MS and illustrate the potential of 

these miRNAs as biologically relevant biomarkers and therapeutic 

targets. 

Supported by: National Institutes of Health R21 NS067383-01 

Disclosure: Nothing to disclose

Works in Progress 

WORKS IN PROGRESS 

CATEGORY: COGNITION, DEPRESSION, AND 

PSYCHOSOCIAL 

W1 

CAREGIVING AND PHYSICIAN FACTORS RELATED 

TO MULTIPLE SCLEROSIS CAREGIVER HEALTH 

BEHAVIORS 

Lara Stepleman, 1,2 Marie-Christine Rutter Goodworth, 1,3 Rhonda S. Casillas, 1 

Michael Rollock, 1 Rebecca Rahn, 4 Mitzi J. Williams 4 

1 Psychiatry & Health Behavior, Medical College of Georgia, Augusta, GA; 

2 Education Discovery Institute, Medical College of Georgia, Augusta, GA; 

3 Clinical Psychology, George Fox University, Newberg, OR; 4 Neurology, 

Medical College of Georgia, Augusta, GA 

Background: Caregiving can be a stressful activity and has 

been linked with poor physical and emotional health and low 

levels of self-care. Because multiple sclerosis (MS) caregivers 

are often younger than other caregivers, they could spend 

more years in the caregiver role while also having active 

career and family responsibilities, making self-care difficult. 

Therefore, it is crucial to explore aspects of MS caregivers 

and caregiving related to healthy behaviors. Objectives: 

To investigate factors associated with health-promoting 

behaviors in an MS caregiver sample. Methods: Caregivers 

were invited to complete a survey that assessed caregiver 

distress, health behaviors, MS physician encouragement of 

caregiver health, and caregiver/caregiving characteristics. 

Five types of distress were assessed by the Caregiver Distress 

Scale (CDS): relationship, emotional burden, care-receiver 

demands, social impact, and personal cost. The Health and 

Human Services Health Style Self-Test was used to assess six 

health behaviors: smoking, alcohol/drug use, eating habits, 

exercise, stress control, and safety. Results: Forty-four caregivers 

are enrolled to date. The sample is 54% Caucasian 

and 50% female, and ages range from 26 to 75 years. Most 

are spousal caregivers, with a mean of 8.5 years in this role. 

Caregiver and caregiving factors correlated to at least one 

health behavior (P < .05) include being female (exercise), 

being a nonspousal caregiver (smoking, stress control), not 

being employed (smoking), fewer hours of caregiving (drug 

and alcohol use, eating, stress control, and safety); and, 

from the CDS, less emotional burden (stress control and 

safety), fewer care-receiver demands (eating, fitness, stress 

control, and safety), and lower personal cost (eating and 

stress control). MS physician encouragement of caregiver 

health was correlated to better reported eating (r = 0.39, P < 

.02), fitness (r = 0.35, P < .03), and stress control (r = 0.42, 

P < .01). Conclusion: Fewer care-receiver demands and 

caregiving hours were related to the most health behaviors, 

indicating possible first targets for caregiver health intervention. 

MS physician encouragement of caregiver health also 

was linked to several health behaviors, suggesting that further 

research may be warranted on the impact that MS providers 

can have on caregiver well-being. 

Disclosures: Nothing to disclose 

Keywords: MS and the caregiver/family, Comprehensive care and MS, 



86 

W2 

PSYCHOEDUCATIONAL GROUPS DESIGNED FOR 

NEWLY DIAGNOSED WOMEN WITH MULTIPLE 

SCLEROSIS CAN BE OF BENEFIT 

Lilyana Amezcua, Barton Kara, Kecia Watari, Leslie Tarlow, Maura Fernandez, 

Fatima Gutierrez, Gail Murdock 

Neurology, University of Southern California, Los Angeles, CA 

Background: Multiple sclerosis (MS) is an inflammatory 

neurologic condition associated with strong psychosocial and 

emotional changes, particularly at diagnosis. Objectives: 

To improve the perceptions of newly diagnosed women with 

MS focusing on fatigue and quality measures, with the goal 

of optimizing living with MS. Methods: Newly diagnosed 

females with MS were invited to participate in an 8-week 

structured psychoeducational group. Groups were led by 

professionals specializing in MS, which included neurologists, 

psychologists, a nurse practitioner, a social worker, and 

a physical therapist. Topics included meditation, self-esteem 

and coping, depression, cognition, women’s health issues 

such as pregnancy and perimenopause/menopause, sexuality, 

and exercise. All participants completed sections of 

the Multiple Sclerosis Quality of Life, Multiple Sclerosis 

Health Status, and Fatigue Severity Scale. Results: Newly 

diagnosed female participants with MS and their clinical 

characteristics will be presented. Fatigue and quality of life 

measures will be presented. Conclusion: Psychoeducational 

groups that are specifically designed for women with MS 

may be of benefit in addressing individual challenges. These 

types of groups have the potential to educate and increase 

self-awareness through discussion, which will help perceptions 

of symptoms such as fatigue and improve quality of life, 

which may or may not be related to the new diagnosis of 

MS. 

Disclosures: Lilyana Amezcua: Biogen (consulting fee); Bayer, Teva, 

Serono (honoraria). Barton Kara: Nothing to disclose. Kecia Watari: 

Nothing to disclose. Leslie Tarlow: Nothing to disclose. Maura Fernandez: 

Nothing to disclose. Fatima Gutierrez: Nothing to disclose. Gail 

Murdock: Nothing to disclose. 

Keywords: Psychosocial issues in MS, Quality of life in MS, Management 


W3 

DEVELOPING A TELEPHONE-DELIVERED SELF- 

MANAGEMENT INTERVENTION 

Jamie L. Wazenkewitz, Dawn M. Ehde 

Multiple Sclerosis Rehabilitation Research and Training Center, University of 

Washington, Seattle, WA 

Background: Although interventions exist that address 

individual multiple sclerosis (MS) symptoms such as pain, 

fatigue, or depression, there is a need for holistic approaches 

to give individuals with MS tools to manage multiple symptoms 

in their daily lives. Self-management interventions have 

been demonstrated to be effective in several chronic disease 

populations (eg, diabetes, arthritis) but are only beginning 

to be applied to MS. Further, there are often barriers to 

accessing psychosocial programs and services, including 

lack of transportation or too much distance from providers. 

“Take Charge” is an individually tailored telephone-delivered 

self-management intervention developed to address these 

challenges. Objectives: Take Charge is a randomized con-

trolled trial (RCT) evaluating the efficacy of an individualized 

self-management intervention. This study aims to reduce the 

occurrence and impact of fatigue, depression, and pain, as 

well as build self-efficacy for managing the multiple effects of 

MS. This poster will describe the development and content of 

the self-management intervention. Methods: Take Charge 

was developed using MS consumer focus group input, piloting, 

and adapting key concepts from other self-management 

and cognitive-behavioral therapies (CBTs). Results: Two 

8-session telephone-based interventions were developed for 

this study. The first is an individualized self-management intervention. 

Each session focuses on key concepts of self-management: 

self-monitoring, goal-setting, problem solving, energy 

management, thought management, emotion regulation, and 

relaxation techniques. Participants learn and rehearse new 

skills as well as how to tailor them to their unique life situations. 

Skill-based homework is required between sessions. 

This intervention will be compared to an education and support 

intervention, with each session providing information 

on MS symptoms and lifestyle changes that could improve 

physical and emotional health. Standardized therapist manuals 

and participant workbooks have been developed for both 

interventions. Procedures were developed to facilitate telephone 

delivery of the intervention. Conclusion: It is feasible 

to adapt existing self-management and CBT interventions to 

address the multiple symptoms of MS. Results of the RCT will 

be important for determining the efficacy of this approach. 


Keywords: Management of activities of daily living in MS, Psychological 


W4 

SELF-EFFICACY IMPROVEMENT IN MULTIPLE 

SCLEROSIS: RESULTS OF A 1-YEAR RANDOMIZED 

TRIAL 

Brant J. Oliver, 1,2 Miriam Franco 3 

1 Neurology, MS Center at Dartmouth, Lebanon, NH; 2 The Dartmouth Institute 

for Health Policy & Clinical Practice, Lebanon, NH; 3 Sociology, Immaculata 

University, Immaculata, PA 

Background: Nursing outreach programs have demonstrated 

effectiveness in improving immunotherapy treatment 

adherence but are less effective in addressing psychological 

factors that are related to reduced self-efficacy and treatment 

adherence. A guided imagery relaxation program has been 

developed specifically for multiple sclerosis (MS) patients 

taking immunotherapy medications. This study will investigate 

the effect of this program when added to a nursing 

outreach program. Objectives: To determine whether an 

outreach program consisting of nursing services augmented 

with MS-specific guided imagery stress reduction will result in 

superior self-efficacy and treatment adherence compared with 

nursing services alone. Methods: Patients with clinically isolated 

syndrome (CIS) or relapsing-remitting multiple sclerosis 

(RRMS) initiating interferon beta-1b (IFNβ-1b) and meeting 

inclusion and exclusion criteria were offered participation 

and provided informed consent. Participants were randomly 

assigned to one of two groups: 1) nursing outreach services + 

relaxation training; or 2) nursing outreach services alone. The 

primary outcome is illness control self-efficacy (Multiple Sclerosis 

Self-Efficacy [MSSE] Control Scale). Secondary outcome 

measures include disease-modifying therapy (DMT) treat- 


87 


ment adherence, depression, anxiety, cognitive functioning, 

and working memory processing speed. Data analysis will 

be conducted using between-subjects t tests for differences 

between the major time points (baseline and 12 months) and 

analysis of variance (ANOVA) analyses for longitudinal differences 

across all time points. Results: Interim results for 

participants completing the 3- and 6-month time points (n = 

16) were presented at the 2010 Consortium of Multiple Sclerosis 

Centers (CMSC) conference and revealed significantly 

higher immunotherapy treatment adherence (P < .05) and a 

trend favoring higher illness control self-efficacy (P = .06) in 

the intervention group. Data collection will be complete in 

December 2011, and final results for participants completing 

the 3-month (n = 24), 6-month (n = 20), and 12-month (n = 8) 

time points (as of May 2011) will be available for presentation 

at the 2011 CMSC conference. Conclusion: This study 

will inform future research on the effect of relaxation training 

on self-efficacy, psychological symptom management, and 

treatment adherence in patients with CIS and relapsing MS. 


Keywords: Nursing management in MS, Psychological issues and MS, 

Complementary/alternative therapies in MS 

W5 

REACHING OUT AND PARTNERNING FOR SUCCESS: 

MULTIPLE SCLEROSIS AWARENESS AND REGIONAL 

SEAMLESS SERVICES IN ALBERTA 

Douglas Tokaryk, Garry Wheeler, Adeline Blumer, Mark Wolff, Lorraine 

Evans-Cross, Morgen Zoeller 

The MS Society of Canada, Alberta and Northwest Territories Division, 

Edmonton, AB, Canada 

Background: Alberta has one the highest prevalence rates 

of multiple sclerosis (MS) in the world. Many patients reside 

in rural areas, resulting in a disconnect from peers, healthprofessional 

support, and MS Society services. Objectives: 

By the end of 2012, the Alberta and Northwest Territories 

Division Office will deliver seamless local services and integrated 

support programs that utilize the efforts of the division, 

chapter, regional, and volunteer staffed offices. Services will 

be available to an increased base population of 500,000 

people. Methods: Division and chapter boards were given 

recommendations by a Boundary Review Committee on 

territory expansion and the creation of regional offices (Division 

Board) from 2008 to 2009. Results: The expansion 

implementation has changed the landscape of services for 

people with MS and their support networks by offering locally 

accessible services. Community awareness has increased 

exponentially, and partnership opportunities have emerged. 

The six chapter offices have expanded their catchment service 

areas. The Alberta and Northwest Territories Division 

office have opened regional offices in St. Paul and Hinton 

and have reorganized the Grande Prairie office. Scheduled 

to open in the next 24 months are offices in Fort McMurray, 

Yellowknife, Camrose, and Westlock/Barrhead. Staff, advisory 

councils, office space, governance policies, business 

plans, and operating budgets are in place. Across Alberta, 

over 40 provincial outreach events and all chapter offices 

have dedicated resources and planned expansion for this initiative. 

Conclusion: Early successes have been information 

and education events in community and health-professional 

settings, the creation of community support groups, client


service visits, collaborations between agencies, media awareness, 

and increase in funding requests. Challenges remain in 

formation and governance of advisory councils and creating 

a sustainability plan within the individual communities. 


CATEGORY: DISEASE MEASUREMENT, MECHANISMS, 

AND TREATMENT 

W6 

THE EFFECT OF NATALIZUMAB (TYSABRI) ON 

SEXUAL DYSFUNCTION IN MULTIPLE SCLEROSIS 

Stanley Krolczyk, Dominique Rosales, Angela Seevers 

Neurology, University of South Florida, Tampa, FL 

Background: Most patients with multiple sclerosis (MS) 

eventually develop secondary progression leading to a constellation 

of chronic sequelae, including profound muscle 

weakness, impaired gait and mobility, bladder and bowel 

dysfunction, cognitive and visual impairments, and sexual 

dysfunction. Symptoms of this disorder involve disturbances 

of vision, motor and sensory systems, coordination and balance, 

bowel/bladder/sexual, and cognition. Age of onset 

typically ranges from 10 to 59 years, with most cases occurring 

between 20 and 40 years. As with most other autoimmune 

disorders, MS is more than twice as common among 

women. Sexual dysfunction is a common complication for 

patients with MS. Often this results in loss of self-esteem and 

reduced quality of life (QOL). However, there have been 

indications that Tysabri may be beneficial in these situations. 

It has been demonstrated that patients receiving Tysabri have 

improved QOL parameters (Rudick et al., 2007). This observation 

in addition to our own experience leads us to hypothesize 

that Tysabri administration may result in key improvements 

in sexual dysfunction that in turn may lead to improved 

QOL. Objectives: 1) Decrease in level of sexual dysfunction 

demonstrated by comparison of Multiple Sclerosis Intimacy 

and Sexuality Questionnaire–19 (MSISQ-19) responses at 

end of study to baseline sexual function. 2) Change in composite 

score in the sexual function subscale of the Multiple 

Sclerosis Quality of Life–54 (MSQOL-54) over 6 months of 

natalizumab treatment. 3) Improvement shown in at least one 

area designated in the MSISQ-19 Fatigue Improved score on 

the Functional Assessment of Multiple Sclerosis (FAMS) questionnaire 

fatigue scale for MSQOL. 4) Improved score on 

the MSQOL-54 from end of study compared with baseline. 

5) Improvement shown in the sexual function component of 

the MSQOL. Methods: Observational, prospective 6-month 

study with four study visits at which the patients will be administered 

three questionnaires: the MSISQ-19, the MSQOL-54, 

and the FAMS. Results: Currently enrolling. 

Disclosure: Stanley Krolczyk: Biogen Idec (honoraria, other financial 

benefits). Dominique Rosales: Nothing to disclose. Angela Seevers: Nothing 

to disclose. 

Keywords: Comprehensive care and MS, Quality of life in MS, Symptomatic 

treatment of MS 

W7 

CHARACTERISTICS ASSOCIATED WITH CAREGIVER 

ACTIVATION IN MULTIPLE SCLEROSIS CAREGIVERS 

Rhonda S. Casillas, 1 Marie-Christine Goodworth, 2 Lara Stepleman, 1 Michael 

Rollock, 1 Mitzi Williams 3 


88 

1 Psychiatry and Health Behavior, Medical College of Georgia, Augusta, GA, 

United States; 2 Clinical Psychology, George Fox Univeristy, Newberg, OR; 

3 Neurology, Medical College of Georgia, Augusta, GA 

Background: Multiple sclerosis (MS) caregivers (CGs) differ 

in their ability to initiate, maintain, and persist in caregiving 

duties, also called caregiver activation. Characteristics 

of the CG and caregiving relationship likely contribute to a 

caregiver’s activation level, including factors such as time 

spent caregiving and caregiver distress. To assess these 

characteristics relative to CG activation, we used an adapted 

version of the Patient Activation Measure (PAM) of Hibbard et 

al. (2004) to assess whether CGs’ involvement can be understood 

in a similar 4-level model of activation. Objectives: 

The purpose of this study is to investigate CG characteristics 

that are associated with engagement in the caregiving process 

and what characteristics of MS CGs might help or hinder 

that involvement. Methods: Individuals providing 1 hour 

or more of MS caregiving per week completed a survey that 

included the Caregiver Activation Measure (CAM), which 

assesses levels of CG engagement and is adapted from the 

PAM; the Caregiver Distress Scale (CDS), which measures 

five areas of distress (relationship distress, emotional burden, 

care-receiver demands, social impact, personal cost); and 

characteristics of caregivers (eg, gender) and caregiving (eg, 

hours per week). Results: The current sample (data collection 

ongoing) of 44 CGs is 50% female, 54.5% Caucasian, 

66% married, and aged 26 to 75 years. Hibbard’s PAM 

scoring guidelines applied to the CAM did not yield expected 

relationships. Instead, the CAM raw scores were divided 

into three groups: the bottom 25%, middle 50%, and top 

25% of scores. Results indicate a relationship between the 

CAM and gender (r = 0.32, P < .03). A chi-square trended 

toward significance, with women more frequently in the highest 

CAM group (P = .10). Other correlation trends suggest 

that caregivers who are Caucasian, are married, have at 

least some college education, and report less CG emotional 

burden are more engaged in caregivers’ activities (P < .10). 

Current statistical power likely limited findings. Conclusion: 

The CAM appears to be influenced by similar demographics 

found in PAM research, but the CAM needed a 3-level rather 

than 4-level scoring system to capture group differences. 

These results need confirmation with a larger sample. More 

research on factors influencing CG activation may provide 

insight into challenges of staying an engaged MS CG. 


Keywords: MS and the caregiver/family, Quality of life in MS, Psychosocial 


W8 

MULTIPLE SCLEROSIS RESEARCH EDUCATIONAL 

NEWSLETTER FOR PATIENTS 

Katherine A. Barker, 1 Joseph H. Ostroff, 1,2 Kelly L. McGowan, 3 Bianca 

Weinstock-Guttman, 1,3 Barbara E. Teter 1,2 

1 The New York State Multiple Sclerosis Consortium, Buffalo, NY; 2 SUNY 

Buffalo, Buffalo, NY; 3 The Jacobs Neurological Institute, Buffalo, NY 

Background: The New York State Multiple Sclerosis Consortium 

(NYSMSC) consists of over 8500 registered patients 

with multiple sclerosis (MS) who are followed longitudinally. 

These patients (74.1% female and 6.5% African American) 

consent to participate in research to assist scientists in understanding 

the disease; however, they are rarely informed as

to how their contribution affects the field. Patients who understand 

the results of their contributions to research are more 

likely to continue participating in research as well as realize 

that they play an important role in reducing the burden of the 

disease. Objectives: To produce a comprehensive newsletter 

to inform participants of past and current MS-related 

research findings, and to evaluate the effectiveness of the 

newsletter as a tool for patient education. Methods: A 

newsletter was created by NYSMSC staff and researchers. 

The newsletter included sensitive, lay-language explanations 

of research findings to inform rather than discourage or 

unrealistically encourage patients with regard to current MSrelated 

news. Some of the research topics in the newsletter 

included measurement of MS-related disability, gender and 

racial associations of MS incidence, potentially protective 

traits and environmental factors, patient-reported outcomes of 

disease, quality of life issues, and implications of research. 

A survey including questions addressing patients’ opinions 

of the newsletter was distributed to newsletter recipients at 

random. Questions included topics such as layout, content of 

the newsletter relative to readability and comprehension, and 

whether material was educationally informative. Results: 

The results of this evaluation will determine whether a comprehensive 

newsletter is an effective tool for patient education 

and the fostering of patient involvement in research. Conclusion: 

Patient participation in research plays an important 

role in the advancement of MS while improving the quality of 

life of patients. Patients lie at the heart of research; they provide 

the data that lead to knowledge about symptomatology 

and outcomes. It is anticipated that a patient newsletter will 

help to close the communication gap between patient provision 

of data and study results. 

Disclosure: Katherine A. Barker: Nothing to disclose. Joseph H. Ostroff: 

Nothing to disclose. Kelly L. McGowan: Nothing to disclose. Bianca 

Weinstock-Guttman: EMD Serono, Biogen Idec, Teva Neuroscience, 

Acorda, Cognition, Aspreva, National Institutes of Health, National 

Multiple Sclerosis Society, Novartis, Pfizer (other financial benefits). 

Barbara E. Teter: EMD Serono, Teva Neuroscience, Biogen Idec (other 

financial benefits). 

Keywords: Epidemiology of MS, Quality of life in MS 

W9 

NATALIZUMAB TREATMENT INTERRUPTION: 

RESTORE STUDY BASELINE DATA 

Robert Fox, 1 Ludwig Kappos, 2 Bruce Cree, 3 Michael Kaufman, 4 Douglas 

Jeffery, 5 Bianca Weinstock-Guttman, 6 Hans-Peter Hartung, 7 Ralf Gold, 8 Xavier 

Montalban, 9 Jerome De Seze, 10 Amy Natarajan, 11 Richard Morse, 11 Petra 

Duda 11 

1 Mellen Center for Multiple Sclerosis, Cleveland, OH; 2 Neurology and 

Department of Biomedicine, University Hospital, Basel, Switzerland; 3 Multiple 

Sclerosis Center, University of California San Francisco, San Francisco, CA; 

4 Carolinas Heath Care System, Charlotte, NC; 5 Wake Forest University 

Medical Center, Washington, DC; 6 Buffalo Neuroimaging Analysis Center, 

State University of New York, Buffalo, NY; 7 Neurology, Heinrich-Heine 

University, Dusseldorf, Germany; 8 St. Josef-Hospital, Ruhr University–Bochum, 

Bochum, Germany; 9 Vall d’Hebron University Hospital, Barcelona, Spain; 

10 Hospital Civil, Strasbourg, France; 11 Biogen Idec Inc, Weston, MA 

Background: In postmarketing experience with natalizumab, 

the risk of developing progressive multifocal leukoencephalopathy 

(PML) increases with increasing treatment duration. 

Improved outcomes have been seen in patients with PML 

when reconstitution of the immune system has occurred. It has 

been hypothesized that treatment interruption might decrease 

the risk of PML; however, underlying multiple sclerosis (MS) 

may also return. Because PML is rare, a randomized study to 


89 


evaluate the potential impact of treatment interruption on PML 

risk would be prohibitively large. Objectives: RESTORE is 

an ongoing randomized, placebo-controlled, parallel-group 

study to evaluate the effect of a 24-week interruption in natalizumab 

treatment on various immune parameters and MS disease 

activity compared with continuing natalizumab therapy 

or switching to alternative immunomodulatory therapies. A 

detailed study outline and baseline data will be presented. 

Methods: Eligible patients received natalizumab for at least 

the preceding 12 months without relapse and did not have 

gadolinium-enhancing lesions on screening brain magnetic 

resonance imaging (MRI). Patients were randomized to continue 

infusions of natalizumab or discontinue and switch to 

either placebo infusions (given double-blind) or alternative 

open-label immunodulatory therapy. Following the 24-week 

treatment interruption, open-label natalizumab is reintroduced 

for 24 weeks. Results: A total of 175 patients were 

enrolled. As of December 15, 2010, 172 patients (female, 

77%) aged 20 to 61 years (mean, 41.2 years) were randomized. 

Disease duration at baseline was between 2 and 

41 years (median, 11.0 years), and patients had received 

a median of 29 prior doses (range, 12–51) of natalizumab. 

In the year prior to initial natalizumab therapy, 39% of 

subjects had two or more relapses. At baseline, the mean ± 

SD Expanded Disability Status Scale score in the RESTORE 

patient population was 3.2 ± 1.72. Anti-JC virus antibody 

was detected in 56% of patients. Available baseline immune 

parameters will be presented. Conclusion: Longitudinal 

RESTORE data will evaluate pharmacodynamic markers, 

immune function, and disease activity during a 24-week interruption 

of natalizumab. 

Disclosure: Robert Fox: Biogen Idec, Genentech (consulting fees); 

Biogen Idec, Teva Neuroscience (honoraria); Biogen Idec, Genentech 

(other financial benefits). Ludwig Kappos: Acorda, Actelion, Allozyne, 

BaroFold, Bayer HealthCare Pharmaceuticals, Bayer Schering 

Pharma, Bayhill, Biogen Idec, Boehringer Ingelheim, Elan, Genmab, 

Glenmark, GlaxoSmithKline, Merck Serono, Medicinova, Novartis, 

Sanofi-Aventis, Santhera, Shire, Roche, Teva, UCB, Wyeth; Swiss MS 

Society, Swiss National Research Foundation, European Union, Gianni 

Rubatto Foundation, Novartis and Roche Research Foundations (other 

financial benefits). Bruce Cree: Biogen Idec, Genzyme, Sanofi-Aventis, 

Teva Neuroscience (consulting fees); EMD Serono, Genentech (other 

financial benefits). Michael Kaufman: Biogen Idec (honoraria); Bayer, 

Novartis, EMD Serono, Teva Neuroscience (other financial benefits); 

Department of Defense (consulting fee). Douglas Jeffery: Berlex, Glaxo- 

SmithKline, Pfizer, Serono, Teva Neuroscience (consulting fees); Berlex, 

Pfizer, Serono, Teva Neuroscience (other financial benefits). Bianca 

Weinstock-Guttman: Biogen Idec, EMD Serono, Novartis, Pfizer, Teva 

Neuroscience (honoraria); Aspreva, Acorda, National Multiple Sclerosis 

Society, National Institutes of Health, ITN, Biogen Idec, EMD Serono, 

Cognition, Teva Neuroscience (other financial benefits); Hans-Peter 

Hartung: Bayer HealthCare, Biogen Idec, BioMS, Genzyme, Merck 

Serono, Novartis, Teva, Sanofi-Aventis (honoraria). Ralf Gold: Bayer 

HealthCare, Biogen Idec, Merck Serono, Teva Pharma (honoraria); 

Biogen Idec (royalty); Bayer HealthCare, Biogen Idec, Merck Serono, 

Novartis, Teva Pharma (other financial benefits); Xavier Montalban: 

Almirall, Bayer Schering Pharma, Biogen Idec, EMD Merck Serono, 

Genentech, Genzyme, Novartis, Sanofi-Aventis, Teva Pharmaceuticals 

(honoraria). Jerome De Seze: Bayer Schering, Biogen Idec, Merck Serono, 

LFB, Novartis, Sanofi-Aventis, Teva (honoraria). Amy Natarajan: 

Biogen Idec (salary). Richard Morse: Biogen Idec (salary). Petra Duda: 

Biogen Idec (salary). 

Keywords: Disease-modifying treatment in MS, Immunology and MS


W10 

MULTIPLE SCLEROSIS PATIENTS’ EXPERIENCES WITH 

BARIATRIC SURGERY 

Sara Fridinger, 1 Margie O’Leary, 2 Rock Heyman 1,2 

1 University of Pittsburgh School of Medicine, Pittsburgh, PA; 2 University of 

Pittsburgh Medical Center, Pittsburgh, PA 

Background: Multiple sclerosis (MS) patients may experience 

obesity and a corresponding need for bariatric surgery. 

Bariatric surgery patients usually undergo preoperative medical 

and psychiatric evaluation and nutritional counseling. 

Postoperative follow-ups are with the surgeon and family physician. 

No standardized recommendations exist for patients 

with MS, and there is a dearth of literature addressing this 

topic. Issues pertinent to MS may require modifications to 

standard bariatric care. Weight loss may be more difficult 

for MS patients with exercise limitations or medication use. 

A decrease in weight may ease mobility difficulties and 

improve function. Postoperative absorptive changes may 

alter medication and nutrient absorption. Bone health issues 

may be aggravated. MS symptoms require differentiation 

from complications due to B12, B6, thiamine, or vitamin E 

deficiencies. Objectives: The purpose of this endeavor is to 

explore issues for MS patients undergoing bariatric surgery. 

Methods: Fifteen subjects have been identified through 

ongoing care. Focused interviews are in progress. MS history 

and laboratory values from routine care are reviewed for 

each patient. The study is ongoing. Results: Two patients 

will be presented here. Ms. X, a 28-year-old female with 

MS, had a Roux-en-Y gastric bypass (RYGB) 4 years ago. 

Her body-mass index (BMI) decreased from 47.9 to 28.7, 

and her hypertension disappeared. She reports that she can 

no longer swallow large pills and that her mobility, weakness, 

mood, and bladder functions have improved. Ms. Y, 

a 45-year-old female with MS, had an RYGB 12 years ago. 

Her BMI decreased from 61.2 to 27.4. She reports 1 month 

of postoperative numbness, tingling, and leg weakness. Her 

mobility improved following the surgery. Both patients consider 

their surgeries successful and would recommend the operation 

to other MS patients. Conclusion: Bariatric surgery may 

serve an important role for MS patients. MS care practitioners 

should be aware of special considerations that may include 

medication dosing and absorption, nutrient deficiencies, 

mobility, and exercise issues. 


Keywords: Comprehensive care and MS, Service delivery in MS, Management 


W11 

EVALUATION OF THE MILLON BEHAVIORAL 

MEDICINE DIAGNOSTIC WITH A MULTIPLE 

SCLEROSIS POPULATION 

Kimberly B. McGuire, 1 Megan Castano, 2 Lauren Strober 3 


Orange, NJ; 2 Seton Hall University, South Orange, NJ; 3 Kessler Foundation, 

West Orange, NJ 

Background: The Millon Behavioral Medicine Diagnostic 

(MBMD; Millon, Antoni, Millon, Meagher & Grossman, 

2001) is an assessment that has been normed with a medical 

population. It assists in identifying psychosocial factors 

that can interfere with or support the course of medical 

treatment for individuals living with a chronic illness, such as 


90 

multiple sclerosis (MS). Individuals with MS were included in 

the development sample for the MBMD, along with those with 

other neurologic disorders, yet there is no known research 

that has evaluated the use of the MBMD specifically with an 

MS population. Objectives: To evaluate the validity of the 

MBMD for use in MS by comparing the internal consistency 

of the development sample with an MS sample. Methods: 

Fifty-six individuals diagnosed with MS were referred for 

neuropsychological assessment between January 2007 and 

December 2010. The MBMD was administered as part of a 

larger neuropsychological assessment. Analyses (Cronbach 

α) were conducted to compare the internal consistency of 

the 32 MBMD subscales between an MS sample and the 

development sample. Results: Reliable internal consistency 

was found in two-thirds of the scales. However, poor internal 

consistency was found in the following scales: Desirability, 

Guardedness, Introversive, Sociable, Confident, Forceful, 

Respectful, Spiritual Absence, and Medication Abuse. Findings 

suggest that these scales may not be most valid in an MS 

sample, compared with the development sample. Additional 

results will be discussed. Conclusion: Results indicate that 

the MBMD demonstrates some utility in identifying psychosocial 

factors that may assist clinicians working with individuals 

with MS to guide appropriate treatment interventions and 

ultimately improve their overall quality of life. However, 

given the poor internal consistency of one-third of the scales, 

additional research pertaining to the use of the MBMD in MS 

appears warranted. 


Keywords: Psychosocial issues in MS, Comprehensive care and MS 

W12 

EVALUATING THE IMPACT OF CHRONIC 

CEREBROSPINAL VENOUS INSUFFICIENCY ON 

MULTIPLE SCLEROSIS PATIENTS IN A COMMUNITY- 

BASED MULTIPLE SCLEROSIS CLINIC 

Jill R. Nelson, Janene E. Spring, Galina Vorobeychik 

Fraser Health MS Clinic, Burnaby Hospital, Burnaby, BC, Canada 

Background: Since the Canadian media first reported on 

a possible connection of multiple sclerosis (MS) to chronic 

cerebrospinal venous insufficiency (CCSVI) in November 

2009, MS clinics nationwide have been overwhelmed with 

patients expressing an intense interest in “fast-tracking” 

research and treatment options for CCSVI in Canada after 

preliminary results. Although clinical trials to attempt to validate 

a connection between MS and CCSVI are under way 

in several MS center, many patients tell us that they “cannot 

wait” and are choosing to travel to other countries to pursue 

CCSVI treatment even with a lack of scientific evidence and 

unknown safety data. Objectives: To assess the impact of 

both the media reporting and scientific process on patients’ 

health-care decision-making processes and the impact that 

both of these have on a patient’s emotional well-being and 

relationships with their health-care providers and others. 

Methods: A survey was distributed that focused on patients’ 

current knowledge of CCSVI, information sources, and their 

resulting levels of hope versus skepticism related to the emergence 

of CCSVI information. This survey was given to all 

MS patients who attended the Fraser Health MS Clinic over 

a period of 4 months. Results: Surveys were distributed to 

75 consecutive patients attending the clinic for their regular

medical appointments between the months of October 2010 

and January 2011. All patients with a diagnosis of MS were 

included regardless of disease course, gender, age, and disease 

duration. Final analysis will be based on these patients’ 

self-assessed factors that influence their decision-making 

process related to their health care. Conclusion: Results of 

the survey will be used to better understand the impact that 

both the media and the CCSVI issue itself have had on MS 

patients attending our clinic. We hope to use these results to 

better support and assist patients through nursing care and 

education. 

Disclosures: Jill R. Nelson: Biogen Idec, Teva Neuroscience, EMD 

Serono, Novartis, Bayer (honoraria). Janene E. Spring: Biogen Idec, 

Teva Neuroscience, EMD Serono, Novartis, Bayer (honoraria). Galina 

Vorobeychik: Biogen Idec, Bayer, EMD Serono, Teva Neuroscience, 

Novartis (honoraria). 

Keywords: Nursing management in MS 

W13 

COMPARISON OF DIFFUSION PARAMETERS ALONG 

CORTICOSPINAL TRACTS OF MULTIPLE SCLEROSIS 

PATIENTS AND HEALTHY SUBJECTS 

Scott Bendix, 1,2 Kourosh Jafari-Khouzani, 3 Hamid Soltanian-Zadeh, 3 Suzanne 

Croll, 1 Quan Jiang, 1 Mirela Cerghet 1 

1 Neurology, Henry Ford Hospital, Detroit, MI; 2 School of Medicine, Wayne 

State University, Detroit, MI; 3 Radiology, Henry Ford Hospital, Detroit, MI 

Background: Multiple sclerosis (MS) is a disabling disease 

that affects young adults. Although magnetic resonance 

imaging (MRI) is extensively used to help in diagnosis and 

monitoring of MS, conventional MRI has limitations and cannot 

differentiate between an inflammatory, demyelinating, 

or vascular process; moreover, it is insensitive to changes in 

normal-appearing white or gray matter. Several advanced 

(nonconventional) MRI techniques have been applied to 

detect and understand disease progression and correlation 

with disability in MS. Diffusion tensor imaging (DTI) allows 

visualization and quantification of white matter tracts and 

their diffusion properties. Few studies have been done using 

DTI to assess the corticospinal tract (CST) in MS. Objectives: 

To determine the value of DTI of motor tract integrity 

in patients with different stages of MS and compare with 

healthy controls. Methods: Five patients with MS (relapsingremitting 

MS [RRMS] or secondary progressive MS [SPMS]) 

and five age-matched healthy subjects underwent DTI. DTI 

data with 55 gradient directions and 6 b0 images were analyzed 

using two software programs, Slicer and DTI Studio. 

Regions of interest (ROIs) were placed in the brainstem over 

the crus cerebri and over the posterior limb of the internal 

capsule to select the CST. Four quantities were measured 

along all fibers of the CST bundle: fractional anisotropy (FA), 

mean diffusivity, parallel (axial) diffusion, and perpendicular 

(radial) diffusion using Slicer. With DTI Studio, FA and fiber 

density of the CST were measured. Mean values of these 

quantities were then calculated across all fibers, by the two 

methods. Results: No significant differences in FA between 

MS patients and healthy subjects were found in the CST. 

However, the FA pattern along the CST was different in MS 

patients. Mean perpendicular (radial) diffusion was higher 

in the CST of both hemispheres of the MS patients relative to 

the healthy subjects, but the difference did not reach statistical 

significance. Conclusion: Experimental results show that 

the proposed approach reveals abnormal regions of the CST 


91 


of MS patients. Further analysis is planned to determine the 

relationship between pattern of motor tract damage and disability 

in a larger cohort. 

Disclosure: Scott Bendix: Foundation of the Consortium of Multiple 

Sclerosis Centers (other financial benefit). Kourosh Jafari-Khouzani: 

Nothing to disclose. Hamid Soltanian-Zadeh: Nothing to disclose. 

Suzanne Croll: Nothing to disclose. Quan Jiang: Nothing to disclose. 

Mirela Cerghet: Nothing to disclose. 


CATEGORY: REHABILITATION 

W14 

A MODEL FOR FACILITATING REHABILITATIVE CARE 

FOR PEOPLE WITH MULTIPLE SCLEROSIS 

Tracy Flemming-Tracy, 1 Jan Bell, 2 Jodi Cavin, 1,3 Cecilia Graham, 4 Karlie 

Lewis, 1 Bess Martin, 3 Emily Riser, 1,2 Lisa Williamson 1 

1 Rehabilitation, Healthsouth Lakeshore Rehabilitation Hospital, Homewood, 

AL; 2 Alabama and Mississippi Chapter, National Multiple Sclerosis Society, 

Birmingham, AL; 3 Outpatient Physical Therapy, Brookwood Medical Center, 

Birmingham, AL; 4 Physical Therapy, University of Alabama at Birmingham, 


Background: Due to the complexity and unpredictablity 

of multiple sclerosis (MS), it is imperative that all health-care 

practitioners be educated regarding the variety of symptoms, 

treatments, and language associated with the disease. 

Therefore, we have developed a rehabilitation workgroup 

consisting of occupational therapists, physical therapists, 

a speech therapist, a neurologist, a representative of the 

National Multiple Sclerosis Society (NMSS), a cognitive 

therapist, and rehabilitation research experts to stay current 

on MS research, develop a specialty base of therapists, and 

provide programming to both lay and professional audiences. 

Objectives: To provide a systematic and integrative 

approach to connect physicians, therapists, and patients with 

a special interest in MS, with a focus on underserved areas 

of Alabama and Mississippi. Methods: We are developing 

a network of practitioners from academic and clinical 

facilities who speak the same language in order to provide 

model care for clients with MS. This is being accomplished 

by monthly meetings of the rehabilitation workgroup, developing 

curricula for continuing education programs, staying 

abreast of emerging therapies, collaborating with the NMSS, 

and participating in educational opportunites for lay people. 

Results: A network of therapists across settings who are 

able to respond to the needs of people with MS in our community 

has emerged. We have partnered with the local 

NMSS chapter to provide programs for the MS clients. Feedback 

from the initial workshop was positive, and future events 

have been scheduled. Provision of continuing education for 

clinicians is ongoing. Conclusion: Our goal is that this 

workgroup will lead to a better quality of life for people with 

MS through improved communication, understanding, and 

treatment approaches. The workgroup will continue to serve 

as a resource and act as a referral base as well as provide 

ongoing educational opportunities. 




W15 

A PILOT INTERDISCIPLINARY GROUP COGNITIVE 

REHABILITATION INTERVENTION FOR MULTIPLE 

SCLEROSIS 

Margaret J. Kazmierski, Lisa M. Mitchell, Patricia B. Ryan, Terry Lee-Wilk 

Mental Health, VA Maryland Health Care System, Baltimore, MD 

Background: Patients with multiple sclerosis (MS) 

often report cognitive difficulties in learning, memory, 

processing speed, attention, working memory, executive 

functioning, and visual perception (Benedict et al., 

2006). These symptoms may affect mood and quality of 

life (QOL). Providers with different expertise often work 

independently, but patients may benefit from a more 

holistic approach to patient care. Objectives: 1) Assess 

the clinical utility of a manualized group rehabilitation 

intervention (Cognifitness, NMSS Southern CA, 2008) for 

improved cognition, mood, and QOL in veterans with MS. 

2) Assess the utility of using an interdisciplinary format 

(nursing, social work, neuropsychology, neurocognitive 

rehabilitation) for patient care. Methods: Letters were sent 

to 400 veterans identified in a VA registry as having MS. 

They were invited to participate in a psychoeducational 

program designed for MS patients in the community. 

Thirteen veterans responded, of whom 7 were available to 

participate. Neuropsychology assessed cognitive strengths 

and weaknesses. Baseline testing using a consensus 

neuropsychological battery was completed. Staff from 

social work, nursing, and neurocognitive rehabilitation 

implemented the intervention in four 1-hour sessions. Group 

activities targeted attention, memory, executive functioning, 

and problem-solving skills. Social work facilitated discussion 

of psychosocial aspects of living with MS and provided 

coping strategies. Nursing provided education on MS 

disease and treatment. Participants completed anonymous 

postintervention surveys. Follow-up neuropsychological 

testing was performed 3 months after intervention. Results: 

Baseline neuropsychological testing revealed some cognitive 

inefficiencies in domains typically associated with MS. 

Follow-up neuropsychological testing was not completed at 

the time of abstract submission. Postintervention evaluation 

surveys indicated satisfaction with social support and 

increased health self-efficacy. Most helpful were access to 

resources, case management assistance, and peer support. 

Conclusion: Preliminary findings suggest that Cognifitness 

(2008) is a promising intervention for MS care using an 

interdisciplinary format. Peer support and patient education 

were noted as most useful facets of the group. Changes in 

cognition were not yet assessed. 


Keywords: Rehabilitation strategies and therapy and MS, Psychosocial 

issues in MS, Quality of life in MS 

W16 

A MULTICOMPONENT CURRICULUM TO EDUCATE 

PHYSICAL THERAPY STUDENTS ON MULTIPLE 

SCLEROSIS–RELATED COMPETENCIES: A BLENDED 

LEARNING APPROACH 

Angela Rosenberg, 1 Kasey Gore, 1 Kelly Thomas, 1 Karen McCulloch, 1 Diane 

Meyer, 2 Cari Eicher, 1 April Fay 1 

1 School of Medicine, Division of Physical Therapy, University of North 

Carolina at Chapel Hill, Chapel Hill, NC; 2 Outpatient Physical Therapy, 

University of North Carolina Hospitals, Chapel Hill, NC 


92 

Background: The Education and Scholarship Track in 

Multiple Sclerosis (MS) is a unique collaboration between the 

University of North Carolina at Chapel Hill (UNC-CH), Division 

of Physical Therapy (PT), and the Eastern North Carolina 

Chapter of the National Multiple Sclerosis Society. A 

specialized MS problem-based learning (PBL) curriculum was 

created to standardize the didactic learning component of 

the Education and Scholarship Track in MS. The MS problembased 

curriculum will be a required course of study in the 

Doctor of Physical Therapy (DPT) Multiple Sclerosis Scholarship 

Track in the Division of Physical Therapy, UNC-CH, and 

offered as an elective course of study for a limited number of 

additional students interested in neurology with an emphasis 

on MS. Objectives: The goal of the MS PBL curriculum is to 

enhance the MS-related competencies of an annual cohort 

of DPT students and to prepare them as evidence-based clinicians, 

advocates, leaders, and change-agents relative to 

contemporary practice issues in the MS arena. The desired 

outcome is to prepare graduates of the program to sit for 

the MS Specialist Certification Examination. Methods: This 

curriculum will utilize a PBL format of instruction using student 

learning groups of two to four students. PBL scenarios will 

be solicited from and facilitated by clinicians, researchers, 

educators, and community partners working with individuals 

with MS. Each PBL case will be evaluated to assess both 

learning of content and retention of material immediately following 

coursework as well as evaluation of MS knowledge, 

skills, and targeted competencies at the end of the program. 

Results: Preliminary evaluation outcomes indicate increased 

student competencies in MS-specific knowledge using a PBL 

teaching method. Improvements in student competencies were 

found between pre- and postcourse evaluations. Qualitative 

results reflect positive student perceptions of the PBL format 

and enhanced clinical reasoning, critical thinking skills, evidence-based 

practice, and teamwork. Conclusion: It is our 

goal that this curriculum will serve as an educational model 

for other universities seeking to advance the competencies of 

entry-level PTs or PT professionals to provide services for individuals 

diagnosed with MS. 


W17 

EMPOWERING PATIENTS IN COMMUNITY 

RE-INTEGRATION: DESCRIBING AN INNOVATIVE 

MODEL FOR THE DELIVERY OF OUTPATIENT 

MULTIPLE SCLEROSIS REHABILITATION SERVICES 

Iona Yim, 1,2 Vivien Poon, 1,3 Jane Stretton, 1 Kristina Ellis, 1 Miranda Hong, 1,3 Lisa 

Miller-Halman, 1 Elaine Widgett, 1 Tania R. Bruno 1,4 

1 Neuro Rehabilitation, Toronto Rehab, Toronto, ON, Canada; 2 Department 

of Occupational Science and Occupational Therapy, University of Toronto, 

Toronto, ON, Canada; 3 Department of Physical Therapy, University of 

Toronto, Toronto, ON, Canada; 4 Departments of Medicine and Neurology/ 

Neurosurgery, McGill University, Montreal, QC, Canada 

Background: Multiple sclerosis (MS) is a progressive 

chronic disease with changing needs over time. The Empowering 

Patients In Community Re-integration (EPIC) service 

delivery model was implemented at Toronto Rehab in 2008. 

It aims to improve transition from hospital to community; to 

optimize accessibility of MS rehabilitation services; and to 

provide outpatient services that better complement patient 

goals and readiness. In the EPIC model, up to three blocks

of therapies are offered to each patient. Each block consists 

of 4 weeks of active goal-directed interdisciplinary rehabilitation. 

Patients and their therapy teams negotiate how these 

blocks are delivered so that each patient can optimize their 

goal attainment. A key feature of this model is the time off 

between treatment blocks that allows patients to integrate 

rehabilitation skills, follow up with team recommendations, 

work independently on interim goals, and promote readiness 

for further behavior change. Objectives: We present the 

results of a quality improvement project, describing the EPIC 

service delivery model and its implementation in an adult outpatient 

MS rehabilitation setting. Methods: A retrospective 

chart review was conducted on patient charts with admissions 

from September 2008 to September 2010. A process-based 

program evaluation framework was used to describe the data 

and determine whether the EPIC implementation reflected 

the model as conceptualized. Both demographic and service 

delivery indicators were collected. Service delivery indicators 

include variables related to therapy timelines, lengths of 

stay, types of goals, and rehabilitation outcomes. Results: 

Initial data describe how a functionally diverse population 

of patients received interdisciplinary rehabilitation services 

to address a variety of goals. These goals span the physical, 

cognitive, social, and emotional domains. Data also describe 

variation in how therapy timelines are configured in the EPIC 

service delivery model. Conclusion: This quality improvement 

project described the implementation of the EPIC service 

delivery model over a 2-year period. Recommendations are 

subsequently made to optimize delivery of outpatient MS 

rehabilitation services. 


Keywords: Service delivery in MS 

W18 

EFFECTS OF EXERCISE AND COPAXONE ON 

BALANCE FUNCTIONS IN PATIENTS WITH MULTIPLE 

SCLEROSIS: A PILOT STUDY 

Seema R. Khurana, Alexandria G. Beranger, James Moore 

Rehabilitation Medicine, University of Miami, Miami, FL 

Background: Multiple sclerosis (MS) is an unpredictable 

and disabling condition affecting over 300,000 Americans. 

Combinations of symptoms give rise to balance dysfunctions 

and falls early on in the disease. One of the very few studies 

done examining virtual reality showed improved balance 

measures, confidence, and greater enjoyment after three 

exercise sessions per week for 6 weeks. Objectives: This 

study investigates the effects of virtual exercise and physical 

therapy on outcomes examining balance in patients with 

relapsing-remitting multiple sclerosis (RRMS) on Copaxone 

monotherapy. The overarching objective is to reduce the 

energy cost and improve efficiency of walking for ambulatory 

patients with MS. Methods: This is a prospective, 

investigator-blinded, open-label, randomized pilot trial using 

performance-based and computerized balance tools as study 

outcomes to evaluate 18 individuals with relapsing-remitting 

disease with self-reported balance dysfunction. Qualified subjects 

meeting the inclusion/exclusion criteria are randomized 

to one of three groups: either physical therapy or virtual exercise 

for 1-hour sessions three times weekly for 12 weeks, or 

Copaxone plus usual daily activity. The control subjects keep 


93 


a daily log of any exercise activity during the 12 weeks for 

greater than 10 minutes. All subjects attend four evaluation 

sessions during which questionnaires containing demographics, 

duration and severity of MS, general health, fatigue, and 

falls are collected along with assessment of balance using the 

BalanceMaster. Evaluation sessions are scheduled 1 week 

prior to initiation of therapy, and 6 weeks, 12 weeks, and 

3 months after therapy. During the initial and 12-week visit, 

subjects are given pedometers to track cadence. An opencircuit 

spirometer is used for the first three visits to measure 

oxygen consumption. Subjects are contacted bimonthly for 

12 weeks to follow up on compliance with the protocol. 

Results: Data for this study are still being collected, and 

will be analyzed by a two-factor analysis of variance for 

repeated measures. Main effects will be tested for “group” 

(virtual exercise vs. physical therapy) and “time” (pretreatment 

vs. posttreatment). If indicated, post hoc analysis will be 

performed using simple effects tests. Conclusion: Study is 

currently ongoing. 



of activities of daily living in MS, Quality of life in MS 

CATEGORY: SYMPTOMS MANAGEMENT 

W19 

ASSESSING PATIENT EDUCATION PROGRAMS IN 

A PROVINCIAL MULTIPLE SCLEROSIS CENTER IN 

CANADA 

Cindy McCarron, 1,2 Trudy Campbell, 3,4 Melinda Nickerson, 2 Amanda 

Lankester, 2,3 Michael E. Kehoe, 2 Linda Scott, 2 Virender Bhan 2,4 

1 Nursing, University of Prince Edward Island, Charlottetown, PE, Canada; 

2 Dalhousie Multiple Sclerosis Research Unit, Capital Health, Halifax, NS, 

Canada; 3 Nursing, Dalhousie University, Halifax, NS, Canada; 4 Medicine, 

Dalhousie University, Halifax, NS, Canada 

Background: The Dalhousie Multiple Sclerosis Research 

Unit (DMSRU) is the provincial multiple sclerosis center in 

Nova Scotia, Canada. DMSRU physicians and Multiple Sclerosis 

Certified Nurses provide patient and family education 

in a variety of formats including print materials, individualized 

education sessions, telehealth broadcasts, webinars, a 

website, and small- and large-group seminars. Objectives: 

To systematically evaluate the educational programs offered 

by DMSRU and to use the results to revise current programs 

and develop additional educational offerings. Methods: 

Using OPINIO software, a clinic-specific survey that included 

Likert rating scale responses and qualitative responses was 

developed to evaluate our educational offerings. It is anticipated 

that approximately 200 patients will take part in this 

quality assurance study. Patient participation was invited 

through a posting on our website, an invitation letter sent by 

mail, and poster advertisements in DMSRU. Results: Demographic 

data will be presented. Quantitative and qualitative 

responses to questions about each of our programs will be 

analyzed and reported. Results will be stratified by age, gender, 

and geographic region. Recommendations for program 

modification will be discussed. Conclusion: Results of this 

patient satisfaction survey will guide the revision of existing


and development of additional patient education programs 

and improve the quality of care offered by the DMSRU. 

Disclosure: Cindy McCarron: Nothing to disclose. Trudy Campbell: 

Biogen Idec, EMD Serono, Teva Neuroscience, Bayer Health Care (honoraria). 

Melinda Nickerson: Nothing to disclose. Amanda Lankester: 

Nothing to disclose. Michael E. Kehoe: Biogen Idec, Novartis, EMD 

Serono (honoraria). Linda Scott: Nothing to disclose. Virender Bhan: 

Biogen Idec, Novartis, EMD Serono, Teva Neuroscience (honoraria). 

Keywords: Comprehensive care and MS, Service delivery in MS, Nursing 

management in MS 

W20 

DYSAUTONOMIC FEATURES IN MULTIPLE SCLEROSIS 

Mirla Avila, Jose Avila-Ornelas, Patricia DeJesus, Milena Stosic, George J. 

Hutton, Victor M. Rivera 

Neurology, Baylor College of Medicine, Houston, TX 

Background: Autonomic dysfunction (AD) can be a manifestation 

of multiple sclerosis (MS). Symptoms can present as 

paroxysmal arrhythmias, syncope, pulmonary edema, heart 

failure, and skin manifestations. AD is not routinely tested 

in MS; it can decrease the patient’s quality of life and can 

eventually lead to increases in morbidity and mortality in MS 

patients. Objectives: To describe a group of patients with 

MS and autonomic dysfunction. Methods: Epidemiologic 

data, treatment history, type of MS, and disease duration 

were documented. Patients with concomitant disease (diabetes 

mellitus, vascular insufficiency) were excluded. A complete 

neurologic evaluation was performed in each patient. Patients 

reporting AD including syncope, intermittent heart rate, or 

blood pressure changes and lower-limb skin discoloration 

were further evaluated depending on each case. Results: 

This is an ongoing study. We have so far documented a total 

of 43 patients (34 female) with a mean age of 51 years. A 

total of 16% of the patients report more than two dysautonomic 

symptoms, including difficulty controlling heart rate 

and blood pressure. A total of 84% have skin discolorations 

and difficulty controlling temperature in the lower extremities. 

Of these, three patients have been evaluated with arterial 

Doppler, which was reported as normal. In two cases autonomic 

features preceded MS diagnosis. Pertinent diagnostic 

testing for autonomic dysfunction and epidemiologic information 

will be provided. Conclusion: AD symptoms are not 

commonly recognized by MS patients. Orthostatic changes 

have been reported in up to 50% of MS patients. Recognition 

and management of AD could improve the quality of life of 

MS patients. 


Keywords: Immunology and MS, Quality of life in MS 


94 

W21 

MULTIPLE SCLEROSIS COMPREHENSIVE CARE 

CENTER: A CENTER WITHOUT WALLS; A NOVEL 

PARTNERSHIP FOR MULTIPLE SCLEROSIS CARE 

Jeryl Werner, 1 Grace E. Connelly, 2 Sarah D. Creswell 2 

1 MS Wellness Program, Good Shepherd Rehabilitation Network, 

Allentown,PA; 2 MS Center of the Lehigh Valley, Lehigh Neurology, LVPG, 

Lehigh Valley Health Network, Allentown, PA 

Background: Multiple sclerosis (MS) is a disease that 

is multidimensional and progressive throughout a lifetime. 

For optimal MS management and person-centered care, it 

is vital for the individual and their family to receive lifetime 

comprehensive and coordinated care. To do so, we need 

to provide a variety of services that address the medical, 

psychosocial, and rehabilitative needs generated by the 

disease process of MS. A “center without walls” approach 

recognizes all the needs that may not be met under the traditional 

medical care model. Integration of all the necessary 

elements of comprehensive care, overseen by the managing 

medical team, can focus on social needs, adaptation to community 

living, employment, and maintaining quality of life. 

Objectives: 1) To describe the National Multiple Sclerosis 

Society’s MS Comprehensive Care model that illustrates how 

a novel “center without walls” integrates all the elements of 

comprehensive care through partnering an MS neurology 

practice with a local freestanding rehabilitation facility. 2) 

To illustrate how a center without walls offers essential and 

appropriate care to individuals with MS and their families by 

broadening access to the toolbox of resources, thus empowering 

them with the ability to maximize their potential across 

the lifespan of the disease. 3) To show how a comprehensive 

model avoids fragmentation of care. Methods: Case studies 

will be presented in illustration of the benefits and challenges 

of providing comprehensive MS care services through 

a “center without walls” partnership. Elements of this model 

will be analyzed. Secondary benefits and challenges will be 

discussed. Results: By partnering a neurology center and a 

freestanding rehabilitation facility, the comprehensive care 

center without walls serves the broadest needs of people with 

MS and their families and builds a comprehensive partnership 

while reducing fragmented and disconnected care. This 

model also provides appropriate services in a timely manner 

and improves participant satisfaction. Conclusions: Our 

comprehensive care center, a “center without walls” model, 

maximizes the range of services that address the broad spectrum 

of needs generated by MS, with the goals of maximizing 

health, independence, and quality of life. 


Keywords: Comprehensive care and MS, Service delivery in MS, Quality 

of life in MS

Palais des Congrès de Montréal - International Journal of MS Care

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