Zeitschrift für Rheumatologie – Supplement 1 - Deutsche ...

S6
Abstracts
Th e requirement of infl ammatory back pain for SpA to be diagnosed
limits the sensitivity of the diagnostic algorithm.
1. Rudwaleit, et al. Ann Rheum Dis 2004; 63:535-43
2. Rudwaleit, et al. Arthritis Rheum 2005; 52:1000-8
FV1-6
Validation of the spinal pain score (spips) as an instrument
performed by the rheumatologist to assess disease activity in ankylosing
spondylitis
Song IHS., Haibel HH., Hilgert EH., Sieper JS., Rudwaleit MR.
Med. Klinik I, Rheumatologie, Charité Campus Benjamin-Franklin
Background: Th e objective assessment of disease activity in ankylosing
spondylitis (AS) through the rheumatologist limited to patient based
instruments (BASDAI, patient’s global).
Objective: Evaluation of a spinal pain score (SpiPS) performed by the
rheumatologist according to the OMERACT fi lters.
Methods: Th e spinal pain score (range 0-16) was assessed according to
the aspects of the Outcome Measures in Rheumatology Clinical Trail
(OMERACT) fi lters (1) reproducibility, 2) truth, 3) discrimination and
4) feasibility) in 4 diff erent AS populations (three clinical trial populations
(n= 578) and an out-patient population (n= 154)).
Results: Ad 1) Reproducibility: Intra-observer variability (assessed in 31
AS patients) and inter-observer variability (assessed in 33 AS patients)
showed a good correlation (Pearson correlation coeffi cient of 0.930 and
0.789 respectively, p< 0.001). Th ere was a good intraclass correlation
(0.93 and 0.84 respectively). Ad 2) Truth: Th e SpiPS showed a moderate
to good correlation with the BASDAI: Pearson correlation coeffi cients
were between 0.40 and 0.737 in the diff erent AS populations (p < 0.01).
Th ere was no correlation between the SpiPS and C-reactive protein and
ESR. Ad 3) Discrimination: SpiPS was sensitive to change: there was a
signifi cant decrease of the SpiPS by 65.3% while the BASDAI improved
signifi cantly by 53.8% aft er 12 weeks of treatment with TNF alpha inhibitors
(n= 101). In one NSAID trial (n= 458) the SpiPS improved by
37.3% while the BASDAI showed a signifi cant improvement by 26.5%.
Ad 4) Feasibility: assessment of the SpiPS took on averaged 3-5 minutes
and was easy to perform.
Conclusion: Th e spinal pain score fulfi ls all aspects of the OMERACT
fi lter with respect to reproducibility, truth, discrimination and feasibility.
Th e SpiPS being performed by the rheumatologist may serve as an
additional tool to assess the activity of back pain in AS. Th e application
of the SpiPS in trials and daily practice is worth further investigation.
FV1-7
Results of an open label pilot study with 20 mg Methotrexate parenterally
for the Treatment of Active Ankylosing Spondylitis
Haibel H. 1 , Brandt HC. 1 , Song IH. 1 , Brandt A. 2 , Listing J. 3 , Rudwaleit M. 1 ,
Sieper J. 1
1 Rheumatologie, Charité CBF, 2 Medac GmbH, 3 Epidemiologie, Deutsches
Rheumaforschungszentrum
Objective: Methotrexate is the most frequently used disease modifying
antirheumatic drug (DMARD) in rheumatoid arthritis. However its
effi cacy in the therapy of the axial manifestations in active ankylosing
spondylitis (AS) remains unclear. Th e aim of the study was to examine
the potential therapeutic eff ect of methotrexate 20 mg given weekly as
subcutaneous (s.c.) injections in active ankylosing spondylitis (AS).
Patients and Methods: Subcutaneous methotrexate 15 mg per week
monotherapy was administered every week for 4 weeks followed by
subcoutaneous methotrexate 20 mg per week for further 12 weeks in
20 patients (14 males, 6 females; mean age 40 years, range 24–59; mean
disease duration 14 years, range 1–39; 85% HLA-B27 positive) with active
AS (mean Bath Ankylosing Spondylitis Activity Index or BASDAI
of 5.6, range 4–9.3). All patients suff ered from spinal pain and 7 patients
also had peripheral arthritis. Clinical outcome assessments inclu-
| Zeitschrift für Rheumatologie · Supplement 1 · 2006
ded Disease Activity (BASDAI), patient’s, and physician’s global assessments
(NRS), function (BASFI), spinal mobility (BASMI), peripheral
joint assessment, quality of life (SF-36), and C-reactive protein (CRP).
Th e primary endpoint was a ≥20% response according to the Assessment
in AS (ASAS) working group improvement criteria at Week 16.
Results: Using an intention-to-treat analysis, ASAS 20 was achieved in
only 25% of patients. An ASAS 40 response was achieved in 10% of patients
and nobody reached an ASAS 70 response or the ASAS criteria for
partial remission For the mean BASDAI there was no change between
baseline and week 16 (baseline 5.6 versus week 16 5.6). Th ere was no
improvement in any of the clinical parameters or the CRP, except a
small but non-signifi cant decrease in the number of swollen joints in
the 7 patients suff ering from peripheral arthritis (number of swollen
joints at baseline 4.7 versus 1.2 at week 16).
Conclusions: In this open study, methotrexate did not show any benefi t
for the axial symptoms in patients with active AS beyond an expected
placebo-response. Th us, despite current practice, methotrexate should
not be used for this indication.
FV2 Abstract Session II: Rheumatoid Arthritis
FV2-1
Behandlung von Kindern mit juveniler rheumatoider Arthritis (JRA)
mit Adalimumab – Studienergebnisse nach 48 Wochen
Horneff G. 1 , Ruperto N. 2 , Martini A. 3 , Carcereri R. 4
1 Department of Paediactrics, Asklepios Clinic Sankt Augustin, Germany,
2 Pediatrics II, PRINTO-IRCCS G Gaslini, Genova, Italy, 3 PRINTO-IRCCS G
Gaslini, Genova, Italy, 4 Immunosciences, Abbott GmbH and Co. KG, Ludwigshafen,
Germany
Hintergrund: Vorläufi ge Ergebnisse einer off enen Studie an 171 JRA-
Patienten zeigten, dass eine 16-wöchige Th erapie mit Adalimumab
(ADA) zu einer Verbesserung der klinischen Zeichen und Symptome
führte. Mehr als 50% der Patienten erreichten ein Ped-ACR70-Ansprechen.
Ziele: Mit Hilfe dieser Fortsetzungsstudie sollte die Sicherheit und
Wirksamkeit der ADA-Behandlung bei Patienten mit JRA untersucht
werden, bei denen in der off enen Pilotstudie ein Th erapieansprechen
erzielt werden konnte.
Methoden: Patienten mit einem Ped-ACR30-Ansprechen erhielten
in der nachfolgenden doppelblinden Studienphase über 32 Wochen
entweder 24 mg Adalimumab/m2 KOF s.c. alle 14 Tage oder Placebo
(PBO). Primärer Endpunkt war ein Wiederauffl ammen der Symptomatik
defi niert als (1) >30%ige Verschlechterung im Vergleich zum
Ausgangswert in ≥ 3 der 6 Hauptkriterien des Ped-ACR, (2) nicht weniger
als 2 betroff ene Gelenke und (3) >30%ige Verbesserung in nicht
mehr als 1 der 6 Kriterien.
Ergebnisse: Am Ende der 16-wöchigen off enen Pilotstudie erreichten
83% der Patienten ACR30, 74% ACR50 und 52% ACR70. 133 Patienten
(77% Mädchen, mittleres Alter 11,2 Jahre) wurden in die doppelblinde
Studie überführt, 65% erhielten eine MTX-Begleittherapie. Unter
ADA zeigten signifi kant weniger Patienten ein Wiederauffl ammen
der Symptomatik als unter Placebo, sowohl ohne(43,3% vs. 71,4%,
p= 0,031) als auch mit MTX-Begleittherapie (36,8% vs. 64,9%, p=
0,015). Das ACR30/50/70-Ansprechen war in der 48. Woche, d.h. am
Ende der doppelblinden Studienphase, bei den ADA-Patienten signifi -
kant höher (60%/59%/56%) als bei den PBO-Patienten (35%/35%/28%),
(p