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(see Table). The median disease duration remained high (9 years in 2007) although
the proportion of patient with disease 5.1 following failure of ≥2
DMARDs including methotrexate) (n=766) followed for 6 months. Patients completed
the EQ-5D, SF-36 and HAQ at baseline and at a 6-month follow-up assessment.
Predicted EQ-5D scores were estimated using the HAQ (1) or the SF-36 (2) . The mean
difference between predicted and observed EQ-5D scores at baseline and change
during the study was tested using the t-test.
Results: The patients recruited to this study had a mean age of 58, disease duration
of 12 years and predominance of females (Table). HAQ and SF-36 physical
component summary score (PCS) indicated considerable physical disability, and the
patients had low HRQoL scores. Predicted EQ-5D scores were higher than observed
scores at baseline, although this was only significant where estimated using the HAQ
(p=0.007). Over 6 months of follow-up patients improved in physical function and
HRQoL, with change exceeding the minimum important difference (MID) for the HAQ
(MID 0.20), EQ-5D (MID 0.05-0.07), PCS (MID 2-3) and mental component
summary scores (MCS) (MID 3). Change in predicted EQ-5D scores (both methods)
also exceeded the MID, and corresponded well with observed EQ-5D scores. Although
change in EQ-5D appeared to be underestimated when predicted from HAQ scores
and overestimated when predicted from the SF-36, neither were significantly different.
Age Mean (SD) 58.3 (12.2)
Gender N (%) 583 (76%)
Disease duration Mean (SD) 11.8 (10.9)
Baseline
6-month change
n=766 n=699
HAQ Mean (SD) 1.72 (0.71) -0.22 (0.54)
SF-36 PCS Mean (SD) 20.4 (10.8) 4.6 (10.3)
SF-36 MCS Mean (SD) 45.0 (11.3) 3.0 (11.4)
EQ-5D Observed 0.40 (0.33) 0.08 (0.32)
Predicted (using HAQ) 0.44 (0.26) 0.07 (0.24)
Difference, mean (95% CI) 0.04 (0.01, 0.07) -0.02 (-0.05, 0.01)
Observed 0.40 (0.33) 0.08 (0.32)
Predicted (using SF-36) 0.42 (0.25) 0.10 (0.23)
Difference, mean (95% CI) 0.02 (-0.01, 0.05) 0.02 (-0.01, 0.05)
Conclusions: Predicted EQ-5D scores from the HAQ and the SF-36 were reasonable
estimates of mean baseline and change EQ-5D scores in the RA patients with severe
disease. However small differences in response to change could have implications in
assessing the cost-effectiveness of treatments; underestimation of change (e.g.
EQ-5D estimated from the HAQ) may lead to underestimation of cost-effectiveness,
whilst over-estimation (e.g. SF-36 to EQ-5D) may overestimate cost-effectiveness.
For this reason, estimating EQ-5D scores may be valid where no alternative exists or
for sensitivity analyses, however we recommend that prospective studies should
include at least one measure of HRQoL which allows the estimation of utilities.
References (1) Bansback N, Marra C, et al. Arthritis Rheum 2007; 57:963-71. (2)
Ara R & Brazier J. Value in Health 2008; 1131-43
THE INFLUENCE OF ANTI-TNF THERAPY UPON CANCER INCIDENCE IN PATIENTS
WITH RHEUMATOID ARTHRITIS (RA) WHO HAVE HAD PRIOR MALIGNANCY:
RESULTS FROM THE BSRBR
WG Dixon, KD Watson, M Lunt, BSRBR Control Centre Consortium, KL Hyrich, DPM
Symmons, on behalf of the BSR Biologics Register.
Purpose: Anti-TNF therapy is rarely prescribed to patients with a history of prior
malignancy following theoretical safety concerns, clinical trial exclusion criteria and
national guidelines. Thus, there is currently no published evidence regarding the safety
of anti-TNF therapy in patients with prior malignancy. Our aim was to explore the
influence of anti-TNF therapy upon the incidence of cancer in patients with prior
malignancy, using data from a large national register.
Methods: 10735 consecutive anti-TNF treated patients with RA registered with the
BSRBR were followed prospectively. They were compared to 3236 patients with active
RA on disease modifying anti-rheumatic drugs (DMARD). Patients with a malignancy
prior to registration were identified by record linkage with the UK Office for National
Statistics (ONS). Further analysis was restricted to these patients. Incident
malignancies up to 30/9/07 were identified from consultant and patient
questionnaires and ONS. Local recurrence and metastases were included as incident
cancers. Carcinoma-in-situ and non-melanoma skin cancers were excluded from both
prior and incident malignancies. Patients contributed follow-up time until 30/9/07 or
death, whichever came first. An individual patient could contribute >1 incident
malignancy. Incidence rate ratios (IRR) were calculated comparing the anti-TNF to
the DMARD-treated cohorts. Results: 177 (1.6%) anti-TNF and 118 (3.6%)
DMARD-treated patients had a history of prior malignancy. Registration occurred within
10 years of the prior malignancy in 75 (42%) of the anti-TNF and 71 (60%) of the
DMARD treated patients. After median follow-up times of 3.06 and 1.93 years in the
anti-TNF and DMARD-treated cohorts, there were 13 incident cancers in 11/177 (6%)
anti-TNF treated patients compared to 10 cancers in 10/118 (8%) DMARD-treated
patients. The crude rate of incident cancers was lower in the anti-TNF cohort (25.3
events / 1000 person years (pyrs) (95% CI 13.4, 43.2)) compared to the DMARD
cohort (41.9 / 1000 pyrs (20.1, 77.1)). The age- and sex-adjusted IRR for anti-TNF vs
DMARD-treated patients with prior malignancy was 0.53 (0.22-1.26). 17 patients in
the anti-TNF cohort had prior melanomas compared to 10 in the DMARD cohort. Of
concern, 3/11 anti-TNF patients with prior then incident malignancy had prior
melanomas. The time from melanoma to starting anti-TNF therapy was 33%) of patients with ankylosing spondylitis (AS) need to give up work
before normal retirement. The beneficial clinical effects of anti-TNF therapy seen in
patients with AS hopefully will lead to less work disability in the future.
Aim: To describe working status at start of anti-TNF treatment and at three years after
starting anti-TNF therapy.
Methods. 229 consecutive patients with AS (aged