BSRBR|Newsletter - The British Society for Rheumatology

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ABSTRACTS|presented at the BSR AGM 2009 FACTORS ASSOCIATED WITH WORK DISABILITY IN RHEUMATOID ARTHRITIS PATIENTS: RESULTS FROM THE BSR BIOLOGICS REGISTER (BSRBR) SMM Verstappen, KD Watson, K McGrother, DPM Symmons, KL Hyrich, on behalf of the BSR Biologics Register, arc Epidemiology Unit, The University of Manchester, Manchester, United Kingdom. Background: Work disability is one of the major economic problems in patients with rheumatoid arthritis (RA). Treatment with anti-TNF agents has proven to be clinically effective in these patients, but there is limited data available on the effect of biological agents on working status in the UK. Aim: Using data from BSRBR, (i) to describe working status at start of anti-TNF treatment, and (ii) to identify predictors of onset of new work disability. Methods: 2,703 consecutive patients with RA registered with the BSRBR between 01/10/2001 and 01/09/2008 (aged3.2 to 5.1) disease activity. Methods: Patients for this study were selected from the BSR Biologics Register if they had failed treatment with at least 2 standard DMARDs and fell into the moderate or high DAS28 categories. Change in HAQ over the first 12 months of enrolment were compared first between anti-TNF treated and untreated patients in each DAS group, and then between treated patients in the moderate and high DAS groups. Mean change in HAQ was modelled for each comparison using Doubly Robust estimation, which fits both a propensity and a linear regression model to minimise bias in the estimate. Results were adjusted for age, gender, disease duration, baseline HAQ and DAS28 score, number of previous DMARDS and steroid use. Results: The analysis included 4772 and 224 anti-TNF treated and 369 and 325 DMARD only treated patients with high and moderate DAS28 respectively, despite 2 DMARDs. In both DAS28 groups, anti-TNF treated patients tended towards lower age and higher mean DAS28 and HAQ scores at baseline, but had similar disease duration. They had also failed on average one more DMARD than the untreated group (4 versus 3, p5.1. The current UK eligibility criteria for anti-TNF therapy, which limits therapy to patients with DAS28>5.1 should be reconsidered, as substantial functional (and therefore cost-effective) benefits may also be gained by treating those with moderately active disease. Baseline DAS28 > 3.2 – 5.1 > 5.1 Treatment Group DMARD Anti-TNF DMARD Anti-TNF (325) (224) (369) (4772) HAQ baseline (mean (SD)) 1.43 1.78 1.87 2.06 (0.75) (0.61) (0.62) (0.55) HAQ 12 months (mean (SD)) 1.45 1.51 1.86 1.71 (0.78) (0.75) (0.63 (0.71) Mean change in HAQ (95% CI) 0.02 -0.27 -0.01 -0.35 (-0.07, 0.1) (-0.4, -0.15) (-0.09, 0.07) (-0.38, -0.32) Adjusted Mean Change in HAQ ref -0.24 ref -0.28 (95% CI) (-0.33, -0.14) (-0.34, -0.23) Adjusted Mean Change in HAQ ref -0.05 (95% CI) (-0.16, 0.06) SECULAR CHANGES IN UK ANTI-TNF PRESCRIBING PATTERNS AND TREATMENT RESPONSE IN PATIENTS WITH RHEUMATOID ARTHRITIS: RESULTS FROM THE BSRBR Kath Watson 1 , Kimme Hyrich 1 , Mark Lunt 1 , Deborah Symmons 1 , on behalf of the BSRBR 1 1 . arc Epidemiology Unit, The University of Manchester, Manchester, United Kingdom. Anti-TNF therapy for rheumatoid arthritis (RA) has significantly improved outcomes for patients with severe disease. In the UK, changes in financial restrictions and increasing experience with their use may have resulted in changes to the way clinicians use anti-TNF therapies. The aim of this analysis was to study the trends in prescribing patterns of anti-TNF therapies by UK rheumatologists over a 7 year period and compare this with changes in response to treatment. Between October 2001 and June 2007, 10789 patients with RA were registered with the BSRBR. Baseline characteristics were analysed according to year of anti-TNF prescription. Only the first course of anti-TNF was included. Treatment response was determined at 6 months according to EULAR criteria. Changes in baseline disease characteristics and response rates over a seven year period were analysed using univariate linear and logistic regression analysis methods. Over these 7 years, the median level of disease activity and severity of newly treated anti-TNF patients has significantly decreased (p
www.rheumatology.org.uk (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
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