ABATACEPT IS EFFECTIVE AT REDUCING PAIN AND FATIGUE, AND IMPROVING SLEEP QUALITY IN RHEUMATOID ARTHRITIS PATIENTS WITH AN INADEQUATE RESPONSE TO ANTI-TNF THERAPY IN THE ATTAIN TRIAL

A. Russell, Y. Sherrer , R. Westhovens , J. Box , C. Pritchard , I. Nuamah , T. Li , M. Genovese University of Alberta Hospital, Edmonton, Canada, Centre for Rheumatology, Immunology and Arthritis, Fort Lauderdale, United States, Department of Rheumatology, Universitaire Ziekenhuizen Leuven, Leuven, Belgium, Carolina Bone and Joint PA, Charlotte, Rheumatology Research, A Division of Rheumatic Disease Associates, PA, Bristol-Myers Squibb, Princeton, Stanford University Medical Center, Stanford, United StatesObjectives: Fatigue and sleep quality have been identified by the OMERACT study group as significant issues for rheumatoid arthritis (RA) patients. A recent Arthritis Foundation survey of RA patients rated inadequate pain relief and fatigue among their top three concerns. However, the effect of RA treatments on these factors has not been widely reported. The effects of abatacept on pain, fatigue and sleep quality were assessed as part of the ATTAIN (Abatacept Trial in Treatment of Anti-TNF INadequate responders) trial.Methods: ATTAIN was a 6-month, randomized, double-blind, placebo-controlled, multicenter, Phase III trial of a fixed dose of abatacept (∼10 mg/kg) vs. placebo in patients with active RA with an inadequate response to ≥3 months of anti-TNF-alpha therapy (etanercept and/or infliximab). Study medication was administered on Days 1, 15, 29 and then every 28 days thereafter. All patients also received ≥1 background DMARD (abatacept vs. placebo: MTX, 75.6 vs. 82.0%; anakinra, 2.7 vs. 2.3%; all other non-biologic DMARDs were <10% in each group). Pain and fatigue severity were assessed using a Visual Analog Scale (VAS) 100 mm. Sleep quality was assessed using the Medical Outcomes Study Sleep Module (MOS-Sleep), a validated instrument measuring sleep problems, e.g. sleep disturbance, quantity and adequacy. A sleep problems index (0–100, with higher scores indicating more problems) was also generated.Results: A total of 258 and 133 patients were randomized to the abatacept and placebo groups, respectively. Baseline characteristics were similar for abatacept- vs. placebo-treated patients; patients had active, longstanding disease (∼12 years), elevated pain (70.9 ± 19.7 vs. 69.5 ± 18.9) and fatigue (73.8 ± 19.7 vs. 72.2 ± 19.4) and a sleep-problem index value well above the population norm of 29 (49.0 ± 19.0 vs. 46.0 ± 18.4), indicating severe sleep impairment. At 6 months, improvements in sleep quality and fatigue were also significantly greater in the abatacept group vs. the placebo group (Table). Significant improvements in pain were noted at Day 29 (data not shown) for abatacept vs. placebo and were maintained to the end of the study (Table). Abatacept was generally safe and well tolerated. Mean change from baseline at 6 months (SE)* Abatacept (n=256) Placebo (n=133) Pain (0-100 VAS) –27.1 (1.7) –7.9 (2.3) Fatigue (0-100 VAS) –21.9 (1.6) –6.0 (2.3) MOS-Sleep Problems Index (0-100) –9.4 (1.0) –2.8 (1.3) *Last observation carried forward; †p<0.001 vs. placebo. *Last observation carried forward; †p<0.001 vs. placebo.Conclusion: Abatacept is effective at reducing pain and fatigue and improving sleep quality in RA patients with inadequate responses to anti-TNF-alpha therapy. These data indicate that abatacept treatment has the potential to provide meaningful and necessary real-life benefits for RA patients with active disease for whom there are limited treatment options.References: 1. Spritzer KL et al. MOS Sleep Scale: A Manual for Use and Scoring, Version 1.0. Los Angeles, CA, November 2003Citation: Ann Rheum Dis, volume 64, supplement III, year 2005, page 397Session: Health services, economics and outcome research 1