Objectives: This double-blind trial evaluated the efficacy and safety of abatacept or infliximab vs placebo. The primary objective of this study was to evaluate the mean change from baseline in Disease Activity Score (based on erythrocyte sedimentation rates; DAS28 (ESR)) for the abatacept vs placebo groups at day 197.
Methods: Patients with rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX) were randomised 3:3:2 to abatacept (∼10 mg/kg every 4 weeks, n = 156), infliximab (3 mg/kg every 8 weeks, n = 165), or placebo (every 4 weeks, n = 110) and background MTX. Safety and efficacy were assessed throughout the study.
Results: Similar patient demographics and clinical characteristics were present at baseline between groups, with mean scores of ∼1.7 for HAQ-DI and 6.8 for DAS28 (ESR). At 6 months, mean changes in DAS28 (ESR) were significantly greater for abatacept vs placebo (–2.53 vs –1.48, p<0.001) and infliximab vs placebo (–2.25 vs –1.48, p<0.001). For abatacept vs infliximab treatment at day 365, reductions in the DAS28 (ESR) were –2.88 vs –2.25. At day 365, the following response rates were observed for abatacept and infliximab, respectively: American College of Rheumatology (ACR) 20, 72.4 and 55.8%; ACR 50, 45.5 and 36.4%; ACR 70, 26.3 and 20.6%; low disease activity score (LDAS), 35.3 and 22.4%; DAS28-defined remission, 18.7 and 12.2%; good European League Against Rheumatism (EULAR) responses, 32.0 and 18.5%; and Health Assessment Questionnaire Disability Index (HAQ-DI), 57.7 and 52.7%. Mean changes in physical component summary (PCS) were 9.5 and 7.6, and mental component summary (MCS) were 6.0 and 4.0, for abatacept and infliximab, respectively. Over 1 year, adverse events (AEs) (89.1 vs 93.3%), serious AEs (SAEs) (9.6 vs 18.2%), serious infections (1.9 vs 8.5%) and discontinuations due to AEs (3.2 vs 7.3%) and SAEs (2.6 vs 3.6%) were lower with abatacept than infliximab.
Conclusions: In this study, abatacept and infliximab (3 mg/kg every 8 weeks) demonstrated similar efficacy. Overall, abatacept had a relatively more acceptable safety and tolerability profile, with fewer SAEs, serious infections, acute infusional events and discontinuations due to AEs than the infliximab group.
Trial registration number: NCT00095147.
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Funding: This study is based upon clinical trial results from a study sponsored by Bristol-Myers Squibb, Princeton, New Jersey, USA. The authors actively participated in the conduct of these trials, and had full access to the raw data and responsibility for the analysis and interpretation.
Competing interests: RA is an employee of Bristol-Myers Squibb and owns stocks. JCB is an employee of Bristol-Myers Squibb, with stock options and restricted shares. PLNC is an employee of Bristol-Myers Squibb and owns shares. MD has received research grants, consulting fees and been on the speakers’ bureau for Bristol-Myers Squibb, Abbott and Wyeth, and has also received research grants and consulting fees from Centocor and Schering Plough. MK has received research grants and consulting fees from, and is an Advisory Board Member for, Bristol-Myers Squibb. TL is an employee of Bristol-Myers Squibb and owns stocks and shares. CL is an employee of Bristol-Myers Squibb and owns stocks and shares. MS has received research grants and consulting fees from Amgen, Bristol-Myers Squibb, Centocor and Wyeth.
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