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Efficacy and safety of abatacept or infliximab versus placebo in ATTEST: a phase III, multicenter, randomized, double-blind, placebo-controlled study in patients with rheumatoid arthritis and an inadequate response to methotrexate.

Author(s): Schiff M, Keiserman M, Codding C, Songcharoen S, Berman A, Nayiager S, Saldate C, Li T, Aranda R, Becker JC, Lin C, Cornet PL, Dougados M

Affiliation(s): Denver Arthritis Clinic, United States.

Publication date & source: 2007-11-29, Ann Rheum Dis., [Epub ahead of print]

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 of a mean change from baseline in DAS28 (ESR) for the abatacept versus placebo groups at Day 197. METHODS: Patients with rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX) were randomized 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: ACR 20: 72.4 and 55.8%; ACR 50: 45.5 and 36.4%; ACR 70: 26.3 and 20.6%; LDAS: 35.3 and 22.4%; DAS28-defined remission: 18.7 and 12.2%; good EULAR: 32.0 and 18.5%; and HAQ-DI: 57.7 and 52.7%. Mean changes in PCS were 9.5 and 7.6, and MCS were 6.0 and 4.0, for abatacept and infliximab, respectively. Through 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 both 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.

Page last updated: 2008-01-02

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