Maintenance of remission following 2□years of standard treatment then dose reduction with abatacept in patients with early rheumatoid arthritis and poor prognosis


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Abstract

ObjectivesTo evaluate maintenance of response while reducing intravenous abatacept dose from ∼10□mg/kg to ∼5□mg/kg in patients with early rheumatoid arthritis (RA) who achieved disease activity score (DAS)28 (erythrocyte sedimentation rate, ESR) <2.6.MethodsThis 1-year, multinational, randomised, double-blind substudy evaluated the efficacy and safety of ∼10□mg/kg and ∼5□mg/kg abatacept in patients with early RA with poor prognosis who had reached DAS28 (ESR) <2.6 at year 2 of the AGREE study. The primary outcome was time to disease relapse (defined as additional disease-modifying antirheumatic drugs, ≥2 courses high-dose steroids, return to open-label abatacept ∼10□mg/kg, or DAS28 (C reactive protein) ≥3.2 at two consecutive visits).Results108 patients were randomised (∼10□mg/kg, n=58; ∼5□mg/kg, n=50). Three and five patients, respectively, discontinued, and four per group returned to open-label abatacept. Relapse over time and the proportion of patients relapsing were similar in both groups (31% (∼10□mg/kg) vs 34% (∼5□mg/kg); HR: 0.87 (95% CI 0.45 to 1.69)). Mean steady-state trough serum concentration for the ∼10□mg/kg group was 20.3-24.1□μg/mL, compared with 8.8-12.0□μg/mL for the ∼5□mg/kg group.ConclusionsThis exploratory study suggests that abatacept dose reduction may be an option in patients with poor prognosis early RA who achieve DAS28 (ESR) <2.6 after ≥1□year on abatacept (∼10□mg/kg).Trial registration numberNCT00989235.

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