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Westhovens, Rene,Robles, Manuel,Ximenes, Antonio Carlos,Wollenhaupt, Jurgen,Durez, Patrick,Gomez-Reino, Juan,Grassi, Walter,Haraoui, Boulos,Shergy, William,Park, Sung-Hwan,Genant, Harry,Peterfy, Charl H. K. Lewis 2015 Annals of the rheumatic diseases Vol.74 No.3
<P><B>Objectives</B></P><P>To 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.</P><P><B>Methods</B></P><P>This 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).</P><P><B>Results</B></P><P>108 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.</P><P><B>Conclusions</B></P><P>This 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).</P><P><B>Trial registration number</B></P><P>NCT00989235.</P>