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

    loading  Checking for direct PDF access through Ovid

Abstract

Objectives

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.

Methods

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).

Results

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.

Conclusions

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).

Trial registration number

NCT00989235.

Related Topics

    loading  Loading Related Articles