Evaluating Drug-Free Remission With Abatacept in Early Rheumatoid Arthritis: Results From the Phase 3b, Multicenter, Randomised, Active-Controlled AVERT Study of 24 Months, With a 12-Month, Double-Blind Treatment Period
Emery P, Burmester GR, Bykerk VP, et al Ann Rheum Dis. 2015;74:19-26
Study Summary
The Assessing Very Early Rheumatoid Arthritis Treatment (AVERT) study evaluated the efficacy and safety of three treatments in patients with early anti-citrullinated protein antibody (ACPA)-positive rheumatoid arthritis (RA), defined as ≤ 2 years of persistent inflammatory symptoms. In total, 351 patients were randomly assigned to receive either abatacept plus methotrexate (ABA/MTX; n = 119), methotrexate monotherapy (MTX; n = 116), or abatacept monotherapy (ABA; n = 116). Patients who reached remission, as defined by a C-reactive protein-based Disease Activity Score (DAS)-28 score < 2.6 at 12 months, could have all therapy withdrawn (ABA immediately, and MTX and any corticosteroids over 1 month) and were then followed to determine whether remission was sustained.
At the 12-month mark, remission rates by DAS-28 criteria were ~61% in the ABA/MTX arm, ~46% in the MTX arm, and ~43% in the ABA arm, with the differences between ABA/MTX and MTX reaching statistical significance (P=.01).
Across all patients, at 18 months, there was a higher rate of DAS-28–defined remission in the ABA/MTX arm than in the MTX arm (~15% vs ~8%; P=.045). In addition, within the subset of patients who had therapy withdrawn at 12 months, 18 of 73 (~25%) in the ABA/MTX arm were still in DAS remission at 18 months, compared with 9 of 53 (~17%) in the MTX arm and 15 of 50 (~28%) in the ABA arm. These differences were not statistically significant.
