Abstract
IntroductionThis study evaluated various remission criteria in abatacept plus methotrexate (MTX)-treated patients with early rheumatoid arthritis (RA). We aimed to investigate the time to, and sustainability of, remission, and to evaluate the relationship between remission, function and structure.MethodsPost hoc analyses were performed from the 12-month, double-blind period of the Abatacept study to Gauge Remission and joint damage progression in methotrexate (MTX)-naive patients with Early Erosive rheumatoid arthritis (AGREE) in patients with early RA (≤2 years) and poor prognostic factors, comparing abatacept plus MTX (n = 210) versus MTX alone (n = 209).ResultsAt month 12, Disease Activity Score 28, Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index and Boolean remission rates were, for abatacept plus MTX versus MTX alone: 47.6 % versus 27.3 %, 33.3 % versus 12.4 %, 34.3 % versus 16.3 %, and 23.8 % versus 5.7 %, respectively. Cumulative probability demonstrated higher proportions achieving first remission and first sustained remission for abatacept plus MTX versus MTX alone (e.g., 23.3 % [95 % confidence interval (CI): 17.6, 29.1] vs 12.9 % [8.4, 17.5] for first SDAI remission over 0–6 months). For patients in SDAI remission at month 3, mean Health Assessment Questionnaire-Disability Index at month 12 was 0.20 versus 0.50 for abatacept plus MTX versus MTX alone. Mean changes in radiographic score from baseline to month 12 were minimal for patients in SDAI remission at month 3 in both groups, while less structural damage progression was seen, 0.75 versus 1.35, respectively, for abatacept plus MTX versus MTX alone for patients with moderate/high disease activity at month 3 (adjusted mean treatment difference: −0.60 [95 % CI: −1.11, −0.09; P < 0.05]).ConclusionsHigh proportions of abatacept plus MTX-treated patients achieved stringent remission criteria. Remission was associated with long-term functional benefit; dissociation was seen between clinical and structural outcomes for abatacept. These findings highlight the impact of reaching stringent remission targets early, on physical function and structural damage, in MTX-naïve biologic-treated patients.Trial registrationClinicalTrials.gov identifier NCT00122382. Registered 19 July 2005.Electronic supplementary materialThe online version of this article (doi:10.1186/s13075-015-0671-9) contains supplementary material, which is available to authorized users.
Highlights
This study evaluated various remission criteria in abatacept plus methotrexate (MTX)-treated patients with early rheumatoid arthritis (RA)
Disease Activity Score 28 (DAS28) (CRP)
Remission outcomes At month 12, remission was achieved in 27.3 % of patients receiving MTX alone compared with 47.6 % of patients receiving abatacept plus MTX by DAS28 criteria, by 12.4 % and 33.3 % by SDAI criteria, by 16.3 % and 34.3 % by CDAI criteria, and by 5.7 % and 23.8 % by Boolean criteria (Fig. 1)
Summary
This study evaluated various remission criteria in abatacept plus methotrexate (MTX)-treated patients with early rheumatoid arthritis (RA). According to the treat-to-target principle, patients with rheumatoid arthritis (RA) should be monitored closely, with the goal of achieving clinical remission or low disease activity (LDA) within 6 months [1, 2], and regularly assessed for sustained remission [3]. Various criteria have been used to formally define remission in clinical trials, of which the Disease Activity Score (DAS) (score of
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