Attainment and characteristics of clinical remission according to the new ACR-EULAR criteria in abatacept-treated patients with early rheumatoid arthritis: new analyses from the Abatacept study to Gauge Remission and joint damage progression in methotrexate (MTX)-naive patients with Early Erosive rheumatoid arthritis (AGREE).

Abstract

INTRODUCTION:

This 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.

METHODS:

Post 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).

RESULTS:

At 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]).

CONCLUSIONS:

High 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 REGISTRATION:

ClinicalTrials.gov identifier NCT00122382. Registered 19 July 2005.

• Authors: Josef S Smolen, Jürgen Wollenhaupt, Juan J Gomez-Reino, Walter Grassi, Corine Gaillez, Coralie Poncet, Manuela Le Bars, Rene Westhovens
• Journal: Arthritis research & therapy (Arthritis Res Ther) Vol. 17 Pg. 157 (Jun 11 2015) ISSN: 1478-6362 [Electronic] England
• PMID: 26063454 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antirheumatic Agents
• Abatacept
• Methotrexate

Topics

• Abatacept (administration & dosage)
• Adult
• Antirheumatic Agents (administration & dosage)
• Arthritis, Rheumatoid (diagnosis, drug therapy)
• Disease Progression
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Humans
• Male
• Methotrexate (administration & dosage)
• Middle Aged
• Remission Induction (methods)
• Treatment Outcome