Sustained disease remission and inhibition of radiographic progression in methotrexate-naive patients with rheumatoid arthritis and poor prognostic factors treated with abatacept: 2-Year outcomes

J. Bathon, M. Robles, A. C. Ximenes, S. Nayiager, J. Wollenhaupt, P. Durez, J. Gomez-Reino, W. Grassi, B. Haraoui, W. Shergy, S. H. Park, H. Genant, C. Peterfy, J. C. Becker, A. Covucci, D. Moniz Reed, R. Helfrick, R. Westhovens

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: To assess the efficacy and safety of abatacept plus methotrexate versus methotrexate alone in early erosive rheumatoid arthritis (RA). Methods: The AGREE was a 2-year phase IIIb multinational study in early (≤2 years) RA. During the double-blind period (year 1), patients were randomly assigned 1:1 to receive abatacept+methotrexate or methotrexate alone; all patients received open-label abatacept + methotrexate during year 2. Clinical outcomes assessed included 28-joint disease activity score (DAS28) defined remission, low disease activity score (LDAS), American College of Rheumatology (ACR) responses and physical function. Radiographic outcomes were assessed using the Genant-modified Sharp total score (TS). Safety was monitored throughout. Results: Of the 459 patients completing year 1, 433 patients (94.3%) completed year 2. DAS28-defined remission, LDAS, ACR and physical function were sustained through year 2 in the original abatacept+methotrexate group, with 55.2% in remission at 2 years. Upon introduction of abatacept in the methotrexate-alone group, additional patients achieved DAS28-defined remission (44.5% vs 26.9%), LDAS (60.4% vs 43.2%) and improved ACR 70 (49.8% vs 31.7%) for year 2 versus year 1. Less radiographic progression was observed at 2 years in the original abatacept+methotrexate group than the methotrexatealone group (change in TS 0.84 vs 1.75, p

Original languageEnglish (US)
Pages (from-to)1949-1956
Number of pages8
JournalAnnals of the Rheumatic Diseases
Volume70
Issue number11
DOIs
StatePublished - Nov 2011
Externally publishedYes

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Biochemistry, Genetics and Molecular Biology(all)
  • Immunology and Allergy

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