Long-term safety, efficacy and inhibition of radiographic progression with abatacept treatment in patients with rheumatoid arthritis and an inadequate response to methotrexate: 3-year results from the AIM trial. Issue 10 (5th September 2011)

• Record Type: Journal Article
• Authors: Kremer, Joel M; Russell, Anthony S; Emery, Paul; Abud-Mendoza, Carlos; Szechinski, Jacek; Westhovens, Rene; Li, Tracy; Zhou, Xianhuang; Becker, Jean-Claude; Aranda, Richard; Peterfy, Charles; Genant, Harry K
• Is Part Of: Annals of the rheumatic diseases. Volume 70:Issue 10(2011)
• Page Start: 1826
• Page End: 1830
• Publication Date: 2011-09-05
• Subjects: Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/ard.2010.139345
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Objective: To evaluate abatacept treatment over 3 years in patients with rheumatoid arthritis (RA) refractory to methotrexate (MTX). Methods: Patients randomised to abatacept or placebo (+MTX) during the 1-year double-blind period of the A batacept in I nadequate responders to M ethotrexate (AIM) trial received open-label abatacept (+MTX) in the long-term extension (LTE). Safety was assessed for patients who received ≥1 dose of abatacept, regardless of randomisation group. Efficacy was assessed for patients randomised to abatacept who entered the LTE. Results: 433 and 219 patients were randomised and treated with abatacept or placebo, respectively; 378 and 161 entered the LTE. At year 3, 440/539 patients were ongoing. No unexpected safety events were observed in the LTE. By year 3, incidence rates of adverse event and serious adverse events were 249.8/100 and 15.1/100 patient-years, respectively. Incidence rates were generally stable over time. At year 3, 84.8%, 63.4% and 37.5% of patients achieved American College of Rheumatology (ACR) criteria of 20, 50 and 70, respectively, compared with 82.3%, 54.3% and 32.4% of patients at year 1. Mean changes in Genant-modified Sharp scores were reduced progressively over 3 years, with significantly greater inhibition during year 3 compared with year 2 (p=0.022 for total score). Conclusion: In MTX-inadequate responders with RA, abatacept provided consistent safety and sustained efficacy over 3 years. The data suggest an increasing inhibitory disease-modifying effect on radiographic progression.