title: 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.
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 Abatacept in Inadequate responders to Methotrexate (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).
  
  
  CONCLUSIONS
  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.
authors: Center for Rheumatology, Albany Medical College, 1367 Washington Ave, Albany, NY 12206, USA. jkremer@joint-docs.com
authors: Joel M
authors: JM
authors: Kremer
authors: Anthony S
authors: AS
authors: Russell
authors: Paul
authors: P
authors: Emery
authors: Carlos
authors: C
authors: Abud-Mendoza
authors: Jacek
authors: J
authors: Szechinski
authors: Rene
authors: R
authors: Westhovens
authors: Tracy
authors: T
authors: Li
authors: Xianhuang
authors: X
authors: Zhou
authors: Jean-Claude
authors: JC
authors: Becker
authors: Richard
authors: R
authors: Aranda
authors: Charles
authors: C
authors: Peterfy
authors: Harry K
authors: HK
authors: Genant
mesh_terms: D000069594:Abatacept; D000328:Adult; D018501:Antirheumatic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000000981:diagnostic imaging / Q000188:drug therapy*; D001327:Autoimmune Diseases / Q000139:chemically induced; D018450:Disease Progression; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D018796:Immunoconjugates / Q000009:adverse effects* / Q000627:therapeutic use; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D009369:Neoplasms / Q000139:chemically induced; D009894:Opportunistic Infections / Q000139:chemically induced; D011788:Quality of Life; D011859:Radiography; D012720:Severity of Illness Index; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D018796:Immunoconjugates; D007166:Immunosuppressive Agents; D000069594:Abatacept; D008727:Methotrexate