title: Clinical efficacy and safety of abatacept in methotrexate-naive patients with early rheumatoid arthritis and poor prognostic factors.
abstract: OBJECTIVE
  To assess the efficacy and safety of abatacept in methotrexate-naive patients with early rheumatoid arthritis (RA) and poor prognostic factors.
  
  
  METHODS
  In this double-blind, phase IIIb study, patients with RA for 2 years or less were randomly assigned 1 : 1 to receive abatacept (approximately 10 mg/kg) plus methotrexate, or placebo plus methotrexate. Patients were methotrexate-naive and seropositive for rheumatoid factor (RF), anti-cyclic citrullinated protein (CCP) type 2 or both and had radiographic evidence of joint erosions. The co-primary endpoints were the proportion of patients achieving disease activity score in 28 joints (DAS28)-defined remission (C-reactive protein) and joint damage progression (Genant-modified Sharp total score; TS) at year 1. Safety was monitored throughout.
  
  
  RESULTS
  At baseline, patients had a mean DAS28 of 6.3, a mean TS of 7.1 and mean disease duration of 6.5 months; 96.5% and 89.0% of patients were RF or anti-CCP2 seropositive, respectively. At year 1, a significantly greater proportion of abatacept plus methotrexate-treated patients achieved remission (41.4% vs 23.3%; p<0.001) and there was significantly less radiographic progression (mean change in TS 0.63 vs 1.06; p = 0.040) versus methotrexate alone. Over 1 year, the frequency of adverse events (84.8% vs 83.4%), serious adverse events (7.8% vs 7.9%), serious infections (2.0% vs 2.0%), autoimmune disorders (2.3% vs 2.0%) and malignancies (0.4% vs 0%) was comparable for abatacept plus methotrexate versus methotrexate alone.
  
  
  CONCLUSIONS
  In a methotrexate-naive population with early RA and poor prognostic factors, the combination of abatacept and methotrexate provided significantly better clinical and radiographic efficacy compared with methotrexate alone and had a comparable, favourable safety profile.
authors.affiliation: UZ Gasthuisberg, Department of Rheumatology, B-3000 Leuven, Belgium. rene.westhovens@uz.kuleuven.ac.be
authors.forename: R
authors.initials: R
authors.lastname: Westhovens
authors.forename: M
authors.initials: M
authors.lastname: Robles
authors.forename: A C
authors.initials: AC
authors.lastname: Ximenes
authors.forename: S
authors.initials: S
authors.lastname: Nayiager
authors.forename: J
authors.initials: J
authors.lastname: Wollenhaupt
authors.forename: P
authors.initials: P
authors.lastname: Durez
authors.forename: J
authors.initials: J
authors.lastname: Gomez-Reino
authors.forename: W
authors.initials: W
authors.lastname: Grassi
authors.forename: B
authors.initials: B
authors.lastname: Haraoui
authors.forename: W
authors.initials: W
authors.lastname: Shergy
authors.forename: S-H
authors.initials: SH
authors.lastname: Park
authors.forename: H
authors.initials: H
authors.lastname: Genant
authors.forename: C
authors.initials: C
authors.lastname: Peterfy
authors.forename: J-C
authors.initials: JC
authors.lastname: Becker
authors.forename: A
authors.initials: A
authors.lastname: Covucci
authors.forename: R
authors.initials: R
authors.lastname: Helfrick
authors.forename: J
authors.initials: J
authors.lastname: Bathon
mesh_terms: D000069594:Abatacept; D000328:Adult; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000000981:diagnostic imaging / Q000188:drug therapy*; D018450:Disease Progression; D004359:Drug Therapy, Combination; D004812:Epidemiologic Methods; D005260:Female; D006801:Humans; D018796:Immunoconjugates / Q000009:adverse effects / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008297:Male; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D011379:Prognosis; D011788:Quality of Life; D011859:Radiography; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D018796:Immunoconjugates; D007166:Immunosuppressive Agents; D000069594:Abatacept; D008727:Methotrexate