title: Abatacept for Crohn's disease and ulcerative colitis.
abstract: OBJECTIVE
  The efficacy of abatacept, a selective costimulation modulator, in Crohn's disease (CD) and ulcerative colitis (UC) is unknown.
  
  
  METHODS
  Four placebo-controlled trials evaluated the efficacy and safety of abatacept as induction (IP) and maintenance (MP) therapy in adults with active, moderate-to-severe CD (CD-IP; CD-MP) and UC (UC-IP1; UC-MP). In CD-IP and UC-IP1, 451 patients with CD and 490 patients with UC were randomized to abatacept 30, 10, or 3 mg/kg (according to body weight) or placebo, and dosed at weeks 0, 2, 4, and 8. In MP, 90 patients with CD and 131 patients with UC who responded to abatacept at week 12 in the induction trials were randomized to abatacept 10 mg/kg or placebo every 4 weeks through week 52.
  
  
  RESULTS
  In CD-IP, 17.2%, 10.2%, and 15.5% of patients receiving abatacept 30, 10, and 3 mg/kg achieved a clinical response at weeks 8 and 12, vs 14.4% receiving placebo (P = .611, P = .311, and P = .812, respectively). In UC-IP1, 21.4%, 19.0%, and 20.3% of patients receiving abatacept 30, 10, and 3 mg/kg achieved a clinical response at week 12, vs 29.5% receiving placebo (P = .124, P = .043, and P = .158, respectively). In CD-MP, 23.8% vs 11.1% of abatacept vs placebo patients were in remission at week 52. In UC-MP, 12.5% vs 14.1% of patients receiving abatacept vs placebo were in remission at week 52. Safety generally was comparable between groups.
  
  
  CONCLUSIONS
  The studies showed that abatacept is not efficacious for the treatment of moderate-to-severe CD or UC.
authors.affiliation: Division of Gastroenterology, University of California San Diego, La Jolla, California, 92093-0956,USA. wsandborn@ucsd.edu
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: Jean-Frederic
authors.initials: JF
authors.lastname: Colombel
authors.forename: Bruce E
authors.initials: BE
authors.lastname: Sands
authors.forename: Paul
authors.initials: P
authors.lastname: Rutgeerts
authors.forename: Stephan R
authors.initials: SR
authors.lastname: Targan
authors.forename: Remo
authors.initials: R
authors.lastname: Panaccione
authors.forename: Brian
authors.initials: B
authors.lastname: Bressler
authors.forename: Karl
authors.initials: K
authors.lastname: Geboes
authors.forename: Stefan
authors.initials: S
authors.lastname: Schreiber
authors.forename: Richard
authors.initials: R
authors.lastname: Aranda
authors.forename: Sheila
authors.initials: S
authors.lastname: Gujrathi
authors.forename: Allison
authors.initials: A
authors.lastname: Luo
authors.forename: Yun
authors.initials: Y
authors.lastname: Peng
authors.forename: Luisa
authors.initials: L
authors.lastname: Salter-Cid
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Hanauer
mesh_terms: D000069594:Abatacept; D000328:Adult; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D006801:Humans; D018796:Immunoconjugates; D007166:Immunosuppressive Agents; D008297:Male; D008875:Middle Aged
chemical_list: D018796:Immunoconjugates; D007166:Immunosuppressive Agents; D000069594:Abatacept