Abatacept for Crohn's disease and ulcerative colitis

William J. Sandborn*, Jean Frederic Colombel, Bruce E. Sands, Paul Rutgeerts, Stephan R. Targan, Remo Panaccione, Brian Bressler, Karl Geboes, Stefan Schreiber, Richard Aranda, Sheila Gujrathi, Allison Luo, Yun Peng, Luisa Salter-Cid, Stephen B. Hanauer

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

102 Scopus citations

Abstract

Background & Aims: 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. ClinicalTrials.gov NCT00406653, NCT00410410.

Original languageEnglish (US)
Pages (from-to)62-69.e4
JournalGastroenterology
Volume143
Issue number1
DOIs
StatePublished - Jul 2012

Keywords

  • Clinical Trial
  • IBD
  • Inflammatory Bowel Disease
  • T-Cell Signaling Inhibitor

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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