Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn's Disease After Ileocolonic Resection
Abstrakt
Background & Aims: Most patients with Crohn's disease (CD) eventually require an intestinal resection. However, CD frequently recurs after resection.
We performed a randomized trial to compare the ability of infliximab vs placebo to prevent CD recurrence. Methods: We evaluated the efficacy of infliximab in preventing postoperative recurrence of CD in 297 patients at 104 sites worldwide from November 2010 through May 2012.
All study patients had undergone ileocolonic resection within 45 days before randomization. Patients were randomly assigned (1:1) to groups given infliximab (5 mg/kg) or placebo every 8 weeks for 200 weeks.
The primary end point was clinical recurrence, defined as a composite outcome consisting of a CD Activity Index score >200 and a >=70-point increase from baseline, and endoscopic recurrence (Rutgeerts score >=i2, determined by a central reader) or development of a new or re-draining fistula or abscess, before or at week 76. Endoscopic recurrence was a major secondary end point.
Conclusions: Infliximab is not superior to placebo in preventing clinical recurrence after CD-related resection. However, infliximab does reduce endoscopic recurrence.