title: Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn's Disease After Ileocolonic Resection.
abstract: OBJECTIVE
  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.
  
  
  RESULTS
  A smaller proportion of patients in the infliximab group had a clinical recurrence before or at week 76 compared with the placebo group, but this difference was not statistically significant (12.9% vs 20.0%; absolute risk reduction [ARR] with infliximab, 7.1%; 95% confidence interval: -1.3% to 15.5%; P = .097). A significantly smaller proportion of patients in the infliximab group had endoscopic recurrence compared with the placebo group (30.6% vs 60.0%; ARR with infliximab, 29.4%; 95% confidence interval: 18.6% to 40.2%; P < .001). Additionally, a significantly smaller proportion of patients in the infliximab group had endoscopic recurrence based only on Rutgeerts scores ≥i2 (22.4% vs 51.3%; ARR with infliximab, 28.9%; 95% confidence interval: 18.4% to 39.4%; P < .001). Patients previously treated with anti-tumor necrosis factor agents or those with more than 1 resection were at greater risk for clinical recurrence. The safety profile of infliximab was similar to that from previous reports.
  
  
  CONCLUSIONS
  Infliximab is not superior to placebo in preventing clinical recurrence after CD-related resection. However, infliximab does reduce endoscopic recurrence. ClinicalTrials.gov ID NCT01190839.
authors.affiliation: Inflammatory Bowel Disease Center and Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. Electronic address: mdr7@pitt.edu.
authors.forename: Miguel
authors.initials: M
authors.lastname: Regueiro
authors.affiliation: Robarts Research Institute, University of Western Ontario, London, Ontario, Canada.
authors.forename: Brian G
authors.initials: BG
authors.lastname: Feagan
authors.affiliation: Janssen Research & Development, LLC, Spring House, Pennsylvania.
authors.forename: Bin
authors.initials: B
authors.lastname: Zou
authors.affiliation: Janssen Research & Development, LLC, Spring House, Pennsylvania.
authors.forename: Jewel
authors.initials: J
authors.lastname: Johanns
authors.affiliation: Janssen Scientific Affairs, LLC, Horsham, Pennsylvania.
authors.forename: Marion A
authors.initials: MA
authors.lastname: Blank
authors.affiliation: Janssen Research & Development, LLC, Spring House, Pennsylvania.
authors.forename: Marc
authors.initials: M
authors.lastname: Chevrier
authors.affiliation: Janssen Research & Development, LLC, Spring House, Pennsylvania.
authors.forename: Scott
authors.initials: S
authors.lastname: Plevy
authors.affiliation: Janssen Scientific Affairs, LLC, Horsham, Pennsylvania.
authors.forename: John
authors.initials: J
authors.lastname: Popp
authors.affiliation: MSD International, Luzern, Switzerland.
authors.forename: Freddy J
authors.initials: FJ
authors.lastname: Cornillie
authors.affiliation: Charles University, Prague, Czech Republic.
authors.forename: Milan
authors.initials: M
authors.lastname: Lukas
authors.affiliation: Istituto Clinico Humanitas, Milan, Italy.
authors.forename: Silvio
authors.initials: S
authors.lastname: Danese
authors.affiliation: S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Gionchetti
authors.affiliation: Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Hanauer
authors.affiliation: McMaster University, Hamilton, Ontario, Canada; Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
authors.forename: Walter
authors.initials: W
authors.lastname: Reinisch
authors.affiliation: University of California San Diego, La Jolla, California.
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.affiliation: Virginia Tech, Carilion School of Medicine, Roanoke, Virginia; Department of Clinical and Experimental Pathology, University of Udine School of Medicine, Udine, Italy.
authors.forename: Dario
authors.initials: D
authors.lastname: Sorrentino
authors.affiliation: University Hospital Gasthuisberg, Leuven, Belgium.
authors.forename: Paul
authors.initials: P
authors.lastname: Rutgeerts
mesh_terms: D000328:Adult; D003082:Colectomy / Q000009:adverse effects*; D003106:Colon / Q000473:pathology / Q000601:surgery; D003113:Colonoscopy; D003424:Crohn Disease / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D004311:Double-Blind Method; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage*; D006801:Humans; D007082:Ileum / Q000473:pathology / Q000601:surgery; D000069285:Infliximab / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011184:Postoperative Period; D012008:Recurrence; D055502:Secondary Prevention / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D005765:Gastrointestinal Agents; D000069285:Infliximab
keywords: Anti-TNF; CDAI; Inflammatory Bowel Disease; PREVENT