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. 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.

Charles University Prague Czech Republic

Feinberg School of Medicine Northwestern University Chicago Illinois

Inflammatory Bowel Disease Center and Division of Gastroenterology Hepatology and Nutrition University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Istituto Clinico Humanitas Milan Italy

Janssen Research and Development LLC Spring House Pennsylvania

Janssen Scientific Affairs LLC Horsham Pennsylvania

McMaster University Hamilton Ontario Canada; Department of Internal Medicine 3 Medical University of Vienna Vienna Austria

MSD International Luzern Switzerland

Robarts Research Institute University of Western Ontario London Ontario Canada

S Orsola Malpighi Hospital University of Bologna Bologna Italy

University Hospital Gasthuisberg Leuven Belgium

University of California San Diego La Jolla California

Virginia Tech Carilion School of Medicine Roanoke Virginia; Department of Clinical and Experimental Pathology University of Udine School of Medicine Udine Italy

Gastroenterology. 2016 Jun;150(7):1521-1524. doi: 10.1053/j.gastro.2016.04.033. PubMed

Gastroenterology. 2016 Nov;151(5):1040-1041. doi: 10.1053/j.gastro.2016.08.058. PubMed

Gastroenterology. 2016 Nov;151(5):1041-1042. doi: 10.1053/j.gastro.2016.09.044. PubMed

References provided by Crossref.org

Preventing Recurrence of Crohn's Disease Post-Ileocaecal Surgery in Paediatric Patients: A Therapy Guide Based on Systematic Review of the Evidence

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ClinicalTrials.gov
NCT01190839