Journal article
Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn's Disease After Ileocolonic Resection
Gastroenterology (New York, N.Y. 1943), Vol.150(7), pp.1568-1578
06/2016
DOI: 10.1053/j.gastro.2016.02.072
PMID: 26946343
Abstract
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.
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.
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.
Infliximab is not superior to placebo in preventing clinical recurrence after CD-related resection. However, infliximab does reduce endoscopic recurrence. ClinicalTrials.gov ID NCT01190839.
Details
- Title: Subtitle
- Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn's Disease After Ileocolonic Resection
- Creators
- Miguel Regueiro - Inflammatory Bowel Disease Center and Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. Electronic address: mdr7@pitt.eduBrian G Feagan - Robarts Research Institute, University of Western Ontario, London, Ontario, CanadaBin Zou - Janssen Research & Development, LLC, Spring House, PennsylvaniaJewel Johanns - Janssen Research & Development, LLC, Spring House, PennsylvaniaMarion A Blank - Janssen Scientific Affairs, LLC, Horsham, PennsylvaniaMarc Chevrier - Janssen Research & Development, LLC, Spring House, PennsylvaniaScott Plevy - Janssen Research & Development, LLC, Spring House, PennsylvaniaJohn Popp - Janssen Scientific Affairs, LLC, Horsham, PennsylvaniaFreddy J Cornillie - MSD International, Luzern, SwitzerlandMilan Lukas - Charles University, Prague, Czech RepublicSilvio Danese - Istituto Clinico Humanitas, Milan, ItalyPaolo Gionchetti - S. Orsola-Malpighi Hospital, University of Bologna, Bologna, ItalyStephen B Hanauer - Feinberg School of Medicine, Northwestern University, Chicago, IllinoisWalter Reinisch - McMaster University, Hamilton, Ontario, Canada; Department of Internal Medicine III, Medical University of Vienna, Vienna, AustriaWilliam J Sandborn - University of California San Diego, La Jolla, CaliforniaDario Sorrentino - Virginia Tech, Carilion School of Medicine, Roanoke, Virginia; Department of Clinical and Experimental Pathology, University of Udine School of Medicine, Udine, ItalyPaul Rutgeerts - University Hospital Gasthuisberg, Leuven, BelgiumPREVENT Study Group
- Contributors
- David E Elliott (Contributor) - University of Iowa, Internal Medicine
- Resource Type
- Journal article
- Publication Details
- Gastroenterology (New York, N.Y. 1943), Vol.150(7), pp.1568-1578
- DOI
- 10.1053/j.gastro.2016.02.072
- PMID
- 26946343
- ISSN
- 0016-5085
- eISSN
- 1528-0012
- Language
- English
- Date published
- 06/2016
- Academic Unit
- Gastroenterology and Hepatology; Internal Medicine
- Record Identifier
- 9984094511102771
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