Article (Scientific journals)
Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn's Disease After Ileocolonic Resection.
Regueiro, Miguel; Feagan, Brian G.; Zou, Bin et al.
2016In Gastroenterology, 150 (7), p. 1568-78
Peer Reviewed verified by ORBi
 

Files


Full Text
Infliximab reduces endoscopie, but not clinical, recurrence of Crohn's disease after ileocolonic resection-GASTROENTEROLOGY-PostPA.pdf
Author postprint (851.92 kB)
Download

Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.


All documents in ORBi are protected by a user license.

Send to



Details



Keywords :
Anti-TNF; CDAI; Inflammatory Bowel Disease; PREVENT
Abstract :
[en] 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.
Disciplines :
Gastroenterology & hepatology
Author, co-author :
Regueiro, Miguel
Feagan, Brian G.
Zou, Bin
Johanns, Jewel
Blank, Marion A.
Chevrier, Marc
Plevy, Scott
Popp, John
Cornillie, Freddy J.
Lukas, Milan
Danese, Silvio
Gionchetti, Paolo
Hanauer, Stephen B.
Reinisch, Walter
Sandborn, William J.
Sorrentino, Dario
Rutgeerts, Paul
Louis, Edouard  ;  Université de Liège > Département des sciences cliniques > Hépato-gastroentérologie
More authors (8 more) Less
Language :
English
Title :
Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn's Disease After Ileocolonic Resection.
Publication date :
2016
Journal title :
Gastroenterology
ISSN :
0016-5085
eISSN :
1528-0012
Publisher :
Elsevier
Volume :
150
Issue :
7
Pages :
1568-78
Peer reviewed :
Peer Reviewed verified by ORBi
Commentary :
Copyright (c) 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.
Available on ORBi :
since 07 December 2017

Statistics


Number of views
149 (2 by ULiège)
Number of downloads
82 (0 by ULiège)

Scopus citations®
 
235
Scopus citations®
without self-citations
149
OpenCitations
 
211

Bibliography


Similar publications



Contact ORBi