Gastroenterology

Gastroenterology

Volume 136, Issue 2, February 2009, Pages 441-450.e1
Gastroenterology

Clinical—Alimentary Tract
Infliximab Prevents Crohn's Disease Recurrence After Ileal Resection

https://doi.org/10.1053/j.gastro.2008.10.051Get rights and content

Background & Aims

Crohn's disease commonly recurs after intestinal resection. We evaluated whether the administration of infliximab after resective intestinal surgery for Crohn's disease reduces postoperative recurrence.

Methods

We randomly assigned 24 patients with Crohn's disease who had undergone ileocolonic resection to receive intravenous infliximab (5 mg/kg), administered within 4 weeks of surgery and continued for 1 year, or placebo. The primary end point was the proportion of patients with endoscopic recurrence at 1 year. Secondary end points were clinical recurrence and remission and histologic recurrence.

Results

The rate of endoscopic recurrence at 1 year was significantly lower in the infliximab group (1 of 11 patients; 9.1%) compared with the placebo group (11 of 13 patients; 84.6%) (P = .0006). There was a nonsignificant higher proportion of patients in clinical remission in the infliximab group (8 of 10; 80.0%) compared with the placebo group (7 of 13; 53.8%) (P = .38). The histologic recurrence rate at 1 year was significantly lower in the infliximab group (3 of 11 patients; 27.3%) compared with the placebo group (11 of 13 patients; 84.6%) (P = .01). The occurrence of adverse events was similar between the placebo and infliximab groups, and none occurred in the immediate postoperative period.

Conclusions

Administration of infliximab after intestinal resective surgery was effective at preventing endoscopic and histologic recurrence of Crohn's disease.

Section snippets

Study Design

A randomized, two-armed, double-blind, placebo-controlled trial was conducted at the Inflammatory Bowel Disease Center at the University of Pittsburgh Medical Center. Eligible and consenting patients (described later) were assigned randomly in a blocked 1:1 manner to a regimen of either infusions of infliximab 5 mg/kg or placebo. Because of the blocking mechanism and small sample size, random assignment did not ensure exact 1:1 treatment allocation. The protocol was approved by the

Baseline Demographics

Twenty-four patients were included in the study: 11 in the infliximab group and 13 in the placebo arm. Three patients withdrew before 1 year of follow-up evaluation; 1 patient in the placebo group and 2 patients in the infliximab group. All patients had end-of-study colonoscopic evaluation and were included in the intention-to-treat analysis.

The baseline characteristics of the 2 groups are summarized in Table 2. Characteristics were relatively similar for sex, age, duration of Crohn's disease,

Discussion

We found infliximab to effectively prevent Crohn's disease relapse in the neoterminal ileum after resective surgery. Infliximab prevented endoscopic, clinical, and histologic recurrence of Crohn's disease 1 year after surgery in this cohort of patients. The proportion of patients with endoscopic recurrence at 1 year was only 9.1% in the infliximab group compared with 84.6% in the placebo group. In addition, proportions of patients with clinical and histologic recurrence at 1 year were much

References (31)

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The authors disclose no conflicts.

This work was funded in part by an unrestricted grant from Centocor, Inc Miguel Regueiro, Scott Plevy, and Leonard Baidoo participate or participated as a consultant or speaker for Centocor, Inc.

Registered with www.clinicaltrials.gov (NCT00688636).

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