Clinical—Alimentary TractInfliximab Prevents Crohn's Disease Recurrence After Ileal Resection
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)
- et al.
Early lesions of recurrent Crohn's disease caused by infusion of intestinal contents in excluded ileum
Gastroenterology
(1998) The problem of postoperative recurrence of Crohn's disease
Med Clin North Am
(1990)Prevention of postoperative recurrence in Crohn's disease
Clin Gastroenterol Hepatol
(2008)- et al.
Controlled trial of metronidazole treatment for prevention of Crohn's recurrence after ileal resection
Gastroenterology
(1995) - et al.
Ornidazole for prophylaxis of postoperative Crohn's disease recurrence: a randomized, double-blind, placebo-controlled trial
Gastroenterology
(2005) - et al.
Postoperative maintenance of Crohn's disease remission with 6-mercaptopurine, mesalamine, or placebo: a 2-year trial
Gastroenterology
(2004) - et al.
Effects of cigarette smoking on the long-term course of Crohn's disease
Gastroenterology
(1996) - et al.
National Cooperative Crohn's Disease Study: factors determining recurrence of Crohn's disease after surgery
Gastroenterology
(1979) - et al.
Risk factors for early postoperative recurrence of Crohn's disease
Gastroenterology
(1998) - et al.
National Cooperative Crohn's Disease Study: results of drug treatment
Gastroenterology
(1979)
Prophylactic mesalamine treatment decreases postoperative recurrence of Crohn's disease
Gastroenterology
Mesalamine in the prevention of endoscopic recurrence after intestinal resection for Crohn's disease
Gastroenterology
Prophylaxis of postoperative relapse in Crohn's disease with mesalamine: European Cooperative Crohn's Disease Study VI
Gastroenterology
A randomized, placebo-controlled, double-blind trial of mesalamine in the maintenance of remission of Crohn's diseaseThe Canadian Mesalamine for Remission of Crohn's Disease Study Group
Gastroenterology
Impact of increasing use of immunosuppressants in Crohn's disease on the need for intestinal surgery
Gut
Cited by (547)
Fragility index analysis for randomized controlled trials of approved biologicals and small molecule drugs in inflammatory bowel diseases
2024, International ImmunopharmacologyCrohn's disease
2024, The LancetUse of biologics for the management of Crohn's disease: IG-IBD technical review based on the GRADE methodology
2023, Digestive and Liver DiseaseUstekinumab and vedolizumab for the prevention of postoperative recurrence of Crohn's disease: Results from the ENEIDA registry
2023, Digestive and Liver DiseaseAre the New Biologics Effective in the Management of Postoperative Crohn’s Disease?
2024, Inflammatory Bowel Diseases
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).