Original articleAlimentary tractPostoperative Therapy With Infliximab Prevents Long-term Crohn’s Disease Recurrence
Section snippets
Study Design
The study design consisted of a prospective, open-label long-term follow-up study (>5 years) of patients from our previously published randomized controlled trial of infliximab vs placebo for postoperative Crohn’s disease.12 The study was conducted at the Inflammatory Bowel Disease Center at the University of Pittsburgh Medical Center, with collection of data beyond the initial 1-year randomized controlled study approved by the Institutional Review Board at the University of Pittsburgh Medical
Study Population
The 24 participants in the original study (infliximab, n = 11; placebo, n = 13) were enrolled between October 2004 and April 2007 and completed their participation by December 2012. The mean length of study participation was 6.5 ± 0.6 years, with a minimum of 5.4 and maximum of 7.7 years. Mean years of participation were similar between patients assigned to infliximab (6.4 ± 0.8) or to placebo (6.5 ± 0.5, P = .88). As previously reported, baseline characteristics of the 2 groups were similar
Discussion
This is the longest postoperative Crohn’s disease study to date and provides insight into the natural course of disease after surgical resection as well as the impact of postoperative treatment. Patients originally assigned to infliximab had a significantly longer time to first endoscopic recurrence and the need for re-resection compared with placebo patients. When considering each colonoscopy as a separate event, more than three-fourths of the colonoscopies done on patients on infliximab
Acknowledgments
The authors thank the Sigal Family Research & Education Inflammatory Bowel Disease Fund for their support and Marilyn Pesci, RN, for her assistance with study coordination and data collection.
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Conflicts of interest This author discloses the following: Miguel Regueiro has served as a consultant for Abbvie, Janssen, Shire, Takeda, and UCB. The remaining authors disclose no conflicts.