Original article
Alimentary tract
Postoperative Therapy With Infliximab Prevents Long-term Crohn’s Disease Recurrence

https://doi.org/10.1016/j.cgh.2013.12.035Get rights and content

Background & Aims

A previous randomized, placebo-controlled study showed that infliximab maintenance therapy prevented recurrence of Crohn’s disease 1 year after an ileocolonic resection. We evaluated recurrence of Crohn’s disease, on the basis of endoscopic examination and/or the need for additional surgical resection, beyond the first postoperative year.

Methods

In a prospective, open-label, long-term follow-up study, 24 patients previously randomly assigned to receive infliximab for 1 year after an ileocolonic resection were given the option to continue, stop, or start infliximab therapy. The primary end point was the time to recurrence of Crohn’s disease, on the basis of endoscopic evidence (endoscopic recurrence), from the initial assignment to postoperative infliximab or placebo. Secondary end points were rate of endoscopic recurrence, time to reoperation, and rate of surgical recurrence in relation to the total time on infliximab.

Results

All patients were followed for at least 5 years after surgery. Patients assigned to the infliximab group in the first year after surgery had a longer mean time to first endoscopic recurrence (1231 ± 747 days) than patients originally assigned to the placebo group (460 ± 121 days, P = .003). Colonoscopies identified Crohn’s disease recurrence in 22.2% of patients who received long-term infliximab and in 93.9% of those not on infliximab (P < .0001). Compared with no infliximab, the adjusted rate ratio for being in endoscopic remission while on infliximab was 13.47 (95% confidence interval, 3.52–61.53; P = .0001). Patients originally assigned to the infliximab group had a mean longer time to surgery (1798 ± 359 days) than patients originally assigned to the placebo group (1058 ± 529 days, P = .04). The rate of surgical recurrence (required additional surgical resection) was significantly lower among patients who received infliximab for most of the follow-up period than patients who received it for shorter periods (20.0% vs 64.3%, P = .047).

Conclusions

Postoperative infliximab maintenance beyond 1 year prevents recurrence of Crohn’s disease.

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.

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