Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
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Postoperative therapy with infliximab prevents long-term Crohn's disease recurrence.

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.

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