The study featured 24 patients who were randomized to receive infliximab (5 mg/kg IV) or placebo after ileal resection, starting within 4 weeks of surgery and continued for 1 year. The main endpoint was the proportion of patients with endoscopic recurrence at 1 year.
Just 1 of 11 patients (9.1%) in the infliximab group had endoscopic recurrence, compared with 11 of 13 patients (84.6%) in the control group, the authors found (p = 0.0006).
The histologic recurrence rate at 1 year was also lower in the infliximab group: 27.3% vs. 84.6% (p = 0.01). The clinical remission rate was non-significantly higher in the infliximab group: 80.0% vs. 53.8%.
Rates of adverse events did not differ between the study groups, the authors note.
"In our practice, we now consider patients with a high risk for postoperative recurrence of Crohn's disease, such as ileal penetrating disease and recurrent resective surgery, for postoperative infliximab prophylaxis," the investigators conclude.
Gastroenterology 2009;136:441-450.
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