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Postoperative therapy with infliximab for Crohn's disease: a 2-year prospective randomized multicenter study in Japan
Kouhei Fukushima1, Akira Sugita2, Kitaro Futami2
1Surgical Research Group, the Research Comittee of Inflammatory Bowel Disease, the Ministry of Health, Welfare and Labor of Japan, Tokyo, Japan. kouhei@surg1.med.tohoku.ac.jp.
Purpose:
The prevention of postoperative recurrence is a critical issue in surgery for Crohn's disease. Prospective randomized trials in Western countries have shown that the postoperative use of anti-tumor necrosis factor α-antibodies was effective in reducing the recurrence rate. We investigated the efficacy of infliximab (IFX) for the prevention of postoperative Crohn's disease recurrence.
Methods:
We performed a prospective randomized multicenter study. Patients who underwent intestinal resection were assigned to groups treated with or without IFX. Immediately after surgery, patients in the IFX group received IFX at 5 mg/kg at 0, 2, and 6 weeks, followed by every 8 weeks for 2 years. The primary study outcome was the proportion of patients with endoscopic and/or clinical recurrence at 2 years after surgery.
Results:
Thirty-eight eligible patients participated in this study: 19 in the IFX group and 19 in the non-IFX group. The disease recurrence rate in the IFX group was 52.6% (10/19), which was significantly lower than that in the non-IFX group (94.7% [18/19]).
Conclusion:
The postoperative use of IFX is effective in preventing Crohn's disease recurrence for 2 years.