Postoperative Infliximab Is Not Associated with An Increase in Adverse Events in Crohn’s Disease
- نوع فایل : کتاب
- زبان : انگلیسی
- مؤلف : Miguel Regueiro Sandra El-Hachem Kevin E. Kip Wolfgang Schraut Leonard Baidoo Andrew Watson Jason Swoger Marc Schwartz Arthur Barrie
- چاپ و سال / کشور: 2011
Description
Background Infliximab is effective treatment for Crohn’s disease and has been associated with rare, but serious infectious complications. Emerging data suggest a benefit of infliximab in preventing postoperative Crohn’s disease recurrence. It is not known whether administration of infliximab shortly after resective surgery for Crohn’s disease increases postoperative complications. Aims To evaluate the risk of developing postoperative complications among Crohn’s disease patients receiving infliximab within 4 weeks of intestinal resection. Methods As part of a randomized placebo-controlled infliximab postoperative prevention study, adverse events were prospectively monitored. Crohn’s disease patients undergoing intestinal resection were randomized to placebo or infliximab 2–4 weeks after surgery. Study infusions were administered at 0, 2, and 6 weeks then every 8 weeks for 1 year. To evaluate whether infliximab increased postoperative complications, we analyzed all adverse events for 1 year after surgery. Results Twenty-four patients were randomized to infliximab or placebo after intestinal resection for Crohn’s disease. Mean time to first postoperative infusion was 20 days (range 14–25 days). Over the course of 1 year, there were 22 total adverse events, but no difference between infliximab and placebo patients (12 versus 10, respectively, P = 1.0). In the immediate postoperative period, within 8 weeks of surgery, the number of adverse events was also similar between the two groups (3 infliximab and 5 placebo patients, P = 0.68). There were no serious adverse events and no complications related to wound healing or infection. Conclusions Initiation of infliximab within 4 weeks of intestinal resection was not associated with postoperative complications
Dig Dis Sci DOI 10.1007/s10620-011-1785-9 Received: 2 March 2011 / Accepted: 4 June 2011
