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- Title
Postoperative infliximab is not associated with an increase in adverse events in Crohn's disease.
- Authors
Regueiro, Miguel; El-Hachem, Sandra; Kip, Kevin; Schraut, Wolfgang; Baidoo, Leonard; Watson, Andrew; Swoger, Jason; Schwartz, Marc; Barrie, Arthur; Pesci, Marilyn; Binion, David; Kip, Kevin E
- Abstract
<bold>Background: </bold>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.<bold>Aims: </bold>To evaluate the risk of developing postoperative complications among Crohn's disease patients receiving infliximab within 4 weeks of intestinal resection.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>Initiation of infliximab within 4 weeks of intestinal resection was not associated with postoperative complications.
- Subjects
INFLAMMATORY bowel disease treatment; POSTOPERATIVE period; INFLIXIMAB; ADVERSE health care events; PHARMACODYNAMICS; DISEASE relapse; SURGICAL complications; CROHN'S disease diagnosis; PREVENTION of surgical complications; COLECTOMY; COLONOSCOPY; COMPARATIVE studies; DRUG administration; DOSE-effect relationship in pharmacology; CROHN'S disease; GASTROINTESTINAL agents; INTRAVENOUS therapy; LONGITUDINAL method; RESEARCH methodology; MEDICAL cooperation; MONOCLONAL antibodies; POSTOPERATIVE care; RESEARCH; STATISTICAL sampling; TUMOR necrosis factors; EVALUATION research; RANDOMIZED controlled trials; TREATMENT effectiveness; DISEASE incidence; BLIND experiment; CHEMICAL inhibitors
- Publication
Digestive Diseases & Sciences, 2011, Vol 56, Issue 12, p3610
- ISSN
0163-2116
- Publication type
journal article
- DOI
10.1007/s10620-011-1785-9