Journal article
Postoperative Infliximab Is Not Associated with An Increase in Adverse Events in Crohn's Disease
Digestive diseases and sciences, Vol.56(12), pp.3610-3615
01 Dec 2011
PMID: 21681507
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
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.
To evaluate the risk of developing postoperative complications among Crohn's disease patients receiving infliximab within 4 weeks of intestinal resection.
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.
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.
Initiation of infliximab within 4 weeks of intestinal resection was not associated with postoperative complications.
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Details
- Title
- Postoperative Infliximab Is Not Associated with An Increase in Adverse Events in Crohn's Disease
- Creators
- Miguel Regueiro - University of PittsburghSandra El-Hachem - University of PittsburghKevin E. Kip - University of South FloridaWolfgang Schraut - University of PittsburghLeonard Baidoo - University of PittsburghAndrew Watson - University of PittsburghJason Swoger - University of PittsburghMarc Schwartz - University of PittsburghArthur Barrie - University of PittsburghMarilyn Pesci - University of PittsburghDavid Binion - University of Pittsburgh
- Publication Details
- Digestive diseases and sciences, Vol.56(12), pp.3610-3615
- Publisher
- Springer Nature
- Number of pages
- 6
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- General Internal Medicine
- Web of Science ID
- WOS:000297747300027
- Scopus ID
- 2-s2.0-84856165095
- Other Identifier
- 991022054322104721
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Gastroenterology & Hepatology