title: Postoperative infliximab is not associated with an increase in adverse events in Crohn's disease.
abstract: 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.
  
  
  OBJECTIVE
  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.
authors.affiliation: Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center, University of Pittsburgh School of Medicine, 200 Lothrop Street, PUH-C Wing Mezzanine Level, Pittsburgh, PA 15213, USA. mdr7@pitt.edu
authors.forename: Miguel
authors.initials: M
authors.lastname: Regueiro
authors.forename: Sandra
authors.initials: S
authors.lastname: El-Hachem
authors.forename: Kevin E
authors.initials: KE
authors.lastname: Kip
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Schraut
authors.forename: Leonard
authors.initials: L
authors.lastname: Baidoo
authors.forename: Andrew
authors.initials: A
authors.lastname: Watson
authors.forename: Jason
authors.initials: J
authors.lastname: Swoger
authors.forename: Marc
authors.initials: M
authors.lastname: Schwartz
authors.forename: Arthur
authors.initials: A
authors.lastname: Barrie
authors.forename: Marilyn
authors.initials: M
authors.lastname: Pesci
authors.forename: David
authors.initials: D
authors.lastname: Binion
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D003082:Colectomy / Q000009:adverse effects*; D003113:Colonoscopy; D003424:Crohn Disease / Q000175:diagnosis / Q000188:drug therapy / Q000601:surgery*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005765:Gastrointestinal Agents / Q000008:administration & dosage; D006801:Humans; D015994:Incidence; D000069285:Infliximab; D007262:Infusions, Intravenous; D008297:Male; D011182:Postoperative Care / Q000379:methods*; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab