caa a22 4500 445794496 CHVBK 20180317145120.0 cr unu---uuuuu 170323e20111201xx s 000 0 eng 10.1007/s10620-011-1785-9 doi (NATIONALLICENCE)springer-10.1007/s10620-011-1785-9 Postoperative Infliximab Is Not Associated with An Increase in Adverse Events in Crohn's Disease [Elektronische Daten] [Miguel Regueiro, Sandra El-Hachem, Kevin Kip, Wolfgang Schraut, Leonard Baidoo, Andrew Watson, Jason Swoger, Marc Schwartz, Arthur Barrie, Marilyn Pesci, David Binion] 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 4weeks 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 2-4weeks after surgery. Study infusions were administered at 0, 2, and 6weeks then every 8weeks for 1year. To evaluate whether infliximab increased postoperative complications, we analyzed all adverse events for 1year 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 20days (range 14-25days). Over the course of 1year, 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 8weeks 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 4weeks of intestinal resection was not associated with postoperative complications. Springer Science+Business Media, LLC, 2011 Surgery nationallicence Crohn's disease nationallicence Infliximab nationallicence Safety nationallicence Postoperative nationallicence Adverse events nationallicence Regueiro Miguel Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center, University of Pittsburgh School of Medicine, 200 Lothrop Street, PUH-C Wing Mezzanine Level, 15213, Pittsburgh, PA, USA aut El-Hachem Sandra Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center, University of Pittsburgh School of Medicine, 200 Lothrop Street, PUH-C Wing Mezzanine Level, 15213, Pittsburgh, PA, USA aut Kip Kevin Research Center, College of Nursing, University of South Florida, Tampa, FL, USA aut Schraut Wolfgang Division of Surgical Oncology, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA aut Baidoo Leonard Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center, University of Pittsburgh School of Medicine, 200 Lothrop Street, PUH-C Wing Mezzanine Level, 15213, Pittsburgh, PA, USA aut Watson Andrew Division of Surgical Oncology, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA aut Swoger Jason Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center, University of Pittsburgh School of Medicine, 200 Lothrop Street, PUH-C Wing Mezzanine Level, 15213, Pittsburgh, PA, USA aut Schwartz Marc Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center, University of Pittsburgh School of Medicine, 200 Lothrop Street, PUH-C Wing Mezzanine Level, 15213, Pittsburgh, PA, USA aut Barrie Arthur Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center, University of Pittsburgh School of Medicine, 200 Lothrop Street, PUH-C Wing Mezzanine Level, 15213, Pittsburgh, PA, USA aut Pesci Marilyn Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center, University of Pittsburgh School of Medicine, 200 Lothrop Street, PUH-C Wing Mezzanine Level, 15213, Pittsburgh, PA, USA aut Binion David Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center, University of Pittsburgh School of Medicine, 200 Lothrop Street, PUH-C Wing Mezzanine Level, 15213, Pittsburgh, PA, USA aut Digestive Diseases and Sciences Springer US; http://www.springer-ny.com 56/12(2011-12-01), 3610-3615 0163-2116 56:12<3610 2011 56 10620 https://doi.org/10.1007/s10620-011-1785-9 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s10620-011-1785-9 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Regueiro Miguel Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center, University of Pittsburgh School of Medicine, 200 Lothrop Street, PUH-C Wing Mezzanine Level, 15213, Pittsburgh, PA, USA aut NATIONALLICENCE 700 1- El-Hachem Sandra Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center, University of Pittsburgh School of Medicine, 200 Lothrop Street, PUH-C Wing Mezzanine Level, 15213, Pittsburgh, PA, USA aut NATIONALLICENCE 700 1- Kip Kevin Research Center, College of Nursing, University of South Florida, Tampa, FL, USA aut NATIONALLICENCE 700 1- Schraut Wolfgang Division of Surgical Oncology, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA aut NATIONALLICENCE 700 1- Baidoo Leonard Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center, University of Pittsburgh School of Medicine, 200 Lothrop Street, PUH-C Wing Mezzanine Level, 15213, Pittsburgh, PA, USA aut NATIONALLICENCE 700 1- Watson Andrew Division of Surgical Oncology, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA aut NATIONALLICENCE 700 1- Swoger Jason Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center, University of Pittsburgh School of Medicine, 200 Lothrop Street, PUH-C Wing Mezzanine Level, 15213, Pittsburgh, PA, USA aut NATIONALLICENCE 700 1- Schwartz Marc Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center, University of Pittsburgh School of Medicine, 200 Lothrop Street, PUH-C Wing Mezzanine Level, 15213, Pittsburgh, PA, USA aut NATIONALLICENCE 700 1- Barrie Arthur Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center, University of Pittsburgh School of Medicine, 200 Lothrop Street, PUH-C Wing Mezzanine Level, 15213, Pittsburgh, PA, USA aut NATIONALLICENCE 700 1- Pesci Marilyn Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center, University of Pittsburgh School of Medicine, 200 Lothrop Street, PUH-C Wing Mezzanine Level, 15213, Pittsburgh, PA, USA aut NATIONALLICENCE 700 1- Binion David Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center, University of Pittsburgh School of Medicine, 200 Lothrop Street, PUH-C Wing Mezzanine Level, 15213, Pittsburgh, PA, USA aut NATIONALLICENCE 773 0- Digestive Diseases and Sciences Springer US; http://www.springer-ny.com 56/12(2011-12-01), 3610-3615 0163-2116 56:12<3610 2011 56 10620 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer