Postoperative Outcomes in Vedolizumab-Treated Patients Undergoing Abdominal Operations for Inflammatory Bowel Disease

J Crohns Colitis. 2017 Feb;11(2):185-190. doi: 10.1093/ecco-jcc/jjw147. Epub 2016 Aug 19.

Abstract

Introduction: Vedolizumab was recently approved by the Food and Drug Administration for the treatment of moderate to severe ulcerative colitis [UC] and Crohn's disease [CD]. No study to date has examined the rate of postoperative infectious complications among patients who received vedolizumab in the perioperative period. We sought to determine the 30-day postoperative infectious complication rate among inflammatory bowel disease [IBD] patients who received vedolizumab within 12 weeks of an abdominal operation as compared to patients who received tumour necrosis factor α [TNFα] inhibitors or no biological therapy.

Methods: A retrospective chart review between May 1, 2014 and December 31, 2015 of adult IBD patients who underwent an abdominal operation was performed. The study cohort comprised patients who received vedolizumab within 12 weeks of their abdominal operation and the control cohorts were patients who received TNFα inhibitors or no biological therapy.

Results: In total, 94 patients received vedolizumab within 12 weeks of an abdominal operation. Fifty experienced postoperative complications [53%], 35 of which were surgical site infections [SSIs] [36%]. The vedolizumab group experienced significantly higher rates of any postoperative infection [53% vs 33% anti-TNF and 28% non-biologics; p<0.001] and SSI [37% vs 10% and 13%; p<0.001]. On univariate and multivariate analysis, exposure to vedolizumab remained a significant predictor of postoperative SSI [p<0.001].

Conclusions: Thirty-seven per cent of IBD patients who received vedolizumab within 30 days of a major abdominal operation experienced a 30-day postoperative SSI, significantly higher than patients receiving TNFα inhibitors or no biological therapy. Vedolizumab within 12 weeks of surgery remained the only predictor of 30-day postoperative SSI on multivariate analysis.

Keywords: Vedolizumab; postoperative outcomes; surgical outcomes.

MeSH terms

  • Adult
  • Aged
  • Antibodies, Monoclonal, Humanized* / administration & dosage
  • Antibodies, Monoclonal, Humanized* / adverse effects
  • Colitis, Ulcerative* / drug therapy
  • Colitis, Ulcerative* / immunology
  • Colitis, Ulcerative* / surgery
  • Crohn Disease* / drug therapy
  • Crohn Disease* / immunology
  • Crohn Disease* / surgery
  • Female
  • Gastrointestinal Agents / administration & dosage
  • Gastrointestinal Agents / adverse effects
  • Humans
  • Infliximab* / administration & dosage
  • Infliximab* / adverse effects
  • Male
  • Middle Aged
  • Retrospective Studies
  • Risk Assessment
  • Risk Factors
  • Surgical Procedures, Operative / adverse effects*
  • Surgical Wound Infection* / diagnosis
  • Surgical Wound Infection* / epidemiology
  • Surgical Wound Infection* / etiology
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors
  • United States

Substances

  • Antibodies, Monoclonal, Humanized
  • Gastrointestinal Agents
  • Tumor Necrosis Factor-alpha
  • vedolizumab
  • Infliximab