title: Postoperative Outcomes in Vedolizumab-Treated Patients Undergoing Abdominal Operations for Inflammatory Bowel Disease.
abstract: BACKGROUND
  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.
authors.affiliation: Division of Colon and Rectal Surgery, Mayo Clinic, Rochester, MN, USA Lightner.amy@mayo.edu.
authors.forename: Amy L
authors.initials: AL
authors.lastname: Lightner
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.
authors.forename: Laura E
authors.initials: LE
authors.lastname: Raffals
authors.affiliation: Division of Colon and Rectal Surgery, Mayo Clinic, Rochester, MN, USA.
authors.forename: Kellie L
authors.initials: KL
authors.lastname: Mathis
authors.affiliation: Division of Colon and Rectal Surgery, Mayo Clinic, Rochester, MN, USA.
authors.forename: Robert R
authors.initials: RR
authors.lastname: Cima
authors.affiliation: Division of Internal Medicine, Mayo Clinic, Rochester, MN, USA.
authors.forename: Chung Sang
authors.initials: CS
authors.lastname: Tse
authors.affiliation: Division of Colon and Rectal Surgery, Mayo Clinic, Rochester, MN, USA.
authors.forename: John H
authors.initials: JH
authors.lastname: Pemberton
authors.affiliation: Division of Colon and Rectal Surgery, Mayo Clinic, Rochester, MN, USA.
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Dozois
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.
authors.forename: Edward V
authors.initials: EV
authors.lastname: Loftus
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D003093:Colitis, Ulcerative / Q000188:drug therapy / Q000276:immunology / Q000601:surgery; D003424:Crohn Disease / Q000188:drug therapy / Q000276:immunology / Q000601:surgery; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D000069285:Infliximab / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013514:Surgical Procedures, Operative / Q000009:adverse effects*; D013530:Surgical Wound Infection / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors; D014481:United States
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D005765:Gastrointestinal Agents; D014409:Tumor Necrosis Factor-alpha; C543529:vedolizumab; D000069285:Infliximab
keywords: Vedolizumab; postoperative outcomes; surgical outcomes