Background: Vedolizumab, a gut specific monoclonal antibody targeting the α4β7 integrin, was recently approved for treatment of moderate to severe ulcerative colitis (UC) and Crohn's disease (CD). We combined data from four institutions to investigate the 30-day postoperative complication rate among IBD patients who received vedolizumab within 12 weeks of an abdominal operation as compared to patients who received TNFα inhibitors or no biologic therapy.
Methods: A multicenter retrospective review of adult IBD patients who underwent an abdominal operation between 5/20/2014 and 12/31/2015 was performed. The study cohort was comprised of patients who received vedolizumab within 12 weeks of their abdominal operation and the control cohorts were patients who received TNFα inhibitors or no biologic therapy.
Results: 142 patients received vedolizumab within 12 weeks prior to an abdominal operation. Vedolizumab treated patients were younger (p<0.001) and were more likely to have taken steroids and/or immunomodulators (IMM) within the 12 weeks prior to surgery (p<0.001). Fewer vedolizumab treated patients had a primary anastomosis (p=0.001), but more underwent laparoscopic surgery (p=0.003) and had an ostomy formed at the time of their operation (p=0.029). Vedolizumab treated patients had a significantly increased risk of any postoperative Surgical Site Infection (SSI) (p<0.001), superficial SSI (p<0.001), deep space SSI (p=0.001), anastomotic leak (p=0.032), and mucocutaneous separation of the diverting stoma (p=0.017).
On univariate and multivariate analysis, exposure to vedolizumab remained a significant predictor of postoperative SSI (p<0.001).
There were no significant differences found across the four institutions in the SSI rate.
Conclusions: We found vedoliuzmab treated patients are at significantly increased risk of postoperative SSIs and anastomotic leaks following a major abdominal operation. Consideration to be given to delaying surgery in elective settings and diverting anastomoses with a protective stoma.