736 Vedolizumab: Peri-Operative Infection Rates in Patients With IBD

Abstract

INTRODUCTION: Vedolizumab (VDZ), a humanized monoclonal antibody, binds to the alpha4beta7 integrin and blocks the interaction of mucosal cell adhesion molecule-1 thus inhibiting the migration of memory T-lymphocytes into inflamed GI parenchymal tissue. This interaction is a hallmark of Ulcerative colitis (UC) and Crohn's disease (CD). It has been used as an alternative therapy to anti-tumor necrosis factor (anti-TNF) agents for Induction and maintenance in patients with moderate to severe inflammatory bowel diseases (IBD). Due to its immunosuppressive effects, VDZ maybe associated with increased risks of infections. Therefore, it is imperative to study the infection rate in this population, particularly during the perioperative period. Our objective is to identify perioperative infection rates in patients with Inflammatory Bowel Disease (IBD). METHODS: A retrospective multi-center case-control study was conducted. Patients with IBD in the period from May 2014 to Dec 2017 were included. Two groups were studied (Pt with IBD and on VDZ, Pt with IBD and not on VDZ). The perioperative period was identified as up to 30 days post-index surgery. ICD-10 codes for intra-abdominal surgeries and infections were used to identify population. Patients developing only new infections were included. Data were classified into two cohorts for the purpose of comparison: Cohort 1 included all-infections and Cohort 2 included only intra-abdominal infection. Different models of logistic regression data analysis were performed. RESULTS: Logistic regression data analysis was performed including simple, multiple and mixed model for both cohorts. The mixed model included multiple encounters per person, age, gender, ethnicity, and race. Results of Cohort 1 showed odds ratio (OR) = 1.332 (CI 0.599-2.965, P = 0.4821). Results of Cohort 2: OR = 1.286 (CI 0.426-3.882, P = 0.6551). These findings indicated that there was no statistical significance between increased rates of peri-operative infection rates and VDZ use. CONCLUSION: Our findings suggested that VDZ is relatively safe to use during the perioperative period. There are a few small studies indicating similar results, however, a unique aspect of our study was to include broad-spectrum infection types (sepsis from any source such as pneumonia, UTI) and not only intra-abdominal or surgery-related infections. We do recommend further investigations with more controlled study and larger population coverage to further solidify our findings.