2909 Vedolizumab Safety Profile in Treatment of Elderly IBD Patients

Abstract

INTRODUCTION: Vedolizumab is an anti-integrin therapy for IBD. It is a monoclonal antibody that selectively inhibits the interaction between the MAdCAM-1 receptor and α4β7 integrin in the gut. Vedolizumab, in comparison to other biologics, has a smaller pool of literature designating it's safety profile, specifically in the elderly (age >65 years of age) population of IBD patients. The GEMINI post-hoc trials have indicated an acceptable rate of infections, adverse reactions leading to hospitalization, and rate of malignancy in patients older than 55 years of age. The elderly subset of patients, designated as those 60-65 years of age or older by prior literature, is a growing population in need of effective and safe treatment of their IBD. METHODS: We searched the Epic database for Lahey patients with a diagnosis of inflammatory bowel disease, searching for patients who had been prescribed vedolizumab for this diagnosis. Of the compiled list of patients collected with these criteria, we searched the patient charts for the occurrence of flares, infections, development of malignancy, and death. Reasons for exclusion from the study include discontinuation of vedolizumab before completion of induction dosing, not being on vedolizumab, and lack of gastroenterology follow-up at Lahey Medical Center by a Lahey gastroenterologist. RESULTS: Of a total of 86 patients with IBD, ages ranging from 23-81 years of age, there was no significant difference found in the time to flare, time to remission from flare, incidence of infections, arthralgias, or malignancy in patients with IBD >65 after starting vedolizumab. Non-melanomatous skin cancer was the most common malignancy diagnosed after starting vedolizumab in both groups. CONCLUSION: Our data indicated no statistical difference between the adverse reactions leading to hospitalization, time to flare, and malignancy between the elderly and non-elderly IBD patients undergoing treatment with vedolizumab. However, our current data is primarily limited by small sample size and unequal study arm size. Also, our sample is primarily Caucasian, limiting our data's application to non-white IBD patient populations. We are currently working to combine our data with that of other hospital populations to overcome this limitation.