Vedolizumab Has No Effect on the Course of Non-Alcoholic Fatty Liver Disease: A Retrospective Cohort Analysis

Background and Aim: Non-Alcoholic Fatty Liver Disease (NAFLD) is the commonest cause of chronic liver disease and is a leading cause of liver transplantation in the United States, with no approved medication to halt or reverse its progression. Recent animal-model prospective trial-suggested that drug Vedolizumab leads to improvement and reversal in the NAFLD-related metabolic derangements. Vedolizumab is an α4β7 integrin-inhibitor that is approved for use in IBD patients. Our study aims to understand Vedolizumab's impact on the course of NAFLD in inflammatory bowel disease (IBD) patients. Methods: We conducted a retrospective cohort analysis of 158 subjects with NAFLD who received Vedolizumab at Cleveland Clinic Foundation (CCF). One cohort of 79 patients with NAFLD who received Vedolizumab were matched with control group of 79 patients. We determined the primary outcome as the response to Vedolizumab measured as Fibrosis-4 (Fib-4) regression to <1.3 points after one year of treatment. Results: We observed that there was no statistically significant difference response (p= 0.576), progression of the disease (p= 1.000) or change in the number of cirrhosis decompensation episodes (in those with NAFLD cirrhosis) among Vedolizumab recipients. Conclusions: In this retrospective cohort analysis, and unlike in the previous animal model, Vedolizumab was not associated with statistically significant improvement or progression in the Fib-4 score after one year of treatment, and among those with NAFLD-cirrhosis, there was no statistical difference in the complication rates.