Abstract BACKGROUND The global prevalence of obesity and inflammatory bowel disease (IBD) has increased in recent decades. Body mass index (BMI) is a commonly used surrogate measure of adiposity routinely reported as demographic data in clinical trials. The subcutaneous (SC) formulation of vedolizumab was approved in the USA in 2023 as a maintenance therapy for adults with moderate to severe ulcerative colitis (UC); however, treatment outcomes with vedolizumab SC in patients living with obesity have not been assessed. This post hoc analysis of the VISIBLE 1 phase 3 trial (NCT02611830) evaluated the efficacy and safety of vedolizumab SC in patients with UC stratified by BMI. METHODS This analysis used data from patients with moderate to severe UC receiving vedolizumab SC as maintenance therapy or placebo in the VISIBLE 1 trial. Patients were stratified by baseline BMI ( 20, 20– 25, 25– 30, ≥ 30). Efficacy outcomes at week 52 included clinical remission (a total Mayo score of ≤ 2 and no individual sub-score 1), durable clinical response (a reduction in total Mayo score of ≥ 3 and ≥ 30% from baseline with an accompanying decrease in rectal bleeding sub-score of ≥ 1 or absolute rectal bleeding sub-score of 0 or 1 at weeks 6 and 52), endoscopic improvement (a Mayo endoscopic sub-score of 0 or 1), and patient-reported outcome-2 (PRO-2) remission (a rectal bleeding score and stool frequency score of 0). Safety outcomes included treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs leading to treatment discontinuation. Baseline characteristics and the proportion of patients with each efficacy and safety outcome were analyzed by BMI group using descriptive statistics. RESULTS In total, 106 patients receiving vedolizumab SC and 56 patients receiving placebo were included. Mean (standard deviation SD) age and UC duration at baseline, respectively, for each group were: BMI 20 (vedolizumab SC, 31.6 11.0 years, 7.8 7.0 years; placebo, 40.6 13.4 years, 6.9 5.4 years); BMI 20– 25 (vedolizumab SC, 39.0 14.2 years, 7.7 5.6 years; placebo, 38.5 10.1 years, 8.9 7.0 years); BMI 25– 30 (vedolizumab SC, 38.3 11.1 years, 7.2 5.7 years; placebo, 39.9 12.5 years, 7.2 9.3 years); BMI ≥ 30 (vedolizumab SC, 50.6 10.4 years, 11.9 8.2 years; placebo, 38.7 13.5 years, 4.0 1.8 years). Across all BMI groups, a greater proportion of patients receiving vedolizumab SC consistently achieved efficacy outcomes compared with those receiving placebo (Table 1). No new safety signals were identified in either treatment arm across any BMI group (Table 2). CONCLUSION This post hoc analysis demonstrates that, when stratified by baseline BMI, the proportions of patients with UC who achieved efficacy outcomes during VISIBLE 1 were higher for those receiving vedolizumab SC than placebo. Safety outcomes were similar across all BMI groups.
Cohen et al. (Thu,) studied this question.