Gastro hep advances · 2026
Impact of Vedolizumab on Bowel Urgency in Ulcerative Colitis: Post Hoc Analysis of the GEMINI 1, VISIBLE 1, and VARSITY Trials.
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Collins Angelina E, Gift Thais, Kim Edward, Robinson Ian
Аннотация
BACKGROUND AND AIMS: Bowel urgency is a particularly burdensome symptom for adults with ulcerative colitis. This post hoc analysis of 3 phase 3 studies evaluated the effects of vedolizumab on bowel urgency using selected items from the Inflammatory Bowel Disease Questionnaire (IBDQ).
METHODS: Data were pooled from 3 phase 3 randomized trials: GEMINI 1 (NCT00783718), VISIBLE 1 (NCT02611830), and VARSITY (NCT02497469). Adults with moderate to severe ulcerative colitis who received vedolizumab or placebo and completed the IBDQ were included. Items Q11, Q16, and Q26 from the IBDQ were combined to create a bowel urgency composite score. Bowel urgency resolution was defined as the absence of symptoms across all 3 items. Primary outcomes were the change in bowel urgency composite score and the proportion of patients with bowel urgency resolution at week 52. Exploratory outcomes included change in bowel urgency composite score and bowel urgency resolution stratified by anti-tumor necrosis factor-α exposure status, disease activity, and treatment arm (intravenous vedolizumab once every 8 weeks vs placebo), and the relationship between bowel urgency and clinical and endoscopic outcomes.
RESULTS: Overall, 1225 patients were included. Patients receiving vedolizumab had greater changes in bowel urgency composite scores than placebo overall and when stratified into subgroups. A greater proportion of patients in the vedolizumab group (44%) attained bowel urgency resolution than the placebo group (22%). Bowel urgency resolution at week 6 was significantly associated with attaining all clinical and endoscopic outcomes at week 6, and with attaining clinical remission, endoscopic improvement, and symptomatic remission at week 52 (all P < .05).
CONCLUSION: Bowel urgency-related symptoms, assessed by the IBDQ, were improved in patients receiving vedolizumab vs placebo.
METHODS: Data were pooled from 3 phase 3 randomized trials: GEMINI 1 (NCT00783718), VISIBLE 1 (NCT02611830), and VARSITY (NCT02497469). Adults with moderate to severe ulcerative colitis who received vedolizumab or placebo and completed the IBDQ were included. Items Q11, Q16, and Q26 from the IBDQ were combined to create a bowel urgency composite score. Bowel urgency resolution was defined as the absence of symptoms across all 3 items. Primary outcomes were the change in bowel urgency composite score and the proportion of patients with bowel urgency resolution at week 52. Exploratory outcomes included change in bowel urgency composite score and bowel urgency resolution stratified by anti-tumor necrosis factor-α exposure status, disease activity, and treatment arm (intravenous vedolizumab once every 8 weeks vs placebo), and the relationship between bowel urgency and clinical and endoscopic outcomes.
RESULTS: Overall, 1225 patients were included. Patients receiving vedolizumab had greater changes in bowel urgency composite scores than placebo overall and when stratified into subgroups. A greater proportion of patients in the vedolizumab group (44%) attained bowel urgency resolution than the placebo group (22%). Bowel urgency resolution at week 6 was significantly associated with attaining all clinical and endoscopic outcomes at week 6, and with attaining clinical remission, endoscopic improvement, and symptomatic remission at week 52 (all P < .05).
CONCLUSION: Bowel urgency-related symptoms, assessed by the IBDQ, were improved in patients receiving vedolizumab vs placebo.