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Research Article: Long-term effectiveness and safety of vedolizumab in ulcerative colitis: a real-world retrospective cohort study over 2?years

Date Published: 2026-05-18

Abstract:
Vedolizumab (VDZ), a gut-selective anti-integrin therapy, has demonstrated efficacy in ulcerative colitis (UC) clinical trials, but real-world long-term data from Asia, particularly from Chinese populations, remain limited. Therefore, this study aimed to evaluate the long-term effectiveness and safety of vedolizumab in Chinese patients with UC in a real-world setting over a 2-year period. In this retrospective cohort study conducted at a tertiary hospital in China, patients aged ?18?years old who received VDZ for UC between December 2020 and August 2023 were enrolled. Information on the clinical characteristics, prior/concomitant treatment, and safety during the observation period was collected. The data obtained from 112 patients (males, n =?62) were analyzed. The median age at VDZ induction was 40.37?years old. VDZ was indicated as the first biologic in 85.71% of patients. Clinical remission rates at weeks 14, 54, and 104 were 61.61, 66.96, and 58.93%, respectively. VDZ persistence was 78.57% at 1?year and 61.61% at 2?years. Concomitant use of 5-ASA or steroids was associated with poorer drug persistence (HR?=?3.13 and 5.03, p <?0.01). Clinical response at week 14 predicted sustained remission (OR?=?6.07, p <?0.001). Nine adverse drug reactions (ADRs) were noted, none severe. This real-world study confirms vedolizumab’s sustained effectiveness in UC, with durable remission and excellent safety over 2?years. The findings support its position in treatment algorithms and highlight the value of early response assessment in guiding therapeutic decisions.

Introduction:
Vedolizumab (VDZ), a gut-selective anti-integrin therapy, has demonstrated efficacy in ulcerative colitis (UC) clinical trials, but real-world long-term data from Asia, particularly from Chinese populations, remain limited. Therefore, this study aimed to evaluate the long-term effectiveness and safety of vedolizumab in Chinese patients with UC in a real-world setting over a 2-year period.

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