Frontiers in medicine · 2026
Long-term effectiveness and safety of vedolizumab in ulcerative colitis: a real-world retrospective cohort study over 2 years.
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Zhang Peipei, Yu Xin, He Shengfu, Guan Jing, Wu Yumei, Zhao Yuanyuan, Hu Jing, Liu Qiuyuan, Wu Juan, Mei Qiao, Han Wei
Аннотация
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.