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维多珠单抗治疗中老年与青年中重度溃疡性结肠炎患者的疗效及安全性:一项中国的回顾性真实世界研究

Efficacy and safety of vedolizumab in elderly and younger patients with moderate-to-severe ulcerative colitis: a retrospective real-world study in China.

作者信息

Zhang Hao, Ding Xue-Li, Xu Yong-Hong, Wu Jun, Wang Yue-Yuan, Liu Shu-Xian, Yan Jing, Liu Hua, Tian Zi-Bin, Liu Ai-Ling

机构信息

Department of Gastroenterology, The Affiliated Hospital of Qingdao University, No. 16 Jiangsu Road, Qingdao, Shandong Province, 266003, China.

出版信息

BMC Gastroenterol. 2025 Jul 24;25(1):531. doi: 10.1186/s12876-025-04125-1.

Abstract

BACKGROUND

Limited data exist regarding the efficacy and safety of vedolizumab (VDZ) in China's elderly adult population with ulcerative colitis (UC) in China. In this investigation, a comparative analysis of its efficacy and safety was performed between elderly and younger adult UC cohorts.

METHODS

Patients with moderate-to-severe UC and at least three VDZ infusions at our clinic between March 2021 and November 2024 were retrospectively recruited. The elderly adult patients (≥ 60 years at first VDZ dose) were matched clinically 1:2 to younger patients (18-59 years).

RESULTS

This study included 30 elderly and 60 younger adult patients. There were no significant differences between the two groups regarding sex, body mass index, percentage of smokers, disease duration, disease extent, disease activity, Mayo endoscopic scores, extra-intestinal manifestations, perianal disease, history of bowel-related surgery, or previous and concomitant therapies. At week 6, the clinical remission and steroid-free clinical remission (SFCR) rates were significantly lower (10.00% vs. 33.33%, P = 0.017; 3.33% vs. 26.67%, P = 0.005) in the elderly group than in the younger group, but there was no significant difference in the clinical response rates (P = 1.000). There was no significant difference in the clinical response, remission, and SFCR rates between the two groups at weeks 14, 22, 38, 46, and 54 (P > 0.05). The frequency of adverse events associated with VDZ was comparable between the two groups (33.33% vs. 38.33%, P = 0.643).

CONCLUSIONS

The efficacy and safety of VDZ in elderly and younger adult patients with UC are similar. Thus, VDZ can be considered both safe and efficacious for treating elderly adult patients with UC.

摘要

背景

关于维多珠单抗(VDZ)在中国老年溃疡性结肠炎(UC)患者中的疗效和安全性的数据有限。在本研究中,对老年和年轻成年UC队列之间的疗效和安全性进行了比较分析。

方法

回顾性招募了2021年3月至2024年11月期间在我院接受至少三次VDZ输注的中度至重度UC患者。将老年成年患者(首次VDZ剂量时≥60岁)与年轻患者(18 - 59岁)按1:2进行临床匹配。

结果

本研究纳入了30例老年患者和60例年轻成年患者。两组在性别、体重指数、吸烟者百分比、病程、疾病范围、疾病活动度、梅奥内镜评分、肠外表现、肛周疾病、肠道相关手术史或既往及伴随治疗方面无显著差异。在第6周时,老年组的临床缓解率和无类固醇临床缓解(SFCR)率显著低于年轻组(10.00%对33.33%,P = 0.017;3.33%对26.67%,P = 0.005),但临床反应率无显著差异(P = 1.000)。在第14、22、38、46和54周时,两组的临床反应、缓解和SFCR率无显著差异(P > 0.05)。两组与VDZ相关的不良事件发生率相当(33.33%对38.33%,P = 0.643)。

结论

VDZ在老年和年轻成年UC患者中的疗效和安全性相似。因此,VDZ可被认为对治疗老年UC患者既安全又有效。

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