Hisamatsu Tadakazu, Kobayashi Taku, Motoya Satoshi, Fujii Toshimitsu, Kunisaki Reiko, Shibuya Tomoyoshi, Matsuura Minoru, Hiraoka Sakiko, Takeuchi Ken, Yasuda Hiroshi, Yokoyama Kaoru, Takatsu Noritaka, Maemoto Atsuo, Tahara Toshiyuki, Tominaga Keiichi, Shimada Masaaki, Kuno Nobuaki, Fernandez Jovelle L, Hirose Lisa, Ishiguro Kaori, Cavaliere Mary, Hibi Toshifumi
Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, Tokyo, Japan.
Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
J Gastroenterol Hepatol. 2025 Jun;40(6):1435-1445. doi: 10.1111/jgh.16936. Epub 2025 May 15.
Vedolizumab (VDZ) is often used in older patients with ulcerative colitis (UC) in clinical practice; however, real-world evidence is still limited, including in those with late-onset UC.
This post hoc analysis of a multicenter, retrospective, observational chart review, enrolling 370 patients with UC receiving VDZ between December 2018 and February 2020, compared effectiveness and safety of VDZ among patients ≥ 70 (n = 40) versus < 70 years (n = 330), and among patients ≥ 70 years with and without late-onset UC (age at disease onset: ≥ 70 [n = 13] versus < 70 years [n = 26]).
There were no differences between patients ≥ 70 and < 70 years in clinical remission rates (week 6: 57.5% vs. 47.6%, p = 0.9174; week 14: 62.5% vs. 54.8%, p = 0.1317; week 54: 47.5% vs. 46.4%, p = 0.8149), primary nonresponse (10.0% vs. 15.5%, p = 0.6248), loss of response (12.5% vs. 9.4%, p = 0.5675), or overall safety. Among patients ≥ 70 years, the incidence of adverse drug reactions was numerically greater in those with concomitant corticosteroids than in those without. For older patients with and without late-onset UC, week 54 remission rates were 23.1% versus 57.7% (p = 0.0544); surgery was reported in 3/13 versus 2/26 patients and hospitalization in 5/13 versus 6/26 patients. One death was reported in patients with late-onset UC.
VDZ effectiveness and safety were similar in patients ≥ 70 and < 70 years; VDZ may be a suitable treatment option for patients ≥ 70 years with UC. Patients with late-onset UC tended to have more frequent surgery/hospitalization and lower effectiveness than those without, possibly necessitating greater caution when using VDZ.
Japanese Registry of Clinical Trials registration number: jRCT-1080225363.
在临床实践中，维多珠单抗（VDZ）常用于老年溃疡性结肠炎（UC）患者；然而，包括晚发型UC患者在内的真实世界证据仍然有限。
这项多中心、回顾性、观察性图表审查的事后分析纳入了2018年12月至2020年2月期间接受VDZ治疗的370例UC患者，比较了年龄≥70岁（n = 40）与<70岁（n = 330）患者以及年龄≥70岁且有和无晚发型UC患者（疾病发病年龄：≥70岁[n = 13]与<70岁[n = 26]）中VDZ的有效性和安全性。
年龄≥70岁和<70岁的患者在临床缓解率（第6周：57.5%对47.6%，p = 0.9174；第14周：62.5%对54.8%，p = 0.1317；第54周：47.5%对46.4%，p = 0.8149）、原发性无反应（10.0%对15.5%，p = 0.6248）、反应丧失（12.5%对9.4%，p = 0.5675）或总体安全性方面无差异。在年龄≥70岁的患者中, 同时使用皮质类固醇的患者药物不良反应发生率在数值上高于未使用者。对于有和无晚发型UC的老年患者，第54周的缓解率分别为23.1%和57.7%（p = 0.0544）；报告手术的患者分别为3/13和2/26，住院患者分别为5/13和6/26。晚发型UC患者中有1例死亡报告。
VDZ在年龄≥70岁和<70岁的患者中有效性和安全性相似；VDZ可能是年龄≥70岁UC患者的合适治疗选择。与无晚发型UC的患者相比，晚发型UC患者手术/住院频率更高，有效性更低，使用VDZ时可能需要更加谨慎。
日本临床试验注册中心注册号：jRCT-1080225363。
