Week 2 remission with vedolizumab as a predictor of long-term remission in patients with ulcerative colitis: a multicenter, retrospective, observational study.

IF 3.9 Q2 GASTROENTEROLOGY & HEPATOLOGY

Intestinal Research Pub Date : 2025-07-14 DOI:10.5217/ir.2025.00047

Taku Kobayashi, Tadakazu Hisamatsu, Satoshi Motoya, Toshimitsu Fujii, Reiko Kunisaki, Tomoyoshi Shibuya, Minoru Matsuura, Ken Takeuchi, Sakiko Hiraoka, Hiroshi Yasuda, Kaoru Yokoyama, Noritaka Takatsu, Atsuo Maemoto, Toshiyuki Tahara, Keiichi Tominaga, Masaaki Shimada, Nobuaki Kuno, Mary Cavaliere, Kaori Ishiguro, Jovelle L Fernandez, Toshifumi Hibi

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引用次数: 0

Abstract

Background/aims: Vedolizumab (VDZ), a gut-selective monoclonal antibody for ulcerative colitis (UC) treatment, has no established biomarkers or clinical features that predict long-term remission. Week 2 remission, a potential predictor of long-term remission, could inform maintenance treatment strategy.

Methods: This retrospective, observational chart review included patients with UC in Japan who initiated VDZ between December 2018 and February 2020. Outcome measures included 14- and 54-week remission rates in patients with week 2 and non-week 2 remission (remission by week 14), 54-week remission rates in patients with week 14 remission and primary nonresponse, and predictive factors of week 2 and week 54 remission (logistic regression).

Results: Overall, 332 patients with UC (176 biologic-naïve and 156 biologic-non-naïve) were included. Significantly more biologic-naïve than biologic-non-naïve patients achieved week 2 remission (36.9% vs. 28.2%; odds ratio [OR], 1.43; 95% confidence interval [CI], 1.05-1.94; P= 0.0224). Week 54 remission rates were significantly different between week 14 remission and primary nonresponse (both groups: P< 0.0001), and between week 2 and non-week 2 remission (all patients: OR, 2.41; 95% CI, 1.30-4.48; P= 0.0052; biologic-naïve patients: OR, 2.40; 95% CI, 1.10-5.24; P= 0.0280). Week 2 remission predictors were male sex, no anti-tumor necrosis factor alpha exposure, and normal/mild endoscopic findings. Week 54 remission was significantly associated with week 2 remission and no tacrolimus use.

Conclusions: Week 2 remission with VDZ is a predictor of week 54 remission in patients with UC. Week 2 may be used as an evaluation point for UC treatment decisions. (Japanese Registry of Clinical Trials: jRCT-1080225363).

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vedolizumab第2周缓解作为溃疡性结肠炎患者长期缓解的预测因子：一项多中心、回顾性、观察性研究

背景/目的：Vedolizumab （VDZ）是一种用于治疗溃疡性结肠炎（UC）的肠道选择性单克隆抗体，没有确定的生物标志物或预测长期缓解的临床特征。第2周缓解是长期缓解的潜在预测指标，可以为维持治疗策略提供信息。方法：这项回顾性观察图综述包括2018年12月至2020年2月期间在日本开始VDZ治疗的UC患者。结果测量包括第2周和非第2周缓解患者的14周和54周缓解率（第14周缓解），第14周缓解和主要无反应患者的54周缓解率，以及第2周和第54周缓解的预测因素（logistic回归）。结果：共纳入332例UC患者（176例biologic-naïve和156例biologic-non-naïve）。达到第2周缓解的患者biologic-naïve明显多于biologic-non-naïve (36.9% vs. 28.2%；优势比[OR]， 1.43；95%置信区间[CI]， 1.05-1.94；P = 0.0224)。第54周的缓解率在第14周缓解和原发性无缓解之间存在显著差异（两组均P< 0.0001），在第2周缓解和非第2周缓解之间存在显著差异(所有患者：OR， 2.41；95% ci, 1.30-4.48；P = 0.0052;biologic-naïve患者：OR， 2.40；95% ci, 1.10-5.24；P = 0.0280)。第2周缓解预测因子为男性，无抗肿瘤坏死因子暴露，内窥镜检查结果正常/轻微。第54周缓解与第2周缓解和未使用他克莫司显著相关。结论：第2周VDZ缓解是UC患者第54周缓解的预测因子。第2周可以作为UC治疗决策的评估点。（日本临床试验登记处：jRCT-1080225363）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Intestinal Research GASTROENTEROLOGY & HEPATOLOGY-

CiteScore

7.40

自引率

10.20%

发文量

审稿时长

38 weeks

期刊介绍： Intestinal Research (Intest Res) is the joint official publication of the Asian Organization for Crohn''s and Colitis (AOCC), Chinese Society of IBD (CSIBD), Japanese Society for IBD (JSIBD), Korean Association for the Study of Intestinal Diseases (KASID), Taiwan Society of IBD (TSIBD) and Colitis Crohn''s Foundation (India) (CCF, india). The aim of the Journal is to provide broad and in-depth analysis of intestinal diseases, especially inflammatory bowel disease, which shows increasing tendency and significance. As a Journal specialized in clinical and translational research in gastroenterology, it encompasses multiple aspects of diseases originated from the small and large intestines. The Journal also seeks to propagate and exchange useful innovations, both in ideas and in practice, within the research community. As a mode of scholarly communication, it encourages scientific investigation through the rigorous peer-review system and constitutes a qualified and continual platform for sharing studies of researchers and practitioners. Specifically, the Journal presents up-to-date coverage of medical researches on the physiology, epidemiology, pathophysiology, clinical presentations, and therapeutic interventions of the intestinal diseases. General topics of interest include inflammatory bowel disease, colon and small intestine cancer or polyp, endoscopy, irritable bowel syndrome and other motility disorders, infectious enterocolitis, intestinal tuberculosis, and so forth. The Journal publishes diverse types of academic materials such as editorials, clinical and basic reviews, original articles, case reports, letters to the editor, brief communications, perspective, statement or commentary, and images that are useful to clinicians and researchers.