Efficacy and safety of etrasimod in Japanese patients with ulcerative colitis: results from a phase 2 dose-ranging study.

IF 3.4 Q2 GASTROENTEROLOGY & HEPATOLOGY

Intestinal Research Pub Date : 2025-04-25 DOI:10.5217/ir.2024.00213

Ken Takeuchi, Hiroshi Nakase, Tadakazu Hisamatsu, Katsuyoshi Matsuoka, Shoko Arai, Hirotoshi Yuasa, Motoki Oe, Ryosuke Ono, Michael Keating, Guibao Gu, Krisztina Lazin, Aoibhinn McDonnell, Koki Fukuta, Toshifumi Hibi

{"title":"Efficacy and safety of etrasimod in Japanese patients with ulcerative colitis: results from a phase 2 dose-ranging study.","authors":"Ken Takeuchi, Hiroshi Nakase, Tadakazu Hisamatsu, Katsuyoshi Matsuoka, Shoko Arai, Hirotoshi Yuasa, Motoki Oe, Ryosuke Ono, Michael Keating, Guibao Gu, Krisztina Lazin, Aoibhinn McDonnell, Koki Fukuta, Toshifumi Hibi","doi":"10.5217/ir.2024.00213","DOIUrl":null,"url":null,"abstract":"Background/aims: Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). However, its efficacy, safety, and the appropriate dosage have not been extensively investigated in the Japanese population.Methods: This phase 2, multicenter, randomized, double-blind, placebo-controlled dose-ranging, 12-week trial was carried out among Japanese patients with moderately to severely active UC. Patients were randomized 1:1:1 to receive etrasimod 1 mg once daily (QD), etrasimod 2 mg QD, or placebo. The primary efficacy endpoint was the proportion of patients achieving clinical remission at week 12. Secondary efficacy endpoints and treatmentemergent adverse events (TEAEs) were also investigated. Efficacy endpoints were presented as proportions of patients achieving each outcome.Results: Overall, 17, 19, and 18 patients received etrasimod 1 mg QD, etrasimod 2 mg QD, and placebo, respectively. One patient receiving etrasimod 1 mg (6.7%), 5 patients receiving etrasimod 2 mg (26.3%), and no patients receiving placebo (0%) achieved clinical remission. More patients receiving etrasimod versus placebo achieved secondary endpoints, except endoscopic normalization, at week 12. TEAEs were experienced by 9 patients receiving etrasimod 1 mg (52.9%), 13 patients receiving etrasimod 2 mg (68.4%), and 10 patients receiving placebo (55.6%). None of the TEAEs were serious and none experienced by patients receiving etrasimod led to treatment discontinuation.Conclusions: Overall, etrasimod 2 mg QD for up to 12 weeks appeared efficacious and safe in these Japanese patients with moderately to severely active UC. All TEAEs were mild to moderate in severity. (ClinicalTrials.gov: NCT05061446).","PeriodicalId":14481,"journal":{"name":"Intestinal Research","volume":" ","pages":""},"PeriodicalIF":3.4000,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Intestinal Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.5217/ir.2024.00213","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Background/aims: Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). However, its efficacy, safety, and the appropriate dosage have not been extensively investigated in the Japanese population.

Methods: This phase 2, multicenter, randomized, double-blind, placebo-controlled dose-ranging, 12-week trial was carried out among Japanese patients with moderately to severely active UC. Patients were randomized 1:1:1 to receive etrasimod 1 mg once daily (QD), etrasimod 2 mg QD, or placebo. The primary efficacy endpoint was the proportion of patients achieving clinical remission at week 12. Secondary efficacy endpoints and treatmentemergent adverse events (TEAEs) were also investigated. Efficacy endpoints were presented as proportions of patients achieving each outcome.

Results: Overall, 17, 19, and 18 patients received etrasimod 1 mg QD, etrasimod 2 mg QD, and placebo, respectively. One patient receiving etrasimod 1 mg (6.7%), 5 patients receiving etrasimod 2 mg (26.3%), and no patients receiving placebo (0%) achieved clinical remission. More patients receiving etrasimod versus placebo achieved secondary endpoints, except endoscopic normalization, at week 12. TEAEs were experienced by 9 patients receiving etrasimod 1 mg (52.9%), 13 patients receiving etrasimod 2 mg (68.4%), and 10 patients receiving placebo (55.6%). None of the TEAEs were serious and none experienced by patients receiving etrasimod led to treatment discontinuation.

Conclusions: Overall, etrasimod 2 mg QD for up to 12 weeks appeared efficacious and safe in these Japanese patients with moderately to severely active UC. All TEAEs were mild to moderate in severity. (ClinicalTrials.gov: NCT05061446).

查看原文本刊更多论文

伊特拉西莫在日本溃疡性结肠炎患者中的疗效和安全性：来自一项剂量范围研究的结果

背景/目的：Etrasimod是一种口服，每日一次，选择性1-磷酸膦酸膦1,4,5受体调节剂，用于治疗中度至重度活动性溃疡性结肠炎（UC）。然而，其有效性、安全性和适当的剂量尚未在日本人群中进行广泛的调查。方法：这项2期、多中心、随机、双盲、安慰剂对照、剂量范围12周的试验在日本中重度活动性UC患者中进行。患者以1:1:1的比例随机分配，接受伊特拉西莫1mg每日一次（QD）、伊特拉西莫2mg每日一次或安慰剂。主要疗效终点是在第12周达到临床缓解的患者比例。次要疗效终点和治疗不良事件（teae）也进行了调查。疗效终点以达到每个结果的患者比例表示。结果：总体而言，分别有17、19和18名患者接受了伊拉西莫德1mg QD、伊拉西莫德2mg QD和安慰剂治疗。1名接受伊特拉西莫1mg（6.7%）的患者，5名接受伊特拉西莫2mg（26.3%）的患者，没有接受安慰剂（0%）的患者达到临床缓解。在第12周，接受伊特拉西莫德治疗的患者比接受安慰剂治疗的患者达到了次要终点，除了内窥镜正常化。伊特拉西莫德1mg组9例（52.9%），伊特拉西莫德2mg组13例（68.4%），安慰剂组10例（55.6%）发生teae。所有teae均不严重，接受伊特拉西莫的患者均未发生导致治疗中断的teae。结论：总体而言，伊特拉西莫2mg QD治疗12周对这些日本中至重度活动性UC患者有效且安全。所有teae的严重程度均为轻度至中度。(ClinicalTrials.gov: NCT05061446)。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

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.