Guselkumab efficacy and safety in East Asian participants with moderately to severely active Crohn's disease: subgroup analysis of the phase 3 GALAXI 2 and GALAXI 3 trials.

IF 4.7 Q2 GASTROENTEROLOGY & HEPATOLOGY

Intestinal Research Pub Date : 2026-05-21 DOI:10.5217/ir.2025.00150

Hiroshi Nakase, Baili Chen, Qian Cao, Katsuyoshi Matsuoka, Tadakazu Hisamatsu, Dong Il Park, Keira Herr, Bryan Wahking, Wai Chun Yiu, Jianmin Zhuo, Minhu Chen

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Abstract

Background/aims: Guselkumab, a dual-acting interleukin-23p19 subunit inhibitor, demonstrated efficacy and safety in participants with moderately to severely active Crohn's disease in the global phase 3 GALAXI 2 and 3 trials. We report a subgroup analysis in East Asian participants.

Methods: GALAXI 2 and 3 (NCT03466411) are identical, 48-week treat-through trials. Participants were randomized 2:2:2:1 to guselkumab 200 mg IV every 4 weeks (q4w; ×3), followed by 100 mg SC every 8 weeks (q8w) or 200 mg SC q4w; ustekinumab; or placebo. Placebo participants not in clinical response at week (W)12 received ustekinumab. Co-primary endpoints were the composite of clinical response at W12 and clinical remission at W48, and the composite of clinical response at W12 and endoscopic response at W48. This subgroup analysis included participants from China, Japan, South Korea, and Taiwan.

Results: The East Asian subgroup included 192 participants. Rates of clinical response at W12 and clinical remission at W48 with guselkumab were 55.6% (100 mg SC q8w) and 51.0% (200 mg SC q4w) versus 3.1% with placebo. Rates of clinical response at W12 and endoscopic response at W48 with guselkumab were 44.4% (100 mg SC q8w) and 39.2% (200 mg SC q4w), versus 0% for placebo. Numerically higher proportions of guselkumab participants achieved clinical and endoscopic outcomes at W48 relative to ustekinumab. Adverse event rates were consistent with the global population.

Conclusions: Efficacy of guselkumab in East Asian participants was consistent with that observed in the global GALAXI 2 and 3 population. The safety profile was favorable and consistent with previous reports.

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Guselkumab在东亚中度至重度活动性克罗恩病患者中的疗效和安全性：3期GALAXI 2和GALAXI 3试验的亚组分析

背景/目的：Guselkumab是一种双作用的白介素-23p19亚基抑制剂，在全球3期GALAXI 2和3试验中显示出对中度至重度活动性克罗恩病患者的有效性和安全性。我们报告了东亚参与者的亚组分析。方法：GALAXI 2和3 （NCT03466411）是相同的，为期48周的治疗通过试验。参与者以2:2:2:1随机分配至每4周200 mg IV的guselkumab (q4w； ×3)，随后每8周100 mg SC （q8w）或200 mg SC q4w；ustekinumab;或安慰剂。在第12周(W)无临床反应的安慰剂参与者接受ustekinumab治疗。共同主要终点为W12时临床反应和W48时临床缓解的复合终点，以及W12时临床反应和W48时内镜下反应的复合终点。这个亚组分析包括来自中国、日本、韩国和台湾的参与者。结果：东亚亚组包括192名参与者。guselkumab在W12时的临床缓解率和W48时的临床缓解率分别为55.6% （100 mg SC q8w）和51.0% (200 mg SC q4w)，而安慰剂组为3.1%。guselkumab在W12和W48时的临床缓解率分别为44.4% （100 mg SC q8w）和39.2% (200 mg SC q4w)，而安慰剂组为0%。在数值上，与ustekinumab相比，guselkumab参与者在W48时达到临床和内镜结果的比例更高。不良事件发生率与全球人群一致。结论：guselkumab在东亚参与者中的疗效与在全球GALAXI 2和3人群中观察到的疗效一致。安全概况是有利的，与以前的报道一致。

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.