Ulcerative colitis disease severity affects the speed of symptom relief under filgotinib treatment: a post hoc analysis of the phase 2b/3 SELECTION study.

IF 3.9 Q2 GASTROENTEROLOGY & HEPATOLOGY

Intestinal Research Pub Date : 2025-06-30 DOI:10.5217/ir.2024.00169

Masayuki Saruta, Silvio Danese, Yoshie Takatori, Toshihiko Kaise, Christine Rudolph, Marc Ferrante, Toshifumi Hibi

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引用次数: 0

Abstract

Background/aims: Filgotinib is an oral, once-daily, Janus kinase 1 preferential inhibitor approved for the treatment of ulcerative colitis (UC). This study aimed to assess symptomatic response with filgotinib 200 mg (FIL200) according to disease severity using baseline partial Mayo Clinic Score (pMCS).

Methods: In the phase 2b/3 SELECTION study (NCT02914522), adults with moderate-to-severe UC were randomized to receive FIL200, filgotinib 100 mg, or placebo for 11 weeks in induction studies A (biologic-naive) and B (biologic-experienced). In this post hoc analysis, symptomatic remission (Mayo rectal bleeding subscore of 0 and stool frequency subscore ≤ 1) rates were assessed daily from baseline to day 15 and fortnightly from week 2 to week 10 by baseline pMCS (pMCS ≥ 7, pMCS < 7) in patients who received induction FIL200.

Results: Of those who received FIL200 in induction studies A and B, 90 and 148 patients had a pMCS ≥ 7, and 155 and 114 had a pMCS < 7, respectively. Symptomatic remission rates were generally significantly higher in the pMCS < 7 than ≥ 7 group from day 2-15 (day 2: 8.4% vs. 1.1%, P= 0.009 [induction study A]; 8.8% vs. 0.7%, P= 0.004 [induction study B]). However, by week 10, there was no longer a significant difference in the rates between the pMCS ≥ 7 and < 7 groups (43.3% vs. 54.8%, P= 0.124 [induction study A]; 26.4% vs. 39.5%, P= 0.099 [induction study B]).

Conclusions: Symptomatic response to FIL200 occurred more rapidly in the less severe disease groups than in the more severe disease groups; however, regardless of disease severity, both groups benefited from continued FIL200 treatment.

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溃疡性结肠炎疾病严重程度影响非戈替尼治疗下症状缓解的速度：一项2b/3期SELECTION研究的事后分析

背景/目的：非哥替尼是一种口服，每日一次，Janus激酶1优先抑制剂，被批准用于治疗溃疡性结肠炎（UC）。本研究旨在根据疾病严重程度，使用基线部分梅奥临床评分（pMCS）评估非戈替尼200mg （FIL200）的症状反应。方法：在2b/3期选择研究（NCT02914522）中，在诱导研究A（生物学新手）和B（生物学经验）中，患有中重度UC的成年人随机接受FIL200、filgotinib 100mg或安慰剂治疗11周。在这项事后分析中，通过基线pMCS （pMCS≥7,pMCS < 7）评估接受诱导FIL200的患者的症状缓解率（Mayo直肠出血亚评分为0，大便频率亚评分≤1），从基线到第15天每天评估一次，从第2周到第10周每两周评估一次。结果：在诱导研究A和B中接受FIL200治疗的患者中，pMCS≥7的患者分别为90例和148例，pMCS < 7的患者分别为155例和114例。第2-15天，pMCS < 7组的症状缓解率普遍显著高于≥7组（第2天：8.4% vs. 1.1%， P= 0.009）；8.8% vs. 0.7%， P= 0.004[诱导研究B])。然而，到第10周，pMCS≥7和< 7组之间的发生率不再有显著差异（43.3% vs. 54.8%， P= 0.124）[诱导研究a]；26.4% vs. 39.5%， P= 0.099[诱导研究B])。结论：在病情较轻的组中，FIL200的症状反应比病情较重的组更快；然而，无论疾病严重程度如何，两组都从持续的FIL200治疗中获益。

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.