Impact of filgotinib on health-related quality of life over 3 years in Japanese patients with ulcerative colitis: a post hoc analysis of the SELECTION and SELECTION long-term extension trials.

IF 4.7 Q2 GASTROENTEROLOGY & HEPATOLOGY

Intestinal Research Pub Date : 2026-03-04 DOI:10.5217/ir.2025.00219

Katsuyoshi Matsuoka, Stefan Schreiber, Erina Hata, Toshihiko Kaise, Toshifumi Hibi

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引用次数: 0

Abstract

Background/aims: This post hoc analysis of the phase 2b/3 SELECTION (NCT02914522) study and its long-term extension (SELECTIONLTE; NCT02914535) evaluated the impact of filgotinib 200 mg (FIL200) on health-related quality of life (HRQoL) and work productivity in Japanese patients with ulcerative colitis over 3 years.

Methods: Patients in SELECTION were randomized to FIL200, filgotinib 100 mg, or placebo (PBO) during the induction phase. Week-10 responders were re-randomized to continue assigned treatment or PBO in the 47-week maintenance phase. Patients who completed the SELECTION induction and maintenance phases (completers) and week-10 non-responders could enter SELECTIONLTE. HRQoL and work productivity were assessed using EQ 5-dimension (EQ-5D), EQ visual analog scale, Inflammatory Bowel Disease Questionnaire (IBDQ), 36-item Short Form Health Survey (SF-36), and Work Productivity and Activity Impairment (WPAI) questionnaires at week 10 (FIL200 vs. PBO), and at week 10 and years 1-3 (completers and non-responders who received only FIL200 in SELECTION+SELECTIONLTE).

Results: Proportions of patients with minimal clinically important differences (MCIDs) at week 10 were higher with FIL200 versus PBO for IBDQ total score (77% vs. 54%), SF-36 mental component summary (58% vs. 21%), and SF-36 physical component summary (54% vs. 36%). All measures (except WPAI absenteeism) showed mean score changes from baseline at week 10 in the direction of improved HRQoL with FIL200 versus PBO. MCID rates were maintained in completers up to 3 years and increased notably in non-responders (except WPAI absenteeism and EQ-5D) from week 10 to years 1-3.

Conclusions: FIL200 treatment was associated with sustained improvements in HRQoL and work productivity over 3 years in Japanese patients with ulcerative colitis, consistent with the overall SELECTION and SELECTIONLTE trial populations.

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非戈替尼对日本溃疡性结肠炎患者3年以上健康相关生活质量的影响：对SELECTION和SELECTION长期扩展试验的事后分析

背景/目的：这项2b/3期SELECTION （NCT02914522）研究及其长期延伸（SELECTIONLTE; NCT02914535）的事后分析评估了非戈替尼200mg （FIL200）对日本溃疡性结肠炎患者3年以上健康相关生活质量（HRQoL）和工作效率的影响。方法：在诱导期，患者被随机分配到FIL200、filgotinib 100 mg或安慰剂（PBO）。第10周应答者被重新随机分配到47周维持期继续指定治疗或PBO。完成SELECTION诱导和维持阶段（完成者）和第10周无反应的患者可以进入SELECTIONLTE。在第10周（FIL200 vs. PBO）、第10周和第1-3年（完成者和仅在SELECTION+SELECTIONLTE中获得FIL200的无反应者），使用EQ 5维（EQ- 5d）、EQ视觉模拟量表、炎症性肠病问卷（IBDQ）、36项简短健康调查（SF-36）以及工作效率和活动障碍（WPAI）问卷评估HRQoL和工作效率。结果：与PBO相比，FIL200在第10周的IBDQ总分、SF-36心理成分总结（58%对21%）和SF-36身体成分总结（54%对36%）中具有最小临床重要差异（MCIDs）的患者比例更高。所有测量（WPAI缺勤除外）显示，在第10周时，FIL200与PBO改善HRQoL的方向上，平均评分从基线变化。从第10周到第1-3年，无应答者（WPAI缺勤和EQ-5D除外）的MCID率维持了3年。结论：FIL200治疗与日本溃疡性结肠炎患者3年内HRQoL和工作效率的持续改善相关，与总体SELECTION和SELECTIONLTE试验人群一致。

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.