Effectiveness of Galcanezumab and Traditional Oral Migraine Preventive Medications: Interim 3-Month Japan Subgroup Findings from the TRIUMPH Study.

IF 4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL

Advances in Therapy Pub Date : 2026-04-22 DOI:10.1007/s12325-026-03588-2

Takao Takeshima, Yasuhiko Matsumori, Daisuke Danno, Tsubasa Takizawa, Kaname Ueda, Zhihong Cai, Chie Hashimoto, Hideaki Katagiri

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Abstract

Introduction: Galcanezumab, a humanized calcitonin gene-related peptide monoclonal antibody, is approved in Japan for migraine prevention, but real-world effectiveness data are limited. This analysis describes the 3-month treatment outcomes of galcanezumab and traditional oral migraine preventive medications (TOMPs) in the TReatment of mIgraine: oUtcoMes for Patients in real-world Healthcare systems (TRIUMPH) study's Japan subgroup.

Methods: TRIUMPH, an international, prospective, observational, 24-month cohort study, included adults with migraine who initiated or switched to galcanezumab or TOMP. Japan subgroup data were collected from September 2021 to November 2024. Physicians decided on the treatment course in routine clinical practice. The primary outcome was achieving a clinically meaningful response at 3 months, defined as a ≥ 50% reduction in monthly migraine headache days for episodic migraine and ≥ 30% for chronic migraine. Secondary outcomes included changes in migraine headache days and patient-reported outcomes (PROs): Migraine Disability Assessment (MIDAS), Headache Impact Test-6 (HIT-6), Migraine Interictal Burden Scale-4 (MIBS-4), Migraine-Specific Quality of Life Questionnaire (MSQv2.1), and Work Productivity and Activity Impairment (WPAI). Inverse probability of treatment weighting was used to adjust for baseline differences in the primary analysis. No alpha was allocated for comparative formal testing between treatment groups.

Results: Of 846 patients, 469 received galcanezumab and 377 received TOMPs. In the galcanezumab and TOMP groups, the 3-month weighted response rates were 59.4% and 38.3%, and the reduction in mean migraine headache days from baseline was - 6.2 [95% confidence interval (CI): - 6.9, - 5.5] and - 4.2 (95% CI: - 5.0, - 3.4), respectively. Mean change at 3 months from baseline was numerically higher in the galcanezumab group than in the TOMP group for all the PROs.

Conclusions: Patients receiving galcanezumab had numerically greater 3-month response rates and experienced improved PROs after initiating galcanezumab. These real-world findings may help physicians make treatment decisions in clinical settings.

Trial registration: EU PAS Register number-EUPAS33068.

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Galcanezumab和传统口服偏头痛预防药物的有效性：TRIUMPH研究中为期3个月的中期日本亚组结果

Galcanezumab是一种人源化降钙素基因相关肽单克隆抗体，在日本被批准用于偏头痛预防，但实际疗效数据有限。该分析描述了galcanezumab和传统口服偏头痛预防药物（TOMPs）在偏头痛治疗中的3个月治疗结果：现实世界医疗保健系统（TRIUMPH）研究的日本亚组患者的结果。方法：TRIUMPH是一项国际性、前瞻性、观察性、为期24个月的队列研究，纳入了开始或转向galcanezumab或TOMP的偏头痛成人患者。日本子组数据收集于2021年9月至2024年11月。医生在日常临床实践中决定治疗方案。主要结局是在3个月时获得有临床意义的缓解，定义为发作性偏头痛每月偏头痛天数减少≥50%，慢性偏头痛每月偏头痛天数减少≥30%。次要结局包括偏头痛天数和患者报告结局（PROs）的变化：偏头痛残疾评估（MIDAS）、头痛影响测试6 （HIT-6）、偏头痛间期负担量表4 （MIBS-4）、偏头痛特异性生活质量问卷（MSQv2.1）和工作效率和活动障碍（WPAI）。在初步分析中，使用治疗加权的逆概率来调整基线差异。治疗组间的比较正式检验没有分配alpha值。结果：在846例患者中，469例接受galcanezumab治疗，377例接受TOMPs治疗。在galcanezumab和TOMP组中，3个月加权缓解率分别为59.4%和38.3%，平均偏头痛天数较基线分别减少- 6.2[95%可信区间（CI）： - 6.9, - 5.5]和- 4.2 （95% CI: - 5.0, - 3.4）。从基线到3个月的平均变化在所有PROs中，galcanezumab组的数值高于TOMP组。结论：接受galcanezumab治疗的患者在启动galcanezumab治疗后3个月的有效率更高，PROs也得到改善。这些真实世界的发现可以帮助医生在临床环境中做出治疗决定。试用注册：EUPAS注册号：eupas33068。

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

Advances in Therapy 医学-药学

CiteScore

7.20

自引率

2.60%

发文量

353

审稿时长

6-12 weeks

期刊介绍： Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.