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

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.