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Research Article: Three-year real-world effectiveness, treatment persistence, and planned discontinuation of anti-calcitonin gene-related peptide monoclonal antibodies for migraine prevention: a single-center cohort from Japan

Date Published: 2026-05-13

Abstract:
Long-term real-world evidence beyond 24?months for anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies is scarce, particularly regarding treatment persistence and planned discontinuation after goal attainment. We conducted a single-center retrospective study of consecutive patients aged ?15 years who initiated galcanezumab or fremanezumab (monthly/quarterly) between May 2021 and June 2022. Specifically, patients aged ?15 years with episodic migraine (EM; <15 headache days/month), high-frequency EM (HFEM; 8–14?days/month), or chronic migraine (CM; ?15?days/month) were included according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria. The outcomes included monthly migraine days (MMDs), the Migraine Disability Assessment Scale (MIDAS), the Headache Impact Test (HIT-6), and the Visual Analogue Scale (VAS), which were assessed at baseline and at 1, 3, 6, 12, and 36?months. Responder rates (RRs) (?50%, ?75, and 100%) and continuation/discontinuation reasons were summarized with prespecified and sensitivity analyses. The primary subgroup analysis was prespecified as EM vs. HFEM+CM. Overall, 50 patients were analyzed at baseline (mean age: 42.5?years; 88% women); 28 of the 50 (56%) patients continued therapy for 3?years. Among patients who continued therapy, MMDs decreased from 12.0?±?5.4 to 5.6?±?5.4 at 36?months, with parallel improvements in the MIDAS, HIT-6, and VAS (all p <?0.01). Responder rates were durable (?50%: 55.6% at 36?months; ?75%: 29.6%; 100%: 11.1%). Discontinuation frequently reflected treatment completion after goal attainment (24%); no adverse-event–related discontinuations occurred. Over 3?years, anti-CGRP monoclonal antibodies provided sustained preventive effectiveness and favorable tolerability in routine practice, supporting individualized decision-making regarding continuation, planned discontinuation, and regimen selection.

Introduction:
Long-term real-world evidence beyond 24?months for anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies is scarce, particularly regarding treatment persistence and planned discontinuation after goal attainment.

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