European journal of neurology · 2026
Long-Term Improvements Following Initial Migraine Response in Eptinezumab-Treated Participants With Migraine for Whom 2-4 Prior Preventive Treatments Have Failed.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Ailani Jessica, Ashina Messoud, Awad Susanne F, Lee Xin Ying, Boserup Line Pickering, Soni-Brahmbhatt Seema, Sperling Bjørn, Lipton Richard B
Аннотация
BACKGROUND: In the DELIVER trial, eptinezumab administration was associated with sustained reductions in headache frequency and migraine-related impact in participants for whom previous preventive treatments have failed. This post hoc analysis evaluated long-term maintenance of initial ≥ 50% and ≥ 75% migraine response.
METHODS: DELIVER was a 24-week, randomized, double-blind, placebo-controlled trial with a 48-week dose-blinded extension. For participants with initial ≥ 50% or ≥ 75% reduction in monthly migraine days-defined as response following their first dose (Weeks 1-12) or first and second dose (Weeks 1-24)-maintenance of ≥ 50% or ≥ 75% migraine response was assessed for each subsequent 12-week dosing interval. Proportions of severe migraine attacks, 6-Item Headache Impact Test (HIT-6) total score, migraine-specific Work Productivity and Activity Impairment (WPAI:M) presenteeism subscore, and Patient Global Impression of Change (PGIC) categories were also evaluated in Weeks 1-12 responders.
RESULTS: Of participants with ≥ 50% migraine response over Weeks 1-12, 61.0% (69/113, 100 mg) and 73.8% (93/126, 300 mg) maintained response over the entire 72-week treatment period; ≥ 50% responders (Weeks 1-24) and ≥ 75% responders (Weeks 1-12 and 1-24) showed similar trends. Weeks 1-12 responders (≥ 50% and ≥ 75%) experienced sustained reductions in migraine severity, HIT-6 total score, and presenteeism subscore, with most reporting improvements per the PGIC.
CONCLUSIONS: For both eptinezumab doses, ≥ 50% or ≥ 75% migraine response over Weeks 1-12 or 1-24 was maintained for the entire 72-week treatment period for many participants. An initial response within the first two doses of eptinezumab can indicate long-term improvements.
TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT04418765; URL: https://clinicaltrials.gov/study/NCT04418765); EudraCT (Identifier: 2019-004497-25; URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2019-004497-25).
METHODS: DELIVER was a 24-week, randomized, double-blind, placebo-controlled trial with a 48-week dose-blinded extension. For participants with initial ≥ 50% or ≥ 75% reduction in monthly migraine days-defined as response following their first dose (Weeks 1-12) or first and second dose (Weeks 1-24)-maintenance of ≥ 50% or ≥ 75% migraine response was assessed for each subsequent 12-week dosing interval. Proportions of severe migraine attacks, 6-Item Headache Impact Test (HIT-6) total score, migraine-specific Work Productivity and Activity Impairment (WPAI:M) presenteeism subscore, and Patient Global Impression of Change (PGIC) categories were also evaluated in Weeks 1-12 responders.
RESULTS: Of participants with ≥ 50% migraine response over Weeks 1-12, 61.0% (69/113, 100 mg) and 73.8% (93/126, 300 mg) maintained response over the entire 72-week treatment period; ≥ 50% responders (Weeks 1-24) and ≥ 75% responders (Weeks 1-12 and 1-24) showed similar trends. Weeks 1-12 responders (≥ 50% and ≥ 75%) experienced sustained reductions in migraine severity, HIT-6 total score, and presenteeism subscore, with most reporting improvements per the PGIC.
CONCLUSIONS: For both eptinezumab doses, ≥ 50% or ≥ 75% migraine response over Weeks 1-12 or 1-24 was maintained for the entire 72-week treatment period for many participants. An initial response within the first two doses of eptinezumab can indicate long-term improvements.
TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT04418765; URL: https://clinicaltrials.gov/study/NCT04418765); EudraCT (Identifier: 2019-004497-25; URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2019-004497-25).