Early and Sustained Shift in Headache Day Frequency Following Eptinezumab Treatment in Adults With Migraine for Whom 2-4 Previous Preventive Treatments Have Failed: A Post Hoc Analysis of the Randomized DELIVER Trial
Abstract
BACKGROUND: This post hoc analysis examined the reduction in monthly headache days (MHDs) by frequency category shifts and associated improvements following eptinezumab treatment.
METHODS: The DELIVER trial evaluated eptinezumab in adults with migraine for whom 2-4 previous preventive treatments failed. During a 24-week, double-blind, placebo-controlled period followed by a 48-week extension period, participants received IV eptinezumab 100 mg, 300 mg, or placebo every 12 weeks, with all receiving eptinezumab beginning Week 25 (dose-blinded). Participants were categorized by MHD frequency: > 14, 8-14, 4 to 14 baseline MHDs and early ≥ 50% responders). In participants reporting < 8 MHDs after all doses, the associated changes in headache intensity and disease status were evaluated.
RESULTS: Of randomized participants, 88% (782/890) completed the trial. The percentage of participants randomized initially to eptinezumab who reported 14 to < 8 MHDs, 66% (49/74) reported < 8 MHDs for the rest of the trial. Reduction to < 8 MHDs was associated with robust improvements in headache intensity and disease burden.
CONCLUSIONS: Eptinezumab was associated with sustained reduction in MHD category, with some achieving headache/migraine freedom in patients with a history of preventive treatments that failed.
TRIAL REGISTRATION: ClinicalTrials.gov (identifier: NCT04418765; https://www.
CLINICALTRIALS: gov/ct2/show/NCT04418765) and EudraCT (identifier: 2019-004497-25;…
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Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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