ArticleNeurology and therapy2026
Sustained Efficacy of Eptinezumab in Participants with Migraine for Whom Prior Preventive Treatments Failed and Who Self-reported Psychiatric Comorbidities: Post Hoc Analysis of the Placebo-controlled DELIVER Trial.
Article in Neurology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04418765 (Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With an Extension Period to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments), which is not on this map. Not yet cited in PubMed.
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Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With an Extension Period to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments
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Abstract
introductionPsychiatric comorbidities increase the risk of migraine disease progression. These post hoc analyses explored whether self-reported psychiatric comorbidities at screening had an impact on the short- and long-term efficacy of eptinezumab in the DELIVER trial.
methodsDELIVER was a multinational trial that evaluated eptinezumab in adults with migraine with 2-4 prior preventive treatment failures. Participants were initially randomized to intravenous eptinezumab 100 mg, 300 mg, or placebo every 12 weeks. Participants receiving placebo during the 24-week double-blind placebo-controlled period were switched to eptinezumab 100 mg or 300 mg for the 48-week dose-blinded extension, while those initially randomized to eptinezumab continued their assigned dose. Subgroups included participants self-reporting a psychiatric condition at screening, within which participants self-reporting a depressive condition at screening were also analyzed. Outcomes were changes from baseline in monthly migraine days (MMDs), ≥ 50% migraine responder rates (MRRs), and participants who improved per Patient Global Impression of Change (PGIC; much or very improved). As post hoc analyses, no p-values were generated.
resultsOf the total population, 122/890 (13.7%) self-reported ≥ 1 psychiatric comorbidity, including 68/890 (7.6%) who self-reported depression. The mean change from baseline in MMDs over Weeks 1-12 in the psychiatric comorbidity subgroup was - 4.6 with eptinezumab versus - 0.9 with placebo, with similar mean changes observed in those with comorbid depression (eptinezumab, - 4.7; placebo, 0.0). In the psychiatric comorbidity subgroup, ≥ 50% MRRs over Weeks 1-12 were higher with eptinezumab (42%; odds ratio [OR] vs placebo = 25.3) than with placebo (3%), as were the proportions of participants with PGIC improvement (eptinezumab, 60%, OR = 6.7; placebo, 19%). During the extension period, participants switching from placebo to eptinezumab reported similar improvements to the eptinezumab-eptinezumab group, with similar outcomes in the subgroups with psychiatric comorbidities.
conclusionsPsychiatric comorbidities, including depressive conditions, did not appear to impact the short- or long-term efficacy of eptinezumab in participants with migraine for whom 2-4 prior preventive treatments had failed.
trial registrationEudraCT (2019-004497-25); ClinicalTrials.gov (NCT04418765).
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