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
Abstract
INTRODUCTION: Psychiatric 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.
METHODS: DELIVER 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.
RESULTS: Of 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…
How strong is the evidence?
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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