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.
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.
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.
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 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.
Psychiatric 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.
EudraCT (2019-004497-25); ClinicalTrials.gov (NCT04418765).
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.
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 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.
Psychiatric 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.
EudraCT (2019-004497-25); ClinicalTrials.gov (NCT04418765).
Authors
Pozo-Rosich Pozo-Rosich, Tassorelli Tassorelli, Boserup Boserup, Awad Awad, Lee Lee, Ailani Ailani
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