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Introduction <p>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.</p> Methods <p>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&#xa0;mg, 300&#xa0;mg, or placebo every 12&#xa0;weeks. Participants receiving placebo during the 24-week double-blind placebo-controlled period were switched to eptinezumab 100&#xa0;mg or 300&#xa0;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 <i>p</i>-values were generated.</p> Results <p>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.</p> Conclusions <p>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.</p> Trial Registration <p>EudraCT (2019–004497–25); ClinicalTrials.gov (NCT04418765).</p> Graphical Abstract <p></p>

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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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月11日

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  • Patricia Pozo-Rosich,
  • Cristina Tassorelli,
  • Line Pickering Boserup,
  • Susanne F. Awad,
  • Xin Ying Lee,
  • Jessica Ailani

摘要

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 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.

Conclusions

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.

Trial Registration

EudraCT (2019–004497–25); ClinicalTrials.gov (NCT04418765).

Graphical Abstract