Eptinezumab Treatment was Associated with Longer Interictal Periods and Larger Improvements in Quality of Life Than Placebo in Participants with Migraine for Whom 2-4 Prior Preventive Treatments had Failed: A Post Hoc Analysis of the DELIVER Trial
Stewart Tepper1, Shivang Joshi2, Joe Hirman3, Seema Soni-Brahmbhatt4, Divya Asher4, Cristina Tassorelli5
1The New England Institute for Neurology and Headache, 2Community Neuroscience Services, 3Pacific Northwest Statistical Consulting, Inc, 4Lundbeck, 5Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy; Headache Science and Neurorehabilitation Unit, IRCCS Mondino Foundation, Pavia, Italy
Objective:
This post-hoc analysis of the DELIVER trial evaluated the impact of eptinezumab versus placebo on interictal (headache-free) period durations and improvements in patient-reported outcomes.
Background:
In DELIVER, eptinezumab treatment was associated with long-term reductions in headache days and improvements in patient-reported outcomes in a population in whom 2-4 prior preventive treatments had failed.
Design/Methods:
In DELIVER, participants were randomized (1:1:1) to placebo, eptinezumab 100-mg, or eptinezumab 300-mg. This post-hoc analysis evaluated longest interictal (headache-free) periods in each treatment group during Weeks 1-24 (placebo-controlled period). This analysis focused on the >14-day and >21-day longest interictal period categories. Proportions of participants in those categories with clinically meaningful responses on the Patient Global Impression of Change (PGIC) and 6-item Headache Impact Test (HIT-6) were evaluated with eptinezumab (pooled) and placebo.
Results:
Among included participants (N=832), the mean±SD longest interictal period duration during Weeks 1-24 was longer with eptinezumab (100-mg, 22.4±23.4 days; 300-mg, 24.2±25.8 days) versus placebo (13.8±14.2 days). A greater proportion of participants receiving eptinezumab experienced interictal periods >14 days (100-mg, 53.5%; 300-mg, 58.7%) and >21 days (100-mg, 32.2%; 300-mg, 38.0%) versus placebo (33.9% and 12.0%, respectively). In both the >14-day and >21-day categories, respectively, more participants treated with eptinezumab reported a clinically meaningful improvement on the PGIC, with 76.3% and 85.0% rating their status as “much/very much improved” compared with 47.9% and 50.0% with placebo. Similarly, a higher proportion of eptinezumab-treated participants achieved a clinically meaningful response on HIT-6 (≥5-point total score reduction) versus placebo.
Conclusions:
In this post-hoc analysis, participants treated with eptinezumab during the first 24 weeks of DELIVER experienced longer interictal periods versus placebo. Among participants experiencing similar longest interictal period durations, more participants on eptinezumab experienced clinically meaningful improvements on PGIC and HIT-6 than on placebo, suggesting that length and quality of headache-free periods are both important components for individuals with migraine.
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