Vyepti Safe and Effective Long-Term for Migraine Prevention in Those With Previous Treatment Failures
Patients who switched from placebo to Vyepti (eptinezumab, Lundbeck, Copenhagen, Denmark) during a 24-week extension period of the phase 3b DELIVER clinical trial (NCT04418765) experienced a reduction in migraine symptoms, according to a study presented at the 65th Annual Scientific Meeting of the American Headache Society.
DELIVER was a 24-week multicenter, parallel-group, randomized, double-blind, placebo-controlled phase 3b clinical trial of 891 eligible participants who were assigned 1:1:1 to receive infusions of placebo, 100 mg of Vyepti, or 300 mg of Vyepti. In the 48-week extension period, participants who were previously assigned to placebo were randomized 1:1 to receive either 100 mg or 300 mg of Vyepti, while participants who were administered Vyepti in the initial period continued at their assigned dose. The primary endpoints were change from baseline in the 6-item Headache Impact Test (HIT-6), change from baseline in monthly migraine days (MMDs), and percentage of responders according to MMD. Researchers also assessed change in the percentage of severe migraine attacks and acute medication usage.
Patients who switched from placebo to Vyepti experienced a sharp and sustained decline in MMDs relative to baseline. The percentage of responders increased significantly after the first dose of Vyepti. HIT-6 scores decreased in participants who switched from placebo, and by the end of the extension period, scores were similar across all groups. The amount of migraine attacks reported as severe by patients reduced in all groups by 23%-27% during the final 12 weeks of the extension period, and participants in all groups used acute medications approximately 5 fewer days than at baseline. No new safety signals were identified.
The study authors are from the Mayo Clinic Arizona, Danish Headache Center, University of Copenhagen, Dartmouth Hitchcock Medical Center, Praxis Gendolla, and H. Lundbeck A/S.