Abstract text (incl. figure legends and references)

Objective: DELIVER evaluated the efficacy and safety of eptinezumab for migraine prevention in patients with migraine and prior preventive treatment failures.

Methods: DELIVER (NCT04418765) is a phase 3b, randomized clinical trial evaluating eptinezumab (100mg and 300mg administered intravenously every 12 weeks) for migraine prevention. The study includes a 24-week double-blind, placebo-controlled period and a 48-week dose-blinded extension conducted in adults (18-75y) with episodic or chronic migraine and 2-4 preventive treatment failures within the past 10y. The primary endpoint in the placebo-controlled period was change from baseline in monthly migraine days (MMDs) over Weeks (Wks) 1-12.

Results: A total of 891 individuals received ≥1 dose of study drug, and 865 completed the placebo-controlled period. Eptinezumab achieved statistically significant reductions in MMDs versus placebo over Wks1-12 (100mg, -4.8; 300mg, -5.3; placebo, -2.1; P<0.0001), which was maintained over Wks13-24. Over Wks1-12, more eptinezumab-treated patients achieved ≥50% and ≥75% MMD reduction vs placebo (P<0.0001). Additionally, efficacy endpoints on patient-reported outcomes were achieved. Incidence of treatment-emergent adverse events was 42.5% (100mg), 40.8% (300mg), and 39.9% (placebo).

Conclusions: In adults with migraine and prior preventive treatment failures, eptinezumab robustly decreased MMDs across Wks1-12 and Wks13-24 compared to placebo, with a favorable safety and tolerability profile.