Eptinezumab significantly reduced monthly migraine days (MMD) up to week 24 compared with placebo among patients with episodic or chronic migraine who had 2 to 4 prior treatment failures. These are study findings presented at the 2022 American Headache Society (AHS) Annual Scientific Meeting, held from July 9-12, in Denver, Colorado, and virtually.
In phase 3 trials, eptinezumab, an anti-calcitonin gene-related peptide monoclonal antibody, demonstrated safety, tolerability, and efficacy for preventing against migraine.
The DELIVER study was a phase 3b, multicenter, parallel-group, double-blind, randomized clinical trial of eptinezumab. Patients (N=891) with episodic or chronic migraine who had 2 to 4 preventative treatment failures in the past 10 years were randomized to receive 100 mg (n=299) or 300 mg (n=294) eptinezumab or placebo (n=298) intravenous infusions administered every 12 weeks. The study comprised a 28-30-day screening period, a 24-week placebo-controlled period, and 48 weeks of a dose-blinded extension period. The primary endpoint for this analysis was change in MMD during the placebo-controlled period.
A total of 865 patients completed the placebo-controlled portion of the trial.
Eptinezumab significantly reduced MMD at 12 weeks from baseline among the 100 mg (mean difference, [MD], -4.8) and 300 mg (MD, -5.3) recipients compared with placebo (MD, -2.1; P <.0001).
Between weeks 13 and 24, a 50% or greater reduction in MMD was maintained among 42.1% of the low dose and 49.5% of the high dose eptinezumab cohorts compared with 13.1% of the placebo group (P <.0001). A 75% or greater reduction in MMD was maintained among 15.7%, 18.8%, and 2.0% of the 100 mg and 300 mg eptinezumab and patients in the placebo cohort, respectively (P <.0001).
Eptinezumab was also associated with significant decreases to the Headache Impact Test (HIT-6) at week 12 compared with baseline among the recipients who took 100 mg (mean difference, -6.9) and 300 mg (MD, -6.9) compared with placebo (MD, -3.1; P <.0001).
Treatment-emergent adverse event (42.5% vs 40.8% vs 39.9%) and serious adverse event (1.7% vs 2.4% vs 1.3%) rates were similar among the low- and high-dose eptinezumab and placebo cohorts, respectively.
The researchers concluded that “eptinezumab robustly decreased MMDs and improved responder rates across Wks1-12 and Wks13-24 compared to placebo, with a safety and tolerability profile comparable to that observed previously.”
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Ashina M, Lanteri-Minet M Pozo-Rosich P, et al. Efficacy and safety of eptinezumab for migraine prevention in patients with 2–4 prior preventive treatment failures. Presented at: AHS 2022 Annual Scientific Meeting; July 9-12, 2022; Denver, Colorado. Poster 164.