Eptinezumab Robustly Prevents Migraine in Patients With Prior Treatment Failures

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 June 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.

Reference

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; June 9-12, 2022; Denver, Colorado. Poster 164.