Eptinezumab Reduces Migraine Days in Adults With Previous Treatment Failures

Eptinezumab shows promise for migraine prevention in adults with multiple previous treatment failures, according to early trial findings in the population published in The Lancet Neurology.

“The monoclonal antibody eptinezumab, which targets calcitonin gene-related peptide, has shown migraine preventive effects starting the day following infusion and acceptable safety and tolerability in phase 3 trials, but benefits in the subpopulations of patients with previous preventive treatment failures were not examined,” researchers explained in the background of the study.

The phase 3b DELIVER trial includes a 24-week double-blind, placebo-controlled period and a 48-week dose-blinded extension, the latter of which is ongoing. The trial focuses on adults with episodic or chronic migraine and proof of 2 to 4 previous preventive treatment failures at sites in the United States and Europe.

Between June 1, 2020, and October 7, 2021, 891 participants were randomly assigned to receive either eptinezumab 100 mg, eptinezumab 300 mg, or placebo.

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The change in average monthly migraine days from baseline to weeks 1–12 was –4.8 with eptinezumab 100 mg, –5.3 with eptinezumab 300 mg, and –2.1 with placebo, according to reported study results. The difference compared with placebo was significant for both eptinezumab 100 mg and eptinezumab 300 mg.

Treatment-emergent adverse events occurred in 42% of patients in the eptinezumab 100 mg group, 41% in the eptinezumab 300 mg group, and in 40% in the placebo group. COVID-19 was most common. Serious adverse events occurred in 2% in each of the eptinezumab groups and included COVID-19 in 1 patient in each of the eptinezumab groups, and anaphylactic reactions in 2 patients in the eptinezumab 300 mg group.

“In adults with migraine and two-to-four previous preventive treatment failures, eptinezumab provided significant migraine preventive effects compared with placebo, with acceptable safety and tolerability, indicating that eptinezumab might be an effective treatment option for this patient population,” researchers concluded. “The dose-blinded extension period will provide additional long-term safety data in patients with migraine and previous preventive treatment failures.”

Pharmaceutical company H. Lundbeck funded the study.

Reference

Ashina M, Lanteri-Minet M, Pozo-Rosich P, et al. Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): a multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2022;21(7):597-607. doi: 10.1016/S1474-4422(22)00185-5.