Eptinezumab Found to Lower Severity, Frequency of Migraine Headache Days

Treatment with eptinezumab (Vyepti) was observed to reduce the monthly severity and frequency of migraine headache days and episodes compared with placebo, according to the results of the PROMISE-2 study, which were published in Cephalalgia.

Chronic migraine (CM) has a high prevalence and is associated with reduced quality of life, which can impact work, school, and the social life of patients. Those diagnosed with the condition can experience frequent headaches of 15 or more days per month, at least 8 of which meet the International Classification of Headache Disorders criteria for migraine. CM also carries a higher level of disability, comorbidity, and costs than episodic migraine.

Eptinezumab is a calcitonin gene-related peptide antagonist FDA-approved for the preventive treatment of migraine. The treatment is administered via infusion once every 12 weeks.

“In the PROMISE-2 clinical study, eptinezumab significantly reduced migraine frequency when administered to patients with CM, with a rapid onset of sustained preventive efficacy demonstrated in the 24 hours after dosing and with benefits of treatment maintained throughout the 6-month (2-dose) trial,” the study authors wrote. “Eptinezumab treatment was also associated with greater reductions in acute medication use and improvements in patient-reported outcome measures of daily functioning, including greater reduction in severe headache-related life impact (6-item Headache Impact Test [HIT-6]) and greater improvements in patient-identified most bothersome symptom (patient-identified MBS) and overall health (Patient Global Impression of Change) compared with placebo.”

PROMISE-2 was a double-blind, placebo-controlled, parallel-group trial that randomized 1072 patients with CM to receive eptinezumab 100 mg, 300 mg, or placebo intravenously every 12 weeks for up to 24 weeks. Migraine and non-migraine headache episodes and characteristics were recorded by participants in daily electronic diaries during the 28-day baseline and throughout the 24-week treatment period.

Among the 1072 patients, mean monthly headache days were reduced by 8.9 in the 100 mg cohort and 9.7 in the 300 mg cohort versus a 7.3 reduction in the placebo group over the first 4-week interval post initial dose. These reductions were maintained across the 24-week treatment period.

Mean monthly headache episodes dropped by 8.4 in the 100 mg cohort and 9.0 in the 300 mg cohort versus 7.1 in the placebo group. The proportion of migraine headache episodes dropped by 11.2% in the 100 mg cohort, 12.4% in the 300 mg cohort, and 3.9% in the placebo cohort.

The study also found that reductions in severe pain, nausea, phonophobia, photophobia, and physical activity limitation were numerically greater than in the placebo group.

The study concluded that patients with CM treated with eptinezumab experienced a reduction the monthly severity and frequency of headache days and episodes compared with placebo.

“Beyond decreased headache frequency, patients treated with eptinezumab reported a reduction in the percent of remaining headache episodes that were migraine attacks, as well as a decrease in burdensome symptoms of headache episodes, indicating additional decreased headache severity after eptinezumab treatment,” the study authors wrote.

Reference

McAllister P, Kudrow D, Cady R, Hirman J, Ettrup A. Reduction in migraine-associated burden after eptinezumab treatment in patients with chronic migraine. Cephalalgia. 2022 Mar 25:3331024221089567. doi: 10.1177/03331024221089567. Epub ahead of print. PMID: 35332807.