Eptinezumab Reduced Migraine Activity, Utilization of Triptan/Ergotamine

Two presentations at the 2018 American Academy of Neurology Annual Meeting highlighted the benefits of the intravenous migraine treatment eptinezumab.

David B Kudrow, MD, medical director at the California Medical Clinic for Headache, and colleagues studied data from the PROMISE-2 phase 3 clinical trials, a 12-week trial  of eptinezumab.

“Calcitonin gene-related peptide plays an important role in migraine pathophysiology,” Dr Kudrow and colleagues explained. “Eptinezumab, a humanized, anti-CGRP monoclonal antibody with 100% bioavailability following IV administration, selectively and potently inhibits CGRP.” 

The 12-week clinical trial of chronic migraine patients studied the impact of eptinezumab on migraine activity after the first day of intravenous infusion through 4 weeks and 12 weeks. Study participants included 1072 adults with chronic migraine. Patients were randomized into three study groups, 100 mg of eptinezumab, 300 mg of eptinezumab, and placebo. The researchers administered intravenous infusions at the start of the study and at 12 weeks. 

Dr Kudrow and colleagues found that eptinezumab significantly reduced monthly migraine days at both 100 mg and 300 mg compared with placebo (P < .0001). The researchers also found that the average percent of patients with a migraine on any day throughout the study period was 57.5% in the 100-mg group, 57.4% in the 300-mg group, and 58% in the placebo group.

“A single infusion of eptinezumab significantly reduced monthly migraine days for 3 months in subjects with chronic migraine,” Dr Kudrow and colleagues said. “The percentage of subjects with a migraine on day 1 was reduced by approximately 50% following eptinezumab infusion.”

A second study presented at the meeting, by Stephen D Silberstein, MD, director of the headache center at Jefferson University Hospitals and colleagues, examined how eptinezumab impacted migraine frequency and utilization of triptan/ergotamine.

This presentation used the same set of clinical trial data from the PROMISE-2 trial. They measured the change in days of triptan/ergotamine use over the 12 weeks of study. Within the study groups, average triptan/ergotamine use days per month at baseline were 6.6 in the 100-mg group , 6.7 in the 300-mg group, and 6.2 in the placebo group. 

Study results showed that use of eptinezumab significantly reduced use of triptan/ergotamine to 3.3 days per month in the 100-mg group and 3.2 in the 300-mg group compared with 4.3 days in the placebo group. 

“A single infusion of eptinezumab in subjects with chronic migraine significantly reduced mean monthly migraine days over 3 months,” Dr Silberstain and colleagues concluded. “This benefit was associated with overall reductions of approximately 50% in triptan/ergotamine use and meaningful improvements in HIT-6 scores.”

PROMISE-2 clinical trials were funded by Alder BioPharmaceuticals. Eptinezumab is expected to receive approval from the FDA sometime in 2019.

—David Costill