|The following article is part of conference coverage from the 2018 American Headache Society Annual Scientific Meeting in San Francisco, California. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from AHS 2018.|
SAN FRANCISCO—Eptinezumab may be a fast-working and effective option for the prevention of chronic migraine, according to results from the PROMISE-2 study presented at the 2018 American Headache Society Annual Scientific Meeting, June 28-July 1, 2018 in San Francisco, California.
Eptinezumab, a humanized monoclonal antibody raised against calcitonin gene-related peptide (CGRP), which has been implicated in the pathogenesis of migraine, has shown 100% bioavailability when administered intravenously, and was found to effectively inhibit CGRP.
For this study, (Clinicaltrials.gov identifier: NCT02974153), 1072 adults with chronic migraine — as assessed using the International Classification of Headache Disorders, third edition — were randomly assigned to receive an infusion of eptinezumab at 100 mg, 300 mg, or placebo at day 0 and at week 12. For a 28-day period prior to treatment, study participants were asked to record headache occurrence using an electronic diary. The study’s primary outcome was the change in frequency of monthly migraine days over a period of 12 weeks. Secondary outcomes included the presence of migraine 1 day after the initial infusion, and the percentage of study participants presenting with migraine on any day during the first 4 weeks after the initial infusion.
The frequency of monthly migraine days at baseline was 16.1, 16.1, and 16.2 in participants receiving eptinezumab 100 mg, 300 mg, and placebo, respectively, and was reduced by 57.5%, 57.4%, and 58.0% at week 12, respectively. The percentage of patients who reported experiencing a migraine on the day after the initial infusion was lower in those who had received an eptinezumab infusion vs placebo (eptinezumab 100 mg: 28.6%, 50.3% reduction from baseline, P =.0001; eptinezumab 300 mg: 27.8%, 51.6% reduction, P <.0001; placebo: 42.3%, 27.1% reduction). Comparable reductions were observed in the percentage of study participants who experienced a migraine on any day during the 4-week period following the initial infusion.
“The preventive benefit was observed as early as day 1, when the percent of subjects with a migraine was reduced by approximately 50% following eptinezumab infusion,” the study investigators noted.
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Kudrow D, Diamond M, McGill L, et al. Eptinezumab achieved meaningful reductions in migraine activity as early as day 1: PROMISE-2 (PRevention of Migraine via Intravenous Eptinezumab Safety and Efficacy-2) phase 3 trial in chronic migraine. Presented at: 2018 American Headache Society Annual Scientific Meeting. June 28-July 1, 2018; San Francisco, CA. Abstract 449229.