Eptinezumab for Frequent Episodic Migraine: Results of Phase 3 PROMISE-1 Study
Frequent episodic migraine was defined as ≤14 headache days per month, 4 of which meet the International Classification of Headache Disorders second edition criteria for migraine.
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LOS ANGELES — Eptinezumab, a humanized monoclonal antibody specific to calcitonin gene-related peptide, may be an effective prophylactic agent for individuals with frequent episodic migraines, according to a study presented at the American Academy of Neurology 2018 Annual Meeting, held April 21-28, 2018, in Los Angeles, California
In this randomized double-blind placebo-controlled phase 3 trial (Prevention of Migraine via Intravenous Eptinezumab Safety and Efficacy-1 or PROMISE-1 Trial; ClinicalTrials.gov identifier: NCT02559895), 888 adult patients with frequent episodic migraine, defined as ≤14 headache days per month, 4 of which meet the International Classification of Headache Disorders, Second Edition, criteria for migraine, were enrolled. Study participants were randomly assigned to receive intravenous infusion eptinezumab at 30 mg, 100 mg, or 300 mg, or placebo every 12 weeks. Eptinezumab was found to have 100% bioavailability by this route of administration. The trial's primary endpoint was reduction in monthly migraine days (baseline, ~8.5 days per month) during the first 12 weeks of treatment.
Monthly migraine days were reduced from baseline in patients receiving eptinezumab at all doses compared with placebo during the first 12 weeks (monthly migraine day reduction: eptinezumab 30 mg, 4 days [P =.0045]; eptinezumab 100 mg, 3.9 days [P =.0179]; eptinezumab 300 mg, 4.3 days [P =.0001]; placebo: 3.2 days). A greater percentage of patients receiving eptinezumab reported experiencing ≥75% reduction in the number of monthly migraine days during the 12-week study period compared with those administered placebo (eptinezumab 30 mg, 24.7% [P =.027]; eptinezumab 100 mg, 22.2% [no significant difference]; eptinezumab 300 mg, 29.7% [P =.001]; vs placebo, 16.2%).
Similarly, the percentage of study participants achieving ≥50% reduction in monthly migraine days during the first 12 weeks of treatment was greater in the eptinezumab vs placebo group (eptinezumab 30 mg, 50.2% [P =.006]; eptinezumab 100 mg, 49.8% [P =.009]; eptinezumab 300 mg, 56.3% [P <.001]; vs placebo: 37.4%). Response rates ≥75% during the first 4 weeks of treatment were also greater in patients receiving eptinezumab vs placebo (eptinezumab 30 mg, 30.0% [P =.017]; eptinezumab 100 mg, 30.8% [P =.011]; eptinezumab 300 mg, 31.5% [P =.007]; vs placebo, 20.3%). In the day after eptinezumab infusion, the probability of experiencing migraine was reduced for study participants who had received eptinezumab vs placebo (eptinezumab 30 mg, 45% reduction [P =.074]; eptinezumab 100 mg, 51.3% [P =.0167]; eptinezumab 300 mg, 53.6% [P =.0087]; vs placebo, 20.7%). Rates of adverse events were comparable in all groups.
"All doses of eptinezumab significantly reduced migraine activity through 3 months after first infusion in patients with [frequent episodic migraine]," concluded the study authors, adding, "The probability of migraine was significantly reduced on Day 1 posttreatment and benefits were maintained for 3 months with a single infusion."
Disclosure: the study was funded by Alder BioPharmaceuticals, Inc., which developed eptinezumab.
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Saper J, Lipton R, Kudrow D. Primary results of PROMISE-1 (Prevention of Migraine via Intravenous Eptinezumab Safety and Efficacy-1) trial: a phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of eptinezumab for prevention of frequent episodic migraines. Presented at: American Academy of Neurology 2018 Annual Meeting; April 21-27; Los Angeles, CA. Poster S20.