Key clinical point: In adults with episodic migraine, intravenous eptinezumab administered every 12 weeks for up to 4 doses provides early and sustained migraine preventive efficacy and is well tolerated with an acceptable safety profile.
Major finding: The reduction in mean monthly migraine days was maintained with eptinezumab throughout the study period (100 mg: −3.9, −4.5, −4.7, and −4.5 days; 300 mg: −4.3, −4.8, −5.1, and −5.3 days; and placebo: −3.2, −3.8, −4.0, and −4.0 days during weeks 1-12, 13-24, 25-36, and 37-48, respectively). The percentage of patients with a reduction of 50% or greater and 75% or greater in migraine for each 12-week interval was consistently higher in the eptinezumab group vs. placebo group. Adverse events were similar across dosing periods.
Study details: Results of phase 3 PROMISE-1 through 1 year of treatment (up to 4 doses). In PROMISE-1, 888 patients with episodic migraine were randomly assigned in a ratio of 1:1:1:1 to receive eptinezumab 30 mg, 100 mg, 300 mg, or placebo every 12 weeks.
Disclosures: No study sponsor was identified. The presenting author has been a consultant and/or scientific advisor for Alder/Lundbeck, Amgen, Biohaven, Eli Lilly, Impel Neuropharma, and Theranica, and has received research support from Alder/Lundbeck, Allergan, Amgen, Biohaven, Charleston Labs, Eli Lilly, Electrocore, Novartis, Novo Nordisk, Satsuma, Theranica, and Vorso.
Source: Smith TR et al. Clin Ther. 2020 Nov 27. doi: 10.1016/j.clinthera.2020.11.007.