Key clinical point: Intravenous (IV) eptinezumab (100 and 300 mg) demonstrates clinically significant migraine preventive effects over multiple efficacy measures, along with acceptable safety and tolerability in patients with chronic migraine.
Major finding: At 12 weeks, eptinezumab 100 and 300 mg demonstrated significant reductions in monthly migraine days (mean, −7.7 and −8.2 days; respectively; P less than .0001) vs. placebo (mean, −5.6 days). Treatment-emergent adverse events were similar across all study groups (100 mg: 43.5%; 300 mg: 52.0%; placebo: 46.7%).
Study details: PROMISE-2 was a phase 3, multicenter, double-blind, parallel-group study of 1,072 patients with migraine randomly assigned to receive eptinezumab 100 mg, eptinezumab 300 mg, or placebo in a 1:1:1 ratio, which was administered on day 0 and week 12.
Disclosures: The study was funded by H. Lundbeck A/S, Copenhagen, Denmark. Barbara A. Schaeffler, Roger Cady, and Susan Pederson are full-time employees of Lundbeck Seattle BioPharmaceuticals. Joe Hirman is a contracted service provider of biostatistical resources to Lundbeck Seattle BioPharmaceuticals. Richard B. Lipton reported honoraria from Alder BioPharmaceuticals. David M. Biondi, Jeff Smith, and Brent Allan are full-time employees of Alder BioPharmaceuticals. Peter J. Goadsby reported grants and personal fees from Amgen and Eli Lilly & Co and personal fees from Alder BioPharmaceuticals, Allergan, Autonomic Technologies, Biohaven Pharmaceuticals, Dr Reddy’s Laboratories, Electrocore LLC, eNeura, Impel Neuropharma, Mundi-Pharma, Novartis, Oxford University Press’
Lipton RB et al. Neurology. 2020 Mar 24. doi: 10.1212/WNL.0000000000009169.