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Published on: June 2, 2014
Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2
Richard B Lipton1, Peter J Goadsby2, Jeff Smith2
1From the Montefiore Headache Center (R.B.L.); Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Alder BioPharmaceuticals, Ltd (J.S.), Dublin, Ireland; Lundbeck Seattle BioPharmaceuticals, Inc (B.A.S., D.M.B., S.P., B.A., R.C.), Bothell, WA; and Pacific Northwest Statistical Consulting, Inc (J.H.), Woodinville, WA. Dr. Biondi is now at Cohen Veterans Bioscience, Cambridge, MA. Dr. Allan is now at Global Safety Docs, Paradise Valley, AZ. richard.lipton@einsteinmed.org.
Objective:
To evaluate the efficacy and safety of eptinezumab, a humanized anti-calcitonin gene-related peptide monoclonal antibody, in the preventive treatment of chronic migraine (CM).
Methods:
The Prevention of Migraine via Intravenous ALD403 Safety and Efficacy-2 (PROMISE-2) study was a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Adults with CM were randomly assigned to receive IV eptinezumab 100 mg, eptinezumab 300 mg, or placebo administered on day 0 and week 12. The primary endpoint was change from baseline in mean monthly migraine days (MMDs) over weeks 1 to 12.
Results:
Among treated participants (n = 1,072), baseline mean number of MMDs was ≈16.1 across groups. Treatment with eptinezumab 100 and 300 mg was associated with significant reductions in MMDs across weeks 1 to 12 compared with placebo (placebo -5.6, 100 mg -7.7, p < 0.0001 vs placebo; 300 mg -8.2, p < 0.0001 vs placebo). Treatment-emergent adverse events (TEAEs) were reported by 43.5% (100 mg), 52.0% (300 mg), and 46.7% (placebo) of patients. Nasopharyngitis was the only TEAE reported for >2% of eptinezumab-treated patients at an incidence of >2% over placebo; it occurred in the 300 mg eptinezumab arm (eptinezumab 9.4%, placebo 6.0%).
Conclusion:
In patients with CM, eptinezumab 100 and 300 mg was associated with a significant reduction in MMDs from the day after IV administration through week 12, was well tolerated, and demonstrated an acceptable safety profile.
Classification Of Evidence:
This study provides Class I evidence that for patients with CM, a single dose of eptinezumab reduces MMDs over 12 weeks of treatment.
Clinicaltrialsgov Identifier:
NCT02974153.
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