Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1)
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- Messoud Ashina
- Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
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- Joel Saper
- Michigan Headache & Neurological Institute, Ann Arbor, MI, USA
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- Roger Cady
- Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA
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- Barbara A Schaeffler
- Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA
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- David M Biondi
- Alder BioPharmaceuticals, Inc., Bothell, WA, USA
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- Joe Hirman
- Pacific Northwest Statistical Consulting, Inc., Woodinville, WA, USA
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- Susan Pederson
- Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA
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- Brent Allan
- Alder BioPharmaceuticals, Inc., Bothell, WA, USA
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- Jeff Smith
- Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA
Description
<jats:sec><jats:title>Objective</jats:title><jats:p> To evaluate the efficacy and safety of eptinezumab, a humanized anti-calcitonin gene-related peptide monoclonal antibody, in the preventive treatment of episodic migraine. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> The PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy-1 (PROMISE-1) study was a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Adults with episodic migraine were randomized to eptinezumab 30 mg, 100 mg, 300 mg, or placebo for up to four intravenous (IV) doses administered every 12 weeks. The primary endpoint was change from baseline in monthly migraine days (MMDs) over weeks 1–12. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> A total of 888 patients received treatment across 84 study sites. Mean MMDs at baseline was ∼8.6 across treatment groups. Eptinezumab 100 mg and 300 mg met the primary endpoint, significantly reducing MMDs across weeks 1–12 compared with placebo (30 mg, −4.0; 100 mg, −3.9, p = 0.0182; 300 mg, −4.3; placebo, −3.2, p = 0.0001). Treatment-emergent adverse events were reported by 58.4% (30 mg), 63.2% (100 mg), 57.6% (300 mg), and 59.5% (placebo) of patients. Treatment-emergent adverse events reported by ≥2% of eptinezumab-treated patients at an incidence greater than placebo included: upper respiratory tract infection (30 mg, 11.4%; 100 mg, 9.9%; 300 mg, 10.3%; placebo, 7.2%), and fatigue (30 mg, 2.3%; 100 mg, 3.6%; 300 mg, 3.6%; placebo, <1%). </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> Eptinezumab (100 mg or 300 mg) significantly reduced migraine frequency, was well tolerated, and had an acceptable safety profile when used for the preventive treatment of migraine in adults with episodic migraine. ClinicalTrials.gov identifier: NCT02559895 </jats:p></jats:sec>
Journal
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- Cephalalgia
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Cephalalgia 40 (3), 241-254, 2020-02-19
SAGE Publications
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Details 詳細情報について
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- CRID
- 1360011145847538176
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- ISSN
- 14682982
- 03331024
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- Data Source
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- Crossref