Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2
Neurology® Apr 02, 2020
Lipton RB, Goadsby PJ, Smith J et al, et al. - Via performing a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study, researchers tested the safety and effectiveness of eptinezumab—a humanized anti-calcitonin gene-related peptide monoclonal antibody—for the preventive treatment of chronic migraine (CM). They randomized adult participants with CM to receive IV eptinezumab 100 mg, eptinezumab 300 mg, or placebo administered on day 0 and week 12. Baseline mean number of mean monthly migraine days (MMDs) was approximately 16.1 across groups. The only treatment-emergent adverse event reported for > 2% of eptinezumab-treated patients at an incidence of > 2% over placebo was nasopharyngitis. It occurred in the 300-mg eptinezumab arm (eptinezumab 9.4%, placebo 6.0%). Eptinezumab 100 mg and 300 mg were linked to significant reductions in MMDs in patients with CM from the day after IV administration through week 12, were well tolerated, and displayed acceptable safety profiles.
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