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BOSTON – In a phase 3 trial, treatment with erenumab reduced migraine frequency, monthly migraine days, and migraine medication use in patients with episodic migraine.
Results of the ARISE trial (ClinicalTrials.gov Identifier: NCT02483585) were presented at the 2017 American Academy of Neurology (AAN) Annual Meeting, April 22-28, 2017, in Boston.
Erenumab, a fully human monoclonal antibody, works by inhibiting the calcitonin gene-related peptide (CGRP) receptor, which is believed to play a significant role in the pathophysiology of migraine.
The 12-week study included 577 adult patients with episodic migraine (mean 8.3 monthly migraine days at baseline). Participants were randomly assigned to receive either placebo or erenumab 70 mg subcutaneously once monthly. The primary end point was change in monthly migraine days from baseline to weeks 9 through 12. Secondary end points included a 50% or more reduction in monthly migraine days, change in acute migraine prophylactic use, and a 5-point or greater reduction in physical impairment and impact on everyday activities as measured by the Migraine Physical Function Impact Diary.
Patients who received erenumab experienced a statistically significant mean reduction in monthly migraine days compared with placebo (-2.9 vs -1.8; P <.001). In addition, 40% of patients in the treatment group experienced a 50% or more reduction in monthly migraine days compared with 30% of patients in the placebo group (odds ratio [OR] 1.6; P =.010).
As for secondary end points, patients in the treatment group were able to reduce their monthly acute migraine prophylactic use by 1.2 days compared with 0.6 days in the placebo group (P =.002). In addition, 33% and 40% of patients in the treatment group achieved a ≥5 point reduction in physical impairment and impact on everyday activities compared with placebo (27% and 36%, respectively.)
Erenumab was found to be generally safe and well tolerated. The most common adverse events included upper respiratory infection, pain at the injection site, and nasopharyngitis.
Disclosure: This study was supported by Amgen, Inc.
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Dodick D, Ashina M, Kudrow D, et al. A phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of erenumab in migraine prevention: primary results of the ARISE trial. Presented at: 2017 American Academy of Neurology Annual Meeting. April 22-28, 2017; Boston, MA.