A 70-mg preventive dose of erenumab taken monthly may reduce migraine frequency and acute migraine-specific medication use significantly for patients with episodic migraine, according to results published in Cephalagia.
Erenumab is a human monoclonal antibody that inhibits the canonical calcitonin gene-related peptide receptor.
The randomized, double-blind, placebo-controlled, phase 3 study (ClinicalTrials.gov Identifier: NCT02483585) included 577 participants with episodic migraine. Participants were randomly assigned to receive either placebo or 70 mg of erenumab. The researchers compared change in monthly migraine days from baseline to 3 months of follow-up.
Participants who received erenumab had a -2.9-day change in monthly migraine days, compared with -1.8 days for placebo (least-squares mean treatment difference = 1.0; 95% CI, 1.6-0.5; P <.001).
A 50% reduction in monthly migraine days was achieved by 39.7% of participants taking erenumab and 29.5% of participants taking placebo (odds radio [OR] 1.59; 95% CI, 1.12-2.27; P =.010).
Participants taking erenumab had 1.2 fewer migraine-specific medication treatment days compared with 0.6 fewer days for participants treated with placebo, a treatment difference of 0.6 (95% CI, 1.0-0.2; P =.002).
The 5-point reduction rates in Migraine Physical Function Impact Diary-Physical Impairment were 33.0% for participants taking erenumab compared with 27.1% for those taking placebo (OR 1.33; 95% CI, 0.92-1.90; P =.13). For Migraine Physical Function Impact Diary-Everyday Activities, the reduction rates were 40.4% for participants taking erenumab compared with 35.8% for those taking placebo (OR 1.22; 95% CI, 0.87-1.71; P =.26).
The safety and adverse event profiles of erenumab were similar to those of placebo. The most frequently-reported adverse events were upper respiratory tract infection, injection site pain, and nasopharyngitis.
“This phase 3 study provides evidence that once-monthly subcutaneous injection of erenumab is a potential new preventive therapy in patients with episodic migraine,” the study authors concluded.
Disclosures:The ARISE clinical trial was funded by Amgen. Erenumab is co-developed in partnership with Amgen and Novartis.
Dodick DW, Ashina M, Brandes JL, et al. ARISE: a phase 3 randomized trial of erenumab for episodic migraine [published online January 1, 2018]. Cephalagia. doi:10.1177/0333102418759786