To evaluate the long-term effect of fremanezumab on response rates, acute headache medication use, and disability in adults with episodic migraine (EM).

 Migraine preventive treatment is intended to reduce the frequency, severity, and disability associated with migraine attacks. Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), is approved for the preventive treatment of migraine.

In this 52-week, multicenter, randomized, double-blind, parallel-group study, patients with EM (rolled over from a placebo-controlled study and new patients) received either subcutaneous fremanezumab quarterly (675 mg every 3 months) or monthly (225 mg every month). The percentage of patients achieving ≥50% reduction in monthly average number of migraine days or headache days of at least moderate severity, the mean change from baseline in the monthly number of days of use of any acute headache medications, and the mean change from baseline in Migraine Disability Assessment (MIDAS) scores were assessed.

This study enrolled 780 patients (119 new, 661 rollover). The proportion achieving ≥50% reduction in migraine days at Month 12 was 66% with quarterly dosing and 68% with monthly dosing. Similar response rates were observed for headache days of at least moderate severity (quarterly 68%, monthly 66%). The mean change in monthly number of days of use of any acute headache medications from baseline to Month 12 in patients with EM was –4.6 days in the quarterly group and –4.4 days in the monthly group. The change from baseline in the MIDAS disability score in patients with EM was similar in both treatment groups at Month 12; disability scores decreased by 26.0 and 27.4, respectively, in the quarterly and monthly groups.