Long-Term Efficacy and Safety of Fremanezumab in Migraine: Results of a 1-Year Study (S38.004)

Objective: To assess the long-term efficacy and safety of fremanezumab in adults with migraine.

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

Design/Methods: In this 52-week, multicenter, randomized, double-blind, parallel-group study, adults with chronic migraine (CM) and episodic migraine (EM) who completed placebo-controlled studies, as well as new patients, received subcutaneous fremanezumab either monthly (225 mg monthly; CM: starting dose of 675 mg), or quarterly (675 mg every 3 months).

Results: Of the 1890 patients enrolled, 1494 (79%) completed 12 months of treatment as of the cutoff (30 May 2018). The mean change in the monthly number of migraine days from baseline to Month 12 in CM patients (n=1110) was −7.2 days for quarterly and −8.1 days for monthly, with ≥50% response rates of 53% and 57% in the quarterly and monthly groups, respectively. Similar decreases were seen for headache days of at least moderate severity (quarterly: −6.4 days; monthly: −6.8 days) and any severity (quarterly: −7.2 days; monthly: −7.8 days). The mean change in the monthly number of migraine days from baseline to Month 12 in EM patients (n=780) was −5.2 for quarterly and −5.1 days for monthly, with ≥50% response rates of 66% and 68% in the quarterly and monthly groups, respectively. Headache days of at least moderate severity (quarterly: −4.4 days; monthly: −4.2 days) and any severity (quarterly: −4.9 days; monthly: −4.8 days) also decreased. The most-common AEs were injection-site reactions (26–33%); most were mild to moderate. Serious AEs occurred in 3% of patients; none were considered related to treatment.

Conclusions: Efficacy and safety of fremanezumab was maintained over 12 months.

Disclosure: Dr. Goadsby has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Amgen Eli-Lilly and Company, Alder Biopharmaceuticals, Allergan, Autonomic Technologies Inc., Dr Reddy’s Laboratories, Electrocore LLC, eNeura, Novartis, Scion, Teva Pharmaceuticals, and Trigemina Inc. Dr. Goadsby has received personal compensation in an editorial capacity for Journal Watch- Massachusetts Medical Society. Dr. Goadsby has received research support from Amgen and Eli-Lilly and Company. Dr. Monteith has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Electrocore, Supernus, Promius, Teva, and Allergan, and Eli Lilly & Company. Dr. Yeung has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Cohen has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Teva Pharmaceuticals. Dr. Cohen has received research support from This study was funded by Teva Pharmaceuticals, Petach Tikva, Israel. Dr. Yang has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals.