Impact of Fremanezumab on Response Rates, Acute Medication Use, and Disability in Patients With Episodic Migraine Who Have Failed at Least One Prior Migraine Preventive Medication (P2.10-001)

Objective: To assess the effects of fremanezumab on response rates, acute headache medication use, and disability in episodic migraine (EM) patients who failed at least one prior preventive migraine medication.

Background: Preventive medication is recommended for EM patients with ≥4 headache days per month. Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), is efficacious in preventing EM, but its effectiveness in patients who failed previous preventive medications is unknown.

Design/Methods: In this Phase 3, multicenter, randomized, double-blind, placebo-controlled study, patients were randomized 1:1:1 to receive subcutaneous fremanezumab quarterly (675 mg at baseline and placebo at Weeks 4 and 8), fremanezumab monthly (225 mg at baseline, Weeks 4 and 8), or placebo (at baseline, Weeks 4 and 8). Analyses were performed in patients who failed at least one prior preventive migraine medication (due to lack of efficacy or intolerability). Endpoints included the proportion of patients with ≥50% reduction in the monthly average number of migraine days, mean change from baseline in the monthly average number of days of acute headache medication use or the Migraine Disability Assessment (MIDAS) score during the 12-week treatment period.

Results: A greater proportion of patients who received fremanezumab had a ≥50% reduction in migraine days (quarterly: 38%, P=0.0115; monthly: 42%, P=0.0015) compared with placebo (18%). Fremanezumab significantly reduced the days of any acute headache medication use (quarterly [least-squares mean change]: −3.1 days; monthly: −3.4 days) compared with placebo (−1.1 days; both, P<0.0001). Fremanezumab significantly improved disability, based on the change in MIDAS score (quarterly: −24.7, P=0.0006; monthly: −27.0, P<0.0001) compared with placebo (−11.3).

Conclusions: Among EM patients with prior preventive migraine medication failure, fremanezumab was efficacious, reduced acute headache medication use, and improved disability, with effect sizes greater than those in the overall trial population.

Disclosure: Dr. Winner has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Amgen, Supernus, Teva, Novartis, Avanir, and Promius. Dr. Halker has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with WebMD/Medlink, Amgen, and Allergan. Dr. Halker has received personal compensation in an editorial capacity for Current Neurology & Neuroscience Reports. Dr. Cohen has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Teva Pharmaceuticals. Dr. Yang has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Yeung has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Gargano has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals.