Efficacy of Fremanezumab in Patients With Chronic Migraine Who Had Prior Use of Topiramate or OnabotulinumtoxinA (P4.104)

Objective: To determine the efficacy of fremanezumab in patients with chronic migraine (CM) who have previously used topiramate or onabotulinumtoxinA. Background: A high unmet need exists for patients with CM, most of whom have discontinued currently available preventive migraine therapies. Fremanezumab (TEV-48125), a fully humanized monoclonal antibody targeting calcitonin gene-related peptide (CGRP), has demonstrated efficacy in migraine prevention. Design/Methods: In this Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study, eligible patients with prospectively confirmed CM (≥15 headache days and ≥8 migraine days per month), were randomized 1:1:1 to receive subcutaneous injections of fremanezumab quarterly (675 mg at baseline and placebo at Weeks 4 and 8), fremanezumab monthly (675 mg at baseline and 225 mg at Weeks 4 and 8), or placebo at each time point over a 12-week treatment period. Change from baseline in the monthly average number of headache days of at least moderate severity and migraine days in patients with prior topiramate or onabotulinumtoxinA use were assessed as exploratory endpoints. Results: This analysis included 338 patients with prior topiramate use (quarterly, N=106; monthly, N=115; placebo, N=117) and 165 patients with prior onabotulinumtoxinA use (quarterly, N=66; monthly, N=50; placebo, N=49). During the 12-week treatment period, both dosing arms of fremanezumab resulted in significant reductions from baseline in the mean number of monthly headache days of at least moderate severity (quarterly: −4.4±0.57; monthly: −4.7±0.55) versus placebo (−1.7±0.60) in patients with prior topiramate use (both, P P =0.03). Significant reductions were observed as early as 4 weeks after initiation of treatment for patients who previously used topiramate or onabotulinumtoxinA ( P Conclusions: Fremanezumab demonstrated efficacy in patients with CM who previously used topiramate or onabotulinumtoxinA. Study Supported by: This study was funded by Teva Pharmaceutical Industries, Petach Tikva, Israel. Disclosure: Dr. Yeung has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Spierings has received research support from Teva Pharmaceuticals. Dr. Blankenbiller has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Ning has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Yang has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Ma has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Bigal has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Aycardi has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals.