38 - Impact of Fremanezumab on Any Acute Headache Medication Use in Migraine Patients With Medication Overuse and Documented Inadequate Response to 2-4 Migraine Preventive Medication Classes in the Multicenter, Randomized, Placebo-controlled FOCUS Study
Lawrence Newman1, Joshua M. Cohen2, Verena Ramirez Campos2, Lindsay Janka2, Hans-Christoph Diener3
1Department of Neurology, Headache Division, NYU Langone Medical Center, New York, NY, USA. 2Teva Pharmaceuticals Industries, West Chester, PA, USA. 3Faculty of Medicine, University Duisburg-Essen, Essen, Germany
Purpose Patients who overuse acute medications for migraine generally experience a greater disease burden, including more migraine days, more severe pain intensity, and greater disability. The FOCUS study of fremanezumab, a fully-humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), was the first and largest study of a migraine preventive treatment in adults with either chronic migraine (CM) or episodic migraine (EM) and documented inadequate response to 2 to 4 classes of migraine preventive medication classes. Changes in use of any acute headache medication were evaluated in a subgroup of patients with medication overuse (use of any acute medication on ≥15 days/month or use of triptans, ergots, or combination medications on ≥10 days/month) at baseline. Methods For 12 weeks of double-blind treatment in the randomized, double-blind, placebo-controlled period of the phase 3b FOCUS study, patients were randomized (1:1:1) to quarterly fremanezumab (month 1: 675 mg; months 2 and 3: placebo), monthly fremanezumab (month 1: CM, 675 mg; EM, 225 mg; months 2 and 3: 225 mg), or matched monthly placebo. Changes from baseline in the monthly average number of days with acute headache medication use at 4 and 8 weeks and during the 12 weeks after the first dose were compared using mixed-effects model for repeated measures. Results Of 838 randomized patients, 435 had medication overuse. Reductions from baseline in monthly average days of any acute headache medication use were significantly greater with fremanezumab versus placebo at 4 weeks (least-squares mean [standard error] change: quarterly fremanezumab, −4.2 [0.60]; monthly fremanezumab, −5.0 [0.54] vs placebo, −0.3 [0.60]; P<0.0001) and 8 weeks (quarterly fremanezumab, −3.8 [0.70]; monthly fremanezumab, −4.9 [0.63] vs placebo, −1.1 [0.71]; P≤0.0016). Reductions from baseline in monthly average days of use of any acute headache medication were also significantly greater with fremanezumab versus placebo during the 12 weeks after the first study drug dose (quarterly fremanezumab, −3.9 [0.61]; monthly fremanezumab, −4.9 [0.55] vs placebo, −0.8 [0.61]; P<0.0001). Conclusions Fremanezumab provided early and consistent reductions in the use of any acute headache medication versus placebo in migraine patients with medication overuse at baseline and documented inadequate response to 2 to 4 classes of migraine preventive medications.