Reduction in migraine days with aura with fremanezumab in patients with documented inadequate response to 2-4 classes of migraine preventive medications in the focus study

Abstract

The FOCUS phase 3b study of fremanezumab was the first and largest study of a migraine preventive treatment in adults with both episodic migraine (EM) and chronic migraine (CM) and documented inadequate response to 2-4 classes of migraine preventive medications. This post-hoc analysis evaluated change from baseline in monthly number of migraine days with aura. FOCUS was an international, multicentre, randomised, placebo-controlled phase 3b study. After Institutional Review Board approval, 838 patients were randomised (1:1:1) to quarterly fremanezumab (month 1: 675 mg; months 2/3: placebo), monthly fremanezumab (month 1: CM, 675 mg; EM, 225 mg; months 2/3: 225 mg), or matched monthly placebo for 12 weeks of double-blind treatment. Changes from baseline in monthly number of migraine days with aura were evaluated and compared using a mixed-effects model for repeated measures. Aura was identified based on the following 2 questions: “Did you experience something like seeing spots, stars, lines, flashing lights, zigzag lines, or ‘heat waves’ around the time of your headache?”; “Did you have feelings such as numbness or tingling in any part of your body or face around the time of your headache?” Reductions from baseline in the monthly number of migraine days with aura at Week 4 and during the 12-week treatment period were significantly greater with both fremanezumab dosing regimens versus placebo (all P ≤ 0.0062; Table). Quarterly and monthly fremanezumab significantly reduced the monthly number of migraine days with aura versus placebo in patients with migraine and documented inadequate response to 2–4 classes of migraine preventive medications.