Efficacy of fremanezumab by country in patients with documented inadequate response to 2-4 classes of migraine preventive medications in the multicentre, randomised, placebo-controlled focus study

Abstract

The FOCUS phase 3b study of fremanezumab was the first and largest study of a migraine preventive treatment in adults with episodic or chronic migraine (EM or CM) and documented inadequate response (poor response, intolerability, or contraindication/unsuitability) to 2-4 classes of migraine preventive medications. Efficacy by country was an exploratory endpoint. After IRB approval, 838 patients were randomised (1:1:1) to monthly fremanezumab (month1: CM, 675mg; EM, 225mg; months2/3: 225mg), quarterly fremanezumab (month1: 675mg; months2/3: placebo), or matched monthly placebo for 12 weeks of double-blind treatment. Change from baseline in the monthly average number of migraine headache days over 12 weeks (primary endpoint) was evaluated by country for all migraine patients (EM and CM combined). Of 14 countries contributing data, the Czech Republic (n=188;22%), United States (n=120;14%), and Finland (n=85;10%) enrolled the most patients. Baseline monthly average numbers of migraine headache days were lower in the Czech Republic (Table). Changes from baseline in the monthly average numbers of migraine headache days over 12 weeks were significantly greater with both fremanezumab dosing regimens versus placebo for patients in the Czech Republic, United States, or Finland (all P ≤0.0123; Table). Monthly and quarterly fremanezumab significantly reduced the monthly average number of migraine headache days versus placebo regardless of country and continent (North America versus Europe) in migraine patients with documented inadequate response to 2-4 migraine preventive medication classes.