Fremanezumab impact on disability and MSQOL in patients with inadequate response to 2-4 classes of preventive medications who reverted from chronic to episodic migraine

Abstract

Headache-related disability and migraine-specific quality of life (MSQoL) were exploratory endpoints of the FOCUS phase 3b study of fremanezumab, the first and largest study of preventive treatment in adults with episodic or chronic migraine (EM or CM) and documented inadequate response to 2-4 classes of migraine preventive medications. This post-hoc analysis evaluated disability and MSQoL in patients reverting from CM to EM during the study. After obtaining IRB approval, patients with CM were randomised (1:1:1) to double-blind treatment with quarterly fremanezumab (month 1: 675 mg; months 2/3: placebo), monthly fremanezumab (month 1: 675 mg; months 2/3: 225 mg), or matched monthly placebo for 12 weeks. Reversion rates were defined as: A) ≥15 headache days (HDs) at baseline but <15 HDs at all 3 months or B) ≥15 HDs at baseline but <15 HDs on average over 12 weeks. Of the CM patients, 18/167(11%) with placebo, 59/167(35%) with quarterly fremanezumab, and 59/172(34%) with monthly fremanezumab reverted to EM using definition A, and 50/167(30%), 81/167(49%), and 91/172(53%), respectively, reverted using definition B. Reductions from baseline in the 6-item Headache Impact Test (HIT-6) and Migraine Disability Assessment (MIDAS) scores and improvements from baseline in all MSQoL domain scores were greater with fremanezumab versus placebo during the 4 weeks after the third dose of study drug (Table). Fremanezumab was associated with improvements in headache-related disability and all MSQoL domain scores versus placebo in patients with documented inadequate response to 2-4 classes of migraine preventive medications who reverted from CM to EM.