To assess disability response to fremanezumab using the Migraine Disability Assessment (MIDAS) and the 6-item Headache Impact Test (HIT-6).

Fremanezumab, a fully-humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), has demonstrated efficacy in migraine prevention in adults.

This analysis included patients with episodic (EM) or chronic migraine (CM) from 3 double-blind phase 3 trials (HALO EM, HALO CM, and FOCUS) who were randomized 1:1:1 to quarterly or monthly fremanezumab or matched placebo for 12 weeks. MIDAS and HIT-6 were used to assess patients in HALO EM/FOCUS and HALO CM/FOCUS, respectively. Measurements of disability response were defined per AHS guidelines: for MIDAS, reduction of ≥5 points when baseline score is 11-20 or ≥30% when baseline score is >20; for HIT-6, reduction of ≥5 points. Proportions of patients demonstrating shifts in severity for each disability outcome were also evaluated.

For patients with a baseline MIDAS score of 11-20, the proportion achieving a 5-point reduction from baseline was significantly higher with fremanezumab (quarterly, 71%; monthly, 70%) versus placebo (49%; P<0.01 for both). For patients with a baseline MIDAS score >20, the proportion achieving a ≥30% reduction was significantly higher with fremanezumab (quarterly, 69%; monthly, 79%) versus placebo (58%; P<0.001 for both). The proportion of patients achieving a 5-point reduction from baseline in HIT-6 scores was also significantly higher with fremanezumab (quarterly, 53%; monthly, 55%) versus placebo (39%; P<0.0001 for both). Likewise, the proportion of patients who experienced a shift of 1, 2, or 3 grades down in disability severity, according to MIDAS or HIT-6 scores, were significantly greater with quarterly and monthly fremanezumab versus placebo (all P<0.0001).

This pooled analysis demonstrated that fremanezumab resulted in clinically meaningful improvements in headache- and migraine-related disability severity, further supporting the efficacy of fremanezumab in patients with difficult-to-treat migraine.