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Abstract Details

Impact of Fremanezumab on Disability Severity in Patients With Episodic and Chronic Migraine: Pooled Results of 3 Randomized, Double-blind, Placebo-controlled Phase 3 Studies
Headache
Headache Posters (7:00 AM-5:00 PM)
027

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

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

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.

Authors/Disclosures
Abraham J. Nagy, MD (Nevada Headache Institute)
PRESENTER
No disclosure on file
Peter J. McAllister, MD, FAAN (New England Inst for Neurology and Headache) Dr. McAllister has received personal compensation for serving as an employee of Revance. Dr. McAllister has received personal compensation for serving as an employee of AbbVie. Dr. McAllister has received personal compensation for serving as an employee of Merz. Dr. McAllister has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aeon. Dr. McAllister has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for lilly. Dr. McAllister has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for teva. Dr. McAllister has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for abbvie. Dr. McAllister has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for biohaven. Dr. McAllister has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for lundbeck.
Joshua *use 125685 Cohen (Teva Pharmaceuticals Industries) Joshua Cohen has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Xiaoping Ning (Teva pharmaceuticals) Ms. Ning has received personal compensation for serving as an employee of Teva Pharmaceutical . Ms. Ning has received personal compensation for serving as an employee of Teva Pharmaceutical.
Verena *use 212969 Ramirez Campos (Teva Pharmaceuticals) Verena Ramirez Campos has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Evelyn Du (Teva Pharmaceuticals) Evelyn Du has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Messoud Ashina, MD, PhD (Dept. of Neurology) Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AbbVie. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer.