Abstract Details

Title Reduction in the Number of Headache Hours in Chronic and Episodic Migraine With Fremanezumab

Topic Headache

Presentation(s) P2 - Poster Session 2 (5:30 PM-6:30 PM)

Poster/Presentation
Number 13-008

Objective To assess the change in headache hours with fremanezumab in patients with chronic (CM) and episodic migraine (EM).

Background

Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), is efficacious in preventing migraine.

Design/Methods In two concurrent Phase 3, 12-week, multicenter, randomized, double-blind, parallel-group studies, patients with prospectively confirmed CM (≥15 headache days and ≥8 migraine days/month) or EM (6–14 headache days and ≥4 migraine days/month) were randomized 1:1:1 to receive subcutaneous fremanezumab quarterly (675 mg at baseline, and placebo at Weeks 4 and 8), fremanezumab monthly (CM: 675 mg at baseline and 225 mg at Weeks 4 and 8; EM: 225 mg at baseline, Weeks 4 and 8), or placebo (at baseline, Weeks 4 and 8). The change from baseline in the monthly average number of hours with headache of any severity and of at least moderate severity during the 12-week treatment period was evaluated.

Results

In patients with CM, headache hours of at least moderate severity were reduced from baseline (quarterly [mean]: 66.4 hours; monthly: 68.0 hours; placebo: 68.5 hours) with both fremanezumab dosing regimens (quarterly [least-squares mean]: –24.4 hours, P=0.0001; monthly: –26.4 hours, P<0.0001) compared with placebo (–14.1 hours). Similar reductions were seen in headache hours of any severity (quarterly: P=0.0002, monthly: P<0.0001). In patients with EM, headache hours of at least moderate severity were reduced from baseline (quarterly [mean]: 33.3 hours; monthly: 31.7 hours; placebo: 31.6 hours) with both fremanezumab dosing regimens (quarterly [least-squares mean]: –14.5 hours, P<0.0001; monthly: –15.5 hours, P<0.0001) compared with placebo (–8.1 hours). Similar reductions were seen in headache hours of any severity (quarterly: P=0.0007, monthly: P<0 0001).

Conclusions

Fremanezumab treatment reduced headache hours of any severity and of at least moderate severity among patients with CM and EM.

Authors/Disclosures
PRESENTER	No disclosure on file
Sanjay Gandhi, MD (Teva Pharmaceuticals)	Dr. Gandhi has received personal compensation for serving as an employee of Teva Pharmaceuticals.
	No disclosure on file

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