Abstract Details

Title Reduction in the Severity of Headache in Patients With Chronic and Episodic Migraine With Fremanezumab Treatment

Topic Headache

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

Poster/Presentation
Number 13-002

Objective To evaluate changes in headache severity in patients with chronic migraine (CM) and episodic migraine (EM) after treatment with fremanezumab.

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, multicenter, randomized, double-blind, parallel-group studies, patients with prospectively confirmed CM or EM 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 (28-day pre-treatment period) in the mean peak severity of headache days during the post-baseline (12-week treatment) period for both fremanezumab dosing arms were compared with placebo. The mean peak severity was calculated by averaging the severity of headache days within each period, where 1=low, 2=moderate, and 3=severe.

Results In patients with CM (fremanezumab quarterly: n=375; fremanezumab monthly: n=375; placebo: n=371), the baseline percentages of moderate and severe headache days were 67%, 68%, and 69% for fremanezumab quarterly, fremanezumab monthly, and placebo. A decrease in the percentage of moderate and severe headache days from baseline was observed for all groups (fremanezumab quarterly: 10%; fremanezumab monthly: 11%; placebo: 6%) during the post-baseline period. In patients with EM (fremanezumab quarterly: n=288; fremanezumab monthly: n=287; placebo: n=290), the decreases in moderate and severe headache days were 13%, 10%, and 7% in fremanezumab quarterly, fremanezumab monthly, and placebo. Both CM and EM patients had reductions in the mean peak severity of headache days from baseline during the post-baseline period, with both quarterly and monthly fremanezumab compared with placebo (P<0.0001).

Conclusions Fremanezumab treatment reduced the severity of headache in patients with migraine.

Authors/Disclosures
Messoud Ashina, MD, PhD (Dept. of Neurology) PRESENTER	Dr. Ashina has received personal compensation in the range of $10,000-$49,999 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 Eli Lilly. Dr. Ashina has received personal compensation in the range of $10,000-$49,999 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 $10,000-$49,999 for serving as a Consultant for Teva. Dr. Ashina has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astra Zeneca. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GlaxoSmithKline. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Incyte. The institution of Dr. Ashina has received research support from The Lundbeck Foundation. The institution of Dr. Ashina has received research support from Novo Nordisk Foundation . The institution of Dr. Ashina has received research support from Danish National Research Foundation . Dr. Ashina has received publishing royalties from a publication relating to health care.
	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

��ɫ��

��ɫ��