Abstract Details

Title Efficacy and Safety of Fremanezumab in Patients With Episodic and Chronic Migraine and Documented Inadequate Response to 2-4 Classes of Migraine Preventive Medications During the Open-label Period of the Phase 3b FOCUS Study

Topic Headache

Presentation(s) P5 - Poster Session 5 (8:00 AM-9:00 AM)

Poster/Presentation
Number 7-010

Objective To evaluate efficacy and tolerability of fremanezumab, a fully-humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), in the 12-week open-label extension (OLE) of the phase 3b FOCUS study of patients with episodic and chronic migraine (EM and CM) and documented inadequate response to 2-4 classes of migraine preventive medications.

Background

Results from 12 weeks of double-blind treatment in the FOCUS study reported previously showed that fremanezumab was effective and well-tolerated. Results of the OLE are reported herein.

Design/Methods The FOCUS study included a 12-week, double-blind, placebo-controlled treatment period (DBP) and 12-week OLE. Patients were initially randomized (1:1:1) to quarterly fremanezumab (Month 1/2/3: 675mg/placebo/placebo), monthly fremanezumab (Month 1/2/3: 675mg[CM],225mg[EM]/225mg/225mg), or matched monthly placebo for the 12-week DBP. All patients completing the DBP entered the OLE and received three monthly doses of fremanezumab (225mg). Changes from baseline (assessed during 28-day run-in period before first double-blind dose) in monthly average migraine days (primary endpoint) and headache days of at least moderate severity were evaluated during the OLE and summarized by double-blind randomization group.

Results Of 838 patients randomized, 807 completed the DBP and entered OLE. All 807 patients completed the OLE. In the placebo, quarterly fremanezumab, and monthly fremanezumab groups, respectively, mean (SD) changes from baseline in monthly average migraine days at week 24 of the study (end of OLE) were −4.7(5.41), −5.1(4.71), and −5.5(4.96). Mean (SD) changes in monthly average headache days of at least moderate severity were −4.5(5.04), −4.8(4.47), and −5.2(4.94), respectively. The most common adverse events (AEs) were injection-site reactions, such as injection-site erythema (6%), and there were low rates of AEs leading to discontinuation (<1%) and serious AEs (1%).

Conclusions Fremanezumab demonstrated sustained efficacy up to 6 months and was well-tolerated long-term in patients with EM or CM and inadequate response to multiple migraine preventive medication classes.

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.
Joshua M. Cohen, MD	No disclosure on file
	No disclosure on file
Verena Ramirez Campos, MD (Teva)	Dr. Ramirez Campos has received personal compensation for serving as an employee of teva.
Ronghua Yang, PhD (Teva Pharmaceutical)	No disclosure on file
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.
H. C. Diener, MD, F�鶹��ýӳ�� (University Duisburg-Essen)	Dr. Diener has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Diener has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for TEVA. Dr. Diener has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck. Dr. Diener has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Springer. Dr. Diener has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Thieme. The institution of Dr. Diener has received research support from German Research Council.

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