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Abstract Details

Number Needed to Treat/Harm for Fremanezumab in Patients Who Had Inadequate Response to 2-4 Prior Migraine Preventive Medication Classes
Headache
Headache Posters (7:00 AM-5:00 PM)
118

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

To determine the number needed to treat (NNT), number needed to harm (NNH), and likelihood of being helped or harmed (LHH) in the FOCUS study.

In the 12-week, double-blind, placebo-controlled study, patients were randomized (1:1:1) to quarterly fremanezumab, monthly fremanezumab, or monthly placebo. NNT was based on responder analysis defined as ≥30% and ≥50% reduction in monthly migraine days at 12 weeks for CM and EM patients, respectively. NNH was based on discontinuations due to adverse events (AEs); if NNH ≤0, it was imputed as 1000. LHH is an indirect measure of effect size and determined as NNH divided by NNT.

Among CM patients (N=509) receiving quarterly fremanezumab, monthly fremanezumab, and placebo, respectively, response rates were 49%, 54%, and 19%, and discontinuations due to AEs were 0%, 2%, and <1%. Among EM patients (N=328) receiving quarterly fremanezumab, monthly fremanezumab, and placebo, respectively, response rates were 47%, 43%, and 10%, and discontinuations due to AEs were <1% in all 3 groups. For quarterly and monthly fremanezumab, respectively, these results translated to NNT of 3.3 and 2.9, NNH of 1000 and 71, and LHH of 300 and 25 for CM patients; to NNT of 2.7 and 3.0, NNH of 1000 and 1000, and LHH of 370 and 330 for EM patients; and to NNT of 3.0 and 2.9, NNH of 1000 and 333, and LHH of 330 and 113 for the combined CM/EM group.

The NNT, NNH, and LHH were generally favorable for both fremanezumab dosing regimens in this population with EM or CM and inadequate response to 2-4 prior migraine preventive treatment classes.

Authors/Disclosures
Messoud Ashina, MD, PhD (Dept. of Neurology)
PRESENTER
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.
Joshua *use 125685 Cohen (Teva Pharmaceuticals Industries) Joshua Cohen has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Maja *use 301657 Galic No disclosure on file
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.
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. Christoph Diener, MD, FAAN (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.