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Abstract Details

Cardiovascular Safety of Fremanezumab in Patients With Migraine and Cardiovascular Medical History or Risk Factors: A Pooled Analysis of Phase 3 Studies
Headache
Headache Posters (7:00 AM-5:00 PM)
034

Understanding CV safety of medications targeting the calcitonin gene-related peptide (CGRP) pathway is important given the vasodilatory properties of CGRP. Fremanezumab, a fully-humanized monoclonal antibody (IgG2Δa) that selectively targets CGRP, has proven efficacy for the preventive treatment of migraine in adults.

To assess the cardiovascular (CV) safety of fremanezumab in a large population of patients with episodic migraine (EM) and chronic migraine (CM) based on CV medical history and CV/cerebrovascular risk factors (CVRFs).

This analysis of CV safety of fremanezumab included data from the 2 HALO studies (1 in EM, 1 in CM) and the FOCUS study (EM or CM patients with inadequate response to 2-4 classes of migraine preventive medications). In all 3 trials, patients were randomized 1:1:1 to quarterly fremanezumab, monthly fremanezumab, or placebo for 12 weeks. CV adverse events (CVAEs) were evaluated in patients with and without CV medical history and by number of CVRFs at baseline.

Among patients with CV medical history (fremanezumab, n = 325; placebo, n = 153), CVAEs occurred in similar, low proportions of patients across treatment groups (3%-6%); the most common CVAE was hypertension (0%-2%). Among patients without CV medical history (fremanezumab, n = 1,572; placebo, n = 792), CVAEs also occurred in similar, low proportions of patients across treatment groups (1%-2%). In total, 499 of 2,842 pooled patients had ≥2 CVRFs; of these, 66% had CV medical history. CVAEs were infrequent in patients with ≥2 or ≥3 CVRFs (0%-2%); no CVAEs were reported in patients with ≥4 CVRFs. No CV safety signals were identified.

This pooled analysis demonstrates a favorable CV safety profile for fremanezumab in patients with CV medical history or with ≥2 CVRFs. No CV safety signals were identified. These data support the strong safety profile of this preventive treatment targeting the CGRP pathway.

Authors/Disclosures
Stephanie J. Nahas, MD, FAAN (Thomas Jefferson University)
PRESENTER
Dr. Nahas has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for AbbVie. Dr. Nahas has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Nahas has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Tonix. Dr. Nahas has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Neurology Learning Network. Dr. Nahas 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. Nahas has received publishing royalties from a publication relating to health care. Dr. Nahas has received publishing royalties from a publication relating to health care. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as a expert/talent for CME event with Medscape/WebMD.
Tim P. Juergens (University Medical Center Rostock, Dept. of Neurology, Headache Center North-Eas) An immediate family member of Tim P. Juergens has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lilly. Tim P. Juergens has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TEVA. Tim P. Juergens has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Tim P. Juergens has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan. Tim P. Juergens has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Hormosan. The institution of Tim P. Juergens has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Tim P. Juergens has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TEVA. Tim P. Juergens has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for TEVA. Tim P. Juergens has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lilly. Tim P. Juergens has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Tim P. Juergens has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Tim P. Juergens has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan. Tim P. Juergens has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Hormosan. The institution of Tim P. Juergens has received research support from GBA. The institution of Tim P. Juergens has received research support from EFRE. Tim P. Juergens has a non-compensated relationship as a President with German Headache and Migraine Society that is relevant to AAN interests or activities.
Yoel Kessler Yoel Kessler 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.
Joshua *use 125685 Cohen (Teva Pharmaceuticals Industries) Joshua Cohen has received personal compensation for serving as an employee of Teva Pharmaceuticals.
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.
Stephen D. Silberstein, MD, FAAN (Jefferson Headache Center) Dr. Silberstein has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Silberstein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alergan. Dr. Silberstein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. Dr. Silberstein has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Silberstein has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Davies McFarland & Carroll, LLC. Dr. Silberstein has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for SHEEHEY FURLONG & BEHM P.C.. The institution of Dr. Silberstein has received research support from Lundbeck. The institution of Dr. Silberstein has received research support from abbvie. The institution of Dr. Silberstein has received research support from lundbeck. Dr. Silberstein has received publishing royalties from a publication relating to health care.