Abstract Details

Title Cardiovascular Safety of Fremanezumab in Patients with Episodic and Chronic Migraine: A Pooled Analysis of Phase 3 Studies

Topic Headache

Presentation(s) S8 - Migraine Therapeutics (4:06 PM-4:18 PM)

Poster/Presentation
Number 004

Objective To evaluate the cardiovascular safety of fremanezumab in patients with episodic migraine (EM) and chronic migraine (CM).

Background Understanding the cardiovascular safety of medications targeting the calcitonin gene-related peptide (CGRP) pathway is critically important given the vasodilatory properties of CGRP. Fremanezumab, a fully-humanized monoclonal antibody (IgG2Δa) that selectively targets CGRP, has been studied in three phase 3 trials.

Design/Methods This analysis of the cardiovascular safety and tolerability of fremanezumab included data from the 2 HALO studies (one in EM and one in CM), and the FOCUS study in patients with EM or CM and prior inadequate response to 2-4 classes of preventive medications. In all 3 trials, patients were randomized 1:1:1 to receive subcutaneous injections of fremanezumab quarterly (Months 1/2/3: EM or CM, 675mg/placebo/placebo), fremanezumab monthly (Months 1/2/3: EM, 225mg/225mg/225mg; CM, 675mg/225mg/225mg) or matched placebo over 12 weeks. Cardiovascular adverse events (AEs) were evaluated in patients with and without cardiovascular medical history.

Results Among patients with cardiovascular medical history (quarterly fremanezumab [675mg], n=167; monthly fremanezumab [225mg/225mg/225mg], n=64; monthly fremanezumab [675mg/225mg/225mg], n=94; placebo, n=153), cardiovascular AEs occurred in similar, low proportions of patients across treatment groups (4%, 6%, 6%, and 3% respectively). Among patients with cardiovascular medical history, the most common cardiovascular AE was hypertension (quarterly fremanezumab [675mg], 2%; monthly fremanezumab [225mg/225mg/225mg], 0%; monthly fremanezumab [675mg/225mg/225mg], 1%; placebo, <1%). Among patients without cardiovascular medical history (quarterly fremanezumab [675mg], n=776; monthly fremanezumab [225mg/225mg/225mg], n=337; monthly fremanezumab [675mg/225mg/225mg], n=459; placebo, n=792), cardiovascular AEs also occurred in similar, low proportions of patients across treatment groups (2%, 1%,2%, and 2%, respectively).

Conclusions Pooled data from three phase 3 trials indicate that treatment with fremanezumab over 12 weeks has a favorable cardiovascular safety profile, even in patients with a cardiovascular medical history, with no safety signals detected.

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 $50,000-$99,999 for serving as a Consultant for Eli Lilly. Dr. Nahas has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Nahas has received personal compensation in the range of $10,000-$49,999 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 a Consultant for Axsome. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. 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 for CME activities with Medscape/WebMD. Dr. Nahas has a non-compensated relationship as a Board Member-at-Large with American Headache Society that is relevant to AAN interests or activities. Dr. Nahas has a non-compensated relationship as a Board Member-at-Large with Alliance for Headache Disorders Advocacy that is relevant to AAN interests or activities. Dr. Nahas has a non-compensated relationship as a Executive Board Member with The Headache Alliance that is relevant to AAN interests or activities.
	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.
Joshua M. Cohen, MD	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
Stephen D. Silberstein, MD, FAAN (Jefferson Headache Center)	Dr. Silberstein has received publishing royalties from a publication relating to health care.

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