Abstract Details

Title Fremanezumab Cardiovascular and Cerebrovascular Safety Profile: Pooled Data From Placebo-Controlled and Long-Term Studies

Topic Headache

Presentation(s) S17 - Headache: Clinical Trials I (1:44 PM-1:55 PM)

Poster/Presentation
Number 005

Background Calcitonin gene-related peptide (CGRP) is a neuropeptide with vasodilatory properties that is involved in the pathophysiology of migraine. While inhibition of CGRP activity is efficacious in the treatment of migraine, it may affect the cardiovascular system. Fremanezumab, a fully humanized monoclonal antibody (IgG2?a) that selectively targets CGRP, is a novel preventive treatment for migraine.

Objective To summarize the cardiovascular and cerebrovascular safety profile of fremanezumab in patients with migraine.

Design/Methods Four phase 2b/3, 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with migraine examined the efficacy, safety, and tolerability of fremanezumab and placebo in adults with episodic migraine (EM) or chronic migraine (CM). Fremanezumab was administered to 2512 patients at proposed doses of 225 mg monthly (CM: 675 mg starting dose) and 675 mg quarterly, and 2 higher doses (675 mg monthly and 900 mg monthly) administered subcutaneously. An additional long-term safety and tolerability study of fremanezumab is ongoing.

Results Patients with cardiovascular or cerebrovascular risk factors (56%) were included: cardiovascular medical history (13%), obesity (27%), hypertension (10%), lipid metabolism disorders (9%), and diabetes mellitus (2%). Concomitant use of medications with a risk of cardiovascular adverse events (AEs), such as triptans (52%) and birth control pills (18%) were allowed. At the cutoff (9/26/2017), the mean duration of exposure was 244.8 days in patients who received fremanezumab, and the maximum exposure was 465 days. A total of 2289 patients received fremanezumab for ≥3 months, 1731 for ≥6 months, 775 for ≥12 months, and 138 for ≥15 months. Cardiovascular AEs occurred infrequently and at similar rates in all groups. The most-common cardiovascular AEs in fremanezumab-treated patients were hypertension (2%), palpitations (<1%), and hot flush (<1%). There were no notable trends in blood pressure or ECG parameters.

Conclusions Fremanezumab is generally safe and well tolerated, with no cardiovascular safety signals.

Authors/Disclosures
Xiaoping Ning (Teva pharmaceuticals) PRESENTER	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.
	No disclosure on file
	No disclosure on file
Paul P. Yeung, MD, PhD	No disclosure on file
Jimmy A. Schiemann (Takeda)	No disclosure on file
	No disclosure on file
Ernesto Aycardi, MD (Kyowa Kirin)	Dr. Aycardi has received personal compensation for serving as an employee of XENON. Dr. Aycardi has received stock or an ownership interest from XENON.

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