Abstract Details

Title Safety and Tolerability of Fremanezumab in Patients With Episodic and Chronic Migraine: a Pooled Analysis of Phase 3 Studies

Topic Headache

Presentation(s) P1 - Poster Session 1 (12:00 PM-1:00 PM)

Poster/Presentation
Number 7-013

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

Background The safety and tolerability of fremanezumab, a fully-humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), has been evaluated in three randomized, double-blind, placebo-controlled phase 3 trials.

Design/Methods This analysis of the 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 placebo monthly over 12 weeks. Adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation were summarized descriptively.

Results Across the three phase 3 studies, 1,897 patients received fremanezumab (quarterly fremanezumab [675mg], n=943; monthly fremanezumab [225mg/225mg/225mg], n=401; monthly fremanezumab [675mg/225mg/225mg], n=553) and 945 received placebo. AEs were reported for similar proportions of patients across treatment groups (quarterly fremanezumab, 65%; monthly fremanezumab [225mg/225mg/225mg], 59%; monthly fremanezumab [675mg/225mg/225mg], 64%; placebo, 58%). With quarterly fremanezumab, monthly fremanezumab (225mg/225mg/225mg), monthly fremanezumab (675mg/225mg/225mg), and placebo, AEs leading to discontinuation (1%, 1%, 2%, and 2%, respectively) and serious SAEs (<1%, <1%, 1%, and 2%, respectively) were infrequent across treatment groups. In the quarterly fremanezumab, monthly fremanezumab (225mg/225mg/225mg), monthly fremanezumab (675 mg225mg/225mg), and placebo groups, respectively, the most common AEs were injection-site pain (22%, 22%, 19%, and 20%), injection-site induration (15%, 19%, 18%, and 13%), and injection-site erythema (16%, 14%, 16%, and 12%).

Conclusions Over 12 weeks, fremanezumab was well tolerated in >1,800 patients with migraine. Discontinuations due to an AEs and SAEs occurred in ≤1% of patients treated with fremanezumab.

Authors/Disclosures
Peter J. McAllister, MD, FAAN (New England Inst for Neurology and Headache) PRESENTER	Dr. McAllister has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for pfizer. Dr. McAllister has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for lilly. Dr. McAllister has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for abbvie. Dr. McAllister has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for lundbeck.
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.
	No disclosure on file
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