Abstract Details

Title Safety and Efficacy of Fremanezumab in Different Racial and Ethnic Subgroups of Patients With Migraine: A Pooled Analysis of Phase 3 Studies

Topic Headache

Presentation(s) P1 - Poster Session 1 (8:00 AM-9:00 AM)

Poster/Presentation
Number 15-004

Objective These pooled analyses evaluated the safety and efficacy of fremanezumab in racial and ethnic subgroups.

Background The prevalence, severity, and burden of migraine differ by geographic region and across different racial and ethnic groups. Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), has proven efficacy for migraine prevention in adults.

Design/Methods These pooled analyses included data from 3 clinical trials (HALO episodic migraine [EM], HALO chronic migraine [CM], and FOCUS [EM/CM with inadequate response to 2-4 prior preventive classes]), in which patients were randomized to 12 weeks of double-blind treatment with quarterly fremanezumab, monthly fremanezumab, or matched placebo. These pooled analyses assessed changes from baseline in monthly migraine days (MMD), proportion of patients with 50% or greater reduction in MMD from baseline, and adverse events (AEs) based on patients’ racial/ethnic groups.

Results This pooled population included 2,842 patients. Across White and Non-white racial/ethnic group, quarterly and monthly fremanezumab provided reductions in MMD from baseline during 12 weeks vs placebo (White, −4.6 and −4.8 vs −2.4, P<0.0001; Non-white, −4.8 and −4.5 vs −3.3, P<0.05 [Black/African American, −4.5 and −3.6 vs −3.9; Asian, −3.3 and −3.6 vs −0.9, P<0.05; Other, −4.6 and −5.7 vs −2.7]), as well as increases in the proportion of patients with 50% or greater reduction in MMD versus placebo. In the quarterly fremanezumab, monthly fremanezumab, and placebo groups, respectively, ≥1 AE was reported by 64%, 62%, and 59% of White patients and 66%, 61%, and 53% of Non-white patients (Black/African American patients, 60%, 58%, and 54%; Asian patients, 64%, 62%, and 44%; Other, 85%, 68%, and 81%).

Conclusions Treatment with fremanezumab was safe and effective, based on reductions in MMD and increases in ≥50% response rates versus placebo, across White and Non-white racial/ethnic groups, including the Asian subgroup.

Authors/Disclosures
Amarylis Velez-Perez PRESENTER	Amarylis Velez-Perez has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Larry "LC" Charleston IV, MD, MSc, FAHS, FANA (Michigan State University College of Human Medicine)	Dr. Charleston has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Charleston has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal Pharmaceuticals. Dr. Charleston has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma Pharmaceuticals. Dr. Charleston has received personal compensation in the range of $500-$4,999 for serving as a Consultant for LinPharma. Dr. Charleston has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Haleon. Dr. Charleston has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Pfizer. Dr. Charleston has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. Dr. Charleston has stock in Mi-Helper Inc.. Dr. Charleston has a non-compensated relationship as a Associate Editor with Headache Journal: The Journal of Head and Face Pain that is relevant to AAN interests or activities. Dr. Charleston has a non-compensated relationship as a Board Member with Clinical Neurological Society of America that is relevant to AAN interests or activities. Dr. Charleston has a non-compensated relationship as a Chair, EDI Advisory Committee (Non-voting Board Member) with American Headache Society that is relevant to AAN interests or activities.
Joshua M. Cohen, MD	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.
	No disclosure on file
	No disclosure on file
	No disclosure on file
Byung-kun Kim, MD (Eulji Hospital, Dept of Neurology)	Dr. Kim has nothing to disclose.

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