Abstract Details

Title Six-month Safety and Efficacy of Fremanezumab in Migraine: Pooled Analysis from the Phase 3 FOCUS and HALO Studies

Topic Headache

Presentation(s) S31 - Advances in Migraine Therapeutics (4:42 PM-4:54 PM)

Poster/Presentation
Number 007

Background

Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) targeting calcitonin gene-related peptide (CGRP), is approved for migraine prevention in adults.

Objective

This analysis used data pooled from phase 3 studies (HALO EM/CM/LTS and FOCUS double-blind period [DBP]/open-label extension [OLE]) to evaluate 6-month safety and efficacy of quarterly fremanezumab (QTY) and monthly fremanezumab (MLY).

Design/Methods

Participants were randomized 1:1:1 to QTY, MLY, or placebo (PBO) over 3 months in HALO EM/CM and FOCUS DBP. In the HALO LTS, participants from HALO EM/CM QTY/MLY arms continued those dosing regimens, and those who were in the PBO arm were randomized 1:1 to QTY or MLY for 12 months. Participants from FOCUS DBP continued or switched to MLY during the 3-month OLE. The first 6 months of data were pooled for participants rolling over from HALO EM/CM to HALO LTS and participants in FOCUS DBP/OLE. Data were stratified by DBP randomization group; participants in the PBO randomization group received 3 months of PBO and 3 months of fremanezumab treatment (QTY/MLY).

Results This analysis includes 2373 participants. Mean change from baseline at 6 months in monthly migraine days (MMD) was –5.8 in PBO randomization group, –5.6 in QTY randomization group, and –5.9 in MLY randomization group. The proportion of participants with ≥50% reduction in MMD was 49% in PBO randomization group, 47% in QTY randomization group, and 52% in MLY randomization group. Similar results were observed in chronic and episodic migraine. Adverse events (AEs; mostly non-significant, injection-site reactions that resolved without treatment) were reported by 73% of participants in PBO randomization group, 78% in QTY randomization group, and 78% in MLY randomization group, with ≤3% of participants reporting serious AEs or AEs leading to discontinuation across groups.

Conclusions Fremanezumab was safe and well-tolerated in participants with migraine, with ongoing reductions in MMD, over 6 months of treatment.

Authors/Disclosures
PRESENTER	No disclosure on file
Larry Charleston IV, MD, MSc, FAHS (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 Allergan/AbbVie. Dr. Charleston has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biohaven Biopharmaceuticals. Dr. Charleston has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva Pharmaceuticals. 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 $500-$4,999 for serving as a Consultant for Pfizer. 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 at Large with Alliance for Headache Disorders Advocacy 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.
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.
Lynda Krasenbaum	Lynda Krasenbaum has received personal compensation for serving as an employee of Teva Pharmaceuticals.
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