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Abstract Details

Long-term Efficacy of Fremanezumab in Patients With Chronic or Episodic Migraine Who Were Inadequate Responders to Initial Fremanezumab Treatment
Headache
Headache Posters (7:00 AM-5:00 PM)
023

Fremanezumab, a fully-humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), has demonstrated efficacy in migraine prevention. There is a need to understand how long migraine patients should be treated with medications such as fremanezumab and whether patients who do not respond early in the treatment cycle may respond if they remain on treatment longer.

To determine long-term efficacy of fremanezumab in patients with episodic or chronic migraine (EM/CM) considered inadequate responders after 3 months of double-blind (DB) treatment.

During 3 months of DB treatment in the phase 3 HALO EM/CM studies (DBP), patients were randomized (1:1:1) to quarterly fremanezumab, monthly fremanezumab, or placebo. Patients completing treatment in HALO EM/CM and new patients entered the HALO long-term study (LTS), in which quarterly and monthly fremanezumab were maintained and newly enrolled and placebo patients were randomized 1:1 to quarterly or monthly fremanezumab. The subgroup with inadequate response was defined by <25% reduction in monthly migraine days (MDs) at 3 months (end of DBP), and subsequent response was evaluated by baseline category of MDs (<9; ≥9–≤12; ≥12–≤15; ≥15 days).

1,890 patients were enrolled in the LTS, with 210 characterized as inadequate responders. At months 6, 9, and 15 (end of LTS), respectively, for inadequate responders with <9 baseline MDs, a ≥50% reduction from baseline in monthly MDs (MRR) of 28%, 44%, and 50% and ≥50% reduction in headache days of at least moderate severity (HRR) of 50%, 47%, and 53% was shown. Similarly, in inadequate responders with ≥9–≤12, ≥12–≤15, and ≥15 baseline MDs, a ≥50% MRR was shown for 28%–49% of patients and ≥50% HRR for 42%–53% of patients at month 15.

These data show that patients with an inadequate initial response to fremanezumab may experience clinically meaningful reductions in migraine or headache days with continued treatment.

Authors/Disclosures
Stephen D. Silberstein, MD, FAAN (Jefferson Headache Center)
PRESENTER
Dr. Silberstein has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Silberstein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alergan. Dr. Silberstein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. Dr. Silberstein has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Silberstein has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Davies McFarland & Carroll, LLC. Dr. Silberstein has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for SHEEHEY FURLONG & BEHM P.C.. The institution of Dr. Silberstein has received research support from Lundbeck. The institution of Dr. Silberstein has received research support from abbvie. The institution of Dr. Silberstein has received research support from lundbeck. Dr. Silberstein has received publishing royalties from a publication relating to health care.
Mario Ortega No disclosure on file
Shawn Elms Shawn Elms has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Mat D. Davis Mat D. Davis has received personal compensation for serving as an employee of Teva pharmaceuticals. Mat D. Davis has received stock or an ownership interest from Teva Pharmaceuticals.
Joshua *use 125685 Cohen (Teva Pharmaceuticals Industries) Joshua Cohen has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Michael Seminerio Michael Seminerio has received personal compensation for serving as an employee of AbbVie.
Nicholas Gross, MS Nicholas Gross, MS has nothing to disclose.
Andrew M. Blumenfeld, MD, FAAN (The Los Angeles Headache Center) Dr. Blumenfeld has received personal compensation for serving as an employee of The Los Angeles Headache Center. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Allergan. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Best Doctors. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Guidepoint. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GLG. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Theranica. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Aeon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Revance. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lilly. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Abbvie. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Revance. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theranica. Dr. Blumenfeld has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Axsome. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Allergan. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Teva. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Lilly. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck.