Abstract Details

Title Effect of Fremanezumab on the Total Burden of Migraine in Patients with Episodic or Chronic Migraine: Findings from 3 Randomized, Double-blind, Placebo-controlled Phase 3 Studies

Topic Headache

Presentation(s) Headache Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 125

Objective To assess the effect of fremanezumab treatment on the total burden of migraine in patients with episodic or chronic migraine (EM/CM).

Background Fremanezumab, a fully-humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), has proven efficacy in the preventive treatment of migraine in adults.

Design/Methods This post hoc analysis used data from three phase 3 studies: HALO EM (patients with EM), HALO CM (patients with CM), and FOCUS (patients with EM or CM and inadequate response to 2-4 prior migraine preventive medication classes). In all 3 trials, patients were randomized 1:1:1 to receive quarterly fremanezumab, monthly fremanezumab, or matched placebo over 12 weeks. To assess the monthly total migraine burden, severity-weighted duration of migraine days (in hours) was calculated by multiplying hours of migraine recorded and pain severity (rated 0=none to 3=severe) for each migraine day and summing these composite measures over migraine days per month.

Results The monthly total migraine burden (monthly average severity-weighted duration of migraine days) at baseline was similar in the quarterly fremanezumab, monthly fremanezumab, and placebo groups, respectively, in the HALO EM (115.2, 111.6, and 113.0 hours), HALO CM (234.3, 250.2, and 253.5 hours), and FOCUS (225.8, 238.1, and 242.1 hours) studies. Reductions from baseline in the monthly total migraine burden (in hours) over 12 weeks of double-blind treatment were greater with fremanezumab versus placebo in the HALO EM study (least-squares mean change from baseline: quarterly, −48.3; monthly, −56.4 vs placebo, −29.1; both P≤0.0001), HALO CM study (quarterly, −94.6; monthly, −100.6 vs placebo, −56.5; both P<0.0001), and FOCUS study (quarterly, −70.0; monthly, −75.1 vs placebo, −9.0; both P<0.0001).

Conclusions Greater reductions in the monthly total migraine burden, including frequency, severity, and duration, were seen with quarterly and monthly fremanezumab versus placebo for patients with EM and CM, including those with difficult-to-treat migraine.

Authors/Disclosures
Christina Sun-Edelstein, MD (St Vincent's Hospital Melbourne) PRESENTER	Dr. Sun-Edelstein has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Dr. Sun-Edelstein has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Sun-Edelstein has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Sun-Edelstein has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. Dr. Sun-Edelstein has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eli Lilly. Dr. Sun-Edelstein has received publishing royalties from a publication relating to health care.
	No disclosure on file
Sanjay Gandhi, MD (Teva Pharmaceuticals)	Dr. Gandhi has received personal compensation for serving as an employee of Teva Pharmaceuticals.
	No disclosure on file
Jan L. Brandes, MD (Nashville Neuroscience Group, P.C.)	Dr. Brandes has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Brandes has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lilly. Dr. Brandes has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Dr. Brandes has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Brandes has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theranica. Dr. Brandes has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Dr. Brandes has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Lilly. Dr. Brandes has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Amgen. Dr. Brandes has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Brandes has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Allergan. Dr. Brandes has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Brandes has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Lewis Thomason. Dr. Brandes has received research support from Amgen. Dr. Brandes has received research support from Teva. Dr. Brandes has received research support from Allergan. Dr. Brandes has received research support from Biohaven. Dr. Brandes has a non-compensated relationship as a Board Member with National Headache Foundation that is relevant to �鶹��ýӳ�� interests or activities.

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