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Abstract Details

Early Reductions in Headache Severity and Duration With Fremanezumab Treatment in the Randomized, Double-blind Phase 3b FOCUS study
Headache
Headache Posters (7:00 AM-5:00 PM)
021

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

To evaluate early effects of fremanezumab treatment on headache severity and duration in patients with chronic or episodic migraine (CM/EM) and inadequate response to 2-4 prior migraine preventive medication classes.

The FOCUS study was a randomized, double-blind, placebo-controlled phase 3b study in adults with prior inadequate response to 2-4 migraine preventive medication classes. Eligible patients were randomized 1:1:1 to quarterly fremanezumab, monthly fremanezumab, or matched placebo for 12 weeks. Changes from baseline at 4 weeks were evaluated for average headache severity (patient-rated on a scale of 1=mild to 3=severe), monthly average headache hours of any severity and at least moderate severity, and average headache hours per headache day of any severity.

Data were evaluated for 837 enrolled patients. Reductions in average headache severity at 4 weeks were higher with quarterly and monthly fremanezumab dosing (least-squares mean [LSM] change from baseline: quarterly, −0.2; monthly, −0.2) versus placebo (−0.1; both P<0.0001). At 4 weeks, reductions were also seen in monthly average number of headache hours of any severity with fremanezumab (LSM change from baseline: quarterly, −28.1; monthly: −31.4) versus placebo (−3.6; both P<0.0001) and in monthly average number of headache hours of at least moderate severity with fremanezumab (quarterly, −19.6; monthly, −20.1) versus placebo (−2.9; both P<0.0001). Lastly, reductions in average number of headache hours per headache day of any severity at 4 weeks were higher with fremanezumab (LSM change from baseline: quarterly, −0.8; monthly: −0.9) versus placebo (−0.0; both P<0.0001).

After 4 weeks of treatment, quarterly and monthly fremanezumab treatment reduced both headache severity and duration in patients with CM or EM and inadequate response to 2-4 prior migraine preventive medication classes.

Authors/Disclosures
Messoud Ashina, MD, PhD (Dept. of Neurology)
PRESENTER
Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AbbVie. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer.
Joshua *use 125685 Cohen (Teva Pharmaceuticals Industries) Joshua Cohen has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Sanjay Gandhi, MD (Teva Pharmaceuticals) Dr. Gandhi has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Nahum Nesher (Tel Aviv Medical Center) Steve Barash has received personal compensation for serving as an employee of Teva. Steve Barash has received stock or an ownership interest from Teva.
Patricia Pozo-Rosich, MD, PhD Dr. Pozo-Rosich has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Pozo-Rosich has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Pozo-Rosich has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Pozo-Rosich has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva Pharmaceuticals. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medscape. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly Foundation Spain. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Sociedad Española Neurologia.