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Abstract Details

Impact of Fremanezumab on Headache-related Disability in Patients With Migraine and Documented Inadequate Response to 2-4 Classes of Migraine Preventive Medication Classes in the Open–label Extension of the Phase 3b FOCUS Study
Headache
P6 - Poster Session 6 (12:00 PM-1:00 PM)
7-010
Migraine is associated with substantial disability. In the double-blind period of the FOCUS study, fremanezumab, a fully humanized monoclonal antibody that selectively targets calcitonin gene–related peptide (CGRP), demonstrated efficacy in patients with EM or CM who had documented inadequate response to 2-4 classes of prior migraine preventive treatments.
To evaluate the impact of fremanezumab on headache-related disability in patients with episodic migraine (EM) or chronic migraine (CM) and documented inadequate response to 2-4 classes of prior migraine preventive medications, as measured by the Headache Impact Test (HIT–6) and Migraine Disability Assessment (MIDAS).
This study included a 12-week, double-blind, placebo-controlled treatment period and 12-week, open-label treatment period. During the double-blind period, patients were randomized (1:1:1) to subcutaneous (SC) quarterly fremanezumab (Month 1/2/3: 675mg/placebo/placebo), monthly fremanezumab (Month 1/2/3: 225mg[EM]/675mg[CM]/225mg/225mg), or matched monthly placebo. All patients completing double-blind treatment entered the 12-week open-label period, where all patients (CM and EM) received fremanezumab monthly (225mg) for 3 months. Disability was assessed during open-label treatment using the HIT-6 and MIDAS and summarized by randomized treatment group.
Of 838 patients randomized in the double-blind treatment period, 807 entered the open-label period. Substantial reductions in disability were observed across all treatment groups. Reductions from baseline (assessed during 28-day run-in period before first double-blind dose) in HIT-6 scores were slightly higher in the quarterly (mean[SD], –8.4[8.02]) and monthly fremanezumab (–8.3[7.38]) groups than the placebo group (–7.6[8.12]) at 4 weeks after the last open-label dose of study drug. Reductions from baseline in MIDAS scores were generally comparable across treatment groups (mean [SD]: quarterly fremanezumab, –29.9[42.43]; monthly fremanezumab, –33.9[43.73]; placebo, –27.3[48.18]).
Sustained improvements were observed in headache-related disability, based on HIT–6 and MIDAS scores, with fremanezumab treatment over up to 6 months in patients with inadequate response to multiple prior migraine preventive medication classes.
Authors/Disclosures
Amaal J. Starling, MD, FAAN (Mayo Clinic)
PRESENTER
Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Axsome Therapeutics. Dr. Starling has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Starling has received personal compensation in the range of $0-$499 for serving as a Consultant for Med-IQ. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medscape. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Everyday Health. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for WebMD. Dr. Starling has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Miller Medical. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for eNeura.
Verena Ramirez Campos, MD (Teva) Dr. Ramirez Campos has received personal compensation for serving as an employee of teva.
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.
Joshua M. Cohen, MD No disclosure on file
Ronghua Yang, PhD (Teva Pharmaceutical) No disclosure on file