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Abstract Details

Clinically Meaningful Responses to Fremanezumab in Patients With Migraine and Documented Inadequate Response to 2–4 Migraine Preventive Medication Classes in the Open–label Period of the International, Multicenter Phase 3b FOCUS Study
Headache
P5 - Poster Session 5 (8:00 AM-9:00 AM)
7-011
To evaluate clinically meaningful response rates with subcutaneous (SC) quarterly or monthly fremanezumab, a fully-humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), in patients with episodic migraine (EM) or chronic migraine (CM) and documented inadequate response to 2-4 classes of prior migraine preventive medications.
In the double-blind period (DBP) of the FOCUS study, the first and largest study of a migraine preventive treatment in patients with EM or CM who had documented inadequate response to 2-4 classes of prior migraine preventive medications, fremanezumab demonstrated efficacy in patients with difficult-to-treat migraine.
This phase 3b study included both a 12-week, placebo-controlled DBP and a 12-week, open-label treatment period (OLE). In the DBP, patients were randomized (1:1:1) to SC quarterly fremanezumab (Month 1: 675mg; Months 2 and 3: placebo), monthly fremanezumab (Month 1: 225mg [EM]/675mg [CM]; Months 2 and 3: 225mg), or matched monthly placebo. After completing the DBP, patients entered the OLE and all received SC fremanezumab monthly (225mg) for 3 months. The proportions of patients achieving ≥50% and ≥75% reductions from baseline (assessed during 28-day run-in period before first double-blind dose) in the monthly average number of migraine days were evaluated during the OLE and summarized by double-blind randomization group.
Of 838 patients randomized, 807 entered the OLE. With open-label fremanezumab treatment, proportions of patients achieving ≥50% reduction in monthly average migraine days at study week 24 (end of OLE) were generally comparable in the fremanezumab (quarterly, 45%; monthly, 46%) and placebo (38%) groups. Proportions of patients achieving ≥75% reduction were also comparable (quarterly fremanezumab, 15%; monthly fremanezumab, 20%; placebo, 16%). 
Clinically meaningful responses were demonstrated at 6 months in the OLE of the FOCUS study. Clinically meaningful benefit was demonstrated regardless of whether patients had received fremanezumab or placebo in the DBP of the FOCUS study.
Authors/Disclosures
Jonathan P. Gladstone, MD
PRESENTER 		Dr. Gladstone has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lily. Dr. Gladstone has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Gladstone has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan. Dr. Gladstone has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lily. Dr. Gladstone has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Gladstone 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. Gladstone has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan. Dr. Gladstone has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aralez. Dr. Gladstone 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. Gladstone has received publishing royalties from a publication relating to health care.
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
Verena Ramirez Campos, MD (Teva) Dr. Ramirez Campos has received personal compensation for serving as an employee of teva.
Ronghua Yang, PhD (Teva Pharmaceutical) No disclosure on file
Egilius L. Spierings, MD, PhD (MEDVADIS RESEARCH) Dr. Spierings has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Manistee. Dr. Spierings has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Spierings has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lilly. Dr. Spierings has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie.