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• W2893281143 abstract "Objective: Understand the impact of fremanezumab vs. placebo on Migraine-Specific Quality of Life (MSQoL) in episodic migraine (EM). Background: Migraine adversely affects the MSQoL. Fremanezumab, a fully-humanized monoclonal antibody (IgG2Δa), selectively targets calcitonin gene-related peptide (CGRP) andreducesheadaches/migraine days in patients with EM. Design/Methods: In a Phase III, multicenter, randomized, double-blind, placebo-controlled study, eligible patients with confirmed EM (headaches on 6–14 days; ≥4 days fulfilling migraine criteria/month) were randomized to 1 of 3 treatment groups: (1)monthly dosing: 225 mg fremanezumab at months 1, 2 and 3, (2)quarterly dosing: 675 mg fremanezumab at month 1, followed by placebo injections at months 2 and 3, and (3)monthly administration of matching placebo. The mean change in MSQoL was assessed from baseline to month 3 using the MSQoL v2 questionnaire. The MSQoL questionnaire has a 4-week recall interval and assessed the role function-restrictive (RFR), role function-preventive (RFP), and emotional function (EF) domains. Domain scores range from 0–100, with higher scores indicating better HRQoL. Statistical analyses performed using an analysis of covariance and a mixed-effects model for repeated-measures. Results: 865 patients were included in analyses distributed nearly equally among the 3-arms. Compared with placebo, mean MSQoL RFR domain score for each fremanezumab dosing regimen was significantly improved from baseline to 4 weeks after final dose of study drug (least-squares mean ± standard error for quarterly: 4.1±1.4; P =0.0028; monthly: 7±1.4, P P ≤0.001) as was the EF domain score for the monthly group ( P P Conclusions: Fremanezumab improves the MSQoL in patients with EM. Disclosure: Dr. Lipton has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Has reviewed for the NIA and NINDS, serves as consultant, advisory board member, or has received honoraria from: Alder, Allergan, Amgen, Autonomic Technologies, Avanir, Boston Scientific, Dr. Reddy’s, Electrocore, Eli Lilly, eNeura Therapeutics, GlaxoSmit. Dr. Lipton has received royalty, license fees, or contractual rights payments from Receives royalties from Wolff’s Headache, 8th Edition, Oxford University Press, 2009 and Informa. Dr. Lipton holds stock and/or stock options in Holds stock options in eNeura Therapeutics and Biohaven. Dr. Lipton has received research support from Support from the NIH, the Migraine Research Foundation, the National Headache Foundation, Allergan plc, Amgen, Dr Reddy’s, and Novartis. Dr. Gandhi has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceutical Industries. Dr. Fitzgerald, MA, PhD has nothing to disclose. Dr. Yeung has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Cohen has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Ma, MS has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva for employment. Dr. Aycardi has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals." @default.
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• W2893281143 date "2018-04-10" @default.
• W2893281143 modified "2023-09-28" @default.
• W2893281143 title "The Impact of Fremanezumab on Migraine-Specific Health-Related Quality of Life in Episodic Migraine (P4.115)" @default.
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