Abstract
Objective: To assess the effect of fremanezumab versus placebo on medication overuse and acute headache medication use in patients with chronic migraine (CM).
Background: Overuse of acute or symptomatic headache medications, such as triptans, ergot derivatives, opioids, and combination analgesics, can cause medication overuse headache (MOH). CM is often accompanied by MOH. Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), is efficacious in preventing CM.
Design/Methods: In this Phase 3, multicenter, randomized, double-blind, placebo-controlled study, CM patients were randomized 1:1:1 to receive subcutaneous fremanezumab quarterly (675 mg at baseline, and placebo at Weeks 4 and 8), fremanezumab monthly (675 mg at baseline, and 225 mg at Weeks 4 and 8), or placebo (at baseline, Weeks 4 and 8). We assessed the proportion of patients who reverted from overusing medications at baseline to not overusing medications during the 12-week treatment period, and the change from baseline in the number of days of acute headache medication use.
Results: Among patients with medication overuse at baseline (quarterly n=201; monthly n=198; placebo n=188), more patients treated with fremanezumab reported no medication overuse during the treatment period (quarterly: 55%, P=0.0389; monthly: 61%, P=0.0024) than those who received placebo (46%). Response to treatment was seen by Week 4 (quarterly: 51%, P=0.0091; monthly: 54%, P=0.0014; vs placebo: 39%). Among the patients who responded to treatment, the baseline number of days with medication overuse was similar across treatment groups (quarterly [mean]: 16.6 days; monthly: 16.7 days; placebo: 16.6). Within this population, fremanezumab treatment significantly reduced the days of acute headache medication use (quarterly: −9.0 days, P=0.0017; monthly: −8.9 days, P=0.0040) compared with those who received placebo (−7.1 days).
Conclusions: Fremanezumab treatment was associated with a reduction in overuse of acute medications and a corresponding decrease in days using acute medications.
Disclosure: Dr. Silberstein has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Alder Biopharmaceuticals, Allergan, Amgen, Avanir, eNeura, ElectroCore Medical, Labrys Biologics, Medscape, Medtronic, Neuralieve, NINDS, Pfizer, and Teva. Dr. Silberstein has received compensation for serving on the Board of Directors of eNeura and Biohaven. Dr. Silberstein has received royalty, license fees, or contractual rights payments from Biohaven. Dr. Silberstein holds stock and/or stock options in Biohaven which sponsored research in which Dr. Silberstein was involved as an investigator. Dr. Silberstein holds stock and/or stock options in Biohaven. Dr. Silberstein has received research support from Allergan, Amgen, Cumberland Pharmaceuticals, ElectroCore Medical, Labrys Biologics, Eli Lilly, Merz, and Troy Healthcare.. Dr. Ashina has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Provides consultation to Allergan, Eli Lilly, Amgen, Novartis, and Promius and is a speaker for Teva Pharmaceuticals. Dr. Katsarava has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Novartis, Eli Lilly, and Teva Pharmaceuticals. Dr. Bibeau has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Seminerio has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities as an employee of Teva Pharmaceuticals. Dr. Harlow has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with EMD Serono, Inc., Rockland, MA, USA (a business of Merck KGaA, Darmstadt, Germany). Dr. Cohen has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Teva Pharmaceuticals. Dr. Cohen has received research support from This study was funded by Teva Pharmaceuticals, Petach Tikva, Israel.
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