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The study involved the examination of Erenumab, a fully human monoclonal antibody that suppresses the calcitonin gene-related peptide receptor to prevent episodic migraine incidences.
Episodic migraine is last fewer than 15 migraine days or headache days per month. Calcitonin gene-related peptide (CGRP) is involved in the pathophysiology migraine. Erenumab is a fully human monoclonal antibody that selectively and potently binds to the canonical CGRP receptor. In this phase 3 trial, the authors showed that erenumab at the dose of 70 mg or 140 mg significantly reduced migraine frequency, the effects of migraines on daily activities.
The study involved the examination of Erenumab, a fully human monoclonal antibody that suppresses the calcitonin gene-related peptide receptor to prevent episodic migraine incidences.
The patients in the analysis divided into three groups: 70 mg Erenumab, 140 mg Erenumab, and placebo for six months. The variation from baseline to months 4 to 6 in the average number of migraine days per month was taken as the primary outcomes of the analysis. The change in the number of days of utilization of acute migraine-specific medication, everyday-activities domains of the Migraine Physical Function Impact Diary, 50% or more significant reduction in mean migraine days per month, and change in scores on the physical-impairment were considered as the secondary outcomes of the study.
Out of total 955 patients, 317 received 70 mg Erenumab, 319 received 140 mg Erenumab, and 319 received placebo. At baseline, the average number of migraine days per month was 8.3 which reduced up to 3.2 and 3.7 at 4 to 6 months after obtaining 70 and 140 mg Erenumab, respectively as compared to 1.8 days in the placebo group. A total of 43.3% and 50.0% patients of 70 mg and 140 mg Erenumab groups showed a 0% or greater reduction in the mean number of migraine days per month, respectively as compared to 26.6% in the placebo group. Further, 70 mg and 140 mg Erenumab groups exhibited a reduction of 1.1 and 1.6 days in the use of acute migraine-specific medication as compared to 0.2 days in the placebo group. Everyday-activities and Physical-impairment scores and improved by (5.5 and 4.2 points) and (5.9 and 4.8 points) by the 70-mg and 140-mg erenumab groups, respectively as compared to (3.3 and 2.4 points) in the placebo group. However, no difference was noticed in the rates of adverse events between the Erenumab and placebo groups.
The subcutaneous 70 mg or 140 mg Erenumab groups showed a significant decrease in the effects of migraines on daily activities, migraine frequency, and the acute migraine-specific medication use throughout six months. However, additional studies are required to evaluate the long-term safety and durability Erenumab.
N Engl J Med 2017; 377:2123-2132
A Controlled Trial of Erenumab for Episodic Migraine
Peter J. Goadsby et al.
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