학술논문

Efficacy and safety of erenumab in women with a history of menstrual migraine
Document Type
article
Source
The Journal of Headache and Pain. 21(1)
Subject
Headaches
Pain Research
Chronic Pain
Neurosciences
Clinical Trials and Supportive Activities
Clinical Research
Migraines
6.1 Pharmaceuticals
Evaluation of treatments and therapeutic interventions
Adult
Antibodies
Monoclonal
Humanized
Calcitonin Gene-Related Peptide Receptor Antagonists
Dose-Response Relationship
Drug
Double-Blind Method
Female
Humans
Menstrual Cycle
Middle Aged
Migraine Disorders
Self Report
Treatment Outcome
Young Adult
Erenumab
Headache
Episodic migraine
Migraine prevention
Pure menstrual migraine
Menstrually related migraine
Perimenstrual attacks
Genetics
Clinical Sciences
Neurology & Neurosurgery
Language
Abstract
BackgroundWe performed a post hoc, subgroup analysis of a phase 3, randomized, double-blind, placebo-controlled study of erenumab for prevention of episodic migraine (STRIVE) to determine the efficacy and safety of erenumab in women with self-reported menstrual migraine.MethodsPatients received placebo, erenumab 70 mg, or erenumab 140 mg subcutaneously once monthly during the 6-month double-blind treatment phase of STRIVE. Women who reported history of menstrual migraine and who were ≤ 50 years old were included in the analysis. Endpoints were change from baseline in monthly migraine days (MMD) and monthly acute migraine-specific medication days (MSMD; among patients who took acute migraine-specific medications at baseline), proportion of patients achieving ≥ 50% reduction from baseline in MMD, and incidence of adverse events.ResultsAmong 814 women enrolled in STRIVE, 232 (28.5%) reported a history of menstrual migraine and were ≤ 50 years old. Of the 232 patients, 214 (92%) had a baseline MMD > 5, suggesting a high proportion of women with attacks outside of the 5-day perimenstrual window (2 days before and 3 days after the start of menstruation). Information on "migraine days" includes (and does not discriminate between) perimenstrual and intermenstrual migraine attacks. Between-group differences from placebo over months 4-6 for erenumab 70 mg and 140 mg were - 1.8 (P = 0.001) and - 2.1 (P