Efficacy and safety of erenumab in women with a history of menstrual migraine

Autor: Koen Paemeleire, Jo H. Bonner, Jelena M. Pavlovic, Feng Zhang, Alan M. Rapoport, H. Gobel, Daniel D. Mikol, Hernan Picard, Risa Kagan
Rok vydání: 2020
Předmět:
lcsh:Medicine
Menstruation
0302 clinical medicine
Migraines
Monoclonal
Medicine and Health Sciences
Medicine
Episodic migraine
Stroke
Humanized
Menstrually related migraine
RISK
education.field_of_study
Headaches
Migraine prevention
Incidence (epidemiology)
ORAL-CONTRACEPTIVES
05 social sciences
Pain Research
Headache
General Medicine
Middle Aged
PREVALENCE
ESTROGEN
Treatment Outcome
6.1 Pharmaceuticals
Female
Chronic Pain
Drug
BURDEN
STROKE
Research Article
Adult
medicine.medical_specialty
Migraine Disorders
Population
Clinical Trials and Supportive Activities
Pure menstrual migraine
Clinical Sciences
Clinical Neurology
Subgroup analysis
Antibodies
Monoclonal
Humanized
Placebo
Antibodies
Dose-Response Relationship
03 medical and health sciences
Young Adult
Double-Blind Method
Clinical Research
Calcitonin Gene-Related Peptide Receptor Antagonists
Internal medicine
0502 economics and business
Genetics
Humans
Perimenstrual attacks
Adverse effect
education
Menstrual Cycle
Neurology & Neurosurgery
Dose-Response Relationship
Drug
business.industry
lcsh:R
Neurosciences
Evaluation of treatments and therapeutic interventions
medicine.disease
Anesthesiology and Pain Medicine
Migraine
NONMENSTRUAL ATTACKS
050211 marketing
Neurology (clinical)
Self Report
business
030217 neurology & neurosurgery
Erenumab
Zdroj: The journal of headache and pain, vol 21, iss 1
The Journal of Headache and Pain, Vol 21, Iss 1, Pp 1-9 (2020)
The Journal of Headache and Pain
JOURNAL OF HEADACHE AND PAIN
ISSN: 1129-2369
1129-2377
Popis: Background We 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. Methods Patients 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. Results Among 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 P = 0.002) and − 2.4 (P P = 0.024) and 2.8 (P = 0.002) times greater for erenumab 70 mg and 140 mg, respectively, than for placebo. Erenumab had an overall safety profile comparable to placebo. Conclusion Data from this subgroup analysis of women with menstrual migraine are consistent with data from the overall STRIVE episodic migraine population, supporting the efficacy and safety of erenumab in women who experience menstrual migraine. Trial registration: ClinicalTrials.gov, NCT02456740. Registered 28 May 2015.
Databáze: OpenAIRE
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