One-year sustained efficacy of erenumab in episodic migraine: Results of the STRIVE study.
Journal
Neurology
ISSN: 1526-632X
Titre abrégé: Neurology
Pays: United States
ID NLM: 0401060
Informations de publication
Date de publication:
04 08 2020
04 08 2020
Historique:
received:
01
08
2019
accepted:
01
06
2020
pubmed:
9
7
2020
medline:
10
10
2020
entrez:
9
7
2020
Statut:
ppublish
Résumé
To assess efficacy and tolerability of 1-year erenumab treatment in patients with episodic migraine. Patients were randomized (n = 955; 1:1:1) during the 24-week double-blind treatment phase (DBTP) to monthly subcutaneous placebo or erenumab 70 or 140 mg. At week 24, 845 patients were rerandomized (1:1) to erenumab 70 or 140 mg during the 28-week dose-blinded active-treatment phase (ATP). Monthly migraine days (MMD), achieving ≥50%, ≥75%, and 100% reduction in MMD, and safety/tolerability were assessed. Mean MMD at DBTP baseline was 8.3. At week 52, mean changes (SE) from pre-DBTP baseline/week 24 (pre-ATP baseline) in MMD were -4.2 (0.2)/-1.1 (0.2) (70 mg) and -4.6 (0.2)/-1.8 (0.2) (140 mg) irrespective of treatment during the DBTP. For patients reducing dose from 140 (DBTP) to 70 mg (ATP), change in MMD from week 24 to 52 was -0.1 (0.3), and for those increasing from 70 (DBTP) to 140 mg (ATP), -1.8 (0.3). At week 52, 61.0%, 38.5%, and 19.8% of patients on erenumab 70 mg, and 64.9%, 40.8%, and 21.2% on erenumab 140 mg, achieved ≥50%, ≥75%, and 100% reduction in MMD from DBTP baseline, respectively. Among erenumab-treated patients in DBTP who showed ≥50% reduction in MMD during the last 3 months of DBTP and completed ATP, 86% showed sustained responses at ≥50% during the last 3 months of ATP. Safety of erenumab in ATP was similar to DBTP; exposure-adjusted incidence rates of adverse events were similar for either dose. Over 52 weeks, erenumab provided sustained efficacy in episodic migraine; the safety profiles were similar between erenumab dose groups in the presence of dose blinding. NCT02456740. Class II evidence that 52 weeks of treatment with erenumab 70 and 140 mg subcutaneously monthly results in sustained reductions in monthly migraine days and similar dose tolerability for patients with episodic migraine.
Identifiants
pubmed: 32636324
pii: WNL.0000000000010019
doi: 10.1212/WNL.0000000000010019
pmc: PMC7455346
doi:
Substances chimiques
Analgesics
0
Antibodies, Monoclonal, Humanized
0
Calcitonin Gene-Related Peptide Receptor Antagonists
0
erenumab
I5I8VB78VT
Banques de données
ClinicalTrials.gov
['NCT02456740']
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e469-e479Informations de copyright
Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.
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