TY - JOUR
T1 - Erenumab (AMG 334) in episodic migraine
AU - Ashina, Messoud
AU - Dodick, David
AU - Goadsby, Peter J.
AU - Reuter, Uwe
AU - Silberstein, Stephen
AU - Zhang, Feng
AU - Gage, Julia R.
AU - Cheng, Sunfa
AU - Mikol, Daniel D.
AU - Lenz, Robert A.
N1 - Funding Information:
This study was sponsored by Amgen Inc.
Funding Information:
M. Ashina is a consultant or scientific advisor for Allergan, Amgen, Alder, ATI, and Eli Lilly; primary investigator for Amgen and GM-11 gamma-Core-R trials; and reports grants from Lundbeck Foundation, Research Foundation of the Capital Region of Copenhagen, Danish Council for Independent Research-Medical Sciences, and Novo Nordisk Foundation during the conduct of the study. D. Dodick reports consulting fees from Amgen, Alder, Allergan, Eli Lilly, eNeura, Boston Scientific, Teva, Novartis, Autonomic Technologies, Scion Neurostim, Tonix, Trigemina, Supernus, Xenon, GBS, and Xalan; honoraria from Sage Publishing, Wiley, and UpToDate; and royalties from Oxford University Press and Cambridge University Press. P. Goadsby reports for the last 36-month period grants and personal fees from Allergan, Amgen, Eli-Lilly and Company, and eNeura; and personal fees from Ajinomoto Pharmaceuticals Co., Akita Biomedical, Alder Biopharmaceuticals, Autonomic Technologies Inc, Avanir Pharma, Cipla Ltd., Colucid Pharmaceuticals, Ltd., Dr Reddy’s Laboratories, Electrocore LLC, Ethicon, US, WL Gore & Associates, Heptares Therapeutics, Novartis, Nupathe Inc., Pfizer Inc., Promius Pharma, Scion, Teva Pharmaceuticals, and Trigemina Inc.; personal fees from MedicoLegal work, Journal Watch, Up-to-Date, and Oxford University Press; and has a patent Magnetic stimulation for headache pending assigned to eNeura. U. Reuter reports consulting fees, speaking/teaching fees, and/or research grants from Allergan, Amgen Inc., Autonomic Technologies, CoLucid, Electrocore, and Pharm Allergan. S. Silberstein reports consulting fees from Amgen Inc. F. Zhang is an employee and stockholder of Amgen Inc. S. Cheng is an employee and stockholder of Amgen Inc. D. Mikol is an employee and stockholder of Amgen Inc. R. Lenz is an employee and stockholder of Amgen Inc. J. Gage is an employee of Gage Medical Writing, LLC, which received funding from Amgen Inc. for medical writing services on this manuscript. Go to Neurology.org for full disclosures.
Publisher Copyright:
© 2017 American Academy of Neurology.
Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2017/9/19
Y1 - 2017/9/19
N2 - Objective: To assess long-term safety and efficacy of anti-calcitonin gene-related peptide receptor erenumab in patients with episodic migraine (EM). Methods: Patients enrolled in a 12-week, double-blind, placebo-controlled clinical trial (NCT01952574) who continued in an open-label extension (OLE) study will receive erenumab 70 mg every 4 weeks for up to 5 years. This preplanned interim analysis, conducted after all participants had completed the 1-year open-label follow-up, evaluated changes in monthly migraine days (MMD), achievement of ≥50%, ≥75%, and 100% reductions, Headache Impact Test (HIT-6) score, Migraine-Specific Quality of Life (MSQ), Migraine Disability Assessment (MIDAS), and safety. Data reported as observed without imputation for missing data. Results: Of 472 patients enrolled in the parent study, 383 continued in the OLE with a median exposure to erenumab of 575 days (range 28-822 days). Mean (SD) MMD were 8.8 (2.6) at parent study baseline, 6.3 (4.2) at week 12 (beginning of OLE), and 3.7 (4.0) at week 64 (mean change from baseline [reduction] of 5.0 days). At week 64, 65%, 42%, and 26% achieved ≥50%, ≥75%, and 100% reduction in MMD, respectively. Mean HIT-6 scores were 60.2 (6.3) at baseline and 51.7 (9.2) at week 64. MSQ and MIDAS improvements from baseline were maintained through week 64. Safety profiles during the OLE were similar to those in the double-blind phase, which overall were similar to placebo. Conclusions: One-year efficacy, supported by functional improvements and favorable safety and tolerability profiles, supports further investigation of erenumab as a preventive treatment in patients with EM. Clinicaltrials.gov identifier: NCT01952574. Classification of evidence: This study provides Class IV evidence that for patients with episodic migraine, erenumab reduces long-term MMD and improves headache-related disability and migraine-specific quality of life.
AB - Objective: To assess long-term safety and efficacy of anti-calcitonin gene-related peptide receptor erenumab in patients with episodic migraine (EM). Methods: Patients enrolled in a 12-week, double-blind, placebo-controlled clinical trial (NCT01952574) who continued in an open-label extension (OLE) study will receive erenumab 70 mg every 4 weeks for up to 5 years. This preplanned interim analysis, conducted after all participants had completed the 1-year open-label follow-up, evaluated changes in monthly migraine days (MMD), achievement of ≥50%, ≥75%, and 100% reductions, Headache Impact Test (HIT-6) score, Migraine-Specific Quality of Life (MSQ), Migraine Disability Assessment (MIDAS), and safety. Data reported as observed without imputation for missing data. Results: Of 472 patients enrolled in the parent study, 383 continued in the OLE with a median exposure to erenumab of 575 days (range 28-822 days). Mean (SD) MMD were 8.8 (2.6) at parent study baseline, 6.3 (4.2) at week 12 (beginning of OLE), and 3.7 (4.0) at week 64 (mean change from baseline [reduction] of 5.0 days). At week 64, 65%, 42%, and 26% achieved ≥50%, ≥75%, and 100% reduction in MMD, respectively. Mean HIT-6 scores were 60.2 (6.3) at baseline and 51.7 (9.2) at week 64. MSQ and MIDAS improvements from baseline were maintained through week 64. Safety profiles during the OLE were similar to those in the double-blind phase, which overall were similar to placebo. Conclusions: One-year efficacy, supported by functional improvements and favorable safety and tolerability profiles, supports further investigation of erenumab as a preventive treatment in patients with EM. Clinicaltrials.gov identifier: NCT01952574. Classification of evidence: This study provides Class IV evidence that for patients with episodic migraine, erenumab reduces long-term MMD and improves headache-related disability and migraine-specific quality of life.
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U2 - 10.1212/WNL.0000000000004391
DO - 10.1212/WNL.0000000000004391
M3 - Article
C2 - 28835404
AN - SCOPUS:85031020540
VL - 89
SP - 1237
EP - 1243
JO - Neurology
JF - Neurology
SN - 0028-3878
IS - 12
ER -