TY - JOUR
T1 - Erenumab in chronic migraine
T2 - Patient-reported outcomes in a randomized double-blind study
AU - Lipton, Richard B.
AU - Tepper, Stewart J.
AU - Reuter, Uwe
AU - Silberstein, Stephen
AU - Stewart, Walter F.
AU - Nilsen, Jon
AU - Leonardi, Dean K.
AU - Desai, Pooja
AU - Cheng, Sunfa
AU - Mikol, Daniel D.
AU - Lenz, Robert
N1 - Funding Information:
R. Lipton declared consultant fees, honoraria, and/or research grants from Alder, Allergan, Inc., Amgen, Avanir, Biohaven, Dr. Reddy’s Laboratories, eNeura, electroCore, Lilly, Novar-tis, Teva, and Trigemina. He has stock options in eNeura and Biohaven. U. Reuter declared consulting fees from Allergan, Amgen, Autonomic Technologies, Eli Lilly and Co., Novartis, CoLucid, Teva; speaking/teaching fees from Amgen, Novartis, CoLucid; Pharm Allergan, TEVA advisory board for Amgen, Autonomic Technologies, Novartis, Pharm Allergan, TEVA. S. Tepper declared research grants (no personal compensation) from Alder, Allergan, Amgen, ATI, Avanir, Dr. Reddy’s, electroCore, eNeura, Scion NeuroStim, Teva, Zosano; consultant and/or advisory board for Acorda, Alder, Alexza, Allergan, Amgen, ATI, Avanir, Axsome, Charleston Laboratories, Dr. Reddy’s, electroCore, eNeura, Eli Lilly, GLG, Guidepoint Global, Kimberly-Clark, Novartis, Pernix, Pfizer, Scion NeuroStim, Supernus, Teva, Zosano; stock option from ATI; salary from Dartmouth-Hitchcock Medical Center, American Headache Society; royalties from Springer. S. Silberstein declared consultant/ad board fees from Alder Biopharmaceuticals, Allergan, Inc., Amgen, Avanir Pharmaceuticals, Inc., Curelator, Inc., Dr. Reddy’s Laboratories, eNeura Inc., electroCore Medical, LLC, Lilly USA, LLC, Medscape, LLC, NINDS, Supernus Pharmaceuticals, Inc., Teva Pharmaceuticals, Theranica, and Trigemina, Inc. W. Stewart declared consultant fees from Allergan and Amgen Inc. J. Nilsen is an employee and stockholder of Amgen Inc. D. Leonardi was an employee of and held stock/stock options in Amgen Inc. at the time of the study. P. Desai 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. Go to Neurology.org/N for full disclosures.
Funding Information:
This study was fully funded by Amgen. Erenumab is codeveloped in partnership with Amgen and Novartis.
Funding Information:
Vedanta Research Migraine epidemiology and Progression June 2010 - present Boston Scientific Occipital Nerve Stimulation in Migraine March 2013 - present ElectroCore Vagal Nerve Stimulation for Migraine and Cluster May 2013 Novartis Sleep and Migraine September 2012 - present Allergan Botox in Migraine April 2012 - present Allergan Chronic Migraine Epidemiology and Outcome Study January 2012 - present.
Publisher Copyright:
© 2019 American Academy of Neurology.
PY - 2019/5/7
Y1 - 2019/5/7
N2 - ObjectiveTo determine the effect of erenumab, a human monoclonal antibody targeting the calcitonin gene-related peptide receptor, on health-related quality of life (HRQoL), headache impact, and disability in patients with chronic migraine (CM).MethodsIn this double-blind, placebo-controlled study, 667 adults with CM were randomized (3:2:2) to placebo or erenumab (70 or 140 mg monthly). Exploratory endpoints included migraine-specific HRQoL (Migraine-Specific Quality-of-Life Questionnaire [MSQ]), headache impact (Headache Impact Test-6 [HIT-6]), migraine-related disability (Migraine Disability Assessment [MIDAS] test), and pain interference (Patient-Reported Outcomes Measurement Information System [PROMIS] Pain Interference Scale short form 6b).ResultsImprovements were observed for all endpoints in both erenumab groups at month 3, with greater changes relative to placebo observed at month 1 for many outcomes. All 3 MSQ domains were improved from baseline with treatment differences for both doses exceeding minimally important differences established for MSQ-role function-restrictive (≥3.2) and MSQ-emotional functioning (≥7.5) and for MSQ-role function-preventive (≥4.5) for erenumab 140 mg. Changes from baseline in HIT-6 scores at month 3 were -5.6 for both doses vs -3.1 for placebo. MIDAS scores at month 3 improved by -19.4 days for 70 mg and -19.8 days for 140 mg vs -7.5 days for placebo. Individual-level minimally important difference was achieved by larger proportions of erenumab-treated participants than placebo for all MSQ domains and HIT-6. Lower proportions of erenumab-treated participants had MIDAS scores of severe (≥21) or very severe (≥41) or PROMIS scores ≥60 at month 3.ConclusionsErenumab-treated patients with CM experienced clinically relevant improvements across a broad range of patient-reported outcomes.Clinicaltrials.gov identifierNCT02066415.Classification of evidenceThis study provides Class II evidence that for patients with CM, erenumab treatment improves HRQoL, headache impact, and disability.
AB - ObjectiveTo determine the effect of erenumab, a human monoclonal antibody targeting the calcitonin gene-related peptide receptor, on health-related quality of life (HRQoL), headache impact, and disability in patients with chronic migraine (CM).MethodsIn this double-blind, placebo-controlled study, 667 adults with CM were randomized (3:2:2) to placebo or erenumab (70 or 140 mg monthly). Exploratory endpoints included migraine-specific HRQoL (Migraine-Specific Quality-of-Life Questionnaire [MSQ]), headache impact (Headache Impact Test-6 [HIT-6]), migraine-related disability (Migraine Disability Assessment [MIDAS] test), and pain interference (Patient-Reported Outcomes Measurement Information System [PROMIS] Pain Interference Scale short form 6b).ResultsImprovements were observed for all endpoints in both erenumab groups at month 3, with greater changes relative to placebo observed at month 1 for many outcomes. All 3 MSQ domains were improved from baseline with treatment differences for both doses exceeding minimally important differences established for MSQ-role function-restrictive (≥3.2) and MSQ-emotional functioning (≥7.5) and for MSQ-role function-preventive (≥4.5) for erenumab 140 mg. Changes from baseline in HIT-6 scores at month 3 were -5.6 for both doses vs -3.1 for placebo. MIDAS scores at month 3 improved by -19.4 days for 70 mg and -19.8 days for 140 mg vs -7.5 days for placebo. Individual-level minimally important difference was achieved by larger proportions of erenumab-treated participants than placebo for all MSQ domains and HIT-6. Lower proportions of erenumab-treated participants had MIDAS scores of severe (≥21) or very severe (≥41) or PROMIS scores ≥60 at month 3.ConclusionsErenumab-treated patients with CM experienced clinically relevant improvements across a broad range of patient-reported outcomes.Clinicaltrials.gov identifierNCT02066415.Classification of evidenceThis study provides Class II evidence that for patients with CM, erenumab treatment improves HRQoL, headache impact, and disability.
UR - http://www.scopus.com/inward/record.url?scp=85065680853&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85065680853&partnerID=8YFLogxK
U2 - 10.1212/WNL.0000000000007452
DO - 10.1212/WNL.0000000000007452
M3 - Article
C2 - 30996060
AN - SCOPUS:85065680853
SN - 0028-3878
VL - 92
SP - E2250-E2260
JO - Neurology
JF - Neurology
IS - 19
ER -
