TY - JOUR
T1 - Migraine-related disability, impact, and health-related quality of life among patients with episodic migraine receiving preventive treatment with erenumab
AU - Buse, Dawn C.
AU - Lipton, Richard B.
AU - Hallström, Yngve
AU - Reuter, Uwe
AU - Tepper, Stewart J.
AU - Zhang, Feng
AU - Sapra, Sandhya
AU - Picard, Hernan
AU - Mikol, Daniel D.
AU - Lenz, Robert A.
N1 - Funding Information:
RBL has received research support from the National Institutes of Health (NIH): 2PO1 AG003949 (Program Director), 5U10 NS077308 (PI), 1RO1 AG042595 (Investigator), RO1 NS082432 (Investigator), K23 NS09610 (Mentor), and K23 AG049466 (Mentor); received support from the Migraine Research Foundation and the National Headache Foundation; is on the editorial board of Neurology and a senior advisor for Headache; has reviewed for National Institute on Aging (NIA) and National Institute of Neurological Disorders and Stroke (NINDS); holds stock options in eNeura Therapeutics; holds stock in Biohaven; serves as a consultant to, advisory board member for, or reports honoraria from American Academy of Neurology, Alder, Allergan, American Headache Society, Amgen, Autonomic Technologies, Avanir, Biohaven, BioVision, Boston Scientific, CoLucid, Dr. Reddy’s, electroCore, Eli Lilly, eNeura Therapeutics, GlaxoSmithKline, Merck, Pernix, Pfizer, Supernus, Teva, Trigemina, Vector, and Vedanta; and received royalties from Wolff’s Headache, 8th edition (2009), Oxford University Press, Wiley, and Informa. YH is a consultant for Amgen and Novartis.
Funding Information:
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was funded by Amgen Inc. and Novartis (ClinicalTrials.gov, NCT02456740).
PY - 2018/9/1
Y1 - 2018/9/1
N2 - Background: We evaluated the effect of erenumab, a fully human monoclonal antibody that inhibits the canonical calcitonin gene-related peptide receptor, on migraine-related disability, impact, and health-related quality of life among patients with episodic migraine. Methods: Patients enrolled in a phase 3, 6-month, double-blind, placebo-controlled study of once-monthly erenumab 70 and 140 mg for migraine prevention (STRIVE) used an eDiary during the baseline and double-blind treatment phases to complete validated, specific questionnaires, including the modified (monthly) Migraine Disability Assessment Questionnaire; Headache Impact Test; and Migraine-Specific Quality of Life Questionnaire-role function-restrictive (MSQ-RFR), -role function-preventive (MSQ-RFP), and -emotional function (MSQ-EF). Results: A total of 955 patients were randomized to receive erenumab 70 mg (n = 317), erenumab 140 mg (n = 319), or placebo (n = 319). Erenumab versus placebo resulted in significantly greater improvements in all patient-reported outcomes; changes from baseline were numerically higher with 140 mg erenumab. Improvements occurred rapidly and were maintained over 6 months of treatment. Between-group differences from placebo over months 4–6 for the 70- and 140-mg dose groups were, respectively, −2.1 and −2.8 for modified (monthly) Migraine Disability Assessment Questionnaire, −2.1 and −2.3 for Headache Impact Test, 5.1 and 6.5 for MSQ-RFR, 4.2 and 5.4 for MSQ-RFP, and 5.2 and 6.7 for MSQ-EF (p < 0.001 for all). Erenumab also significantly reduced the proportion of patients with severe and very severe migraine-related disability and increased the proportion of patients with clinically meaningful improvements in migraine-related impact and health-related quality of life. Conclusion: Erenumab reduced migraine disability and impact and improved patients’ health-related quality of life, reinforcing its role as a promising new therapy for migraine prevention.
AB - Background: We evaluated the effect of erenumab, a fully human monoclonal antibody that inhibits the canonical calcitonin gene-related peptide receptor, on migraine-related disability, impact, and health-related quality of life among patients with episodic migraine. Methods: Patients enrolled in a phase 3, 6-month, double-blind, placebo-controlled study of once-monthly erenumab 70 and 140 mg for migraine prevention (STRIVE) used an eDiary during the baseline and double-blind treatment phases to complete validated, specific questionnaires, including the modified (monthly) Migraine Disability Assessment Questionnaire; Headache Impact Test; and Migraine-Specific Quality of Life Questionnaire-role function-restrictive (MSQ-RFR), -role function-preventive (MSQ-RFP), and -emotional function (MSQ-EF). Results: A total of 955 patients were randomized to receive erenumab 70 mg (n = 317), erenumab 140 mg (n = 319), or placebo (n = 319). Erenumab versus placebo resulted in significantly greater improvements in all patient-reported outcomes; changes from baseline were numerically higher with 140 mg erenumab. Improvements occurred rapidly and were maintained over 6 months of treatment. Between-group differences from placebo over months 4–6 for the 70- and 140-mg dose groups were, respectively, −2.1 and −2.8 for modified (monthly) Migraine Disability Assessment Questionnaire, −2.1 and −2.3 for Headache Impact Test, 5.1 and 6.5 for MSQ-RFR, 4.2 and 5.4 for MSQ-RFP, and 5.2 and 6.7 for MSQ-EF (p < 0.001 for all). Erenumab also significantly reduced the proportion of patients with severe and very severe migraine-related disability and increased the proportion of patients with clinically meaningful improvements in migraine-related impact and health-related quality of life. Conclusion: Erenumab reduced migraine disability and impact and improved patients’ health-related quality of life, reinforcing its role as a promising new therapy for migraine prevention.
KW - Episodic migraine
KW - erenumab
KW - headache impact
KW - health-related quality of life
KW - migraine-related disability
KW - preventive migraine therapy
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U2 - 10.1177/0333102418789072
DO - 10.1177/0333102418789072
M3 - Article
C2 - 30086681
AN - SCOPUS:85052594967
VL - 38
SP - 1622
EP - 1631
JO - Cephalalgia
JF - Cephalalgia
SN - 0333-1024
IS - 10
ER -