Migraine-related disability, impact, and health-related quality of life among patients with episodic migraine receiving preventive treatment with erenumab

被引:65
作者
Buse, Dawn C. [1 ,2 ]
Lipton, Richard B. [1 ,2 ]
Hallstrom, Yngve [3 ]
Reuter, Uwe [4 ]
Tepper, Stewart J. [5 ]
Zhang, Feng [6 ]
Sapra, Sandhya [7 ]
Picard, Hernan [8 ]
Mikol, Daniel D. [8 ]
Lenz, Robert A. [8 ]
机构
[1] Albert Einstein Coll Med, Dept Neurol, New York, NY 10461 USA
[2] Montefiore Med Ctr, New York, NY 10467 USA
[3] Stockholm Neuro Ctr, Stockholm, Sweden
[4] Charite Univ Med Berlin, Dept Neurol, Berlin, Germany
[5] Dartmouth Coll, Geisel Sch Med, Hanover, NH 03755 USA
[6] Amgen Inc, Global Biostat Sci, Thousand Oaks, CA 91320 USA
[7] Amgen Inc, Global Hlth Econ, Thousand Oaks, CA 91320 USA
[8] Amgen Inc, Global Dev, Thousand Oaks, CA 91320 USA
关键词
Episodic migraine; erenumab; preventive migraine therapy; headache impact; migraine-related disability; health-related quality of life; HEADACHE IMPACT; CLINICAL-TRIAL; QUESTIONNAIRE; BURDEN; PREVALENCE; VALIDATION; COST;
D O I
10.1177/0333102418789072
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
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 140mg 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 70mg (n=317), erenumab 140mg (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 140mg 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.
引用
收藏
页码:1622 / 1631
页数:10
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