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

Author:

Buse Dawn C1,Lipton Richard B1,Hallström Yngve2,Reuter Uwe3,Tepper Stewart J4,Zhang Feng5,Sapra Sandhya6,Picard Hernan7,Mikol Daniel D7,Lenz Robert A7

Affiliation:

1. Department of Neurology, Albert Einstein College of Medicine and Montefiore Medical Center, New York, NY, USA

2. Stockholm Neuro Center, Stockholm, Sweden

3. Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany

4. Geisel School of Medicine at Dartmouth College, Hanover, NH, USA

5. Global Biostatistical Science, Amgen Inc., Thousand Oaks, CA, USA

6. Global Health Economics, Amgen Inc., Thousand Oaks, CA, USA

7. Global Development, Amgen Inc., Thousand Oaks, CA, USA

Abstract

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.

Funder

Amgen Inc.

Publisher

SAGE Publications

Subject

Clinical Neurology,General Medicine

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