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

Dawn C. Buse, Richard B. Lipton, Yngve Hallström, Uwe Reuter, Stewart J. Tepper, Feng Zhang, Sandhya Sapra, Hernan Picard, Daniel D. Mikol, Robert A. Lenz

Research output: Contribution to journalArticle

5 Citations (Scopus)

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.

Original languageEnglish (US)
JournalCephalalgia
DOIs
StateAccepted/In press - Jan 1 2018

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Migraine Disorders
Quality of Life
Placebos
Therapeutics
Headache
Calcitonin Gene-Related Peptide Receptors
Monoclonal Antibodies
Surveys and Questionnaires

Keywords

  • Episodic migraine
  • erenumab
  • headache impact
  • health-related quality of life
  • migraine-related disability
  • preventive migraine therapy

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Migraine-related disability, impact, and health-related quality of life among patients with episodic migraine receiving preventive treatment with erenumab. / Buse, Dawn C.; Lipton, Richard B.; Hallström, Yngve; Reuter, Uwe; Tepper, Stewart J.; Zhang, Feng; Sapra, Sandhya; Picard, Hernan; Mikol, Daniel D.; Lenz, Robert A.

In: Cephalalgia, 01.01.2018.

Research output: Contribution to journalArticle

Buse, Dawn C. ; Lipton, Richard B. ; Hallström, Yngve ; Reuter, Uwe ; Tepper, Stewart J. ; Zhang, Feng ; Sapra, Sandhya ; Picard, Hernan ; Mikol, Daniel D. ; Lenz, Robert A. / Migraine-related disability, impact, and health-related quality of life among patients with episodic migraine receiving preventive treatment with erenumab. In: Cephalalgia. 2018.
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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.

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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.

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KW - health-related quality of life

KW - migraine-related disability

KW - preventive migraine therapy

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