Skip to main content
Top
Published in: Neurology and Therapy 6/2023

Open Access 12-09-2023 | Erenumab | ORIGINAL RESEARCH

Efficacy of Erenumab for Migraine Prevention in Japanese Patients with Episodic and Chronic Migraine: Results of a Post-Hoc Pooled Analysis

Authors: Shigekazu Kitamura, Takao Takeshima, Daishi Yui, Gabriel Paiva da Silva Lima, Reija Koukakis, Cheng Peng, Ryuji Yoshida, Yotaro Numachi, Miki Hasebe

Published in: Neurology and Therapy | Issue 6/2023

Login to get access

Abstract

Introduction

Erenumab, a fully human monoclonal antibody against the calcitonin gene-related peptide receptor, is approved in Japan for the prevention of adult migraine. This post-hoc analysis evaluated the efficacy of erenumab in Japanese patients with low-frequency episodic migraine (LFEM) versus those with high-frequency episodic migraine (HFEM) and chronic migraine (CM).

Methods

A pooled analysis of data from the 24-week double-blind treatment phases (DBTPs) of phase 2 and 3 studies evaluated the efficacy of once-monthly erenumab 70 mg in Japanese patients. Patients were categorized into subgroups by monthly migraine days (MMD): LFEM and HFEM/CM. The main efficacy outcomes were change from baseline in MMD, acute migraine-specific medication treatment days (MSMD), and six-item Headache Impact Test (HIT-6™) scores.

Results

Patients with migraine (n = 532) were included in the analysis (LFEM, n = 215; HFEM, n = 215; CM, n = 102). Overall, mean age was 44 years, 86.5% were female, and 63.3–88.2% had used or were taking migraine preventive treatment at baseline. Throughout the DBTP, the placebo-adjusted mean change from baseline in MMD, MSMD, and HIT-6 scores with erenumab was similar across LFEM and HFEM/CM subgroups. The proportion of patients achieving at least 50% or 75% reduction from baseline in MMD and MSMD was similar across migraine frequency groups. Reduction in MMD moderately correlated with improvement in HIT-6 scores in the LFEM and HFEM/CM groups. Furthermore, the proportion of patients converting from HFEM/CM to LFEM during the DBTP was higher in the erenumab group than in the placebo.

Conclusion

In Japanese patients with different migraine frequencies, erenumab treatment resulted in significant improvements in MMD, MSMD, and headache impact. This pooled analysis of data from phase 2 and 3 studies increases confidence that erenumab is efficacious in patients with high MMD, which is associated with increased disability.
Appendix
Available only for authorised users
Literature
1.
go back to reference Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF, et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68(5):343–9.CrossRefPubMed Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF, et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68(5):343–9.CrossRefPubMed
2.
go back to reference Stovner L, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher A, et al. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007;27(3):193–210.CrossRefPubMed Stovner L, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher A, et al. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007;27(3):193–210.CrossRefPubMed
3.
go back to reference Agosti R. Migraine burden of disease: from the patient’s experience to a socio-economic view. Headache. 2018;58(Suppl 1):17–32.CrossRefPubMed Agosti R. Migraine burden of disease: from the patient’s experience to a socio-economic view. Headache. 2018;58(Suppl 1):17–32.CrossRefPubMed
4.
go back to reference Diseases GBD, Injuries C. Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020;396(10258):1204–22.CrossRef Diseases GBD, Injuries C. Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020;396(10258):1204–22.CrossRef
6.
go back to reference Steiner TJ, Stovner LJ, Jensen R, Uluduz D, Katsarava Z. Lifting the burden: the global campaign against H. Migraine remains second among the world’s causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020;21(1):137.CrossRefPubMedPubMedCentral Steiner TJ, Stovner LJ, Jensen R, Uluduz D, Katsarava Z. Lifting the burden: the global campaign against H. Migraine remains second among the world’s causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020;21(1):137.CrossRefPubMedPubMedCentral
7.
go back to reference Sakai F, Igarashi H. Prevalence of migraine in Japan: a nationwide survey. Cephalalgia. 1997;17(1):15–22.CrossRefPubMed Sakai F, Igarashi H. Prevalence of migraine in Japan: a nationwide survey. Cephalalgia. 1997;17(1):15–22.CrossRefPubMed
8.
go back to reference Takeshima T, Ishizaki K, Fukuhara Y, Ijiri T, Kusumi M, Wakutani Y, et al. Population-based door-to-door survey of migraine in Japan: the Daisen study. Headache. 2004;44(1):8–19.CrossRefPubMed Takeshima T, Ishizaki K, Fukuhara Y, Ijiri T, Kusumi M, Wakutani Y, et al. Population-based door-to-door survey of migraine in Japan: the Daisen study. Headache. 2004;44(1):8–19.CrossRefPubMed
9.
go back to reference Hirata K, Ueda K, Komori M, Zagar AJ, Selzler KJ, Nelson AM, et al. Comprehensive population-based survey of migraine in Japan: results of the ObserVational Survey of the Epidemiology, tReatment, and Care Of MigrainE (OVERCOME [Japan]) study. Curr Med Res Opin. 2021;37(11):1945–55.CrossRefPubMed Hirata K, Ueda K, Komori M, Zagar AJ, Selzler KJ, Nelson AM, et al. Comprehensive population-based survey of migraine in Japan: results of the ObserVational Survey of the Epidemiology, tReatment, and Care Of MigrainE (OVERCOME [Japan]) study. Curr Med Res Opin. 2021;37(11):1945–55.CrossRefPubMed
10.
go back to reference Kikui S, Chen Y, Todaka H, Asao K, Adachi K, Takeshima T. Burden of migraine among Japanese patients: a cross-sectional National Health and Wellness Survey. J Headache Pain. 2020;21(1):110.CrossRefPubMedPubMedCentral Kikui S, Chen Y, Todaka H, Asao K, Adachi K, Takeshima T. Burden of migraine among Japanese patients: a cross-sectional National Health and Wellness Survey. J Headache Pain. 2020;21(1):110.CrossRefPubMedPubMedCentral
11.
go back to reference Meyers JL, Davis KL, Lenz RA, Sakai F, Xue F. Treatment patterns and characteristics of patients with migraine in Japan: a retrospective analysis of health insurance claims data. Cephalalgia. 2019;39(12):1518–34.CrossRefPubMed Meyers JL, Davis KL, Lenz RA, Sakai F, Xue F. Treatment patterns and characteristics of patients with migraine in Japan: a retrospective analysis of health insurance claims data. Cephalalgia. 2019;39(12):1518–34.CrossRefPubMed
12.
go back to reference Blumenfeld AM, Bloudek LM, Becker WJ, Buse DC, Varon SF, Maglinte GA, et al. Patterns of use and reasons for discontinuation of prophylactic medications for episodic migraine and chronic migraine: results from the second international burden of migraine study (IBMS-II). Headache. 2013;53(4):644–55.CrossRefPubMed Blumenfeld AM, Bloudek LM, Becker WJ, Buse DC, Varon SF, Maglinte GA, et al. Patterns of use and reasons for discontinuation of prophylactic medications for episodic migraine and chronic migraine: results from the second international burden of migraine study (IBMS-II). Headache. 2013;53(4):644–55.CrossRefPubMed
13.
go back to reference Hepp Z, Bloudek LM, Varon SF. Systematic review of migraine prophylaxis adherence and persistence. J Manag Care Pharm. 2014;20(1):22–33.PubMed Hepp Z, Bloudek LM, Varon SF. Systematic review of migraine prophylaxis adherence and persistence. J Manag Care Pharm. 2014;20(1):22–33.PubMed
14.
go back to reference Hepp Z, Dodick DW, Varon SF, Gillard P, Hansen RN, Devine EB. Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia. 2015;35(6):478–88.CrossRefPubMed Hepp Z, Dodick DW, Varon SF, Gillard P, Hansen RN, Devine EB. Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia. 2015;35(6):478–88.CrossRefPubMed
15.
go back to reference Tassorelli C, Diener HC, Dodick DW, Silberstein SD, Lipton RB, Ashina M, et al. Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine in adults. Cephalalgia. 2018;38(5):815–32.CrossRefPubMed Tassorelli C, Diener HC, Dodick DW, Silberstein SD, Lipton RB, Ashina M, et al. Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine in adults. Cephalalgia. 2018;38(5):815–32.CrossRefPubMed
16.
go back to reference Aimovig (erenumab-aooe). Full Prescribing Information, Amgen, Inc., Thousand Oaks, CA, 2020. Aimovig (erenumab-aooe). Full Prescribing Information, Amgen, Inc., Thousand Oaks, CA, 2020.
17.
go back to reference Aimovig (erenumab). Summary of Product Characteristics. Dublin, Ireland: Novartis Europharm Limited; 2018. Aimovig (erenumab). Summary of Product Characteristics. Dublin, Ireland: Novartis Europharm Limited; 2018.
18.
go back to reference Sakai F, Takeshima T, Tatsuoka Y, Hirata K, Cheng S, Numachi Y, et al. Long-term efficacy and safety during open-label erenumab treatment in Japanese patients with episodic migraine. Headache. 2021;61(4):653–61.CrossRefPubMedPubMedCentral Sakai F, Takeshima T, Tatsuoka Y, Hirata K, Cheng S, Numachi Y, et al. Long-term efficacy and safety during open-label erenumab treatment in Japanese patients with episodic migraine. Headache. 2021;61(4):653–61.CrossRefPubMedPubMedCentral
19.
go back to reference Sakai F, Takeshima T, Tatsuoka Y, Hirata K, Lenz R, Wang Y, et al. A randomized phase 2 study of erenumab for the prevention of episodic migraine in japanese adults. Headache. 2019;59(10):1731–42.CrossRefPubMedPubMedCentral Sakai F, Takeshima T, Tatsuoka Y, Hirata K, Lenz R, Wang Y, et al. A randomized phase 2 study of erenumab for the prevention of episodic migraine in japanese adults. Headache. 2019;59(10):1731–42.CrossRefPubMedPubMedCentral
20.
go back to reference Takeshima T, Sakai F, Hirata K, Imai N, Matsumori Y, Yoshida R, et al. Erenumab treatment for migraine prevention in Japanese patients: efficacy and safety results from a Phase 3, randomized, double-blind, placebo-controlled study. Headache. 2021;61(6):927–35.CrossRefPubMedPubMedCentral Takeshima T, Sakai F, Hirata K, Imai N, Matsumori Y, Yoshida R, et al. Erenumab treatment for migraine prevention in Japanese patients: efficacy and safety results from a Phase 3, randomized, double-blind, placebo-controlled study. Headache. 2021;61(6):927–35.CrossRefPubMedPubMedCentral
21.
go back to reference Houts CR, Wirth RJ, McGinley JS, Gwaltney C, Kassel E, Snapinn S, et al. Content validity of HIT-6 as a measure of headache impact in people with migraine: a narrative review. Headache. 2020;60(1):28–39.CrossRefPubMed Houts CR, Wirth RJ, McGinley JS, Gwaltney C, Kassel E, Snapinn S, et al. Content validity of HIT-6 as a measure of headache impact in people with migraine: a narrative review. Headache. 2020;60(1):28–39.CrossRefPubMed
22.
go back to reference Chalmer MA, Hansen TF, Lebedeva ER, Dodick DW, Lipton RB, Olesen J. Proposed new diagnostic criteria for chronic migraine. Cephalalgia. 2020;40(4):399–406.CrossRefPubMed Chalmer MA, Hansen TF, Lebedeva ER, Dodick DW, Lipton RB, Olesen J. Proposed new diagnostic criteria for chronic migraine. Cephalalgia. 2020;40(4):399–406.CrossRefPubMed
23.
go back to reference Buse DC, Reed ML, Fanning KM, Bostic RC, Lipton RB. Demographics, headache features, and comorbidity profiles in relation to headache frequency in people with migraine: results of the American migraine prevalence and prevention (AMPP) study. Headache. 2020;60:2340–56.CrossRef Buse DC, Reed ML, Fanning KM, Bostic RC, Lipton RB. Demographics, headache features, and comorbidity profiles in relation to headache frequency in people with migraine: results of the American migraine prevalence and prevention (AMPP) study. Headache. 2020;60:2340–56.CrossRef
24.
go back to reference Ishii R, Schwedt TJ, Dumkrieger G, Lalvani N, Craven A, Goadsby PJ, et al. Chronic versus episodic migraine: the 15-day threshold does not adequately reflect substantial differences in disability across the full spectrum of headache frequency. Headache. 2021;61(7):992–1003.CrossRefPubMed Ishii R, Schwedt TJ, Dumkrieger G, Lalvani N, Craven A, Goadsby PJ, et al. Chronic versus episodic migraine: the 15-day threshold does not adequately reflect substantial differences in disability across the full spectrum of headache frequency. Headache. 2021;61(7):992–1003.CrossRefPubMed
25.
go back to reference Smelt AF, Assendelft WJ, Terwee CB, Ferrari MD, Blom JW. What is a clinically relevant change on the HIT-6 questionnaire? An estimation in a primary-care population of migraine patients. Cephalalgia. 2014;34(1):29–36.CrossRefPubMed Smelt AF, Assendelft WJ, Terwee CB, Ferrari MD, Blom JW. What is a clinically relevant change on the HIT-6 questionnaire? An estimation in a primary-care population of migraine patients. Cephalalgia. 2014;34(1):29–36.CrossRefPubMed
26.
go back to reference Bayliss M, Batenhorst AJL. RI: QualityMetric Incorporated. The HIT-6™ a user’s guide. 2002. Bayliss M, Batenhorst AJL. RI: QualityMetric Incorporated. The HIT-6™ a user’s guide. 2002.
Metadata
Title
Efficacy of Erenumab for Migraine Prevention in Japanese Patients with Episodic and Chronic Migraine: Results of a Post-Hoc Pooled Analysis
Authors
Shigekazu Kitamura
Takao Takeshima
Daishi Yui
Gabriel Paiva da Silva Lima
Reija Koukakis
Cheng Peng
Ryuji Yoshida
Yotaro Numachi
Miki Hasebe
Publication date
12-09-2023
Publisher
Springer Healthcare
Published in
Neurology and Therapy / Issue 6/2023
Print ISSN: 2193-8253
Electronic ISSN: 2193-6536
DOI
https://doi.org/10.1007/s40120-023-00538-w

Other articles of this Issue 6/2023

Neurology and Therapy 6/2023 Go to the issue