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Published in: BMC Neurology 1/2023

Open Access 01-12-2023 | Fremanezumab | Research

Real-world evidence of fremanezumab for treating migraine in Japan: a retrospective study

Authors: Seiya Ohtani, Narumi Watanabe, Keiko Ihara, Nobuyuki Takahashi, Naoki Miyazaki, Kei Ishizuchi, Ryo Takemura, Satoko Hori, Jin Nakahara, Tsubasa Takizawa

Published in: BMC Neurology | Issue 1/2023

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Abstract

Background

There have been very few real-world studies reported in the literature solely focusing on fremanezumab in Asia. This study aimed to evaluate the efficacy and safety of fremanezumab in a real-world setting in Japan.

Method

This single-centered, observational, retrospective study examined patients with migraines who received four doses of fremanezumab between December 2021 and August 2022 at Keio University Hospital. We assessed the changes in monthly migraine days, responder rates, and migraine-associated symptoms, as well as injection site reactions and adverse events.

Result

Twenty-nine patients were enrolled, wherein 79.3% were women. Compared with those at baseline, the monthly migraine days decreased by 5.9 days at 4 months. The 50% responder rate was 55.2% at 4 months. A total of 57.9%, 47.8%, and 65.0% of patients showed improvement in the severity of photophobia, phonophobia, and nausea/vomiting, respectively. Moreover, injection site reactions were the most common adverse events (55.2%).

Conclusion

Fremanezumab is effective and safe for migraine prevention in Japan. Fremanezumab also improved migraine-associated symptoms in half of the patients.
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Literature
1.
go back to reference GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018;17:954–76.CrossRef GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018;17:954–76.CrossRef
2.
go back to reference Sakai F, Igarashi H. Prevalence of migraine in Japan: a nationwide survey. Cephalalgia. 1997;17:15–22.CrossRefPubMed Sakai F, Igarashi H. Prevalence of migraine in Japan: a nationwide survey. Cephalalgia. 1997;17:15–22.CrossRefPubMed
3.
go back to reference Steiner TJ, Stovner LJ, Jensen R, Uluduz D, Katsarava Z, Lifting The Burden: the Global Campaign against Headache. Migraine remains second among the world’s causes of disability, and first among young women: findings from GBD 2019. J Headache Pain. 2020;21:137.CrossRefPubMedPubMedCentral Steiner TJ, Stovner LJ, Jensen R, Uluduz D, Katsarava Z, Lifting The Burden: the Global Campaign against Headache. Migraine remains second among the world’s causes of disability, and first among young women: findings from GBD 2019. J Headache Pain. 2020;21:137.CrossRefPubMedPubMedCentral
4.
5.
go back to reference Sacco S, Amin FM, Ashina M, Bendtsen L, Deligianni CI, Gil-Gouveia R, et al. European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention - 2022 update. J Headache Pain. 2022;23:67.CrossRefPubMedPubMedCentral Sacco S, Amin FM, Ashina M, Bendtsen L, Deligianni CI, Gil-Gouveia R, et al. European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention - 2022 update. J Headache Pain. 2022;23:67.CrossRefPubMedPubMedCentral
6.
go back to reference Dodick DW, Silberstein SD, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, et al. Effect of fremanezumab compared with placebo for prevention of episodic migraine: a randomized clinical trial. JAMA. 2018;319:1999–2008.CrossRefPubMed Dodick DW, Silberstein SD, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, et al. Effect of fremanezumab compared with placebo for prevention of episodic migraine: a randomized clinical trial. JAMA. 2018;319:1999–2008.CrossRefPubMed
7.
go back to reference Ferrari MD, Diener HC, Ning X, Galic M, Cohen JM, Yang R, et al. Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial. Lancet. 2019;394:1030–40.CrossRefPubMed Ferrari MD, Diener HC, Ning X, Galic M, Cohen JM, Yang R, et al. Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial. Lancet. 2019;394:1030–40.CrossRefPubMed
8.
go back to reference Silberstein SD, Dodick DW, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, et al. Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med. 2017;377:2113–22.CrossRefPubMed Silberstein SD, Dodick DW, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, et al. Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med. 2017;377:2113–22.CrossRefPubMed
9.
go back to reference Sakai F, Suzuki N, Kim B, Igarashi H, Hirata K, Takeshima T, et al. Efficacy and safety of fremanezumab for chronic migraine prevention: multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in Japanese and Korean patients. Headache. 2021;61:1092–101.CrossRefPubMedPubMedCentral Sakai F, Suzuki N, Kim B, Igarashi H, Hirata K, Takeshima T, et al. Efficacy and safety of fremanezumab for chronic migraine prevention: multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in Japanese and Korean patients. Headache. 2021;61:1092–101.CrossRefPubMedPubMedCentral
10.
go back to reference Sakai F, Suzuki N, Kim BK, Tatsuoka Y, Imai N, Ning X, et al. Efficacy and safety of fremanezumab for episodic migraine prevention: multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in Japanese and Korean patients. Headache. 2021;61:1102–11.CrossRefPubMedPubMedCentral Sakai F, Suzuki N, Kim BK, Tatsuoka Y, Imai N, Ning X, et al. Efficacy and safety of fremanezumab for episodic migraine prevention: multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in Japanese and Korean patients. Headache. 2021;61:1102–11.CrossRefPubMedPubMedCentral
11.
go back to reference Saigoh K, et al. Fremanezumab for episodic migraine prevention in Japanese patients: subgroup analysis from two international trials. J Pain Res. 2023;16:1673–82.CrossRefPubMedPubMedCentral Saigoh K, et al. Fremanezumab for episodic migraine prevention in Japanese patients: subgroup analysis from two international trials. J Pain Res. 2023;16:1673–82.CrossRefPubMedPubMedCentral
12.
go back to reference Saigoh K, et al. Fremanezumab for chronic migraine prevention in japanese patients: subgroup analysis from two international trials. J Pain Res. 2023;16:1311–9.CrossRefPubMedPubMedCentral Saigoh K, et al. Fremanezumab for chronic migraine prevention in japanese patients: subgroup analysis from two international trials. J Pain Res. 2023;16:1311–9.CrossRefPubMedPubMedCentral
13.
go back to reference Ministry of Health, Labour and Welfare. Guidelines for promotion of optimal use of fremanezumab. Accessed 24 February 2023; published 2021. Ministry of Health, Labour and Welfare. Guidelines for promotion of optimal use of fremanezumab. Accessed 24 February 2023; published 2021.
14.
go back to reference Barbanti P, Egeo G, Aurilia C, d’Onofrio F, Albanese M, Cetta I, et al. Fremanezumab in the prevention of high-frequency episodic and chronic migraine: a 12-week, multicenter, real-life, cohort study (the FRIEND study). J Headache Pain. 2022;23:46.CrossRefPubMedPubMedCentral Barbanti P, Egeo G, Aurilia C, d’Onofrio F, Albanese M, Cetta I, et al. Fremanezumab in the prevention of high-frequency episodic and chronic migraine: a 12-week, multicenter, real-life, cohort study (the FRIEND study). J Headache Pain. 2022;23:46.CrossRefPubMedPubMedCentral
15.
go back to reference Barbanti P, Egeo G, Aurilia C, Torelli P, Finocchi C, d’Onofrio F, et al. Early and sustained efficacy of fremanezumab over 24-weeks in migraine patients with multiple preventive treatment failures: the multicenter, prospective, real-life FRIEND2 study. J Headache Pain. 2023;24:30.CrossRefPubMedPubMedCentral Barbanti P, Egeo G, Aurilia C, Torelli P, Finocchi C, d’Onofrio F, et al. Early and sustained efficacy of fremanezumab over 24-weeks in migraine patients with multiple preventive treatment failures: the multicenter, prospective, real-life FRIEND2 study. J Headache Pain. 2023;24:30.CrossRefPubMedPubMedCentral
16.
go back to reference Takizawa T, Ohtani S, Watanabe N, Miyazaki N, Ishizuchi K, Sekiguchi K, et al. Real-world evidence of galcanezumab for migraine treatment in Japan: a retrospective analysis. BMC Neurol. 2022;22:512.CrossRefPubMedPubMedCentral Takizawa T, Ohtani S, Watanabe N, Miyazaki N, Ishizuchi K, Sekiguchi K, et al. Real-world evidence of galcanezumab for migraine treatment in Japan: a retrospective analysis. BMC Neurol. 2022;22:512.CrossRefPubMedPubMedCentral
18.
go back to reference Suzuki K, Suzuki S, Shiina T, Tatsumoto M, Fujita H, Haruyama Y, et al. Effectiveness of three calcitonin gene-related peptide monoclonal antibodies for migraine: a 12-month, single-center, observational real-world study in Japan. Cephalalgia. 2023;43:3331024231177649.CrossRefPubMed Suzuki K, Suzuki S, Shiina T, Tatsumoto M, Fujita H, Haruyama Y, et al. Effectiveness of three calcitonin gene-related peptide monoclonal antibodies for migraine: a 12-month, single-center, observational real-world study in Japan. Cephalalgia. 2023;43:3331024231177649.CrossRefPubMed
19.
go back to reference Suzuki S, et al. Real-world experience with monthly and quarterly dosing of fremanezumab for the treatment of patients with migraine in Japan. Front Neurol. 2023;14:1220285.CrossRefPubMedPubMedCentral Suzuki S, et al. Real-world experience with monthly and quarterly dosing of fremanezumab for the treatment of patients with migraine in Japan. Front Neurol. 2023;14:1220285.CrossRefPubMedPubMedCentral
20.
go back to reference Ihara K, Ohtani S, Watanabe N, Takahashi N, Miyazaki N, Ishizuchi K, et al. Predicting response to CGRP-monoclonal antibodies in patients with migraine in Japan: a single-centre retrospective observational study. J Headache Pain. 2023;24:23.CrossRefPubMedPubMedCentral Ihara K, Ohtani S, Watanabe N, Takahashi N, Miyazaki N, Ishizuchi K, et al. Predicting response to CGRP-monoclonal antibodies in patients with migraine in Japan: a single-centre retrospective observational study. J Headache Pain. 2023;24:23.CrossRefPubMedPubMedCentral
21.
go back to reference Muramatsu K, Seiryo N, Muramatsu Y, Miyaoka H, Fuse K, Yoshine F, et al. Validation and utility of Japanese version of the GAD-7. PANMINERVA medica. Admin Book 20th World Congress on Psychosomatic Medicine, vol 51; 2009. p. 79. Muramatsu K, Seiryo N, Muramatsu Y, Miyaoka H, Fuse K, Yoshine F, et al. Validation and utility of Japanese version of the GAD-7. PANMINERVA medica. Admin Book 20th World Congress on Psychosomatic Medicine, vol 51; 2009. p. 79.
22.
go back to reference Doi S, Ito M, Takebayashi Y, Muramatsu K, Horikoshi M. Factorial validity and invariance of the 7-item generalized anxiety disorder scale (GAD-7) among populations with and without self-reported psychiatric diagnostic status. Front Psychol. 2018;9:1741.CrossRefPubMedPubMedCentral Doi S, Ito M, Takebayashi Y, Muramatsu K, Horikoshi M. Factorial validity and invariance of the 7-item generalized anxiety disorder scale (GAD-7) among populations with and without self-reported psychiatric diagnostic status. Front Psychol. 2018;9:1741.CrossRefPubMedPubMedCentral
23.
go back to reference Muramatsu K, Miyaoka H, Kamijima K, Muramatsu Y, Tanaka Y, Hosaka M, et al. Performance of the Japanese version of the Patient Health Questionnaire-9 (J-PHQ-9) for depression in primary care. Gen Hosp Psychiatry. 2018;52:64–9.CrossRefPubMed Muramatsu K, Miyaoka H, Kamijima K, Muramatsu Y, Tanaka Y, Hosaka M, et al. Performance of the Japanese version of the Patient Health Questionnaire-9 (J-PHQ-9) for depression in primary care. Gen Hosp Psychiatry. 2018;52:64–9.CrossRefPubMed
24.
25.
go back to reference Zecca C, Cargnin S, Schankin C, Giannantoni NM, Viana M, Maraffi I, et al. Clinic and genetic predictors in response to erenumab. Eur J Neurol. 2022;29:1209–17.CrossRefPubMedPubMedCentral Zecca C, Cargnin S, Schankin C, Giannantoni NM, Viana M, Maraffi I, et al. Clinic and genetic predictors in response to erenumab. Eur J Neurol. 2022;29:1209–17.CrossRefPubMedPubMedCentral
26.
go back to reference Brandes JL, Kudrow D, Yeung PP, Sakai F, Aycardi E, Blankenbiller T, et al. Effects of fremanezumab on the use of acute headache medication and associated symptoms of migraine in patients with episodic migraine. Cephalalgia. 2020;40:470–7.CrossRefPubMed Brandes JL, Kudrow D, Yeung PP, Sakai F, Aycardi E, Blankenbiller T, et al. Effects of fremanezumab on the use of acute headache medication and associated symptoms of migraine in patients with episodic migraine. Cephalalgia. 2020;40:470–7.CrossRefPubMed
27.
go back to reference López-Bravo A, Oliveros-Cid A, Sevillano-Orte L. Treatment satisfaction with calcitonin gene-related peptide monoclonal antibodies as a new patient-reported outcome measure: a real-life experience in migraine. Acta Neurol Scand. 2022;145:669–75.CrossRefPubMed López-Bravo A, Oliveros-Cid A, Sevillano-Orte L. Treatment satisfaction with calcitonin gene-related peptide monoclonal antibodies as a new patient-reported outcome measure: a real-life experience in migraine. Acta Neurol Scand. 2022;145:669–75.CrossRefPubMed
Metadata
Title
Real-world evidence of fremanezumab for treating migraine in Japan: a retrospective study
Authors
Seiya Ohtani
Narumi Watanabe
Keiko Ihara
Nobuyuki Takahashi
Naoki Miyazaki
Kei Ishizuchi
Ryo Takemura
Satoko Hori
Jin Nakahara
Tsubasa Takizawa
Publication date
01-12-2023
Publisher
BioMed Central
Published in
BMC Neurology / Issue 1/2023
Electronic ISSN: 1471-2377
DOI
https://doi.org/10.1186/s12883-023-03449-3

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