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Fremanezumab for Episodic Migraine Prevention in Japanese Patients: Subgroup Analysis from Two International Trials
PURPOSE: The monoclonal antibody fremanezumab has been shown effective and well tolerated in numerous Phase 2 and Phase 3 trials. This subgroup analysis of the international HALO episodic migraine (EM; [NCT02629861]) trial and a similarly designed phase 2b/3 trial in Japanese and Korean patients (NC...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove
2023
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10202207/ https://www.ncbi.nlm.nih.gov/pubmed/37223438 http://dx.doi.org/10.2147/JPR.S393896 |
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author | Saigoh, Kazumasa Takeshima, Takao Nakai, Masami Shibasaki, Yoshiyuki Ishida, Miki Ning, Xiaoping Barash, Steve Isogai, Yuki Koga, Nobuyuki |
author_facet | Saigoh, Kazumasa Takeshima, Takao Nakai, Masami Shibasaki, Yoshiyuki Ishida, Miki Ning, Xiaoping Barash, Steve Isogai, Yuki Koga, Nobuyuki |
author_sort | Saigoh, Kazumasa |
collection | PubMed |
description | PURPOSE: The monoclonal antibody fremanezumab has been shown effective and well tolerated in numerous Phase 2 and Phase 3 trials. This subgroup analysis of the international HALO episodic migraine (EM; [NCT02629861]) trial and a similarly designed phase 2b/3 trial in Japanese and Korean patients (NCT03303092) sought to evaluate the efficacy and safety of fremanezumab in Japanese patients with EM. PATIENTS AND METHODS: In both trials, eligible patients were randomly assigned at baseline to receive subcutaneous monthly fremanezumab, quarterly fremanezumab, or placebo in a 1:1:1 ratio. The primary endpoint was the mean change from baseline in the monthly (28-day) average number of migraine days during the 12-week period after the first dose of fremanezumab or placebo. Secondary endpoints assessed other aspects of efficacy, including disability and medication use. RESULTS: A total of 301 patients in the Japanese and Korean phase 2b/3 trial and 75 patients in the HALO EM trial were Japanese with baseline and treatment characteristics similar between treatment groups. According to ANCOVA analysis of the primary endpoint, both fremanezumab quarterly and monthly led to greater reductions in the monthly (28-day) average number of migraine days than placebo. This was supported by MMRM analysis of the primary endpoint over the initial 4 weeks, highlighting the rapid onset of action of fremanezumab. Results of secondary endpoint analysis supported the primary endpoint analyses. Fremanezumab was well tolerated with no new safety signals seen in this population of Japanese patients. CONCLUSION: Fremanezumab appears to be an effective and well-tolerated preventive medication for Japanese patients with EM. |
format | Online Article Text |
id | pubmed-10202207 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Dove |
record_format | MEDLINE/PubMed |
spelling | pubmed-102022072023-05-23 Fremanezumab for Episodic Migraine Prevention in Japanese Patients: Subgroup Analysis from Two International Trials Saigoh, Kazumasa Takeshima, Takao Nakai, Masami Shibasaki, Yoshiyuki Ishida, Miki Ning, Xiaoping Barash, Steve Isogai, Yuki Koga, Nobuyuki J Pain Res Original Research PURPOSE: The monoclonal antibody fremanezumab has been shown effective and well tolerated in numerous Phase 2 and Phase 3 trials. This subgroup analysis of the international HALO episodic migraine (EM; [NCT02629861]) trial and a similarly designed phase 2b/3 trial in Japanese and Korean patients (NCT03303092) sought to evaluate the efficacy and safety of fremanezumab in Japanese patients with EM. PATIENTS AND METHODS: In both trials, eligible patients were randomly assigned at baseline to receive subcutaneous monthly fremanezumab, quarterly fremanezumab, or placebo in a 1:1:1 ratio. The primary endpoint was the mean change from baseline in the monthly (28-day) average number of migraine days during the 12-week period after the first dose of fremanezumab or placebo. Secondary endpoints assessed other aspects of efficacy, including disability and medication use. RESULTS: A total of 301 patients in the Japanese and Korean phase 2b/3 trial and 75 patients in the HALO EM trial were Japanese with baseline and treatment characteristics similar between treatment groups. According to ANCOVA analysis of the primary endpoint, both fremanezumab quarterly and monthly led to greater reductions in the monthly (28-day) average number of migraine days than placebo. This was supported by MMRM analysis of the primary endpoint over the initial 4 weeks, highlighting the rapid onset of action of fremanezumab. Results of secondary endpoint analysis supported the primary endpoint analyses. Fremanezumab was well tolerated with no new safety signals seen in this population of Japanese patients. CONCLUSION: Fremanezumab appears to be an effective and well-tolerated preventive medication for Japanese patients with EM. Dove 2023-05-18 /pmc/articles/PMC10202207/ /pubmed/37223438 http://dx.doi.org/10.2147/JPR.S393896 Text en © 2023 Saigoh et al. https://creativecommons.org/licenses/by-nc/3.0/This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/ (https://creativecommons.org/licenses/by-nc/3.0/) ). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). |
spellingShingle | Original Research Saigoh, Kazumasa Takeshima, Takao Nakai, Masami Shibasaki, Yoshiyuki Ishida, Miki Ning, Xiaoping Barash, Steve Isogai, Yuki Koga, Nobuyuki Fremanezumab for Episodic Migraine Prevention in Japanese Patients: Subgroup Analysis from Two International Trials |
title | Fremanezumab for Episodic Migraine Prevention in Japanese Patients: Subgroup Analysis from Two International Trials |
title_full | Fremanezumab for Episodic Migraine Prevention in Japanese Patients: Subgroup Analysis from Two International Trials |
title_fullStr | Fremanezumab for Episodic Migraine Prevention in Japanese Patients: Subgroup Analysis from Two International Trials |
title_full_unstemmed | Fremanezumab for Episodic Migraine Prevention in Japanese Patients: Subgroup Analysis from Two International Trials |
title_short | Fremanezumab for Episodic Migraine Prevention in Japanese Patients: Subgroup Analysis from Two International Trials |
title_sort | fremanezumab for episodic migraine prevention in japanese patients: subgroup analysis from two international trials |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10202207/ https://www.ncbi.nlm.nih.gov/pubmed/37223438 http://dx.doi.org/10.2147/JPR.S393896 |
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