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Early Onset and Maintenance Effect of Galcanezumab in Japanese Patients with Episodic Migraine
PURPOSE: This study aimed to extensively evaluate the onset and maintenance effect of galcanezumab compared with placebo for the prevention of episodic migraine in Japanese patients. PATIENTS AND METHODS: This was a post-hoc analysis of a Phase 2, multicenter, randomized, double-blind, placebo-contr...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove
2021
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8605884/ https://www.ncbi.nlm.nih.gov/pubmed/34815708 http://dx.doi.org/10.2147/JPR.S326905 |
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author | Igarashi, Hisaka Shibata, Mamoru Ozeki, Akichika Day, Kathleen Ann Matsumura, Taka |
author_facet | Igarashi, Hisaka Shibata, Mamoru Ozeki, Akichika Day, Kathleen Ann Matsumura, Taka |
author_sort | Igarashi, Hisaka |
collection | PubMed |
description | PURPOSE: This study aimed to extensively evaluate the onset and maintenance effect of galcanezumab compared with placebo for the prevention of episodic migraine in Japanese patients. PATIENTS AND METHODS: This was a post-hoc analysis of a Phase 2, multicenter, randomized, double-blind, placebo-controlled study conducted between December 2016 and January 2019 (ClinicalTrials.gov: NCT02959177). Patients aged between 18 and 65 years with episodic migraine were randomized to receive a monthly injection of galcanezumab (120 mg: N = 115, 240 mg: N = 114) or placebo (N = 230) for 6 months. Outcome measures included onset of effect at weekly and daily intervals—assessed by change from baseline in the number of migraine headache days and the proportion of patients with migraine headache—with galcanezumab versus placebo. To further confirm the onset and maintenance effect, the 50% response rate was also evaluated. RESULTS: The mean change from baseline in weekly migraine headache days was significantly reduced with galcanezumab (–0.97 days) compared with placebo (–0.10 days) at week 1 (p ≤ 0.0001), which was maintained at all subsequent weeks up to week 4 (all p ≤ 0.0001 vs placebo). A significantly smaller proportion of galcanezumab-treated patients had migraine headache compared with placebo-treated patients at day 1 after the first injection (13.6% vs 31.4%, respectively; p ≤ 0.0001), which was also maintained at all subsequent days during the first week after the first injection. Furthermore, the 50% response rate was significantly higher with galcanezumab compared with placebo from week 1 through month 6. CONCLUSION: The onset of the migraine preventive effect of galcanezumab was rapid compared with placebo, starting from day 1 after the first injection in Japanese patients with episodic migraine. The effect was maintained during the first week and first month, and throughout 6 months of monthly injections of galcanezumab. Galcanezumab is a promising preventive treatment in Japanese patients with episodic migraine. |
format | Online Article Text |
id | pubmed-8605884 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Dove |
record_format | MEDLINE/PubMed |
spelling | pubmed-86058842021-11-22 Early Onset and Maintenance Effect of Galcanezumab in Japanese Patients with Episodic Migraine Igarashi, Hisaka Shibata, Mamoru Ozeki, Akichika Day, Kathleen Ann Matsumura, Taka J Pain Res Original Research PURPOSE: This study aimed to extensively evaluate the onset and maintenance effect of galcanezumab compared with placebo for the prevention of episodic migraine in Japanese patients. PATIENTS AND METHODS: This was a post-hoc analysis of a Phase 2, multicenter, randomized, double-blind, placebo-controlled study conducted between December 2016 and January 2019 (ClinicalTrials.gov: NCT02959177). Patients aged between 18 and 65 years with episodic migraine were randomized to receive a monthly injection of galcanezumab (120 mg: N = 115, 240 mg: N = 114) or placebo (N = 230) for 6 months. Outcome measures included onset of effect at weekly and daily intervals—assessed by change from baseline in the number of migraine headache days and the proportion of patients with migraine headache—with galcanezumab versus placebo. To further confirm the onset and maintenance effect, the 50% response rate was also evaluated. RESULTS: The mean change from baseline in weekly migraine headache days was significantly reduced with galcanezumab (–0.97 days) compared with placebo (–0.10 days) at week 1 (p ≤ 0.0001), which was maintained at all subsequent weeks up to week 4 (all p ≤ 0.0001 vs placebo). A significantly smaller proportion of galcanezumab-treated patients had migraine headache compared with placebo-treated patients at day 1 after the first injection (13.6% vs 31.4%, respectively; p ≤ 0.0001), which was also maintained at all subsequent days during the first week after the first injection. Furthermore, the 50% response rate was significantly higher with galcanezumab compared with placebo from week 1 through month 6. CONCLUSION: The onset of the migraine preventive effect of galcanezumab was rapid compared with placebo, starting from day 1 after the first injection in Japanese patients with episodic migraine. The effect was maintained during the first week and first month, and throughout 6 months of monthly injections of galcanezumab. Galcanezumab is a promising preventive treatment in Japanese patients with episodic migraine. Dove 2021-11-16 /pmc/articles/PMC8605884/ /pubmed/34815708 http://dx.doi.org/10.2147/JPR.S326905 Text en © 2021 Igarashi 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 Igarashi, Hisaka Shibata, Mamoru Ozeki, Akichika Day, Kathleen Ann Matsumura, Taka Early Onset and Maintenance Effect of Galcanezumab in Japanese Patients with Episodic Migraine |
title | Early Onset and Maintenance Effect of Galcanezumab in Japanese Patients with Episodic Migraine |
title_full | Early Onset and Maintenance Effect of Galcanezumab in Japanese Patients with Episodic Migraine |
title_fullStr | Early Onset and Maintenance Effect of Galcanezumab in Japanese Patients with Episodic Migraine |
title_full_unstemmed | Early Onset and Maintenance Effect of Galcanezumab in Japanese Patients with Episodic Migraine |
title_short | Early Onset and Maintenance Effect of Galcanezumab in Japanese Patients with Episodic Migraine |
title_sort | early onset and maintenance effect of galcanezumab in japanese patients with episodic migraine |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8605884/ https://www.ncbi.nlm.nih.gov/pubmed/34815708 http://dx.doi.org/10.2147/JPR.S326905 |
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