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Efficacy and Safety of Galcanezumab as a Preventive Treatment for Episodic Migraine in South Korean Patients: A Post-Hoc Analysis of a Phase 3 Clinical Trial

BACKGROUND AND PURPOSE: The estimated prevalence of migraines in South Korea is 6.0%, with affected patients having unmet needs. The efficacy, safety, and tolerability of galcanezumab, a humanized monoclonal antibody, for episodic migraine (EM) prevention was evaluated in South Korean patients. METH...

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Autores principales: Kim, Byung-Kun, Cho, Soo-Jin, Han, Jeong Hee, Dell’Agnello, Grazia, Panni, Tommaso, Kim, Manho, Oh, Kyungmi, Moon, Heui-Soo, Chu, Min Kyung
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Korean Neurological Association 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10471542/
https://www.ncbi.nlm.nih.gov/pubmed/37455511
http://dx.doi.org/10.3988/jcn.2022.0180
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author Kim, Byung-Kun
Cho, Soo-Jin
Han, Jeong Hee
Dell’Agnello, Grazia
Panni, Tommaso
Kim, Manho
Oh, Kyungmi
Moon, Heui-Soo
Chu, Min Kyung
author_facet Kim, Byung-Kun
Cho, Soo-Jin
Han, Jeong Hee
Dell’Agnello, Grazia
Panni, Tommaso
Kim, Manho
Oh, Kyungmi
Moon, Heui-Soo
Chu, Min Kyung
author_sort Kim, Byung-Kun
collection PubMed
description BACKGROUND AND PURPOSE: The estimated prevalence of migraines in South Korea is 6.0%, with affected patients having unmet needs. The efficacy, safety, and tolerability of galcanezumab, a humanized monoclonal antibody, for episodic migraine (EM) prevention was evaluated in South Korean patients. METHODS: During the double-blind period of the EVOLVE-2 phase 3 trial, patients with EM were randomized into placebo, 120 mg-galcanezumab, and 240-mg galcanezumab treatment groups. The primary endpoint was the overall mean change from baseline in the number of monthly migraine headache days during the 6-month double-blind period. We conducted a post-hoc analysis of the South Korean cohort in EVOLVE-2. RESULTS: Among 98 South Korean patients in the intent-to-treat population, significant changes from baseline were observed in the number of monthly migraine headache days in the 240-mg galcanezumab group compared with the placebo group (-2.64, p=0.013), in the percentage of patients with ≥50% reduction in the number of monthly migraine headache days (120 mg: odds ratio=2.43, p=0.030; 240 mg: odds ratio=2.60, p=0.019), in the number of monthly migraine headache days with acute medication use (120 mg: -2.22, p=0.006; 240 mg: -2.23, p=0.005), and in the Migraine-Specific Quality-of-Life Role Function-Restrictive (120 mg: 8.34, p=0.040). Numerical improvements from baseline were observed relative to the placebo group in at least one galcanezumab group for: the percentage of patients with ≥75% reduction in the number of monthly migraine headache days functional impairment, and disease severity. The most common treatment-emergent adverse event in the combined galcanezumab group was injection site reaction, which led to treatment discontinuation for one patient. CONCLUSIONS: Galcanezumab treatment demonstrated efficacy and a favorable safety and tolerability profile in South Korean patients with EM.
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spelling pubmed-104715422023-09-02 Efficacy and Safety of Galcanezumab as a Preventive Treatment for Episodic Migraine in South Korean Patients: A Post-Hoc Analysis of a Phase 3 Clinical Trial Kim, Byung-Kun Cho, Soo-Jin Han, Jeong Hee Dell’Agnello, Grazia Panni, Tommaso Kim, Manho Oh, Kyungmi Moon, Heui-Soo Chu, Min Kyung J Clin Neurol Original Article BACKGROUND AND PURPOSE: The estimated prevalence of migraines in South Korea is 6.0%, with affected patients having unmet needs. The efficacy, safety, and tolerability of galcanezumab, a humanized monoclonal antibody, for episodic migraine (EM) prevention was evaluated in South Korean patients. METHODS: During the double-blind period of the EVOLVE-2 phase 3 trial, patients with EM were randomized into placebo, 120 mg-galcanezumab, and 240-mg galcanezumab treatment groups. The primary endpoint was the overall mean change from baseline in the number of monthly migraine headache days during the 6-month double-blind period. We conducted a post-hoc analysis of the South Korean cohort in EVOLVE-2. RESULTS: Among 98 South Korean patients in the intent-to-treat population, significant changes from baseline were observed in the number of monthly migraine headache days in the 240-mg galcanezumab group compared with the placebo group (-2.64, p=0.013), in the percentage of patients with ≥50% reduction in the number of monthly migraine headache days (120 mg: odds ratio=2.43, p=0.030; 240 mg: odds ratio=2.60, p=0.019), in the number of monthly migraine headache days with acute medication use (120 mg: -2.22, p=0.006; 240 mg: -2.23, p=0.005), and in the Migraine-Specific Quality-of-Life Role Function-Restrictive (120 mg: 8.34, p=0.040). Numerical improvements from baseline were observed relative to the placebo group in at least one galcanezumab group for: the percentage of patients with ≥75% reduction in the number of monthly migraine headache days functional impairment, and disease severity. The most common treatment-emergent adverse event in the combined galcanezumab group was injection site reaction, which led to treatment discontinuation for one patient. CONCLUSIONS: Galcanezumab treatment demonstrated efficacy and a favorable safety and tolerability profile in South Korean patients with EM. Korean Neurological Association 2023-09 2023-07-13 /pmc/articles/PMC10471542/ /pubmed/37455511 http://dx.doi.org/10.3988/jcn.2022.0180 Text en Copyright © 2023 Korean Neurological Association https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0 (https://creativecommons.org/licenses/by-nc/4.0/) ) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Kim, Byung-Kun
Cho, Soo-Jin
Han, Jeong Hee
Dell’Agnello, Grazia
Panni, Tommaso
Kim, Manho
Oh, Kyungmi
Moon, Heui-Soo
Chu, Min Kyung
Efficacy and Safety of Galcanezumab as a Preventive Treatment for Episodic Migraine in South Korean Patients: A Post-Hoc Analysis of a Phase 3 Clinical Trial
title Efficacy and Safety of Galcanezumab as a Preventive Treatment for Episodic Migraine in South Korean Patients: A Post-Hoc Analysis of a Phase 3 Clinical Trial
title_full Efficacy and Safety of Galcanezumab as a Preventive Treatment for Episodic Migraine in South Korean Patients: A Post-Hoc Analysis of a Phase 3 Clinical Trial
title_fullStr Efficacy and Safety of Galcanezumab as a Preventive Treatment for Episodic Migraine in South Korean Patients: A Post-Hoc Analysis of a Phase 3 Clinical Trial
title_full_unstemmed Efficacy and Safety of Galcanezumab as a Preventive Treatment for Episodic Migraine in South Korean Patients: A Post-Hoc Analysis of a Phase 3 Clinical Trial
title_short Efficacy and Safety of Galcanezumab as a Preventive Treatment for Episodic Migraine in South Korean Patients: A Post-Hoc Analysis of a Phase 3 Clinical Trial
title_sort efficacy and safety of galcanezumab as a preventive treatment for episodic migraine in south korean patients: a post-hoc analysis of a phase 3 clinical trial
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10471542/
https://www.ncbi.nlm.nih.gov/pubmed/37455511
http://dx.doi.org/10.3988/jcn.2022.0180
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