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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
DC Field | Value | Language |
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dc.contributor.author | 주민경 | - |
dc.date.accessioned | 2023-10-19T05:43:37Z | - |
dc.date.available | 2023-10-19T05:43:37Z | - |
dc.date.issued | 2023-09 | - |
dc.identifier.issn | 1738-6586 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/196255 | - |
dc.description.abstract | 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. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Korean Neurological Association | - |
dc.relation.isPartOf | JOURNAL OF CLINICAL NEUROLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.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 | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Neurology (신경과학교실) | - |
dc.contributor.googleauthor | Byung-Kun Kim | - |
dc.contributor.googleauthor | Soo-Jin Cho | - |
dc.contributor.googleauthor | Jeong Hee Han | - |
dc.contributor.googleauthor | Grazia Dell'Agnello | - |
dc.contributor.googleauthor | Tommaso Panni | - |
dc.contributor.googleauthor | Manho Kim | - |
dc.contributor.googleauthor | Kyungmi Oh | - |
dc.contributor.googleauthor | Heui-Soo Moon | - |
dc.contributor.googleauthor | Min Kyung Chu | - |
dc.identifier.doi | 10.3988/jcn.2022.0180 | - |
dc.contributor.localId | A03950 | - |
dc.relation.journalcode | J01327 | - |
dc.identifier.eissn | 2005-5013 | - |
dc.identifier.pmid | 37455511 | - |
dc.subject.keyword | South Korea | - |
dc.subject.keyword | calcitonin gene-related peptide | - |
dc.subject.keyword | episodic migraine | - |
dc.subject.keyword | galcanezumab | - |
dc.subject.keyword | monoclonal antibody | - |
dc.contributor.alternativeName | Chu, Min Kyung | - |
dc.contributor.affiliatedAuthor | 주민경 | - |
dc.citation.volume | 19 | - |
dc.citation.number | 5 | - |
dc.citation.startPage | 483 | - |
dc.citation.endPage | 484 | - |
dc.identifier.bibliographicCitation | JOURNAL OF CLINICAL NEUROLOGY, Vol.19(5) : 483-484, 2023-09 | - |
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