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 Trialopen access
- Authors
- Kim, B.-K.[Kim, Byung-Kun]; Cho, S.-J.[Cho, Soo-Jin]; Han, J.H.[Han, Jeong Hee]; Dell’agnello, G.[Dell’agnello, Grazia]; Panni, T.[Panni, Tommaso]; Kim, M.[Kim, Manho]; Oh, K.[Oh, Kyungmi]; Moon, H.-S.[Moon, Heui-Soo]; Chu, M.K.[Chu, Min Kyung]
- Issue Date
- Sep-2023
- Publisher
- Korean Neurological Association
- Keywords
- calcitonin gene-related peptide; episodic migraine; galcanezumab; monoclonal antibody; South Korea
- Citation
- Journal of Clinical Neurology (Korea), v.19, no.5, pp.483 - 494
- Indexed
- SCIE
SCOPUS
KCI
- Journal Title
- Journal of Clinical Neurology (Korea)
- Volume
- 19
- Number
- 5
- Start Page
- 483
- End Page
- 494
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/108423
- DOI
- 10.3988/jcn.2022.0180
- ISSN
- 1738-6586
- 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 galcanezum-ab, 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 chang-es 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 toler-ability profile in South Korean patients with EM. © 2023 Korean Neurological Association.
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Collections - Medicine > Department of Medicine > 1. Journal Articles
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