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

• Published in: Journal of clinical neurology (Seoul, Korea) Vol. 19; no. 5; pp. 483 - 494
• Main Authors: Kim, Byung-Kun, Cho, Soo-Jin, Han, Jeong Hee, Dell’Agnello, Grazia, Panni, Tommaso, Kim, Manho, Oh, Kyungmi, Moon, Heui-Soo, Chu, Min Kyung
• Format: Journal Article
• Language: English
• Published: Korea (South) Korean Neurological Association 01.09.2023; 대한신경과학회
• Subjects: Original; 신경과학; calcitonin gene-related peptide; South Korea; episodic migraine; monoclonal antibody; galcanezumab
• ISSN: 1738-6586; 2005-5013
• DOI: 10.3988/jcn.2022.0180

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. 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. 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, =0.013), in the percentage of patients with ≥50% reduction in the number of monthly migraine headache days (120 mg: odds ratio=2.43, =0.030; 240 mg: odds ratio=2.60, =0.019), in the number of monthly migraine headache days with acute medication use (120 mg: -2.22, =0.006; 240 mg: -2.23, =0.005), and in the Migraine-Specific Quality-of-Life Role Function-Restrictive (120 mg: 8.34, =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. Galcanezumab treatment demonstrated efficacy and a favorable safety and tolerability profile in South Korean patients with EM.