Three-Year Interim Results from a Post-Marketing Surveillance Study of Patients with Migraine Treated with Fremanezumab in South Korea.

Abstract

Background: There is limited real-world evidence on the safety and effectiveness of fremanezumab in South Korea.

Objective: We aimed to evaluate the safety and effectiveness of fremanezumab as a preventive migraine treatment in adults with migraine in real-life clinical practice in South Korea.

Methods: A 6-year, non-interventional, prospective, post-marketing surveillance study conducted in up to 60 clinics and hospitals in South Korea from July 2021 to 2027. Eligible participants are aged ≥ 18 years, have a formal migraine diagnosis, and are receiving fremanezumab for the first time. The primary endpoint is the proportion of new adverse events, including serious adverse events, from first administration of fremanezumab to the 12-week observation period or discontinuation. Secondary endpoints include the mean change from baseline to week 12 in average monthly migraine days (MMD), proportion of participants achieving a ≥ 50% reduction in MMD, and the Patient Global Impression of Change (PGIC) scale at week 12. We present an interim analysis of data collected up to the third year of this study.

Results: As part of the overall study, this 3-year interim analysis included data from 14 sites, with 1230 participants for safety and 1096 for effectiveness analyses (mean age: 46.1 years, standard deviation: 13.7; episodic/chronic migraine: 45.2%/54.8%; mean disease duration: 6.9 years [standard deviation 8.2]). Adverse events were reported by 17.6% of participants; the most common were injection-site reactions (5.7%); serious adverse events were infrequent (1.0%). After 12 weeks of treatment, mean change from baseline in MMD was - 7.8 ± 8.1 days (episodic migraine: - 3.4 ± 4.5 days, chronic migraine: - 11.4 ± 8.7 days), all p < 0.0001; 56.5% of participants (episodic migraine: 55.0%, chronic migraine: 57.7%) achieved a ≥ 50% reduction in MMD. Most participants (87.0%) rated treatment as effective on the PGIC scale.

Conclusions: Fremanezumab was well tolerated and effective for migraine prevention in Korean adults in a real-world setting. These results support the use of fremanezumab in routine clinical practice across South Korea.