Three-Year Interim Results from a Post-Marketing Surveillance Study of Patients with Migraine Treated with Fremanezumab in South Korea - Summary - MDSpire
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Three-Year Interim Results from a Post-Marketing Surveillance Study of Patients with Migraine Treated with Fremanezumab in South Korea
To evaluate the safety and effectiveness of fremanezumab for migraine prevention in a real-world setting in South Korea.
Approach:
Study Design: A 6-year, non-interventional, prospective, post-marketing surveillance study conducted across up to 60 hospitals and clinics in South Korea.
Participants: Participants aged ≥ 18 years receiving fremanezumab for the first time were included, with a follow-up period of 12 weeks.
Data Collection: Data on demographics, migraine history, safety, and efficacy were collected at baseline and week 12.
Key Findings:
Fremanezumab was well tolerated, with ~18% of participants experiencing side effects, mostly mild injection-site reactions.
After 12 weeks, ~57% of participants achieved a ≥ 50% reduction in monthly migraine days.
87% of participants reported meaningful improvements on the Patient Global Impression of Change (PGIC) scale.
Interpretation:
Fremanezumab demonstrated a favorable safety profile and meaningful clinical benefits in the management of migraines in a real-world setting.
Limitations:
The study is ongoing, and these findings are based on interim data.
The non-interventional design may limit the ability to draw causal conclusions.
Conclusion:
Fremanezumab shows promise as a preventive treatment for migraines in routine clinical practice in South Korea.
