Clinical Report: Interim Findings from a Three-Year Post-Marketing Study on the Use of Fremanezumab for Migraine Management in South Korean Patients

Overview

Fremanezumab was well tolerated in South Korean patients with migraines, with approximately 57% achieving a significant reduction in monthly migraine days after 12 weeks of treatment.

Background

Migraine is a leading cause of disability globally, with significant impacts on quality of life. The calcitonin gene-related peptide (CGRP) pathway is crucial in migraine pathophysiology, and monoclonal antibodies targeting CGRP have emerged as effective preventive therapies. Real-world evidence is essential to understand the effectiveness and safety of these treatments outside clinical trial settings.

Data Highlights

In this study, after 12 weeks of treatment with fremanezumab:

• ~57% of participants achieved a ≥ 50% reduction in monthly migraine days.
• 87% reported meaningful improvements on the Patient Global Impression of Change (PGIC) scale.
• Approximately 18% experienced side effects, primarily mild injection-site reactions.

Key Findings

• Fremanezumab demonstrated a favorable safety profile in a real-world setting.
• Significant reductions in monthly migraine days were observed after 12 weeks of treatment.
• Most adverse events reported were mild and related to injection-site reactions.
• Real-world data is crucial for understanding treatment effectiveness beyond clinical trials.

Clinical Implications

The findings indicate that fremanezumab is a viable option for migraine prevention in clinical practice, with a favorable safety profile. Clinicians may consider its use in patients seeking effective migraine management.

Conclusion

The interim analysis indicates that fremanezumab was well tolerated in South Korean patients with migraines.

Related Resources & Content

1. Drug Safety, 2021 -- Safety and Tolerability of Fremanezumab for Migraine Prevention in Japanese Outpatients: Results from a Multicenter, Randomized, Open-Label Trial Over 12 Months
2. Frontiers in Neurology, 2026 -- Three-year real-world effectiveness, treatment persistence, and planned discontinuation of anti-calcitonin gene-related peptide monoclonal antibodies for migraine prevention: a single-center cohort from Japan
3. Drug Safety, 2019 -- Evaluating the Long-Term Safety and Tolerability of OnabotulinumtoxinA in Chronic Migraine Patients: Findings from the COMPEL Study
4. Frontiers in Neurology — Efficacy, tolerability and barriers to the use of anti-CGRP medications among migraine patients in Egypt: real world experience
5. IHS publishes Global Practice Recommendations for Preventive Pharmacological Treatment of Migraine
6. Korean Headache Society’s evidence-based guideline
7. Fremanezumab for the Preventive Treatment of Chronic Migraine
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9. Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial - ScienceDirect
10. Assessing the Long-Term (48-Week) Effectiveness, Safety, and Tolerability of Fremanezumab in Migraine in Real Life: Insights from the Multicenter, Prospective, FRIEND3 Study - PubMed
11. Fremanezumab Effectiveness and Tolerability in Clinical Routine: Interim Real-world Data of the Observational FINESSE Study (P4-12.002) | Neurology
12. Long-term real-world effectiveness and safety of fremanezumab in 1140 patients with migraine and at least 6 months of treatment: third interim analysis of the pan-European PEARL study - PMC