The second interim analysis of Italian participants enrolled in the real-world, Pan-European, prospective, observational, Phase 4 PEARL study of fremanezumab effectiveness

Introduction: Migraine burden encompasses social, economic, and functional burden; most notably in individuals with either chronic or high-frequency episodic migraine (CM, HFEM). This second interim sub-analysis of Italian participants with CM and HFEM enrolled in the PEARL study provides updated real-world evidence of fremanezumab use in Italian clinical practice for up to 12 months of treatment. Methods: In this second interim sub-analysis, data were collected from a sub-population of participants enrolled in PEARL who were treated in Italian headache centers and had completed 12 months of fremanezumab treatment (data cut-off: 15 June 2023). The primary endpoint was the proportion of participants achieving a ≥ 50% reduction in monthly migraine days (MMD) during the 6-month period after fremanezumab initiation. Additional endpoints were assessed up to Month 12 and included mean change from baseline in average MMD. Safety was assessed through adverse events (AEs) reported. Results: Overall, 343/354 participants enrolled in Italian headache centers (HFEM, 36.2%; CM, 63.8%) were included in the effectiveness analysis. Of those with data available, 61.2% of participants achieved a ≥ 50% reduction in average MMD during the 6-month period after fremanezumab initiation. Mean change from baseline (± standard deviation [SD]) in average MMD was − 8.2 ± 7.4 at Month 1 and − 8.9 ± 6.9 at Month 12. No new safety signals were observed. Conclusion: Fremanezumab was effective and well tolerated in Italian clinical practice, with results in line with those previously reported for fremanezumab in a real-world setting.