The second interim analysis of Italian participants enrolled in the real-world, Pan-European, prospective, observational, Phase 4 PEARL study of fremanezumab effectiveness
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 354 participants or records.
Read the paper
Related studies
- Calcium Ions in the Physiology and Pathology of the Central Nervous System
- AI-powered in silico twins: redefining precision medicine through simulation, personalization, and predictive healthcare
- In silico functional, structural and pathogenicity analysis of missense single nucleotide polymorphisms in human MCM6 gene
- In Silico drug repurposing pipeline using deep learning and structure based approaches in epilepsy
- Targeting serotonin receptors with phytochemicals – an in-silico study
- In silico exploration of anti-prostate cancer compounds from differential expressed genes
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.