학술논문
The first interim analysis of Italian patients enrolled in the real-world, Pan-European, prospective, observational, phase 4 PEARL study of fremanezumab effectiveness.
Document Type
Article
Author
Tassorelli, Cristina; Barbanti, Piero; Finocchi, Cinzia; Geppetti, Pierangelo; Kokturk, Pinar; Russo, Antonio; Sacco, Simona; Cepparulo, Mario; Ambrosini, Anna; Bandettini, Monica; Bartolini, Marco; Benedetto, Chiara; Brighina, Filippo; Cevoli, Sabina; Coppola, Gianluca; De Simone, Roberto; Di Fiore, Paola; D'Onofrio, Florindo; Gori, Sara; Granato, Antonio
Source
Subject
*CALCITONIN gene-related peptide
*MONOCLONAL antibodies
*
Language
ISSN
1590-1874
Abstract
Introduction: In 2020, the Italian Medicines Agency (AIFA) approved the reimbursement of calcitonin gene-related peptide (CGRP) pathway monoclonal antibodies (mAbs), including fremanezumab, in patients with a Migraine Disability Assessment Scale (MIDAS) score ≥ 11, with prescription renewals for up to 12 months in patients with ≥ 50% reduction in MIDAS score at Months 3 and 6. In this sub-analysis of the Pan-European Real Life (PEARL) study, we provide real-world data on fremanezumab use in Italian routine clinical practice (EUPAS35111). Methods: This first interim analysis for Italy was conducted when 300 enrolled adult patients with episodic or chronic migraine (EM, CM) completed 6 months of treatment with fremanezumab. The primary endpoint is the proportion of patients achieving ≥ 50% reduction in monthly migraine days (MMD) across the 6 months post-fremanezumab initiation. Secondary endpoints include: proportion of patients achieving ≥ 50% reduction in MIDAS score at Months 3 and 6, and mean change from baseline across Months 1–6 in MMD and headache-related disability. Safety was assessed through adverse events (AEs) reported. Results: Of 354 patients enrolled at Italian centers, 318 (EM, 35.5%, CM, 64.5%) were included in the effectiveness analysis. Of patients with available data, 109 (61.2%) achieved the primary endpoint. 61.0% and 65.1% achieved ≥ 50% reduction in MMDs at Months 3 and 6, respectively; 79.9% and 81.0% experienced ≥ 50% reduction in MIDAS at the same timepoints. Conclusion: Fremanezumab was effective and well-tolerated over the first 6 months of treatment, with approximately 80% of patients meeting Italian criteria for treatment continuation at Months 3 and 6. [ABSTRACT FROM AUTHOR]