The first interim analysis of Italian patients enrolled in the real-world, Pan-European, prospective, observational, phase 4 PEARL study of fremanezumab effectiveness

期刊论文
出版模式：

开放获取
发表日期：

2024年3月1日

查看全文

Cristina Tassorelli,
Piero Barbanti,
Cinzia Finocchi,
Pierangelo Geppetti,
Pinar Kokturk,
Antonio Russo,
Simona Sacco,
Mario Cepparulo,
Anna Ambrosini,
Monica Bandettini,
Marco Bartolini,
Chiara Benedetto,
Filippo Brighina,
Sabina Cevoli,
Gianluca Coppola,
Roberto De Simone,
Paola Di Fiore,
Florindo D’Onofrio,
Sara Gori,
Antonio Granato,
Simona Guerzoni,
Rosario Iannacchero,
Stefano Messina,
Francesco Perini,
Maria Pia Prudenzano,
Innocenzo Rainero,
Renata Rao,
Ester Reggio,
Paola Sarchielli,
Giuliano Sette,
Susanna Usai,
Mariarosaria Valente,
Fabrizio Vernieri

摘要

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.