In the Italian arm of the PEARL study, approximately 80% of migraine patients met treatment continuation criteria after 6 months of fremanezumab, with 65% achieving at least 50% reduction in monthly migraine days.
~80%of patients met Italian criteria for fremanezumab treatment continuation at 6 months
What the researchers found
65.1% of patients achieved ≥50% reduction in monthly migraine days at month 6, and approximately 80% met MIDAS-based Italian criteria for treatment continuation.
Why it matters
Italy has uniquely strict continuation criteria for CGRP antibodies requiring demonstrated disability improvement. This study shows that fremanezumab meets these real-world effectiveness thresholds, supporting its clinical and health-economic value.
The numbers in context
Italian criteria: MIDAS score ≥11 at start, ≥50% MIDAS reduction at months 3 and 6 for renewal. Fremanezumab approved by AIFA in 2020.
How the study worked
Interim analysis of the Italian cohort from PEARL, a pan-European prospective observational phase 4 study, including 318 episodic and chronic migraine patients treated with fremanezumab in routine clinical practice.
Who was studied
Italian migraine patients receiving fremanezumab in routine clinical practice
What this study cannot tell us
Interim analysis without final results; no placebo control (observational design); Italian regulatory criteria may limit generalizability; potential selection bias toward treatment-responsive patients who continue therapy.
How to read the evidence
Moderate evidence from a large, prospective, real-world observational study within a structured healthcare system, though without a control group.
When this study was published
Published in 2024, reflecting current real-world clinical experience with CGRP antibodies in European practice.
The bigger picture
Real-world effectiveness data from structured healthcare systems like Italy's helps bridge the gap between clinical trial results and everyday practice, and supports the cost-effectiveness arguments for CGRP antibody reimbursement across European healthcare systems.
Questions still open
- How do longer-term outcomes beyond 6 months compare for Italian patients on fremanezumab?
- Do the stricter Italian continuation criteria inadvertently select for the most responsive patients?
- How does fremanezumab compare to other CGRP antibodies (galcanezumab, erenumab) under the same Italian criteria?
Common questions
How well does fremanezumab work for migraine in real-world patients?
Does fremanezumab work for both episodic and chronic migraine?
Read the original research
The first interim analysis of Italian patients enrolled in the real-world, Pan-European, prospective, observational, phase 4 PEARL study of fremanezumab effectiveness.
Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology, 45(5), 2353-2363
Citation
Tassorelli, Cristina; Barbanti, Piero; Finocchi, Cinzia; Geppetti, Pierangelo; Kokturk, Pinar; Russo, Antonio; Sacco, Simona; Cepparulo, Mario. (2024). The first interim analysis of Italian patients enrolled in the real-world, Pan-European, prospective, observational, phase 4 PEARL study of fremanezumab effectiveness.. Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology, 45(5), 2353-2363. https://doi.org/10.1007/s10072-024-07357-3