PO-44 | Effectiveness of fremanezumab as preventive treatment of migraine up to 24 months: response rates from the Italian analysis of the PEARL study

Alberto Doretti,¹ Anna Ambrosini,² Simone Braca,³ Florindo D’Onofrio,⁴ Elisa Maria Piella,⁵ Pinar Kokturk,⁶ Rosario Iannacchero⁷ | ¹Department of Neurology-Laboratory of Neuroscience, IRCCS, Istituto Auxologico Italiano, Milan, Italy; ²Mediterranean Neurological Institute NEUROMED IRCCS, Pozzilli (IS), Italy; ³Headache Centre, University of Naples “Federico II”, Naples, Italy; ⁴UOSD Stroke Unit, S.G. Moscati Hospital, Avellino, Italy; ⁵Neurosciences Department, University of Turin, Turin, Italy; ⁶Teva Netherlands B.V., Haarlem, The Netherlands; ⁷Department of Neurology, Headache Center, Regional Hospital “Pugliese-Ciaccio”, Catanzaro, Italy

Background: Fremanezumab is a monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) pathway with proven efficacy as preventive treatment of episodic (EM) and chronic migraine (CM). In Italy, fremanezumab reimbursement for preventive treatment of migraine is available for ≤12 months in individuals who meet Italian Medicines Agency (AIFA) criteria (≥8 monthly migraine days [MMD], a Migraine Disability Assessment score of ≥11 points before treatment and experience of ≥3 other preventive treatment failures). Here, we report long-term effectiveness of fremanezumab for migraine prevention over 24 months in Italian participants enrolled in the Phase 4, non-interventional, observational Pan-European Real Life (PEARL; EUPAS35111) study.

Methods: Eligible participants had EM or CM at enrolment. Primary endpoint was the proportion of participants achieving ≥50% reduction in MMD during 6 months after first dose of fremanezumab. A mandatory ≥1-month treatment discontinuation period occurred following 12 months of treatment. Secondary endpoints included: proportion of participants achieving ≥50%, ≥75% or 100% reduction in MMD at Months 3, 12 and 24 and change from baseline in MMD at Months 3, 12 and 24.

Results: Overall, 354 (EM, 125; CM, 229) eligible participants were enrolled in 30 centres. In total, 61.9% of participants achieved ≥50% reduction in MMD during the 6 months after fremanezumab initiation. A sustained response was observed over 24 months: 61.2%, 35.7% and 10.5% of participants achieved ≥50%, ≥75% or 100% reduction in MMD at Month 3 (n=353), respectively; 62.1%, 38.5% and 14.5% achieved ≥50%, ≥75% or 100% reduction in MMD at Month 12 (n=351), respectively; and 58.5%, 43.9% and 7.3% achieved ≥50%, ≥75% or 100% reduction in MMD at Month 24 (n=41), respectively. Only participants with EM (17.6%) achieved a complete response at Month 24. Mean change from baseline in MMD was –8.2 at Month 1, –9.3 at Month 12 and –10.5 at Month 24. Overall, 24.9% (88/354) of participants discontinued the study (lack of efficacy, 34.1%; lost to follow-up, 20.5%; participant withdrawal, 13.6%; non-compliance, 9.1%).

Conclusion: Although many participants in this study interrupted fremanezumab for ≥1 month due to AIFA requirement, these results indicate that fremanezumab is effective for migraine prevention over 24 months.