Long-term real-world effectiveness and safety of fremanezumab in 1140 patients with migraine and at least 6 months of treatment: third interim analysis of the pan-European PEARL study

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F25%3A10504070" target="_blank" >RIV/00216208:11110/25:10504070 - isvavai.cz</a>

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=j4PACGRTo9" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=j4PACGRTo9</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1007/s10072-025-08484-1" target="_blank" >10.1007/s10072-025-08484-1</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Long-term real-world effectiveness and safety of fremanezumab in 1140 patients with migraine and at least 6 months of treatment: third interim analysis of the pan-European PEARL study

Popis výsledku v původním jazyce

Introduction: Real-world data on the long-term use of fremanezumab for migraine prevention remain limited. This third interim analysis of the PEARL study addresses this gap by investigating the long-term effectiveness, safety, and tolerability of fremanezumab for up to 12 months of treatment. Methods: PEARL is a 24-month, prospective, observational, Phase 4 study conducted in 11 European countries. Eligible participants were adults (&gt;= 18 years) diagnosed with chronic or episodic migraine who received subcutaneous fremanezumab (225 mg monthly or 675 mg quarterly) and completed &gt;= 6 months of treatment. The primary endpoint was defined as the proportion of participants achieving a &gt;= 50% reduction in monthly migraine days (MMD) during the 6-month period following treatment initiation. Secondary endpoints included mean change from baseline to Month 12 in: average MMD, acute migraine medication use, and migraine-related disability scores, as measured by the Migraine Disability Assessment and the 6-item Headache Impact Test. Safety was assessed through the collection of adverse events. Results: At data cut-off (22 September 2022), 968 of 1140 enrolled participants were included in the effectiveness analysis with 58.5% achieving the primary endpoint. Sustained reductions in MMD, acute medication use, and disability scores were observed over 12 months, and no new safety signals were detected. Conclusions: Findings from this third interim analysis of PEARL provide compelling evidence for the long-term effectiveness of fremanezumab in a large, real-world patient population. The results support the continued use of fremanezumab as a preventive strategy for migraine and underscore the value of integrating real-world evidence into migraine management.

Název v anglickém jazyce

Long-term real-world effectiveness and safety of fremanezumab in 1140 patients with migraine and at least 6 months of treatment: third interim analysis of the pan-European PEARL study

Popis výsledku anglicky

Introduction: Real-world data on the long-term use of fremanezumab for migraine prevention remain limited. This third interim analysis of the PEARL study addresses this gap by investigating the long-term effectiveness, safety, and tolerability of fremanezumab for up to 12 months of treatment. Methods: PEARL is a 24-month, prospective, observational, Phase 4 study conducted in 11 European countries. Eligible participants were adults (&gt;= 18 years) diagnosed with chronic or episodic migraine who received subcutaneous fremanezumab (225 mg monthly or 675 mg quarterly) and completed &gt;= 6 months of treatment. The primary endpoint was defined as the proportion of participants achieving a &gt;= 50% reduction in monthly migraine days (MMD) during the 6-month period following treatment initiation. Secondary endpoints included mean change from baseline to Month 12 in: average MMD, acute migraine medication use, and migraine-related disability scores, as measured by the Migraine Disability Assessment and the 6-item Headache Impact Test. Safety was assessed through the collection of adverse events. Results: At data cut-off (22 September 2022), 968 of 1140 enrolled participants were included in the effectiveness analysis with 58.5% achieving the primary endpoint. Sustained reductions in MMD, acute medication use, and disability scores were observed over 12 months, and no new safety signals were detected. Conclusions: Findings from this third interim analysis of PEARL provide compelling evidence for the long-term effectiveness of fremanezumab in a large, real-world patient population. The results support the continued use of fremanezumab as a preventive strategy for migraine and underscore the value of integrating real-world evidence into migraine management.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30103 - Neurosciences (including psychophysiology)

Projekt

—

Návaznosti

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Rok uplatnění

2025

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Neurological Sciences

ISSN

1590-1874

e-ISSN

1590-3478

Svazek periodika

46

Číslo periodika v rámci svazku

12

Stát vydavatele periodika

IT - Italská republika

Počet stran výsledku

15

Strana od-do

6907-6921

Kód UT WoS článku

001585031300001

EID výsledku v databázi Scopus

2-s2.0-105018198667