Descriptive Analysis of Real-World Data on Fingolimod Long-Term Treatment of Young Adult RRMS Patients

Frontiers in Neurology

Benjamin Ettle¹  Luisa Klotz²  Michael Lang³  Christoph Lassek⁴  Stephan Schmidt⁵  Ulf Schulze-Topphoff⁶  Holger Albrecht⁷  Judith Haas⁸  Tjalf Ziemssen⁹ 

[1] Kronenberger, Bonn, Germany;Klinik für Allgemeine Neurologie, Universitätsklinikum Muenster, Muenster, Germany;Nervenärztliche Gemeinschaftspraxis, Ulm, Germany;Neurologische Gemeinschaftspraxis Kassel und Vellmar, Kassel, Germany;;Neurologische Gemeinschaftspraxis Schmidt, Neudecker, Viebahn &Novartis Pharma GmbH, Nuremberg, Germany;Praxis für Neurologie, Munich, Germany;Zentrum für Multiple Sklerose, Juedisches Krankenhaus Berlin, Berlin, Germany;Zentrum für klinische Neurowissenschaften, Universitaetsklinikum Carl Gustav Carus Dresden, Dresden, Germany;

关键词: RRMS;    fingolimod;    young adults;    real-world evidence;    early treatment;    long-term study;   

DOI  :  10.3389/fneur.2021.637107

来源: DOAJ

【 摘 要 】

Background: Fingolimod (Gilenya®) is approved for adult and pediatric patients with highly active relapsing–remitting multiple sclerosis (RRMS).Objectives: The objective was to describe the effectiveness of fingolimod in young adults compared to older patients in clinical practice.Methods: PANGAEA is the largest prospective, multi-center, non-interventional, long-term study evaluating fingolimod in RRMS. We descriptively analyzed demographics, MS characteristics, and severity in two subgroups of young adults (≤20 and >20 to ≤30 years) and older patients (>30 years).Results: Young adults had lower Expanded Disability Status Scale (EDSS) scores compared to older patients (1.8 and 2.3 vs. 3.2) at baseline. The mean EDSS scores remained stable over 5 years in all subgroups. Young adults had higher annual relapse rates (2.0 and 1.7 vs. 1.4) at study entry, which were reduced by approximately 80% in all subgroups over 5 years. The proportion of patients with no clinical disease activity in year 4 was 52.6 and 73.4 vs. 66.9% in patients ≤20, >20 to ≤30 years and >30 years, respectively. The symbol digit modalities test score increased by 15.25 ± 8.3 and 8.3 ± 11.3 (mean ± SD) from baseline in patients >20 to ≤30 and >30 years.Conclusions: Real-world evidence suggests a long-term treatment benefit of fingolimod in young RRMS patients.

【 授权许可】

Unknown