AUTHOR=Ziemssen Tjalf , Albrecht Holger , Haas Judith , Klotz Luisa , Lang Michael , Lassek Christoph , Schmidt Stephan , Ettle Benjamin , Schulze-Topphoff Ulf 

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

JOURNAL=Frontiers in Neurology

VOLUME=12

YEAR=2021

URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.637107

DOI=10.3389/fneur.2021.637107

ISSN=1664-2295

ABSTRACT=<p><bold>Background:</bold> Fingolimod (Gilenya®) is approved for adult and pediatric patients with highly active relapsing–remitting multiple sclerosis (RRMS).</p><p><bold>Objectives:</bold> The objective was to describe the effectiveness of fingolimod in young adults compared to older patients in clinical practice.</p><p><bold>Methods:</bold> 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 &gt;20 to ≤30 years) and older patients (&gt;30 years).</p><p><bold>Results:</bold> 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, &gt;20 to ≤30 years and &gt;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 &gt;20 to ≤30 and &gt;30 years.</p><p><bold>Conclusions:</bold> Real-world evidence suggests a long-term treatment benefit of fingolimod in young RRMS patients.</p>