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

Background: Fingolimod (Gilenya (R)) 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.