Abstract
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.
Highlights
Relapsing multiple sclerosis (MS) represents a continuous spectrum of disease ranging from clinically isolated syndrome over relapsing–remitting multiple sclerosis (RRMS) to secondary progressive MS (SPMS) [1]
Young adults included in PANGAEA had a shorter disease duration on average (2.8 and 4.5 vs. 9.3 years) and lower Expanded Disability Status Scale (EDSS) and multiple sclerosis severity score (MSSS) scores compared to patients older than 30 years (EDSS: 1.8 and 2.3 vs. 3.2; MSSS: 4.7 and 5.0 vs. 5.2)
The EDSS scores were higher in older age groups, the symbol digit modalities test (SDMT) scores were similar in patients aged 20–30 years and patients older than 30 years (SDMT: 45.5 vs. 45.6; SDMT was not assessed in patients
Summary
Relapsing multiple sclerosis (MS) represents a continuous spectrum of disease ranging from clinically isolated syndrome over relapsing–remitting multiple sclerosis (RRMS) to secondary progressive MS (SPMS) [1]. Most RRMS patients are diagnosed at an age of 30–40 years [2], but some patients show early onset of MS at a childhood age or as young adults [3]. Due to the early onset of the disease, these milestones are still reached at a younger age [3]. Overall, these features suggest that MS in younger patients is even more characterized by inflammatory processes than in older patients. Despite differences in disease characteristics and limited efficacy data in younger MS patients, in general, the same treatment regimens should be used for adults, young adults, and even children. Fingolimod (Gilenya®) is approved for adult and pediatric patients with highly active relapsing–remitting multiple sclerosis (RRMS)
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