Long-term outcome in multiple sclerosis patients treated with fingolimod

Background and purpose: Ongoing disease activity during treatment has been associated to worse disability outcomes in patients with Multiple Sclerosis (MS). The aim of this study was to assess the 5-year response to fingolimod (FTY) treatment in patients with relapsing-remitting (RRMS) in a real-life setting.

Methods: We included RRMS patients who received FTY for at least 6 months and had a follow-up ≥ 60 months. Treatment response was assessed through the No Evidence of Disease Activity (NEDA)-3 status.

Results: Eighty-eight patients were included, of which 51 (58.0%) were NTZ-naïve and 37 (42.0%) NTZ-switchers. The mean age was 38.9 (9.5) years and 58 (65.9%) were females. The proportion of patients on FTY treatment who maintained the NEDA-3 status at 5 years was 55.9% among NTZ-naïve patients and 35.0% among NTZ-switchers (p=0.138). Predictors of NEDA-3 status were lower Expanded Disability Status Scale score at baseline (_adjOR=0.28, 95% CI 0.10-0.77; p=0.013) in NTZ-naïve patients and fewer relapses in the 12 months before starting FTY in NTZ-switchers (_adjOR=0.05, 95% CI 0.003-0.79; p=0.034).

Conclusions: This study supports the potential of FTY as a disease-modifying treatment for the long-term management of RRMS patients. Patients with milder disability and fewer clinical relapses before treatment may achieve a better disease control.