Abstract
Aim: To assess retrospectively the clinical efficacy of fingolimod in one or two years of treatment in patients with active multiple sclerosis. Patients and methods: 223 patients were treated with fingolimod for at least one year, 109 of whom were treated for two years. 126 patients were switched to fingolimod from interferon beta or glatiramer acetate, 3 patients were treatment-naive and 94 patients were switched from natalizumab.
Results: In patients switched from IFN beta or GA, the relapse rate decreased by 72% in the first year and by 64% in the first 2 years, in patients switched from natalizumab the decrease was 25% in the first year and 31% during 2 years of treatment. 66% of patients in the overall group and in both subgroups remained relapse-free during the first year of treatment and 50.5% over the 2 years of fingolimod treatment. 80% of patients had stable or improved EDSS in the first year and also after 2 years of treatment. 94.6% of patients did not have a 6-months confirmed disability progression within one or 2-year observational period. No evidence of clinical activity of the disease was observed in 64.6% of patients in the first year and in 50% of patients after the first 2 years of treatment. 16.7% of patients with the washout period of 63 days or less after the last infusion of natalizumab relapsed, while the washout period longer than 63 days led to a relapse in 25% of patients.
Conclusion: Fingolimod is an effective escalation treatment in patients failing on DMDs or as the first line treatment in patients with high activity of MS. After termination of natalizumab treatment, fingolimod is an effective alternative for the majority of patients.