Observations of long-term efficacy and safety fingolimod treatment in multiple sclerosis Review article
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Published:
Jun 30, 2016
Keywords:
multiple sclerosis, fingolimod, relapse rate, no evidence of disease activity, NEDA-4, long-term efficacy, safety profile
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Abstract
Fingolimod is the first oral disease-modifying therapy for treatment of relapsing multiple sclerosis. Efficacy and safety of fingolimod were proven in several, phase III clinical trials. Long-term observations indicate that it’s influence on relapse rate and clinical progression is maintained for 7 years. Percetage subject achieving NEDA (no evidence of disease activity) and NEDA-4 including impact on brain atrophy remains similar to registrations clinical trials. Safety of long-term treatment indicates beneficial profile including subject experienced lymphopenia.
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References
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2. Hartung H.P., Aktas O., Menge T., Kieseier B.C.: Immune regulation of multiple sclerosis. Handb. Clin. Neurol. 2014; 122: 3-14.
3. Criste G., Trapp B., Dutta R.: Axonal loss in multiple sclerosis: causes and mechanisms. Handb. Clin. Neurol. 2014; 122: 101-113.
4. Filippi M., Charil A., Rovaris M. et al.: Insights from magnetic resonance imaging. Handb. Clin. Neurol. 2014; 122: 115-149.
5. Giovannoni G., Turner B., Gnanapavan S. et al.: Is it time to target no evident disease activity (NEDA) in multiple sclerosis? Mult. Scler. Relat. Disord. 2015; 4(4): 329-333.
6. Kappos L., Radue E.W., O’Connor P. et al.: Fingolimod treatment increases the proportion of patients who are free from disease activity in multiple sclerosis: results from a phase 3, placebo-controlled study (FREEDOMS) (Poster PD6.002). Neurology 2011; 76: A563.
7. Havrdova E., Galetta S., Stefoski D., Comi G.: Freedom from disease activity in multiple sclerosis. Neurology 2010; 74(supl. 3): S3-S7.
8. Nixon R., Bergvall N., Tomic D. et al.: No evidence of disease activity: indirect comparison of oral therapies for the treatment of relapsing-remitting multiple sclerosis. Adv. Ther. 2014; 31(11): 1134-1154.
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13. Cree B.A.C., Kappos L., Freedman M.S. et al.: Long-term effects of fingolimod on NEDA by year of treatment. ECTRIMS, Barcelona 2015; P627.
14. Giovanni G., Havrdova E., Gold R. et al.: Long-term follow-up of the effect of delayed-release dimethyl fumarate on no evidence of disease activity in patients with multiple sclerosis (P7.280). American Academy of Neurology 2015.