Fingolimod in the treatment of relapsing–remitting multiple sclerosis: long-term experience and an update on the clinical evidence
- 18 February 2016
- journal article
- review article
- Published by SAGE Publications in Therapeutic Advances in Neurological Disorders
- Vol. 9 (2), 130-147
- https://doi.org/10.1177/1756285616628766
Abstract
Since the approval in 2010 of fingolimod 0.5 mg (Gilenya; Novartis Pharma AG, Basel, Switzerland) in the USA as an oral therapy for relapsing forms of multiple sclerosis, long-term clinical experience with this therapy has been increasing. This review provides a summary of the cumulative dataset from clinical trials and their extensions, plus postmarketing studies that contribute to characterizing the efficacy and safety profile of fingolimod in patients with relapsing forms of multiple sclerosis. Data from the controlled, phase III, pivotal studies [FREEDOMS (FTY720 Research Evaluating Effects of Daily Oral therapy in Multiple Sclerosis), FREEDOMS II and TRANSFORMS (Trial Assessing Injectable Interferon versus FTY720 Oral in Relapsing–Remitting Multiple Sclerosis)] in relapsing–remitting multiple sclerosis have shown that fingolimod has a robust effect on clinical and magnetic resonance imaging outcomes. The respective study extensions show that effects on annualized relapse rates are sustained with continued fingolimod treatment. Consistent, significant reductions in magnetic resonance imaging lesion counts and brain volume loss have also been sustained with long-term treatment. The safety profile of fingolimod is also examined, particularly in light of its long-term use. A summary of the adverse events of interest that are associated with fingolimod treatment and associated label guidelines are also considered, which include cardiac effects following first-dose administration, infections, lymphopenia, macular edema and pregnancy. Historic hurdles to the prescription of fingolimod and how these challenges are being met are also discussed.This publication has 64 references indexed in Scilit:
- Clinical Pharmacokinetics of FingolimodClinical Pharmacokinetics, 2012
- Comparison of fingolimod with interferon beta-1a in relapsing-remitting multiple sclerosis: a randomised extension of the TRANSFORMS studyThe Lancet Neurology, 2011
- Fingolimod (FTY720): discovery and development of an oral drug to treat multiple sclerosisNature Reviews Drug Discovery, 2010
- Assessing brain atrophy rates in a large population of untreated multiple sclerosis subtypesNeurology, 2010
- Mechanism of Action of Oral Fingolimod (FTY720) in Multiple SclerosisClinical Neuropharmacology, 2010
- A Placebo-Controlled Trial of Oral Fingolimod in Relapsing Multiple SclerosisThe New England Journal of Medicine, 2010
- Oral Fingolimod or Intramuscular Interferon for Relapsing Multiple SclerosisThe New England Journal of Medicine, 2010
- Phase II study of oral fingolimod (FTY720) in multiple sclerosis: 3-year resultsMultiple Sclerosis Journal, 2009
- The Heart Rate Decrease Caused by Acute FTY720 Administration Is Mediated by the G Protein-Gated Potassium Channel IKAChAmerican Journal of Transplantation, 2005
- Alteration of Lymphocyte Trafficking by Sphingosine-1-Phosphate Receptor AgonistsScience, 2002