Fingolimod in the treatment of relapsing-remitting multiple sclerosis: long-term experience and an update on the clinical evidence.

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.

journal_name

Ther Adv Neurol Disord

authors

Khatri BO

doi

10.1177/1756285616628766

subject

Has Abstract

pub_date

2016-03-01 00:00:00

pages

130-47

issue

2

eissn

1756-2856

issn

1756-2864

pii

10.1177_1756285616628766

journal_volume

9

pub_type

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