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Fingolimod for multiple sclerosis and emerging indications: appropriate patient selection, safety precautions, and special considerations

Authors Ayzenberg I, Hoepner R, Kleiter I

Received 31 October 2015

Accepted for publication 20 January 2016

Published 19 February 2016 Volume 2016:12 Pages 261—272


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 3

Editor who approved publication: Professor Garry Walsh

Ilya Ayzenberg, Robert Hoepner, Ingo Kleiter

Department of Neurology, St Josef Hospital, Ruhr University Bochum, Bochum, Germany

Abstract: Fingolimod (FTY720), an immunotherapeutic drug targeting the sphingosine-1-phosphate receptor, is a widely used medication for relapsing-remitting multiple sclerosis (MS). Apart from the pivotal Phase III trials demonstrating efficacy against placebo and interferon-β-1a once weekly, sufficient clinical data are now available to assess its real-world efficacy and safety profile. Approved indications of fingolimod differ between countries. This discrepancy, to some extent, reflects the intermediate position of fingolimod in the expanding lineup of MS medications. With individualization of therapy, appropriate patient selection gets more important. We discuss various scenarios for fingolimod use in relapsing-remitting MS and their pitfalls: as first-line therapy, as escalation therapy after failure of previous immunotherapies, and as de-escalation therapy following highly potent immunotherapies. Potential side effects such as bradycardia, infections, macular edema, teratogenicity, and progressive multifocal leukoencephalopathy as well as appropriate safety precautions are outlined. Disease reactivation has been described upon fingolimod cessation; therefore, patients should be closely monitored for MS activity for several months after stopping fingolimod. Finally, we discuss preclinical and clinical data indicating neuroprotective effects of fingolimod, which might open the way to future indications such as stroke, Alzheimer’s disease, and other neurodegenerative disorders.

Keywords: immunotherapy, bradycardia, progressive multifocal leukoencephalopathy, neuroprotection, stroke, Alzheimer’s disease

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