Neurological safety of fingolimod: An updated review

Fingolimod (FTY) is the first oral medication approved for treatment of relapsing-remitting multiple sclerosis (RRMS). Its effectiveness and safety were confirmed in several phase III clinical trials, but proper evaluation of safety in the real patient population requires long-term post-marketing mo...

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Bibliographic Details
Published in:Clinical & experimental neuroimmunology 2017-08, Vol.8 (3), p.233-243
Main Authors: Yoshii, Fumihito, Moriya, Yusuke, Ohnuki, Tomohide, Ryo, Masafuchi, Takahashi, Wakoh
Format: Article
Language:English
Subjects:
Central nervous system
Clinical trials
Heart diseases
Immune reconstitution
Infectious diseases
Inflammation
Leukoencephalopathy
MS/NMO and allied disorders
Multiple sclerosis
Nervous system
Neuromyelitis
Progressive multifocal leukoencephalopathy
Review
Side effects
Substantia alba
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Summary:Fingolimod (FTY) is the first oral medication approved for treatment of relapsing-remitting multiple sclerosis (RRMS). Its effectiveness and safety were confirmed in several phase III clinical trials, but proper evaluation of safety in the real patient population requires long-term post-marketing monitoring. Since the approval of FTY for RRMS in Japan in 2011, it has been administered to approximately 5000 MS patients, and there have been side-effect reports from 1750 patients. Major events included infectious diseases, hepatobiliary disorders, nervous system disorders and cardiac disorders. In the present review, we focus especially on central nervous system adverse events. The topics covered are: (i) clinical utility of FTY; (ii) safety profile; (iii) post-marketing adverse events in Japan; (iv) white matter (tumefactive) lesions; (v) rebound after FTY withdrawal; (vi) relationship between FTY and progressive multifocal leukoencephalopathy; (vii) FTY and progressive multifocal leukoencephalopathy-related immune reconstitution inflammatory syndrome; and (viii) neuromyelitis optica and leukoencephalopathy.
ISSN:1759-1961
1759-1961
DOI:10.1111/cen3.12397