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Neurological safety of fingolimod: An updated review
Author(s) -
Yoshii Fumihito,
Moriya Yusuke,
Ohnuki Tomohide,
Ryo Masafuchi,
Takahashi Wakoh
Publication year - 2017
Publication title -
clinical and experimental neuroimmunology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.297
H-Index - 15
ISSN - 1759-1961
DOI - 10.1111/cen3.12397
Subject(s) - fingolimod , medicine , progressive multifocal leukoencephalopathy , neuromyelitis optica , multiple sclerosis , adverse effect , leukoencephalopathy , clinical trial , natalizumab , pediatrics , immunology , disease
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.