title: Clinical efficacy, safety, and tolerability of fingolimod for the treatment of relapsing-remitting multiple sclerosis.
abstract: Fingolimod is a selective immunosuppressive agent approved worldwide for the treatment of relapsing-remitting multiple sclerosis (MS), a chronic and potentially disabling neurological condition. Randomized double-blind clinical trials have shown that fingolimod significantly reduces relapse rate and ameliorates a number of brain MRI measures, including cerebral atrophy, compared to both placebo and intramuscular interferon-β1a. The effect on disability progression remains controversial, since one Phase III trial showed a significant benefit of treatment while two others did not. Although fingolimod has a very convenient daily oral dosing, the possibility of serious cardiac, ocular, infectious, and other rare adverse events justified the decision of the European Medicines Agency to approve the drug as a second-line treatment for MS patients not responsive to first-line therapy, or those with rapidly evolving course. In the United States, fingolimod is instead authorized as a first-line treatment. The aim of this review is to describe and discuss the characteristics of fingolimod concerning its efficacy, safety, and tolerability in the clinical context of multiple sclerosis management.
authors.affiliation: Department of Neurological, Biomedical and Movement Sciences, University of Verona, Verona, Italy ; Division of Neurology B, Verona University Hospital, Verona, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Gajofatto
authors.affiliation: Division of Neurology B, Verona University Hospital, Verona, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Turatti
authors.affiliation: Department of Neurological, Biomedical and Movement Sciences, University of Verona, Verona, Italy ; Division of Neurology B, Verona University Hospital, Verona, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Monaco
authors.affiliation: Division of Neurology B, Verona University Hospital, Verona, Italy.
authors.forename: Maria Donata
authors.initials: MD
authors.lastname: Benedetti
keywords: efficacy; fingolimod; multiple sclerosis; safety; tolerability