A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with multiple sclerosis

Multiple Sclerosis : Clinical and Laboratory Research
Takahiko SaidaJun-ichi Kira

Abstract

Fingolimod (FTY720) has previously shown clinical efficacy in phase II/III studies of predominantly Caucasian populations with multiple sclerosis (MS). To report six-month efficacy and safety outcomes in Japanese patients with relapsing MS treated with fingolimod. In this double-blind, parallel-group, phase II study, 171 Japanese patients with relapsing MS were randomized to receive once-daily fingolimod 0.5 mg or 1.25 mg, or matching placebo for six months. The primary and secondary endpoints were the percentages of patients free from gadolinium (Gd)-enhanced lesions at months 3 and 6, and relapses over six months, respectively; safety outcomes were also assessed. 147 patients completed the study. Higher proportions of patients were free from Gd-enhanced lesions at months 3 and 6 with fingolimod (0.5 mg: 70%, p = 0.004; 1.25 mg: 86%, p < 0.001) than with placebo (40%). Odds ratios for the proportions of relapse-free patients over six months favoured fingolimod versus placebo but were not significant. Adverse events related to fingolimod included transient bradycardia and atrioventricular block at treatment initiation, and elevated liver enzyme levels. This study demonstrated the clinical efficacy of fingolimod for the first ti...Continue Reading

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Citations

Apr 1, 2014·Journal of Neuroimmunology·Achilles NtranosAnne R Gocke
Feb 11, 2014·Journal of Neuroimmunology·Douglas Kazutoshi SatoMasashi Aoki
May 31, 2016·Multiple Sclerosis and Related Disorders·Fumihito YoshiiWakoh Takahashi
Feb 11, 2014·Genes to Cells : Devoted to Molecular & Cellular Mechanisms·Kanako HagiharaReiko Sugiura
Dec 17, 2016·International Journal of Molecular Sciences·Refik PulThomas Skripuletz
Jan 17, 2013·Multiple Sclerosis : Clinical and Laboratory Research·Masami TanakaKeiko Tanaka
Dec 13, 2016·Clinical Neuropharmacology·Antonio J García-RuizNuria García-Agua Soler
Sep 19, 2015·The Cochrane Database of Systematic Reviews·Irene TramacereGraziella Filippini
Apr 20, 2016·The Cochrane Database of Systematic Reviews·Loredana La MantiaGraziella Filippini
Dec 24, 2019·British Journal of Clinical Pharmacology·Ting YangYi-Min Cui
Sep 22, 2017·Clinical & Experimental Neuroimmunology·Fumihito YoshiiWakoh Takahashi
May 1, 2016·Nihon Naika Gakkai zasshi. The Journal of the Japanese Society of Internal Medicine·Jun-Ichi Kira
Mar 3, 2018·Multiple Sclerosis Journal - Experimental, Translational and Clinical·Ryohei OhtaniSatoshi Kuwabara
Feb 2, 2021·Neurological Sciences : Official Journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology·Jingyi TongQifu Li
Mar 6, 2021·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Juan S LasaLaurent Peyrin-Biroulet
Nov 18, 2021·Journal of Neuro-ophthalmology : the Official Journal of the North American Neuro-Ophthalmology Society·Elena Garcia-MartinMaria J Rodrigo
May 14, 2020·Multiple Sclerosis and Related Disorders·Li Yen GohTimothy L Jackson

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NCT00537082

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