title: A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with multiple sclerosis.
abstract: BACKGROUND
  Fingolimod (FTY720) has previously shown clinical efficacy in phase II/III studies of predominantly Caucasian populations with multiple sclerosis (MS).
  
  
  OBJECTIVE
  To report six-month efficacy and safety outcomes in Japanese patients with relapsing MS treated with fingolimod.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  This study demonstrated the clinical efficacy of fingolimod for the first time in Japanese patients with MS, consistent with the established effects of fingolimod in Caucasian patients.
authors.affiliation: Department of Neurology, Kyoto Min-Iren-Central Hospital, Kyoto, Japan. saida_takahiko@maia.eonet.ne.jp
authors.forename: T
authors.initials: T
authors.lastname: Saida
authors.forename: S
authors.initials: S
authors.lastname: Kikuchi
authors.forename: Y
authors.initials: Y
authors.lastname: Itoyama
authors.forename: Q
authors.initials: Q
authors.lastname: Hao
authors.forename: T
authors.initials: T
authors.lastname: Kurosawa
authors.forename: K
authors.initials: K
authors.lastname: Nagato
authors.forename: D
authors.initials: D
authors.lastname: Tang
authors.forename: L
authors.initials: L
authors.lastname: Zhang-Auberson
authors.forename: J
authors.initials: J
authors.lastname: Kira
mesh_terms: D000293:Adolescent; D000328:Adult; D044466:Asian People; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D000068876:Fingolimod Hydrochloride; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan / Q000453:epidemiology; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000175:diagnosis / Q000188:drug therapy* / Q000208:ethnology; D016017:Odds Ratio; D011409:Propylene Glycols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012008:Recurrence; D013110:Sphingosine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D011409:Propylene Glycols; D000068876:Fingolimod Hydrochloride; D013110:Sphingosine