A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with
multiple sclerosis.
Author(s): Saida T, Kikuchi S, Itoyama Y, Hao Q, Kurosawa T, Nagato K, Tang D,
Zhang-Auberson L, Kira J.
Affiliation(s): Department of Neurology, Kyoto Min-Iren-Central Hospital, Kyoto, Japan.
saida_takahiko@maia.eonet.ne.jp
Publication date & source: 2012, Mult Scler. , 18(9):1269-77
BACKGROUND: Fingolimod (FTY720) has previously shown clinical efficacy in phase
II/III studies of predominantly Caucasian populations with multiple sclerosis
(MS).
OBJECTIVES: 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.
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