Fingolimod in Japanese MS'ers

Epub ahead of printSaida et al. A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with multiple sclerosis. Mult Scler. 2012 Feb 21. 

Background: Fingolimod (FTY720) has previously shown clinical efficacy in phase II/III studies of predominantly Caucasian populations with MS.

Objectives: To report 6-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 MS'ers 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 MS'ers free from gadolinium (Gd)-enhanced lesions at months 3 and 6, and relapses over six months, respectively; safety outcomes were also assessed.

Results: 147 MS'ers completed the study. Higher proportions of MS'ers 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%). 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 MS'ers, consistent with the established effects of fingolimod in Caucasian patients.

"Nothing surprising with these results; both on the efficacy and adverse effects front. Why repeat a study in Japan? The Japanese regulatory authorities require you to show similar efficacy in a Japanese MS population to get a license to sell your drug in Japan. The big news here is that fingolimod is coming home; it was initially discovered by Japanese scientists back in the early 90's."

CoI: multiple

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