Fingolimod in Japanese MS’ers

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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

About the author

Prof G

Professor of Neurology, Barts & The London. MS & Preventive Neurology thinker, blogger, runner, vegetable gardener, husband, father, cook and wine & food lover.

2 comments

  • Is there a difference between ethnicity and MS severity?

    The reason I ask is because in Bradford and Birmingham (and maybe London), they are doing a big study looking at MS in British South Asian communities.

    They seem to think that Asians have a worse pathology. It might be to do with the fact that their bodies have very rapidly had to adjust to life in a cold climate. Their DNA is not geared to deal with low sunlight levels.

    The same may be true of black people with MS.

    Prof G – are people of colour with MS in a more worrying situation?

  • Re: "are people of colour with MS in a more worrying situation?"

    There is quite a literature on this topic already. It is clear that being of African descent and possibly of Asian decent that your MS prognosis is worse; i.e. more severe relapses and poorer recovery. The reason I pause on Asians is that there was a condition called optico-spinal or Asian MS; it is clear now that this is was in the majority of cases NMO or neuro-myelitis optica. Once these cases have been taken out of the mix the prognosis of the so-called "Western-type" MS in this group may be similar to that in Caucasians.

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