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A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with multiple sclerosis.
Mult Scler. 2012 Sep; 18(9):1269-77.MS

Abstract

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.

Authors+Show Affiliations

Department of Neurology, Kyoto Min-Iren-Central Hospital, Kyoto, Japan. saida_takahiko@maia.eonet.ne.jpNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22354739

Citation

Saida, T, et al. "A Randomized, Controlled Trial of Fingolimod (FTY720) in Japanese Patients With Multiple Sclerosis." Multiple Sclerosis (Houndmills, Basingstoke, England), vol. 18, no. 9, 2012, pp. 1269-77.
Saida T, Kikuchi S, Itoyama Y, et al. A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with multiple sclerosis. Mult Scler. 2012;18(9):1269-77.
Saida, T., Kikuchi, S., Itoyama, Y., Hao, Q., Kurosawa, T., Nagato, K., Tang, D., Zhang-Auberson, L., & Kira, J. (2012). A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with multiple sclerosis. Multiple Sclerosis (Houndmills, Basingstoke, England), 18(9), 1269-77. https://doi.org/10.1177/1352458511435984
Saida T, et al. A Randomized, Controlled Trial of Fingolimod (FTY720) in Japanese Patients With Multiple Sclerosis. Mult Scler. 2012;18(9):1269-77. PubMed PMID: 22354739.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with multiple sclerosis. AU - Saida,T, AU - Kikuchi,S, AU - Itoyama,Y, AU - Hao,Q, AU - Kurosawa,T, AU - Nagato,K, AU - Tang,D, AU - Zhang-Auberson,L, AU - Kira,J, Y1 - 2012/02/21/ PY - 2012/2/23/entrez PY - 2012/2/23/pubmed PY - 2013/1/23/medline SP - 1269 EP - 77 JF - Multiple sclerosis (Houndmills, Basingstoke, England) JO - Mult. Scler. VL - 18 IS - 9 N2 - 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. SN - 1477-0970 UR - https://www.unboundmedicine.com/medline/citation/22354739/A_randomized_controlled_trial_of_fingolimod__FTY720__in_Japanese_patients_with_multiple_sclerosis_ L2 - http://journals.sagepub.com/doi/full/10.1177/1352458511435984?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -