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.
N1 - Funding Information:
The authors thank the patients who participated in the study and the study site personnel. The authors take full responsibility for the content of the paper but thank Louise Verrall DPhil (Oxford PharmaGenesis™ Ltd, funded by Novartis Pharma AG, Switzerland) and Hashem Salloukh (Novartis Pharma AG, Switzerland) for editorial assistance, and Gordon Francis (Novartis Pharmaceuticals Corporation, USA), Isao Tsumiyama (Novartis Pharma KK, Japan) and Professor Ludwig Kappos (University Hospital, Basel, Switzerland) for critical review. All of the authors had access to the data, participated in analyses and their interpretation, participated in the preparation of the manuscript, and decided to submit the manuscript for publication. Medical writing assistance was provided by Oxford PharmaGenesis™ Ltd and was funded by Novartis Pharma AG.
Funding Information:
The work was supported by Novartis Pharma KK and Mitsubishi Tanabe Pharma Corp., Tokyo, Japan.
Funding Information:
TS has received funding from, held board membership, spoken at scientific meetings, prepared manuscripts and has had consulting agreements in the past years with Kaketsuken, Biogen Idec, Astelas, Bayer-Schering, Merck-Serono, Nihon Pharmaceutical, Daiich-Sankyo, Ono Pharmaceutical, TDS Japan, Teijin Farma and Sanofi-Aventis. He was funded by grants from the Ministry of Health, Labor and Welfare, Japan. SK has received research support from Mitsubishi Tanabe Pharma Corporation Japan. YI has received research support from the Ministry of Education, Science and Technology of Japan; the Ministry of Health, Labor and Welfare of Japan, and honoraria from Bayer Schering Pharma and Biogen Idec Japan. QH has no conflicts of interest to disclose. TK is an employee of Novartis Pharma KK, Japan. KN is an employee of Mitsubishi Tanabe Pharma Corporation Japan. DT and LZ-A are employees of Novartis Pharma AG, Switzerland. JK is a consultant for Biogen Idec Japan and Novartis Pharma and has received honoraria from Bayer Healthcare, Biogen Idec Japan, Boehringer Ingelheim, Eisai, Pfizer Japan, Otsuka Pharmaceutical, Kyowa Kirin, Teijin Pharma and Mitsubishi Tanabe Pharma, and funding for a trip from Bayer Healthcare and Biogen Idec Japan. He is funded by grants from the Ministry of Health, Labor and Welfare, Japan, and grants from the Japan Science and Technology Agency and the Ministry of Education, Culture, Science, Sports and Technology, Japan.
PY - 2012/9
Y1 - 2012/9
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.
AB - 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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U2 - 10.1177/1352458511435984
DO - 10.1177/1352458511435984
M3 - Article
C2 - 22354739
AN - SCOPUS:84866021501
VL - 18
SP - 1269
EP - 1277
JO - Multiple Sclerosis
JF - Multiple Sclerosis
SN - 1352-4585
IS - 9
ER -