A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with multiple sclerosis
A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with multiple sclerosis
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DOI：
10.1177/1352458511435984
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发表时间：
2012-09-01
影响因子：
5.8
通讯作者：
Kira, J.
中科院分区：
文献类型：
--
作者：
Saida, T.;Kikuchi, S.;Kira, J.
背景资料：芬戈莫德（FTY 720）先前已在II/III期研究中显示出临床疗效，主要针对患有多发性硬化症（MS）的高加索人群。目的：报告用芬戈莫德治疗复发性MS的日本患者的6个月疗效和安全性结局。在这项双盲、平行组、II期研究中，171例复发性MS日本患者随机接受每日一次的芬戈莫德0.5 mg或1.25 mg或匹配的安慰剂治疗6个月。主要和次要终点是患者在3个月和6个月时无钆（Gd）增强病变的百分比，以及6个月以上的复发率;还评估了安全性结局。芬戈莫德组第3个月和第6个月时无Gd增强病变的患者比例（0.5 mg：70%，p = 0.004; 1.25 mg：86%，p < 0.001）高于安慰剂组（40%）。6个月内无复发患者比例的比值比有利于芬戈莫德与安慰剂，但不显著。与芬戈莫德相关的不良事件包括治疗开始时的短暂心动过缓和房室传导阻滞，以及肝酶水平升高。结论：本研究首次证明了芬戈莫德在日本MS患者中的临床疗效，与芬戈莫德在高加索患者中的既定效果一致。
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.