Department of Neurology, Kyoto Min-Iren-Central Hospital, Kyoto, Japan.
Mult Scler. 2012 Sep;18(9):1269-77. doi: 10.1177/1352458511435984. Epub 2012 Feb 21.
Fingolimod (FTY720) has previously shown clinical efficacy in phase II/III studies of predominantly Caucasian populations with multiple sclerosis (MS).
To report six-month efficacy and safety outcomes in Japanese patients with relapsing MS treated with fingolimod.
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.
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.
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.
芬戈莫德（FTY720）在以白种人为主的多发性硬化症（MS）的 II/III 期研究中显示出了临床疗效。
报告在接受芬戈莫德治疗的日本复发型多发性硬化症患者中，六个月的疗效和安全性结果。
在这项双盲、平行组、II 期研究中，171 名日本复发型多发性硬化症患者被随机分为每天一次接受芬戈莫德 0.5mg 或 1.25mg，或匹配安慰剂治疗六个月。主要和次要终点分别为在第 3 个月和第 6 个月无钆增强病变的患者比例，以及六个月内的复发情况；还评估了安全性结果。
147 名患者完成了研究。更高比例的患者在第 3 个月和第 6 个月时无钆增强病变，接受芬戈莫德治疗的患者（0.5mg：70%，p=0.004；1.25mg：86%，p<0.001）比接受安慰剂的患者（40%）更多。六个月内无复发患者的比例，与安慰剂相比，芬戈莫德更有利，但无统计学意义。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。
这项研究首次在日本多发性硬化症患者中证明了芬戈莫德的临床疗效，与芬戈莫德在白种人患者中的既定疗效一致。
