Oral Fingolimod or Intramuscular Interferon for Relapsing Multiple Sclerosis
Oral Fingolimod or Intramuscular Interferon for Relapsing Multiple Sclerosis
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DOI：
10.1056/nejmoa0907839
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发表时间：
2010-02-04
影响因子：
158.5
通讯作者：
Kappos, Ludwig
中科院分区：
文献类型：
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作者：
Cohen, Jeffrey A.;Barkhof, Frederik;Kappos, Ludwig
研究背景Fingolimod(FTY720)是一种神经鞘氨醇受体调节剂，可防止淋巴细胞从淋巴结外流，在一项涉及多发性硬化症患者的2期研究中显示出临床疗效和影像改善。方法在这项为期12个月的双盲双模拟研究中，我们随机分配了1292名近期至少有一次复发病史的复发缓解型多发性硬化症患者，分别接受口服指甲素1.25或0.5 mg或肌肉注射干扰素β-1a(多发性硬化症已有的治疗方法)，每周30 mU。主要终点是年复发率。关键的次要终点是12个月时在T-2加权磁共振成像(MRI)扫描上新发或扩大的病变的数量，以及持续至少3个月的残疾进展。结果共有1153名患者(89%)完成了研究。接受Fingolimod-0.20(95%可信区间，0.16~0.26)和0.16(95%CI，0.12~0.21)治疗的两组患者的年复发率均显著低于干扰素组(0.33；95%CI，0.26~0.42；P
BACKGROUNDFingolimod (FTY720), a sphingosine-1-phosphate-receptor modulator that prevents lymphocyte egress from lymph nodes, showed clinical efficacy and improvement on imaging in a phase 2 study involving patients with multiple sclerosis.METHODSIn this 12-month, double-blind, double-dummy study, we randomly assigned 1292 patients with relapsing-remitting multiple sclerosis who had a recent history of at least one relapse to receive either oral fingolimod at a daily dose of either 1.25 or 0.5 mg or intramuscular interferon beta-1a ( an established therapy for multiple sclerosis) at a weekly dose of 30 mu g. The primary end point was the annualized relapse rate. Key secondary end points were the number of new or enlarged lesions on T-2-weighted magnetic resonance imaging (MRI) scans at 12 months and progression of disability that was sustained for at least 3 months.RESULTSA total of 1153 patients (89%) completed the study. The annualized relapse rate was significantly lower in both groups receiving fingolimod -0.20 (95% confidence interval [CI], 0.16 to 0.26) in the 1.25-mg group and 0.16 ( 95% CI, 0.12 to 0.21) in the 0.5-mg group - than in the interferon group (0.33; 95% CI, 0.26 to 0.42; P