Interferon beta-1b is effective in Japanese RRMS patients
Interferon beta-1b is effective in Japanese RRMS patients
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干扰素 beta-1b 对日本 RRMS 患者有效
DOI：
10.1212/01.wnl.0000151856.10387.e2
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发表时间：
2005
期刊：
影响因子：
9.9
通讯作者：
Z. Zhao
中科院分区：
文献类型：
--
作者：
Takahiko Saida;Kunio Tashiro;Y. Itoyama;T. Sato;Y. Ohashi;Z. Zhao
目的：评价干扰素β -1b （IFNB-1b）治疗日本复发-缓解型多发性硬化症（RRMS）患者的疗效。背景：IFNB对RRMS的影响已经在主要由白人患者组成的研究人群中进行了评估。日本患者的多发性硬化症与白人患者不同，有两种不同的表现——经典多发性硬化症（C-MS）和光学脊髓多发性硬化症（OS-MS）——慢性进行性多发性硬化症很少发生。方法：205名日本RRMS患者被随机分为两组，每隔一天接受50 μg或250 μg(1.6或8.0 MIU) IFNB-1b给药SC，为期2年。主要终点为年复发率。次要终点包括进一步的复发相关和MRI结果测量，以及扩展残疾状态量表和神经评定量表的变化。188例患者进行了疗效评估，192例患者进行了安全性评估。还对OS-MS和C-MS患者进行了补充特设亚组分析。结果：250 μg组年复发率为0.763,50 μg组年复发率为1.069，相对降低28.6% （p = 0.047）。所有次要终点的结果均支持250 μg IFNB-1b。亚组分析表明，OS-MS和C-MS患者的治疗效果的幅度和方向相似，尽管由于样本量小而不显著。结论：干扰素β -1b (IFNB-1b) 250 μg可显著降低日本复发-缓解型多发性硬化症患者的复发率和MRI病变面积的变化，并且在光学-脊髓多发性硬化症（MS）和经典多发性硬化症中似乎同样有效。日本多发性硬化症患者对IFNB-1b治疗的反应表明其与白人患者具有共同的发病机制和潜在的遗传特征。
Objective: To assess the efficacy of interferon beta-1b (IFNB-1b) in Japanese patients with relapsing-remitting multiple sclerosis (RRMS). Background: The effects of IFNB in RRMS have been assessed in study populations comprised predominantly of white patients. MS in Japanese patients is different from that in white patients in that there are two different presentations—classic MS (C-MS) and optic-spinal MS (OS-MS)—and chronic progressive forms are infrequent. Methods: A total of 205 Japanese patients with RRMS were randomized to receive 50 μg or 250 μg (1.6 or 8.0 MIU) IFNB-1b administered SC every other day for up to 2 years. The primary endpoint was annual relapse rate. Secondary endpoints included further relapse-related and MRI outcome measures, as well as changes in Expanded Disability Status Scale and Neurologic Rating Scale. Efficacy was assessed in 188 patients, and safety was assessed in 192 patients. Supplemental ad hoc subgroup analyses were also performed for patients with OS-MS and those with C-MS. Results: Annual relapse rates were 0.763 in the 250 μg group and 1.069 in the 50 μg group, a relative reduction of 28.6% (p = 0.047). Results for all secondary endpoints favored 250 μg IFNB-1b. Subgroup analyses suggested that the magnitude and direction of treatment effect in patients with OS-MS and C-MS was similar, albeit not significant due to small sample size. Conclusions: Interferon beta-1b (IFNB-1b) 250 μg significantly reduced relapse rates and change in MRI lesion area in Japanese patients with relapsing-remitting multiple sclerosis, and seemed to be comparably effective in optic-spinal multiple sclerosis (MS) and classic MS. The response to treatment with IFNB-1b in Japanese patients with MS suggests that a common pathogenesis and underlying genetic characteristics are shared with white patients.