Daclizumab HYP versus Interferon Beta-1a in Relapsing Multiple Sclerosis
Daclizumab HYP versus Interferon Beta-1a in Relapsing Multiple Sclerosis
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DOI：
10.1056/nejmoa1501481
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发表时间：
2015-10-08
影响因子：
158.5
通讯作者：
Elkins, J.
中科院分区：
文献类型：
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作者：
Kappos, L.;Wiendl, H.;Elkins, J.
Daclizumab high-yield process（HYP）是一种人源化单克隆抗体，其结合CD 25（白细胞介素-2受体的α亚基）并调节白细胞介素-2信号传导。白细胞介素-2信号传导的异常与多发性硬化症和其他自身免疫性疾病的发病机制有关。方法我们进行了一项随机、双盲、活性对照、3期研究，涉及1841名复发缓解型多发性硬化症患者，比较每4周皮下注射150 mg剂量的达克珠单抗HYP与干扰素β-1a，以30 μ g的剂量每周一次肌内给药，持续长达144周。主要终点是年复发率。Daclizumab HYP的年复发率低于干扰素β-1a（0.22 vs. 0.39; Daclizumab HYP的年复发率低45%; P
BACKGROUNDDaclizumab high-yield process (HYP) is a humanized monoclonal antibody that binds to CD25 (alpha subunit of the interleukin-2 receptor) and modulates interleukin-2 signaling. Abnormalities in interleukin-2 signaling have been implicated in the pathogenesis of multiple sclerosis and other autoimmune disorders.METHODSWe conducted a randomized, double-blind, active-controlled, phase 3 study involving 1841 patients with relapsing-remitting multiple sclerosis to compare daclizumab HYP, administered subcutaneously at a dose of 150 mg every 4 weeks, with interferon beta-1a, administered intramuscularly at a dose of 30 mu g once weekly, for up to 144 weeks. The primary end point was the annualized relapse rate.RESULTSThe annualized relapse rate was lower with daclizumab HYP than with interferon beta-1a (0.22 vs. 0.39; 45% lower rate with daclizumab HYP; P