Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis
Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis
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DOI：
10.1056/nejmoa1601277
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发表时间：
2017-01-19
影响因子：
158.5
通讯作者：
Kappos, L.
中科院分区：
文献类型：
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作者：
Hauser, S. L.;Bar-Or, A.;Kappos, L.
GROUNDB细胞影响多发性硬化症的发病机制。Ocrelizumab是一种人源化的单克隆抗体，选择性地耗尽CD 20 + B cells. METHODS在两个相同的3期试验，我们随机分配821和835例复发性多发性硬化症患者接受静脉注射ocrelizumab的剂量为600毫克，每24周或皮下注射干扰素β-1 α在剂量为44微克，每周三次，96周。主要终点是年复发率。在试验1中，ocrelizumab的年复发率低于干扰素β-1a（0.16 vs. 0.29; ocrelizumab的年复发率低46%; P
BACKGROUNDB cells influence the pathogenesis of multiple sclerosis. Ocrelizumab is a humanized monoclonal antibody that selectively depletes CD20+ B cells.METHODSIn two identical phase 3 trials, we randomly assigned 821 and 835 patients with relapsing multiple sclerosis to receive intravenous ocrelizumab at a dose of 600 mg every 24 weeks or subcutaneous interferon beta-1a at a dose of 44 mu g three times weekly for 96 weeks. The primary end point was the annualized relapse rate.RESULTSThe annualized relapse rate was lower with ocrelizumab than with interferon beta-1a in trial 1 (0.16 vs. 0.29; 46% lower rate with ocrelizumab; P