B-cell depletion with rituximab in relapsing-remitting multiple sclerosis.
B-cell depletion with rituximab in relapsing-remitting multiple sclerosis.
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DOI：
10.1056/nejmoa0706383
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发表时间：
2008-02-14
期刊：
影响因子：
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通讯作者：
Smith, Craig H
中科院分区：
文献类型：
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作者：
Hauser, Stephen L;Waubant, Emmanuelle;Smith, Craig H
背景技术背景：越来越多的证据表明，B淋巴细胞参与多发性硬化的发病机制，并可能成为治疗的靶点。利妥昔单抗，一种单克隆抗体，选择性的目标和耗尽CD 20 + B lymphocyte.METHODS：在第2阶段，双盲，48周的试验涉及104例复发缓解型多发性硬化症，我们分配69例患者接受1000毫克的静脉注射利妥昔单抗和35例患者接受安慰剂的第1和15天。主要终点是在第12、16、20和24周时通过磁共振成像扫描检测到的钆增强病变的总计数。临床结果包括安全性、复发患者比例和年复发率。结果：与接受安慰剂治疗的患者相比，接受利妥昔单抗治疗的患者在第12、16、20和24周的总钆增强病变计数减少（P
BACKGROUND: There is increasing evidence that B lymphocytes are involved in the pathogenesis of multiple sclerosis, and they may be a therapeutic target. Rituximab, a monoclonal antibody, selectively targets and depletes CD20+ B lymphocytes.METHODS: In a phase 2, double-blind, 48-week trial involving 104 patients with relapsing-remitting multiple sclerosis, we assigned 69 patients to receive 1000 mg of intravenous rituximab and 35 patients to receive placebo on days 1 and 15. The primary end point was the total count of gadolinium-enhancing lesions detected on magnetic resonance imaging scans of the brain at weeks 12, 16, 20, and 24. Clinical outcomes included safety, the proportion of patients who had relapses, and the annualized rate of relapse.RESULTS: As compared with patients who received placebo, patients who received rituximab had reduced counts of total gadolinium-enhancing lesions at weeks 12, 16, 20, and 24 (P