Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis
Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis
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DOI：
10.1056/nejmoa2001180
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发表时间：
2020-09-17
影响因子：
158.5
通讯作者：
Roth, David A.
中科院分区：
文献类型：
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作者：
Furie, Richard;Rovin, Brad H.;Roth, David A.
背景在患有活动性狼疮肾炎的成人中，静脉注射贝利尤单抗与安慰剂相比，当添加到标准治疗（吗替麦考酚酯或环磷酰胺-硫唑嘌呤）时，其疗效和安全性尚不清楚。方法在 21 个国家的 107 个地点进行的一项 3 期、跨国、多中心、随机、双盲、安慰剂对照、为期 104 周的试验中， 除了标准治疗外，我们还以 1:1 的比例分配经活检证实的活动性狼疮肾炎成人接受静脉注射贝利尤单抗（剂量为每公斤体重 10 毫克）或匹配的安慰剂。第104周时的主要终点是主要疗效肾脏反应（尿蛋白与肌酐的比率=每分钟每1.73 m(2)体表面积60 ml，并且不使用抢救治疗），主要次要终点是完全肾脏反应（尿蛋白与肌酐的比率=
BackgroundIn adults with active lupus nephritis, the efficacy and safety of intravenous belimumab as compared with placebo, when added to standard therapy (mycophenolate mofetil or cyclophosphamide-azathioprine), are unknown.MethodsIn a phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 104-week trial conducted at 107 sites in 21 countries, we assigned adults with biopsy-proven, active lupus nephritis in a 1:1 ratio to receive intravenous belimumab (at a dose of 10 mg per kilogram of body weight) or matching placebo, in addition to standard therapy. The primary end point at week 104 was a primary efficacy renal response (a ratio of urinary protein to creatinine of = 60 ml per minute per 1.73 m(2) of body-surface area, and no use of rescue therapy), and the major secondary end point was a complete renal response (a ratio of urinary protein to creatinine of