Rituximab for Severe Membranous Nephropathy: A 6-Month Trial with Extended Follow-Up
Rituximab for Severe Membranous Nephropathy: A 6-Month Trial with Extended Follow-Up
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DOI：
10.1681/asn.2016040449
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发表时间：
2017-01-01
影响因子：
13.6
通讯作者：
Ronco, Pierre
中科院分区：
文献类型：
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作者：
Dahan, Karine;Debiec, Hanna;Ronco, Pierre
利妥昔单抗治疗原发性膜性肾病(PMN)的随机试验尚未进行。我们在31家法国医院进行了一项多中心、随机、对照试验(NCT01508468)。在非免疫抑制抗蛋白尿治疗(NIAT)6个月后，经活检证实的PMN和肾病综合征患者被随机分成两组，分别在第1天和第8天接受NIAT和375 mg/m(2)静脉注射利妥昔单抗治疗6个月(n=37)或单独使用NIAT(n=38)。两组的中位随访时间分别为17.0(四分位数范围12.5-24.0)个月和17.0(四分位数范围13.0-23.0)个月。主要结果是6个月时蛋白尿完全或部分缓解的联合终点。在6个月时，NIAT组有13例患者(35.1%；95%可信区间[95%CI]，19.7~50.5)和8例患者(21.1%；95%CI，8.1~34.0)获得缓解(P=0.21)。3个月时抗磷脂酶A2受体抗体(抗PLA2R-Ab)消失率，硝普利昔单抗组为14/25(56%)，NIAT组为1/23(4.3%)(P
Randomized trials of rituximab in primary membranous nephropathy (PMN) have not been conducted. We undertook a multicenter, randomized, controlled trial at 31 French hospitals (NCT01508468). Patients with biopsy-proven PMN and nephrotic syndrome after 6 months of nonimmunosuppressive antiproteinuric treatment (NIAT) were randomly assigned to 6-month therapy with NIAT and 375 mg/m(2) intravenous rituximab on days 1 and 8 (n=37) or NIAT alone (n=38). Median times to last follow-up were 17.0 (interquartile range, 12.5-24.0) months and 17.0 (interquartile range, 13.0-23.0) months in NIAT-rituximab and NIAT groups, respectively. Primary outcome was a combined end point of complete or partial remission of proteinuria at 6 months. At month 6, 13 (35.1%; 95% confidence interval [95% CI], 19.7 to 50.5) patients in the NIAT-rituximab group and eight (21.1%; 95% CI, 8.1 to 34.0) patients in the NIAT group achieved remission (P=0.21). Rates of antiphospholipase A2 receptor antibody (anti-PLA2R-Ab) depletion in NIAT-rituximab and NIAT groups were 14 of 25 (56%) and one of 23 (4.3%) patients at month 3 (P