Department of Nephrology, The Second Affiliated Hospital of Nanchang University, No. 1, Minde Road, Donghu District, Nanchang, 330006, Jiangxi, People's Republic of China.
Clin Exp Med. 2023 Dec;23(8):5337-5343. doi: 10.1007/s10238-023-01183-1. Epub 2023 Sep 9.
Rituximab (RTX) has been the first option in idiopathic membranous nephropathy (IMN). However, the clinical effect was not very satisfactory. This study aimed to explore the clinical efficacy and safety of the combination of RTX and glucocorticoids (GC) in anti-phospholipase A receptor (anti-PLAR) antibody positive IMN. Sixty-six patients were randomly divided into RTX/GC group (RTX infusion plus short-term oral GC) and RTX group (RTX infusion alone) in this prospective cohort study. Complete remission (CR) and partial remission (PR) were the primary outcomes. Adverse events were the secondary outcomes. The laboratory index including serum albumin, 24 h urinary protein, serum creatinine, estimated glomerular filtration rate, and anti-PLAR antibody titer were also monitored. All patients were followed for at least 12 months. During the 12-month follow-up, the composite remission rates in RTX/GC and RTX groups were 74.3% and 67.7%, and the CR rates were 34.3% and 19.4%, respectively. The median time of remission in RTX/GC group was shorter than the RTX group (P < 0.001). Compared with RTX monotherapy, the combination of RTX and GC significantly decreased the anti-PLAR antibody titer (P = 0.028). No significant difference was observed in the incidence of adverse events. The results of the Kaplan-Meier survival analysis indicated that the cumulative CR rate and cumulative composite remission rate in RTX/GC group were all better than the RTX group (P = 0.043, P = 0.040, respectively). The combination of RTX and GC was better than RTX monotherapy without increasing the adverse events in the treatment of IMN.
利妥昔单抗(RTX)一直是特发性膜性肾病(IMN)的首选治疗方法。然而,其临床效果并不十分令人满意。本研究旨在探讨 RTX 联合糖皮质激素(GC)治疗抗磷脂酶 A2 受体(抗-PLAR)抗体阳性 IMN 的临床疗效和安全性。
在这项前瞻性队列研究中,66 名患者被随机分为 RTX/GC 组(RTX 输注加短期口服 GC)和 RTX 组(RTX 单独输注)。完全缓解(CR)和部分缓解(PR)为主要结局,不良事件为次要结局。还监测了包括血清白蛋白、24 小时尿蛋白、血清肌酐、估计肾小球滤过率和抗-PLAR 抗体滴度在内的实验室指标。所有患者均至少随访 12 个月。
在 12 个月的随访期间,RTX/GC 组和 RTX 组的复合缓解率分别为 74.3%和 67.7%,CR 率分别为 34.3%和 19.4%。RTX/GC 组的缓解时间中位数短于 RTX 组(P<0.001)。与 RTX 单药治疗相比,RTX 联合 GC 治疗可显著降低抗-PLAR 抗体滴度(P=0.028)。两组不良反应发生率无显著差异。Kaplan-Meier 生存分析结果表明,RTX/GC 组的累积 CR 率和累积复合缓解率均优于 RTX 组(P=0.043,P=0.040)。
RTX 联合 GC 治疗特发性膜性肾病的疗效优于 RTX 单药治疗,且不增加不良反应。