Department of Nephrology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, China.
Department of Nephrology, Jinan Shizhong People's Hospital, Jinan, China.
Front Immunol. 2023 Apr 28;14:1156470. doi: 10.3389/fimmu.2023.1156470. eCollection 2023.
Rituximab (RTX) is gaining increasing clinical acceptance in the treatment of primary membranous nephropathy (PMN), with demonstrated efficacy and safety. However, there are few clinical studies on RTX for PMN in Asian populations, especially in China.
To observe and analyse the efficacy and safety of RTX treatment, 81 patients with PMN suffering from nephrotic syndrome (NS) were enrolled and divided into an initial therapy group, a conventional immunosuppressive therapy relapse group, and a conventional immunosuppressive therapy ineffective group according to their pre-RTX treatment background. Patients in each group were followed up for 12 months. The primary outcome was clinical remission at 12 months, and the secondary outcomes were safety and the occurrence of adverse events.
At 12 months, 65 of 81 (80.2%) patients achieved complete (n=21, 25.9%) or partial (n=44, 54.3%) remission after rituximab treatment. Thirty-two of 36 (88.9%) patients in the initial therapy group, 11 of 12 (91.7%) patients in the relapse group and 22 of 33 (66.7%) patients in the ineffective group achieved clinical remission. All 59 patients with positive anti-PLA2R antibodies showed a decreasing trend in antibody levels after RTX treatment, and 55 (93.2%) of them achieved antibody clearance (<20 U/mL). Logistic regression analysis showed that a high anti-PLA2R antibody titer (OR=0.993, P=0.032) was an independent risk factor for nonremission. Adverse events occurred in 18 (22.2%) patients, of which 5 (6.2%) were serious adverse events, and none were malignant or otherwise fatal.
RTX alone can effectively induce remission PMN and maintain stable renal function. It is recommended as the first choice of treatment and is also effective in patients who relapse and have poor responses to conventional immunosuppressive therapy. Anti-PLA2R antibodies can be used as a marker for RTX treatment monitoring, and antibody clearance is necessary to achieve and improve the rates of clinical remission.
利妥昔单抗（RTX）在原发性膜性肾病（PMN）的治疗中越来越被临床接受，具有疗效和安全性。然而，亚洲人群，特别是中国人群中关于 RTX 治疗 PMN 的临床研究较少。
观察和分析 RTX 治疗的疗效和安全性，纳入 81 例肾病综合征（NS）PMN 患者，根据其 RTX 治疗前的背景分为初始治疗组、常规免疫抑制治疗复发组和常规免疫抑制治疗无效组。每组患者均随访 12 个月。主要结局为 12 个月时的临床缓解，次要结局为安全性和不良事件的发生。
81 例患者中，12 个月时，65 例（80.2%）患者接受利妥昔单抗治疗后完全缓解（n=21，25.9%）或部分缓解（n=44，54.3%）。初始治疗组 32 例（88.9%）、复发组 11 例（91.7%）和无效组 22 例（66.7%）患者达到临床缓解。所有 59 例抗 PLA2R 抗体阳性患者在 RTX 治疗后抗体水平均呈下降趋势，55 例（93.2%）患者抗体清除（<20 U/ml）。Logistic 回归分析显示，高滴度抗 PLA2R 抗体（OR=0.993，P=0.032）是未缓解的独立危险因素。18 例（22.2%）患者发生不良事件，其中 5 例（6.2%）为严重不良事件，均非恶性或其他致命事件。
RTX 单独应用可有效诱导 PMN 缓解，维持肾功能稳定。建议作为治疗的首选方案，对常规免疫抑制治疗复发和效果不佳的患者也有效。抗 PLA2R 抗体可作为 RTX 治疗监测的标志物，抗体清除是达到和提高临床缓解率的必要条件。
