Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.
Institute of Nephrology, Zhejiang University, Hangzhou, China.
Am J Nephrol. 2024;55(1):25-36. doi: 10.1159/000535010. Epub 2023 Nov 14.
Rituximab has been proven effective and safe in pediatric patients with frequently relapsing or steroid-dependent nephrotic syndrome (FR/SDNS). We aimed to analyze the efficacy and safety of rituximab in adult FR/SDNS patients with minimal change disease (MCD) and focal segmental glomerulosclerosis (FSGS).
A retrospective cohort study at three nephrology centers in China included adult FR/SDNS patients with biopsy-proven MCD or FSGS. Primary outcomes were relapse frequency and first relapse-free survival time. Adverse events were well recorded, and logistic regression analyses were used to investigate the risk factors of relapse.
Eighty-one patients (age, 25.0 years; interquartile range, 20.0-40.5; 67% males; 82.7% MCD) received an average rituximab dose of 1,393.8 ± 618.7 mg/2 years during the 2-year follow-up period. The relapse frequency, calculated as the ratio of relapse times to follow-up years, significantly decreased after rituximab treatment (0.04 [0.00, 0.08] vs. 1.71 [1.00, 2.45], p < 0.001). The first relapse-free survival time was 16.7 ± 8.0 months. Fifty-seven patients (70.4%) achieved cessation of corticosteroids and immunosuppressants within 3 months after the first rituximab infusion. Adverse events were mostly mild, and no severe treatment-related adverse events were observed. Low serum albumin level before rituximab and high CD56+CD16+ natural killer cell count after rituximab were independent risk factors of relapse within 2 years after rituximab treatment.
Rituximab was proven an effective and safe treatment option for adult FR/SDNS patients with MCD or FSGS in maintaining disease remission and minimizing corticosteroid exposure.
利妥昔单抗已被证明在频繁复发或依赖激素的肾病综合征(FR/SDNS)的儿科患者中安全有效。我们旨在分析利妥昔单抗治疗微小病变肾病(MCD)和局灶节段性肾小球硬化(FSGS)的成人 FR/SDNS 患者的疗效和安全性。
在中国的三个肾脏病中心进行了一项回顾性队列研究,纳入了经活检证实为 MCD 或 FSGS 的成人 FR/SDNS 患者。主要结局是复发频率和首次无复发生存时间。记录了不良事件,并使用逻辑回归分析来探讨复发的危险因素。
81 例患者(年龄 25.0 岁;四分位距 20.0-40.5;67%为男性;82.7%为 MCD)在 2 年的随访期间平均接受利妥昔单抗剂量为 1393.8±618.7mg/2 年。利妥昔单抗治疗后复发频率(复发次数与随访年数之比)显著降低(0.04[0.00,0.08]比 1.71[1.00,2.45],p<0.001)。首次无复发生存时间为 16.7±8.0 个月。57 例(70.4%)患者在首次利妥昔单抗输注后 3 个月内停止使用皮质激素和免疫抑制剂。不良事件大多为轻度,未观察到严重的治疗相关不良事件。利妥昔单抗治疗前血清白蛋白水平低和利妥昔单抗治疗后 CD56+CD16+自然杀伤细胞计数高是利妥昔单抗治疗后 2 年内复发的独立危险因素。
利妥昔单抗是治疗 MCD 或 FSGS 的成人 FR/SDNS 患者的有效且安全的选择,可维持疾病缓解并最大限度减少皮质激素暴露。