Liu Lijun, Liu Yimeng, Li Juan, Tang Chen, Wang Huiming, Chen Cheng, Long Haibo, Chen Xiaowen, Xing Guolan, Cheng Jingru, Liang Jianbo, Peng Xuan, Wang Liang, Shao Sijia, Lin Yongqiang, Chen Tianmu, Tang Ying, Shen Shizhong, Sun Lingyun, Wu Henglan, Yu Yuan, Du Xuanyi, Liu Hong, He Liyu, Liu Hong, Ye Meixing, Chen Wei, Wen Qiong, Zhang Hong, Cao Hongmin, Yuan Jing, Chen Hong, Wang Ming, Lv Jicheng, Zhang Hong
Renal Division, Peking University First Hospital, Peking University Institute of Nephrology, Beijing, China.
Key Laboratory of Renal Disease, Ministry of Health of China, Key Laboratory of Chronic Kidney Disease Prevention and Treatment (Peking University), Ministry of Education, Beijing, China.
Nephron. 2025;149(1):1-10. doi: 10.1159/000540326. Epub 2024 Sep 9.
The efficacy of telitacicept treatment in reducing proteinuria in patients with IgA nephropathy (IgAN) was indicated in a phase II clinical trial with small sample size. In this study, we conducted a large multicenter retrospective study to explore the efficacy and safety of telitacicept in patients with IgAN.
This study recruited patients with IgAN from 19 sites from China who were treated with telitacicept and had been followed up at least once or with side effect reported, since April 1, 2021, to April 1, 2023. The primary outcomes of the study were the changing in proteinuria and eGFR over time.
A cohort of 97 patients with IgAN who were treated with telitacicept were recruited, with a median follow-up duration of 3 months. The median baseline proteinuria was 2.3 [1.3, 3.9] g/day and eGFR was 45.0 [26.8, 73.7] mL/min/1.73 m2. There was a significant reduction of proteinuria at 2, 4, 6 months when compared with baseline (2.3 [1.5, 4.1] vs. 1.5 [0.8, 2.3] g/day; 2.3 [1.1, 3.7] vs. 1.1 [0.6, 1.9] g/day; 2.1 [1.0, 2.7] vs. 0.9 [0.5, 1.7] g/day, all p values <0.01). The level of eGFR were comparable between at the baseline and 2, 4, 6 months of follow-up time (41.5 [29.7, 72.0] vs. 42.5 [28.8, 73.3] mL/min/1.73 m2; 41.0 [26.8, 67.7] vs. 44.7 [31.0, 67.8] mL/min/1.73 m2; 33.7 [24.0, 58.5] vs. 32.6 [27.8, 57.5] mL/min/1.73 m2, all p values >0.26). Telitacicept was well tolerated in the patients.
This study indicates that telitacicept alone or on top of steroids therapy can significantly and safely reduce proteinuria in patients with IgAN. The long-term kidney protection still needs to be confirmed in large phase III trial.
在一项小样本的II期临床试验中,已表明泰它西普治疗对IgA肾病(IgAN)患者蛋白尿的减少具有疗效。在本研究中,我们开展了一项大型多中心回顾性研究,以探讨泰它西普对IgAN患者的疗效和安全性。
本研究招募了来自中国19个地点接受泰它西普治疗且自2021年4月1日至2023年4月1日至少有一次随访或报告有副作用的IgAN患者。该研究的主要结局是蛋白尿和估算肾小球滤过率(eGFR)随时间的变化。
招募了一组接受泰它西普治疗的97例IgAN患者,中位随访时间为3个月。基线蛋白尿中位数为2.3[1.3, 3.9]g/天,eGFR为45.0[26.8, 73.7]mL/min/1.73m²。与基线相比,在2、4、6个月时蛋白尿显著减少(2.3[1.5, 4.1] vs. 1.5[0.8, 2.3]g/天;2.3[1.1, 3.7] vs. 1.1[0.6, 1.9]g/天;2.1[1.0, 2.7] vs. 0.9[0.5, 1.7]g/天,所有p值<0.01)。eGFR水平在基线与随访2、4、6个月时相当(41.5[29.7, 72.0] vs. 42.5[28.8, 73.3]mL/min/1.73m²;41.0[26.8, 67.7] vs. 44.7[31.0, 67.8]mL/min/1.73m²;33.7[24.0, 58.5] vs. 32.6[27.8, 57.5]mL/min/1.73m²,所有p值>0.26)。患者对泰它西普耐受性良好。
本研究表明,单独使用泰它西普或在类固醇治疗基础上加用泰它西普可显著且安全地降低IgAN患者的蛋白尿。长期肾脏保护仍需在大型III期试验中得到证实。