Shu Huapan, Wang Yujuan, Li Xiaoqing, Zhang Lu, Wei Zhongping, Song Yuan, Chen Ju, Cheng Hui, Chen Cheng, Liang Wei, Wang Huiming, Chen Xinghua
Department of Nephrology, Renmin Hospital of Wuhan University, 238 Jiefang Road, Wuhan, 430060, Hubei, China.
Department of Nephrology, Hubei Provincial Hospital of Traditional Chinese Medicine of Hubei University of Chinese Medicine, Wuhan, China.
Clin Exp Med. 2025 Aug 11;25(1):287. doi: 10.1007/s10238-025-01829-2.
Presently, no specific therapies have been recognized for immunoglobulin A nephropathy (IgAN). Mycophenolate mofetil (MMF) has been verified effective for Chinese patients with IgAN. Telitacicept is a full-human TACI-FC fusion preventing B cells maturation and activation, and it has been proven to be beneficial for IgAN in a phase II clinical trial. This study was designed to observe the efficacy and safety of telitacicept plus low-dose MMF for IgAN treatment. This retrospective cohort study included 24 patients with IgAN, and patients were treated with telitacicept plus MMF. The primary outcome was settled as the changing in proteinuria and estimated glomerular filtration rate (eGFR). The subordinate outcome was set as the changing in hematuria. The mean follow-up time was 23 months. The median baseline proteinuria was 2.5 (1.74, 6.58) g/d, and eGFR was 94.97 (56.8, 120.67) mL/min/1.73 m. There were noteworthy reductions in proteinuria at 3, 6, 9, 12, 15, 18, 21 and 24 months when compared to the baseline levels [1.45 (0.78, 1.8) g/d [p = 0.0122], 0.505 (0.26, 0.99) g/d [p < 0.0001], 0.48 (0.28, 0.76) g/d [p < 0.0001], 0.3 (0.17, 0.85) g/d [p < 0.0001], 0.23 (0.18, 0.575) g/d [p < 0.0001], 0.18 (0.12, 0.325) g/d [p < 0.0001], 0.14 (0.105, 0.22) g/d [p < 0.0001] and 0.14 (0.103, 0.278) g/d [p < 0.0001]]. All patients maintained stable eGFR during follow-up times. Besides, telitacicept plus MMF remarkably alleviated the hematuria. Telitacicept plus MMF treatment led to not only remarkable clinically significant reduction in proteinuria and hematuria, but also stable serum creatinine value of patients with IgAN without adverse side effects.
目前，尚未发现针对免疫球蛋白A肾病（IgAN）的特异性疗法。霉酚酸酯（MMF）已被证实对中国IgAN患者有效。泰吉华（telitacicept）是一种全人源TACI-FC融合蛋白，可阻止B细胞成熟和激活，并且在一项II期临床试验中已被证明对IgAN有益。本研究旨在观察泰吉华联合低剂量MMF治疗IgAN的疗效和安全性。这项回顾性队列研究纳入了24例IgAN患者，患者接受泰吉华联合MMF治疗。主要结局设定为蛋白尿和估计肾小球滤过率（eGFR）的变化。次要结局设定为血尿的变化。平均随访时间为23个月。基线蛋白尿中位数为2.5（1.74，6.58）g/d，eGFR为94.97（56.8，120.67）mL/min/1.73m²。与基线水平相比，在3、6、9、12、15、18、21和24个月时蛋白尿有显著降低[1.45（0.78，1.8）g/d [p = 0.0122]，0.505（0.26，0.99）g/d [p < 0.0001]，0.48（0.28，0.76）g/d [p < 0.0001]，0.3（0.17，0.85）g/d [p < 0.0001]，0.23（0.18，0.575）g/d [p < 0.0001]，0.18（0.12，0.325）g/d [p < 0.0001]，0.14（0.105，0.22）g/d [p < 0.0001]和0.14（0.103，0.278）g/d [p < 0.0001]]。所有患者在随访期间eGFR保持稳定。此外，泰吉华联合MMF显著减轻了血尿。泰吉华联合MMF治疗不仅使IgAN患者的蛋白尿和血尿在临床上有显著的明显降低，而且患者的血清肌酐值稳定，无不良副作用。
