Chen Qinlan, Chen Pei, He Rong, Zan Jincan, Shen Xue, Lv Jicheng, Zhang Hong
Renal Division, Department of Medicine, Peking University First Hospital, Beijing China; Institute of Nephrology, Peking University, Beiling, China; Key Laboratory of Renal Disease, Ministry of Health of China, Beijing, China; Key Laboratory of Chronic Kidney Disease Prevention and Treatment (Peking University), Ministry of Education, Beijing 100034, China.
Department of Nephrology, Guizhou Provincial People's Hospital, National Health Commission Key Laboratory of Pulmonary Immunological Diseases, Guiyang, China.
Clin Kidney J. 2025 Jul 1;18(7):sfaf203. doi: 10.1093/ckj/sfaf203. eCollection 2025 Jul.
Targeted release formulation (TRF) budesonide (Nefecon), targeting galactose-deficient immunoglobulin A1 (Gd-IgA1) production and IgA immune complex formation, has been approved for IgA nephropathy (IgAN) treatment. In this study we explored whether early changes in these biomarkers can predict the clinical response to Nefecon therapy.
Plasma samples from 27 IgAN patients treated with Nefecon and followed at least 6 months were collected during routine visits. We measured the levels of Gd-IgA1 and poly-IgA during the treatment, analysing the association between their baseline levels or changes and proteinuria reduction.
The mean proteinuria level was 1.3 ± 0.8 g/day and the estimated glomerular filtration rate was 47.1 ± 21.7 ml/min/1.73 m at baseline. During the follow-up, proteinuria slowly decreased, with alterations of -0.12 g/day, -0.42 g/day, -0.58 g/day and -0.86 g/day at 3, 6, 9 and 12 months, respectively. The plasma levels of Gd-IgA1, poly-IgA and total IgA decreased after Nefecon treatment, with an obvious decrease at 2 months in Gd-IgA1 by -1067.3 ng/ml and poly-IgA by -1.18 mg/l. All biomarker reductions were strongly associated with a proteinuria decrease ( < .0001). Importantly, the early reduction in poly-IgA during the first 2 months was associated with a proteinuria reduction at 6 months ( = 0.47, = .01). Similar trends were observed for Gd-IgA1, though not statistically significant.
The early changes in Gd-IgA1 or poly-IgA, especially poly-IgA, were associated with future proteinuria reduction, supporting the potential of Gd-IgA1 and poly-IgA as biomarkers for predicting Nefecon response in IgAN.
靶向释放制剂（TRF）布地奈德（Nefecon）可靶向半乳糖缺陷型免疫球蛋白A1（Gd-IgA1）的产生和IgA免疫复合物的形成，已被批准用于治疗IgA肾病（IgAN）。在本研究中，我们探讨了这些生物标志物的早期变化是否可以预测对Nefecon治疗的临床反应。
收集27例接受Nefecon治疗并随访至少6个月的IgAN患者在常规就诊期间的血浆样本。我们在治疗期间测量了Gd-IgA1和多聚IgA的水平，分析了它们的基线水平或变化与蛋白尿减少之间的关联。
基线时平均蛋白尿水平为1.3±0.8g/天，估计肾小球滤过率为47.1±21.7ml/min/1.73m²。在随访期间，蛋白尿缓慢下降，在3、6、9和12个月时分别变化-0.12g/天、-0.42g/天、-0.58g/天和-0.86g/天。Nefecon治疗后，血浆Gd-IgA1、多聚IgA和总IgA水平下降，Gd-IgA1在2个月时明显下降1067.3ng/ml，多聚IgA下降1.18mg/l。所有生物标志物的降低都与蛋白尿减少密切相关（P<0.0001）。重要的是，前2个月多聚IgA的早期降低与6个月时蛋白尿减少相关（r=0.47，P=0.01）。Gd-IgA1也观察到类似趋势，尽管无统计学意义。
Gd-IgA1或多聚IgA的早期变化，尤其是多聚IgA，与未来蛋白尿减少相关，支持Gd-IgA1和多聚IgA作为预测IgAN中Nefecon反应生物标志物的潜力。
