Tianjiao Cui, Huibin Wu, Wenjian Zhu, Jiawen Lin, Shuping Li, Yuan Sui, Xuelin Zeng, Zhihua Zheng, Mingcheng Huang
In routine clinical practice, Nefecon showed antiproteinuric efficacy comparable to systemic corticosteroids, with no significant difference in the primary outcome (24hUP) between groups. An exploratory short-term favorable eGFR signal was observed at 6 months, but this was not sustained at 9 months and should not be interpreted as evidence of sustained renal protection. Severe infections and steroid-related adverse events were numerically less frequent in the Nefecon group, but limited event counts warrant cautious interpretation. Longer follow-up is required to determine whether these exploratory findings are clinically meaningful.
BACKGROUND: Targeted-release budesonide (Nefecon) has demonstrated efficacy in randomized trials for IgA nephropathy (IgAN), yet direct comparative real-world evidence against systemic corticosteroids is scarce, limiting clinical decision-making.
METHODS: We conducted a longitudinal real-world study of adult patients with biopsy-proven IgAN treated with either Nefecon or systemic corticosteroids. Renal outcomes, including estimated glomerular filtration rate (eGFR), urinary albumin-to-creatinine ratio (UACR), 24-hour urinary protein excretion (24hUP), and urinary red blood cell count (URBC), were assessed at baseline and at 3, 6, and 9 months. Longitudinal associations were evaluated using linear mixed-effects models adjusted for age, sex, systolic and diastolic blood pressure, with multiple imputation for missing data.
RESULTS: A total of 82 patients were included (Nefecon, n=32; systemic corticosteroids, n=50). Both treatments were associated with significant reductions in proteinuria-related outcomes over time. Compared with systemic corticosteroids, Nefecon showed a trend toward greater early reduction in UACR at 3 months after expanded adjustment and an adjusted exploratory short-term favorable difference in eGFR at 6 months. However, this eGFR difference was not sustained at 9 months, and the primary outcome (24hUP) showed no significant between-group difference at any time point.Severe infections and steroid-related adverse events were numerically less frequent in the Nefecon group.
CONCLUSIONS: In routine clinical practice, Nefecon showed antiproteinuric efficacy comparable to systemic corticosteroids, with no significant difference in the primary outcome (24hUP) between groups. An exploratory short-term favorable eGFR signal was observed at 6 months, but this was not sustained at 9 months and should not be interpreted as evidence of sustained renal protection. Severe infections and steroid-related adverse events were numerically less frequent in the Nefecon group, but limited event counts warrant cautious interpretation. Longer follow-up is required to determine whether these exploratory findings are clinically meaningful.