Targeted-Release Formulation of Budesonide in Real-World Follow-Up Study of Patients with IgA Nephropathy

 

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https://storage.unitedwebnetwork.com/files/1099/f07b288ef20ced6c76f8f0694019e85e.pdf
Targeted-Release Formulation of Budesonide in Real-World Follow-Up Study of Patients with IgA Nephropathy

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Yan
Ouyang
Yan Ouyang doring323@163.com Ruijin hospital Department of Nephrology Shanghai China *
Yiming Tong goodtyme@163.com Ruijin hospital Department of Nephrology Shanghai China -
Zhengying Fang fangzhengying2012@126.com Ruijin hospital Department of Nephrology Shanghai China -
Xiaolin Lin lxling.85@163.com Ruijin hospital Department of Nephrology Shanghai China -
Hongyan Xie 19111010003@fudan.edu.cn Ruijin hospital Department of Nephrology Shanghai China -
Xiaoxia Pan pxx10768@rjh.com.cn Ruijin hospital Department of Nephrology Shanghai China -
Jingyuan Xie nephroxie@163.com Ruijin hospital Department of Nephrology Shanghai China -
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IgA nephropathy (IgAN) is the most common form of primary glomerulonephritis worldwide and is especially common in East Asia. Although supportive treatments have improved, many patients still progress to end-stage renal disease. Nefecon, a targeted-release formulation of budesonide designed to act on the gut-associated lymphoid tissue (GALT), has been shown in clinical trials to reduce proteinuria and slow kidney function decline. However, real-world data on its effectiveness in Chinese patients are still limited.

This multicenter observational study enrolled Chinese adults with biopsy-confirmed IgAN, an estimated glomerular filtration rate (eGFR) of ≥30 mL/min/1.73 m², and 24-hour urinary total protein (UTP) of ≥1 g/day. All participants received oral Nefecon 16 mg once daily for 9 months. Study outcomes included changes in UTP and eGFR over a 15-month observation period. Logistic regression analysis was performed to identify factors associated with a ≥50% reduction in UTP at Month 12, including galactose-deficient IgA1 (Gd-IgA1) levels, age, baseline UTP, baseline eGFR, and the interval between renal biopsy and initiation of Nefecon. Safety events and concomitant medication use were also recorded.

Figure 1Figure 2

A total of 91 patients were enrolled (Figure 1; mean age, 38.1 ± 9.7 years; 54.9% male). The mean baseline eGFR was 64.8 ± 28.4 mL/min/1.73 m², and the median UTP was 1.60 g/day. UTP levels decreased steadily after treatment, with a 22.8% reduction at Month 9 (P < 0.01) and a peak reduction of 40.0% at Month 12 (P < 0.001; Figure 2). At Month 12, 40.7% of patients achieved a ≥50% decrease in UTP, and 20.9% reached UTP < 0.5 g/day. Each additional month of Nefecon therapy increased the likelihood of achieving a ≥50% UTP reduction at Month 12 by 15% (OR = 1.15, 95% CI 1.09–1.22, P < 0.001; Figure 3). A reduction of ≥10% in serum Gd-IgA1 at Month 6 was independently associated with a ≥50% reduction in UTP at Month 12 (OR = 3.14, 95% CI 1.11–9.66, P = 0.036). eGFR showed a biphasic trend, with a transient increase at Month 3, a decline at Month 12, and partial recovery by Month 15.

In this real-world Chinese cohort, Nefecon treatment was associated with a gradual but sustained reduction in proteinuria and relatively stable renal function. An early decrease in serum Gd-IgA1 correlated with subsequent proteinuria response, suggesting its potential role as a pharmacodynamic biomarker. These findings provide real-world evidence supporting the effectiveness of Nefecon in Chinese patients with IgAN and may help guide its use in broader Asian populations.

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