Targeted-Release Budesonide in Chinese Patients with IgA Nephropathy: A Real-World Retrospective Cohort Study
Xinyan Yang1,2, Mengting Luo1,2, Shuman Zhao1,2
1Department of Nephrology, Hangzhou Traditional Chinese Medicine (TCM) Hospital Affiliated to Zhejiang Chinese Medical University, Hangzhou, People's Republic of China.
Background:
Although the NefIgArd trial demonstrated efficacy of targeted-release budesonide (TRF-budesonide) in IgA nephropathy (IgAN), real-world effectiveness in Chinese patients with advanced or highly active disease remains undefined, and predictors of response are underexplored. We aimed to evaluate the effectiveness of TRF-budesonide in routine Chinese practice and to identify baseline clinical and histopathologic features associated with treatment response.
Methods:
We conducted a single-center retrospective cohort study of 106 Chinese patients with biopsy-proven IgAN who received TRF-budesonide (16 mg/day) with optimized supportive care for 6 months. The primary endpoint was the percentage change in 24-hour proteinuria from baseline. Subgroup analyses were performed according to baseline clinical features, treatment regimen, and Oxford MEST-C classification.
Results:
After 6 months of treatment, median proteinuria decreased by 38.77% and urinary red blood cell (uRBC) count by 52.86% (both P < 0.001), while kidney function remained stable, with a modest median eGFR increase of 4.80%; the overall response rate (ORR) was 37.74%. Earlier treatment initiation (<4 years from biopsy) was associated with a higher ORR (53.06% vs 24.56%, P = 0.005) and deeper proteinuria reduction (P = 0.009), and the T0 subgroup showed a numerically larger reduction in proteinuria than the T1+2 subgroup. These subgroup associations were exploratory and were not confirmed after adjustment for baseline differences. Neither ORR nor proteinuria reduction differed significantly between treatment regimens. No major safety events were documented in available records.
Conclusion:
In this Chinese real-world cohort, TRF-budesonide was associated with reduced proteinuria and hematuria over 6 months, with stable to modestly improved kidney function. Exploratory signals related to treatment timing and Oxford T score require prospective validation before they can guide patient selection.