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Background <p>IgA nephropathy (IgAN) is a common glomerular disease characterized by IgA glomerular, typically mensangial&#xa0;deposition, often leading to progressive kidney damage.</p> Methods <p>This meta-analysis assessed the efficacy and safety of TRF-budesonide in IgAN patients, using data from four randomized controlled trials involving 774 participants. We calculated the mean differences in estimated glomerular filtration rate (eGFR) and urine-to-protein-creatinine ratio (UPCR) compared to baseline, with 95% confidence intervals (CIs) after 9&#xa0;months of treatment and at the end of the follow-up period, while also summarizing adverse events.</p> Results <p>TRF-budesonide significantly reduced UPCR (weighted mean difference [WMD] = −&#xa0;0.39&#xa0;g/g, 95% CI −&#xa0;0.51, −&#xa0;0.26, <i>p</i> &lt; 0.00001<i>, I</i><sup>2</sup> = 0%) and slowed the decline in eGFR (WMD = 5.39&#xa0;ml/min/1.73&#xa0;m<sup>2</sup>, 95% CI 3.68, 7.10, <i>p</i> &lt; 0.00001<i>, I</i><sup>2</sup> = 0%), with these effects persisting throughout the follow-up period. However, TRF-budesonide was associated with a higher incidence of adverse events such as acne (OR = 5.04, 95% CI 2.46, 10.34, <i>p</i> &lt; 0.0001), facial edema (OR = 10.12, 95% CI 2.31, 44.22, <i>p</i> = 0.002), hypertension (OR = 4.86, 95% CI 2.40, 9.85, <i>p</i> &lt; 0.0001), and muscle spasms (OR = 3.03, 95% CI 1.64, 5.60, <i>p</i> = 0.0004). Despite these side effects, serious systemic effects were exceptional.</p> Conclusions <p>TRF-budesonide demonstrated efficacy and a tolerable safety profile in the treatment of IgAN.</p> Graphical abstract <p></p>

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Efficacy and safety of TRF-budesonide in IgA nephropathy treatment: a meta-analysis

  • 期刊论文

  • 发表日期：

    2025年7月28日

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  • Jiayi Li,
  • Hongqin Tai,
  • Bo Yang,
  • Jiayu Xu,
  • Chenchen Zhou,
  • Jing Xu,
  • Cheng Xue,
  • Zhiguo Mao

摘要

Background

IgA nephropathy (IgAN) is a common glomerular disease characterized by IgA glomerular, typically mensangial deposition, often leading to progressive kidney damage.

Methods

This meta-analysis assessed the efficacy and safety of TRF-budesonide in IgAN patients, using data from four randomized controlled trials involving 774 participants. We calculated the mean differences in estimated glomerular filtration rate (eGFR) and urine-to-protein-creatinine ratio (UPCR) compared to baseline, with 95% confidence intervals (CIs) after 9 months of treatment and at the end of the follow-up period, while also summarizing adverse events.

Results

TRF-budesonide significantly reduced UPCR (weighted mean difference [WMD] = − 0.39 g/g, 95% CI − 0.51, − 0.26, p < 0.00001, I2 = 0%) and slowed the decline in eGFR (WMD = 5.39 ml/min/1.73 m2, 95% CI 3.68, 7.10, p < 0.00001, I2 = 0%), with these effects persisting throughout the follow-up period. However, TRF-budesonide was associated with a higher incidence of adverse events such as acne (OR = 5.04, 95% CI 2.46, 10.34, p < 0.0001), facial edema (OR = 10.12, 95% CI 2.31, 44.22, p = 0.002), hypertension (OR = 4.86, 95% CI 2.40, 9.85, p < 0.0001), and muscle spasms (OR = 3.03, 95% CI 1.64, 5.60, p = 0.0004). Despite these side effects, serious systemic effects were exceptional.

Conclusions

TRF-budesonide demonstrated efficacy and a tolerable safety profile in the treatment of IgAN.

Graphical abstract