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Background <p>Targeted-release budesonide (TRF-budesonide) is a therapy developed to deliver corticosteroid to ileal Peyer’s patches and has demonstrated efficacy in randomized trials (NEFIGAN, NefIgArd) for patients with immunoglobulin A nephropathy (IgAN). We performed a systematic review and meta-analysis to evaluate the efficacy and safety of budesonide formulations in IgAN.</p> Methods <p>We searched PubMed, Embase, and Cochrane through September 10, 2025. Eligible studies assessed budesonide in biopsy-proven IgAN. Outcomes included change in eGFR, percentage and absolute change in urine protein-to-creatinine ratio (UPCR), and adverse events. Random-effects meta-analyses were performed.</p> Results <p>Nine studies (total N = 465; two RCTs) were included. In the comparative analysis of placebo-controlled trials, TRF-budesonide significantly attenuated eGFR decline compared to placebo (weighted mean difference [WMD] 4.53&#xa0;mL/min/1.73 m<sup>2</sup>; 95% CI 3.08–5.99). In the single-arm analysis assessing absolute change from baseline, the pooled mean eGFR increase was 3.07&#xa0;mL/min/1.73m<sup>2</sup> (95% CI 0.12–6.03). Regarding proteinuria, TRF-budesonide significantly reduced UPCR compared to placebo (percentage change MD − 28.96%; 95% CI − 45.94 to − 11.99). Safety analysis showed budesonide was associated with a higher risk of adverse events versus placebo (RR 1.18; 95% CI 1.01–1.38). In uncontrolled cohorts, pooled adverse event rates were 40% for TRF-budesonide and 44% for enteric-coated formulations.</p> Conclusions <p>Current evidence indicates that TRF-budesonide improves kidney function and reduces proteinuria in adults with IgAN, but conclusions are tempered by limited RCT data, heterogeneity, short follow-up, and sparse histologic end points. Larger, longer randomized trials with standardized outcomes are needed to confirm long-term benefit and safety.</p>

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Efficacy and safety of budesonide for the treatment of IgA nephropathy: a systematic review and meta-analysis

  • 期刊论文

  • 发表日期：

    2026年2月6日

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  • Rayyan Nabi,
  • Muhammad Ansab,
  • Amna Hussain,
  • Hamza Bin Ahmed,
  • Najaf Ahmed Rajpar,
  • Sabahat Ul Ain Munir Abbasi,
  • Priyanka Keshav Lal,
  • Owais Ahmad,
  • Hanzala Ahmed Farooqi,
  • Tabeer Zahid,
  • Muhammad Ahmed,
  • Zahid Nabi

摘要

Background

Targeted-release budesonide (TRF-budesonide) is a therapy developed to deliver corticosteroid to ileal Peyer’s patches and has demonstrated efficacy in randomized trials (NEFIGAN, NefIgArd) for patients with immunoglobulin A nephropathy (IgAN). We performed a systematic review and meta-analysis to evaluate the efficacy and safety of budesonide formulations in IgAN.

Methods

We searched PubMed, Embase, and Cochrane through September 10, 2025. Eligible studies assessed budesonide in biopsy-proven IgAN. Outcomes included change in eGFR, percentage and absolute change in urine protein-to-creatinine ratio (UPCR), and adverse events. Random-effects meta-analyses were performed.

Results

Nine studies (total N = 465; two RCTs) were included. In the comparative analysis of placebo-controlled trials, TRF-budesonide significantly attenuated eGFR decline compared to placebo (weighted mean difference [WMD] 4.53 mL/min/1.73 m2; 95% CI 3.08–5.99). In the single-arm analysis assessing absolute change from baseline, the pooled mean eGFR increase was 3.07 mL/min/1.73m2 (95% CI 0.12–6.03). Regarding proteinuria, TRF-budesonide significantly reduced UPCR compared to placebo (percentage change MD − 28.96%; 95% CI − 45.94 to − 11.99). Safety analysis showed budesonide was associated with a higher risk of adverse events versus placebo (RR 1.18; 95% CI 1.01–1.38). In uncontrolled cohorts, pooled adverse event rates were 40% for TRF-budesonide and 44% for enteric-coated formulations.

Conclusions

Current evidence indicates that TRF-budesonide improves kidney function and reduces proteinuria in adults with IgAN, but conclusions are tempered by limited RCT data, heterogeneity, short follow-up, and sparse histologic end points. Larger, longer randomized trials with standardized outcomes are needed to confirm long-term benefit and safety.