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Kidney Week

Abstract: SA-PO0628

Targeted-Release Budesonide Combined with Telitacicept in IgAN: A Preliminary Real-World Study

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

  • Pei, Juan, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China
  • Shao, Leping, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China
  • Li, Yinan, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China
Background

IgA nephropathy, an autoimmune-related kidney disease, is a leading cause of kidney failure worldwide. Targeted-release budesonide is a therapeutic modality that aims to inhibit galactose-deficient IgA1 (Gd-IgA1) formation underlying IgAN pathophysiology at early stages; Telitacicept is a dual-targets B-lymphocyte stimulator (BLyS) and a Proliferation-Inducing Ligand (APRIL), thereby reducing the pathogenic Gd-IgA1 production by targeting downstream B-cells. The combination of budesonide with telitacicept as a dual therapy could be an innovative approach. The purpose of this study was to evaluate the efficacy and safety of budesonide combined with telitacicept in adults with IgA nephropathy.

Methods

This was a single-center retrospective self-controlled study. Eight patients with biopsy-confirmed IgAN who were treated with budesonide and telitacicept for at least 6 months between January and December 2025. The primary efficacy endpoint was 24-hour urinary protein excretion (24hUP), Secondary endpoints included estimated glomerular filtration rate (eGFR) and urinary red blood cell count. Safety evaluations covered all adverse events recorded during treatment. Statistical analysis was conducted by the Wilcoxon signed-rank test.

Results

After 6 months of therapy, a significant reduction in proteinuria was observed. The median 24hUP decreased from 2.51 g/day (IQR, 0.61-6.32) at baseline to 0.95 g/day (IQR, 0.13-2.98) at month 3 (P=0.028), and to 0.91 g/day (IQR, 0.13-2.11) at month 6 (P=0.028). The clinical remission rate (24hUP <0.5 g/day or ≥50% reduction) reached 75.0%. Renal function remained stable, with median eGFR of 63.40 (IQR, 50.25-94.78), 77.40 (IQR, 55.45-90.08), and 80.56 (IQR, 57.58-103.80) mL/min/1.73m2 at baseline, month 3, and month 6, respectively. Hematuria also improved significantly, with the median urinary RBC count declining from 131.85/μL (IQR, 42.52-393.98) to 18.15/μL (IQR, 11.88-35.05) at month 6 (P=0.028). The therapy demonstrated a favorable safety profile; no serious adverse events were reported.

Conclusion

This preliminary study suggests that the combination of budesonide and telitacicept may effectively reduce proteinuria and hematuria while stabilizing renal function in patients with IgAN over a 6-month period, with good tolerability. These findings provide valuable early real-world evidence to support the efficacy of this dual-target strategy.

Acknowledgment

We are grateful to all participants, the doctors, and nurses of the Nephrology department for their efforts and contributions to this research.