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Abstract: SA-PO0842

Efficacy and Safety of Nefecon in Patients with IgAN: A Real-World Study

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

  • Dong, Lingqiu, West China Hospital of Sichuan University, Chengdu, Sichuan, China
  • Tang, Yi, West China Hospital of Sichuan University, Chengdu, Sichuan, China
  • Qin, Wei, West China Hospital of Sichuan University, Chengdu, Sichuan, China
Background

IgA nephropathy (IgAN) is the most common primary glomerular disease in the world. NEFECON is an oral, targeted-release capsule formulation of budesonide.

Methods

This retrospective real-world study enrolled NEFECON-treated IgAN patients at West China Hospital, Sichuan University, China, from May 2024 to November 2024. Patients were grouped:(1) 24-hour proteinuria > 0.5 g/d: Linear mixed models analyzed absolute eGFR change and percentage 24-hour proteinuria change from baseline. (2) eGFR < 60 ml/min/1.73 m2 and 24-hour urine protein < 0.5 g/d: Absolute and percentage eGFR changes from baseline were calculated.

Results

In the 24-hour proteinuria > 0.5 g/d group (n=21), mean baseline eGFR was 57.8 ± 24.7 ml/min/1.73 m2 and proteinuria was 2.26 ± 1.74 g/d (Table 1). Proteinuria significantly decreased from baseline by 30.1% (95% CI 17.2% -41.0%, P<0.001) at month 3, 35.4% (95% CI 23.2%-45.7%, P<0.001) at month 6, and 25.3% (95% CI 5.1%- 41.3%, P=0.019) at month 9 (Figure 1a). eGFR significantly improved from baseline, with mean changes of 5.96 (95% CI 0.96-11.39, P=0.021), 8.79 (95% CI 3.51-14.53, P=0.002), and 7.34 (95% CI 0.15-15.45, P=0.046) ml/min/1.73 m2 at months 3, 6, and 9, respectively (Figure 1b). These effects were consistent across baseline proteinuria and eGFR subgroups (all interaction P > 0.10; Figures 1c-1f). We also reported on four patients with impaired renal function and proteinuria < 0.5 g/d, a subgroup not detailed in trials like NefIgArd (which required persistent proteinuria). These patients showed preserved eGFR levels during treatment (Figure 1g-1h), suggesting NEFECON may benefit in this newly reported population. In the baseline proteinuria >0.5g/d group, common adverse events included menstrual disorders (42.9%), facial edema (33.3%), acne (23.8%), and dyspepsia (23.8%). Among patients with eGFR < 60 ml/min/1.73 m2 and proteinuria < 0.5 g/d, adverse events were: peripheral edema and rashes (1 patient), weight gain and facial edema (1 patient), and facial edema only (1 patient). No severe adverse events occurred.

Conclusion

NEFECON may reduce proteinuria and preserve eGFR levels in IgAN patients, with a favourable safety profile.

Table 1 and Figure 1

Digital Object Identifier (DOI)