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

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