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Abstract: TH-PO0472

Longitudinal Proteinuria Change and eGFR Trajectory During Nefecon Therapy in Chinese Patients with IgAN: A Nine-Month Real-World Study

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

  • Zhou, Zhenpeng, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
  • Lu, Wanhong, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
Background

Targeted-release formulation of budesonide (Nefecon) is designed to reduce proteinuria and preserve renal function in IgA nephropathy (IgAN) potentially by inhibiting Gd-IgA1 production. The phase 3 NefIgArd trial demonstrated significant benefits in proteinuria reduction and eGFR preservation. However, real-world longitudinal evidence on proteinuria changes, eGFR trajectory during Nefecon therapy in Chinese patients with IgAN remains limited. Moreover, differences in proteinuria changes across patient characteristics, especially pathological features, have not been fully explored.

Methods

This longitudinal real-world study involved 123 IgAN patients treated with Nefecon. The primary outcomes were the least-squares geometric mean percentage change in proteinuria at month 9 and eGFR slope during therapy, estimated by linear mixed-effects models (LMMs). Exploratory proteinuria subgroup analyses were performed across glomerulosclerosis, eGFR, Oxford Classification, supportive therapy intensity, time from disease onset to Nefecon initiation and time from kidney biopsy to Nefecon initiation, using LMMs with time-by-subgroup interactions. Safety analysis focused on the occurrence of adverse reactions.

Results

Median baseline proteinuria was 1.53 g/day (IQR, 1.03-2.49). The least-squares geometric mean percentage change in proteinuria at month 9 was -58.89% (95% CI: -64.79% to -52.01%, P< 0.001). Median baseline eGFR was 77.79 mL/min/1.73 m2 (IQR, 44.43-102.31). The estimated eGFR slope during therapy was 0.43 mL/min/1.73 m2 per month (95% CI, 0.18 to 0.67, P < 0.001). Greater proteinuria reductions were observed in patients with glomerulosclerosis ≤25% than in those with glomerulosclerosis >25% (-67.52% vs -53.88%, P=0.038), patients with M0 than those with M1 lesions (-71.50% vs -43.15%, P< 0.001). 47 adverse reaction events were observed in 28 patients (22.8%) during follow-up but no severe adverse reactions occurred.

Conclusion

In this longitudinal real-world study of Nefecon therapy in Chinese patients with IgAN, proteinuria showed a sustained reduction through month 9, while eGFR remained stable with a modest increase during treatment. Exploratory analyses suggested differences in proteinuria changes across selected pathological features. Larger prospective studies with longer follow-up are warranted to validate these findings.