Real-World Assessment of Nefecon as First-Line Therapy in IgA Nephropathy: Efficacy and Safety Outcomes

 

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Real-World Assessment of Nefecon as First-Line Therapy in IgA Nephropathy: Efficacy and Safety Outcomes

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Min
Han
Yixuan Zhao zyx0940@163.com Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Nephrology Department Wuhan China -
Min Han minhan@tjh.tjmu.edu.cn Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Nephrology Department Wuhan China *
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Nefecon, the gut-targeted formulation of budesonide, designed to modulate gut-associated lymphoid tissue and suppress the synthesis of galactose-deficient IgA1, has shown significant efficacy in reducing proteinuria and preserving renal function in patients with IgA nephropathy (IgAN). However, real-world evidence regarding its efficacy and safety as an initial therapeutic option in the broader IgAN population remains limited.

This single-center retrospective study enrolled patients who were newly diagnosed with primary IgAN. All patients presented with persistent proteinuria (UPCR ≥ 0.5 mg/mg or 24-hour urinary protein [24h UP] ≥ 0.5 g/day) despite optimized supportive therapy and had an eGFR ≥ 10 mL/min/1.73 m². The primary endpoints were changes in 24h UP, UPCR, and urinary RBC count. Secondary outcomes included changes in eGFR and the assessment of adverse events.

  

A Total of 21 eligible patients with IgAN received Nefecon treatment. After 12 weeks of therapy, significant improvements were observed across multiple clinical parameters: The 24h UP decreased from 1.41 mg/mg (IQR 0.772.26) to 0.62 mg/mg (IQR 0.43–1.05) (P < 0.01), with a median reduction of –50.40% (IQR –77.84 to –16.90). The UPCR declined from 1.32mg/mg (IQR 0.691.99) to 0.35 mg/mg (IQR 0.170.74) (P < 0.01), corresponding to a median reduction of –73.26% (IQR –87.98 to –54.00). The urinary RBC count dropped from 90.80 cells/μL (IQR 42.70195.50) to 36.60 cells/μL (IQR 15.33108.80) (P < 0.01), reflecting a median reduction of –53.78% (IQR –81.45 to –6.95). In addition, eGFR increased from 55.27 ± 31.73 mL/min/1.73 m² to 61.50 ± 34.38 mL/min/1.73 m² (P < 0.01), with a median increase of 13.38% (IQR –3.02 to 31.17). No serious adverse events were reported during the treatment period.

Nefecon, as an initial therapeutic option for patients newly diagnosed with primary IgAN, was well tolerated and demonstrated a favorable efficacy profile, significantly reducing proteinuria and hematuria while improving renal function as reflected by eGFR.

Kewords