#3345 Nefecon provides kidney benefit irrespective of baseline eGFR in patients with IgAN: a subanalysis of the NefIgArd study

Abstract Background and Aims Immunoglobulin A nephropathy (IgAN) is a chronic immune complex-mediated kidney disease characterized by galactose-deficient immunoglobulin A1 (Gd-IgA1) deposition in the glomeruli. The Peyer's patches of the gut-associated lymphoid tissue are a major site of Gd-IgA1-producing B cells. Nefecon is an oral targeted-release formulation of budesonide that targets drug release into the distal ileum. Nefecon has been shown to reduce the loss of kidney function in adults with primary IgAN who are at risk of disease progression. Results from the Phase 3 NefIgArd study demonstrated that nefecon 16 mg/day reduced proteinuria and preserved estimated glomerular filtration rate (eGFR) over 9 months of treatment. Proteinuria and eGFR benefit were sustained for up to 15 months of observational follow-up in patients with primary IgAN. Results showed similar treatment effect in those with baseline eGFR <60 or ≥60 mL/min/1.73 m2. Here, we present results from a subanalysis of the NefIgArd study evaluating the efficacy of nefecon 16 mg/day by baseline eGFR deciles, with a focus on the upper and lower eGFR ranges. Method NefIgArd study design and endpoints have been previously described. Briefly, eligible patients were aged ≥18 years with biopsy-confirmed primary IgAN, eGFR 35–90 mL/min/1.73 m2 (calculated using the Chronic Kidney Disease Epidemiology Collaboration formula), proteinuria ≥1 g/24 hours despite optimized renin–angiotensin system (RAS) inhibition, and well-controlled blood pressure. Patients received nefecon 16 mg or placebo daily for 9 months (n = 182 per treatment group) in addition to supportive care (RAS inhibition), followed by a 15-month off-drug observational period on supportive care only. For this subanalysis, patients were divided into eGFR deciles based on the overall population at baseline (defined as the geometric mean of the two most recent measurements before randomization). This subanalysis reports urine protein–creatinine ratio (UPCR) and eGFR results across the subgroups of patients in the upper and lower deciles of kidney function at baseline in the NefIgArd study. Results Median eGFR was 55.49 mL/min/1.73 m2 (IQR: 45.93–69.84 mL/min/1.73 m2) in the overall population and was balanced across nefecon and placebo groups. Patients from the full analysis population were divided into groups based on the decile boundaries of baseline eGFR: above and below 38, 43, 47, 51, 55, 60, 66, 72, and 82 mL/min/1.73 m2. In general, UPCR reduction at 9 and 12 months and eGFR benefit at all time points was observed with nefecon relative to placebo (Table 1). UPCR and eGFR benefit with nefecon relative to placebo was also observed in patients within the lower and higher baseline eGFR decile boundaries, specifically at 9, 12, and 24 months (Fig. 1). Conclusion This NefIgArd subanalysis demonstrated that the efficacy of a 9-month nefecon treatment course in reduction of proteinuria and preservation of kidney function was independent of baseline eGFR, both at the end of 9 months of treatment and throughout the remaining 15 month off-drug observation period.

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