Real-world study on efficacy and safety of Nefecon in IgA nephropathy

Targeted-release budesonide (Nefecon) has demonstrated efficacy in randomized clinical trials of IgA nephropathy (IgAN). However, evidence regarding its effectiveness and safety in routine clinical practice remains limited. This study aimed to evaluate the real-world effectiveness and safety of Nefecon in IgAN. We conducted a retrospective cohort study of patients with IgAN treated with full-dose Nefecon (16 mg once daily) for more than 3 months. Clinical outcomes included changes in urinary protein-to-creatinine ratio (UPCR), urinary red blood cells (URBC), and estimated glomerular filtration rate (eGFR). Adverse events (AEs) were evaluated and graded according to the Common Terminology Criteria for AEs. A total of 308 patients were included, with a median follow-up of 185.5 days. In the subset of patients with available 9‑month follow‑up data ( n = 106), UPCR decreased by 43.6% from baseline and URBC by 69.7%, whereas kidney function remained stable over the entire follow-up period. Subgroup analyses showed greater reductions in proteinuria in patients with disease duration ≤ 1 year and baseline UPCR > 2 g/g. Exploratory analyses suggested that higher baseline IL-17F levels were associated with greater reductions in proteinuria. Most AE were mild (grade 1) and severe infections were uncommon. Menstrual irregularities or abnormal vaginal bleeding occurred in 39.8% of female patients. In this real-world cohort of IgAN patients, Nefecon was associated with significant reductions in proteinuria and hematuria, with stable kidney function. AEs were frequent in real-world practice, though most were mild and manageable.