Comparison of efficacy and safety of systemic glucocorticoids and Nefecon in IgA nephropathy patients: a real-world retrospective cohort study.

BACKGROUND: This study compared the effectiveness and safety profiles of systemic glucocorticoids (sGCs) and Nefecon in the treatment of patients with immunoglobulin A nephropathy (IgAN). METHODS: Patients with IgAN who had an estimated glomerular filtration rate (eGFR) ≥ 15 mL/min/1.73 m² and were treated with sGCs or Nefecon were included. The primary outcome was defined as a ≥ 30% reduction in the urine protein-to-creatinine ratio (UPCR) and a combination of partial or complete remission at 12 months. Analysis of variance (ANOVA) with a mixed-effects model and t-tests was used to compare the therapeutic effectiveness and safety profiles of sGCs and Nefecon. RESULTS: One hundred and eight patients with IgAN were included in the study, with 54 patients receiving sGCs and 54 patients receiving Nefecon. For efficacy, the mean annual change in UPCR after treatment (sGCs versus Nefecon) was -32.01% versus -50.34%, P = 0.007. The total remission rate at 12 months (sGCs versus Nefecon) was 29.63% versus 61.11%. The percentage of patients with a ≥ 30% decline in UPCR at 12 months (sGCs versus Nefecon) was 68.52% versus 90.74%. The mean 12-month change in eGFR after treatment (sGCs versus Nefecon) was 0 versus 2.28 mL/min/1.73 m², P = 0.266. The median annualized change in eGFR after treatment (sGCs versus Nefecon) was -2.31 [-7.49, 3.75] versus 1.36 [-1.23, 6.53] mL/min/1.73 m², P = 0.002. For safety, in sGCs group, there are 3 MAKEs events while no MAKEs event in Nefecon group. Eight patients experienced severe adverse events in the sGCs group, compared with only one patient in the Nefecon group. CONCLUSION: Our study demonstrated that Nefecon had greater efficacy than sGCs at 12 months and a more favorable safety profile in patients with IgAN, although confirmation in larger prospective studies with longer follow-up is warranted.