#3222 Efficacy evaluation of Telitacicept in IgA nephropathy: a real-world study

Abstract Background and Aims IgA nephropathy (IgAN), the most common primary glomerular disease worldwide, progresses to end-stage renal disease (ESRD) in 30%–40% of patients. Despite its significant clinical burden, treatment options for IgAN remain limited. Recent advances in understanding disease mechanisms have led to the development of novel biologic agents, including Telitacicept, a recombinant fusion protein that targets the dysregulated B cell/plasma cell pathway by neutralizing B lymphocyte stimulator (BLyS) and A proliferation-inducing ligand (APRIL). This dual inhibition suppresses B cell-mediated autoimmune responses, offering a promising therapeutic approach. A phase II clinical trial has demonstrated Telitacicept's efficacy and safety in IgAN; however, real-world data are lacking. This study was designed to evaluate the real-world efficacy and safety of Telitacicept in Patients with IgAN. Method This study included 20 patients with biopsy-confirmed primary IgAN treated at Shanghai Sixth People's Hospital between 2023 and 2024. The average follow-up duration was 208.85 ± 96.82 days. Inclusion criteria included 24-hour urine protein levels >0.65 g and an estimated glomerular filtration rate (eGFR) >30 mL/min/1.73 m². All patients received subcutaneous Telitacicept at a dose of 160 mg per week for at least three months. Changes in clinical parameters, including 24-hour urine protein and eGFR, were assessed at 3 months and at the end of the study compared to baseline. Telitacicept-related adverse events were systematically recorded during the treatment period. Results After 3 months of Telitacicept treatment, the median 24-hour urine protein significantly decreased from 1.025 g/24 h at baseline to 0.59 g/24 h (z = −1.979, p < 0.05), while the median eGFR showed no significant change (69.78 mL/min/1.73 m² vs. 62.17 mL/min/1.73 m², p = 0.135). At the study endpoint, the median 24-hour urine protein further declined to 0.585 g/24 h (z = −1.96, p < 0.05), and the median eGFR remained stable (69.78 mL/min/1.73 m² to 58.03 mL/min/1.73 m², p = 0.904). The treatment was well-tolerated, with no reported adverse events such as respiratory infections, urinary tract infections, or injection site reactions. Conclusion In this analysis of a small single-center cohort, Telitacicept demonstrated significant efficacy in reducing proteinuria and preserve renal function in patients with IgAN over both short-term (3-month) and long-term (≥6-month) treatment periods. Additionally, it exhibited an excellent safety profile, with no treatment-related adverse events observed. These findings support the further investigation and clinical application of Telitacicept in the management of IgAN.