Efficacy and Safety of Telitacicept in IgA Nephropathy: A Real-World Study

Background: IgA nephropathy (IgAN) is the most common primary glomerular disease in the world. Telitacicept is a humanized fusion protein composed of a transmembrane activator and calcium-modulating cyclophilin ligand interactor receptor and human IgG. This study was designed to evaluate the efficacy and safety of telitacicept in patients with IgAN. Methods: Biopsy-proven IgAN patients with 24-hour proteinuria greater than 0.5 g/day who received telitacicept 240 mg once a week were recruited in this study and 1:1 matched with patients received supportive treatment only or immunosuppressive treatment by propensity score matching. The primary outcome was the change from baseline in 24-hour proteinuria over the 3-month follow-up. Results: Twenty-one patients in each group were enrolled. The mean eGFR was 80.1 ml/min/1.73m2, and the median 24-hour urine protein was 1.48 g/day. At the end of the 3-month follow-up, telitacicept reduced median proteinuria by 0.72 g/d (54.6%) from baseline, compared with a reduction of 0.18 g/d (20%) in the supportive treatment group (P < 0.001), and 1.12 g/d (72.1%) in the immunosuppressive treatment group (P = 0.814). Preserved eGFR levels were observed in the telitacicept group (1.9 ml/min/1.73 m2 [4.3%]), while the eGFR level declined in the supportive treatment group (- 2.9 ml/min/1.73 m2 [- 5.8%]) and immunosuppression group (- 6.1 ml/min/1.73 m2 [- 8.4%]). No serious adverse events were observed in the telitacicept treatment group. Injection site reactions were more prevalent in the telitacicept group, meanwhile immunosuppression group had more respiratory tract infections. Conclusion: Telitacicept can reduce proteinuria in patients with IgAN and showed a favourable safety profile.Figure 1. Participant recruitment and exclusion flowchart.Figure 2. Changes in proteinuria and eGFR levels from baseline.