Single-Arm, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy of Low-Dosage Administration of Telitacicept in IgAN

Background: Telitacicept is a fusion protein that neutralizes IgAN validated targets: BAFF and APRIL .This study is aim to evaluate the efficacy of Telitacicept with a low-dose administration in IgAN. Methods: Eligible participants had an eGFR ≥30 ml/min per 1.73 m2, proteinuria ≥0.75 g/d or UPCR≥0.5 despite optimal supportive therapy.All participants received a low-dose administration: 1) Stage 1: 160 mg /week for weeks 1 to 12, 2) Stage 2: 160 mg / 2 weeks for weeks 13 to 24, and 3) Stage 3: 160 mg/4 weeks for weeks 25 to 48. Results: 30 participants have enrolled and 9 participants have completed Stage 2. Low-dose administration of Telitacicept reduced proteinuria by 56.8% at week 24 from baseline (1.25±0.32 vs 0.54±0.38，P =0.01) and proteinuria did not increase after taper. The eGFR remained stable over time. No significant change in Immunoglobulin A, G and M. Conclusion: The low-dose administration of Telitacicept effectively reduced the proteinuria and could be a cost-effective treatment for IgAN.Figure 1. The change of UPCR(A) and eGFR(B) from baseline.*: P<0.05, ns: no significance.Figure 2. The change of immunoglobin A(A), G(B) and M(C) through time. Table 1． Baseline characteristics of participants - Characteristics All (n = 30) Age, mean (SD), yr 41.43（12.59） Female sex, n (%) 21（65.60%） Time from diagnosis to start of treatment, median (IQR), days 291.5（1405.0） UPCR, median (IQR) 1.14（0.85) eGFR, median (IQR), ml/min /1.73 m2 70.30（47.00） *Oxford classification，n(%) M1 21(87.5%) E1 4(16.7%) S1 15(63.5%) T1 9(37.5%) C1 10(41.7%) *6 patients showed insufficient glomeruli for Oxford classification, T2 and C2 would be excluded.