Efficacy and safety of telitacicept in systemic lupus erythematosus with lupus nephritis and nephrotic syndrome: a 12-month retrospective cohort study

Abstract

Background: This retrospective cohort study evaluated the therapeutic efficacy and safety profile of telitacicept, a novel dual B-cell-activating factor (BAFF)/a proliferation-inducing ligand (April) inhibitor, in managing systemic lupus erythematosus (SLE) patients with lupus nephritis (LN) and nephrotic syndrome (NS), with particular focus on renal and hematological parameters.

Methods: 12 SLE patients with biopsy-confirmed LN and NS who received weekly subcutaneous telitacicept (80/160 mg) combined with standard therapies for ≥12 months were analyzed. Primary endpoints include changes in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) scores, 24-h urinary protein excretion (24hUpr), complement levels (Complement Component 3/Complement Component 4), anti-double-stranded DNA antibodies (anti-dsDNA) titers, immunoglobulin profiles, serum creatinine, and hemoglobin (HGB) at baseline, 3-month, and 12-month intervals. Statistical analysis was performed using SPSS 26.0 and R 4.1.2. The significance level was assessed using a one-sample t-test of the log ratios, with the null hypothesis assuming no effect.

Results: Significant improvements were observed in the cohort (91.7% female, median age 30): SLEDAI: Median reduction from 13 to 4 (p = 0.0029), 24hUpr: 4.0 g/24 h → 0.83 g/24 h (p < 0.001), anti-dsDNA: 120 IU/mL → 13 IU/mL (p = 0.003), Complement restoration: C3 0.56→0.84 g/L; C4 0.1→0.22 g/L (both p < 0.001), HGB improvement: 110→120 g/L (p = 0.0144). Compared to 80 mg dose subgroup, the 160 mg dose subgroup (83.3%) showed superior outcomes with no severe adverse events.

Conclusion: Telitacicept demonstrates robust clinical efficacy in LN-NS management through dual B-cell regulation and complement restoration mechanisms. These practical findings support its potential as a targeted therapy for renal and hematological manifestations of SLE, requiring further validation through randomized controlled trials.

Keywords: efficacy; lupus nephritis; nephrotic syndrome; safety; telitacicept.

FIGURE 1

Flowchart of the study design.

FIGURE 2

Comparison of SLEDAI, 24hUpr, C3, C4, IgG and anti-dsDNA before and after 3-month treatment with telitacicept.

FIGURE 3

Mean effect size observed for each variable index following 3-month telitacicept treatment. Error bars refer to mean and standard deviation.

FIGURE 4

Comparison of SLEDAI, 24 hUpr, C3, C4, dsDNA, IgG, IgM, Crea and HGB before and after 12-month treatment with telitacicept.

FIGURE 5

Mean effect size observed for each variable index following 12-month telitacicept treatment. Error bars refer to mean and standard deviation.