ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Drugs Outcomes Research and Policies
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1613790
Efficacy and Safety of Telitacicept in Systemic Lupus Erythematosus with Lupus Nephritis and Nephrotic Syndrome: A 12-Month Retrospective Cohort Study
Provisionally accepted
- 1First Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China
- 2Department of Rheumatology, First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China
- 3Guangdong Clinical Research Academy of Chinese Medicine, Guangzhou, China., Guangzhou, China
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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-hour 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, 3month, 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/24h → 0.83 g/24h (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: Telitacicept, Lupus Nephritis, Nephrotic Syndrome, efficacy, Safety
Received: 17 Apr 2025; Accepted: 25 Jun 2025.
Copyright: © 2025 Li, Liu, Xu, Lin and Liu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Qiang Xu, Department of Rheumatology, First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510405, China
Changsong Lin, Department of Rheumatology, First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510405, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.