Frontiers in immunology · 2026
Efficacy and safety of telitacicept in systemic lupus erythematosus: a single-center, retrospective, real-world study.
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Yang Li, Liu Jiayu, Zou Jinmei, Yang Jing
Аннотация
OBJECTIVE: To explore the real-world efficacy and safety of telitacicept in patients with systemic lupus erythematosus (SLE).
METHODS: This retrospective study included SLE patients treated with telitacicept for at least 3 months at Mianyang Central Hospital between January 2022 and December 2025. Baseline characteristics and clinical outcomes at 12, 24, and 52 weeks were assessed.
RESULTS: A total of 139 patients were enrolled in this study. The SLE Disease Activity Index 2000 (SLEDAI-2K) score significantly decreased from a baseline of 11.42 ± 4.68 to 4.623 ± 3.65, 2.42 ± 2.98, and 1.48 ± 2.58 at 12, 24, and 52 weeks, respectively (P < 0.0001). The anti-dsDNA positivity rate declined from 35.25% at baseline to 7.94% by week 52, accompanied by an upward trend in complement 3 (C3) and complement 4 (C4) levels. Among the 74 patients with lupus nephritis, the baseline 24-hour urine protein was 1.59 ± 1.68 g/24h, which significantly decreased to 1.12 ± 1.41 g/24h, 0.42 ± 0.46 g/24h, and 0.39 ± 0.64 g/24h at 12 weeks, 24 weeks, and 52 weeks, respectively (P < 0.001). The serum albumin level significantly increased (P < 0.0001), while the serum estimated glomerular filtration rate (eGFR) showed significant reductions (P < 0.05). Furthermore, white blood cell and platelet count also improved significantly in patients with leukopenia and thrombocytopenia (P < 0.0001). The mean daily glucocorticoids dose (equivalent to prednisone) was successfully tapered from 39.98 ± 10.09 mg/d at baseline to 18.35 ± 7.87 mg/d at 12 weeks, 9.752 ± 4.72 mg/d at 24 weeks, and 5.69 ± 2.95 mg/d at 52 weeks (P < 0.0001). Adverse events occurred in 28 (20.14%) patients, with upper respiratory tract infections being the most common (53%), and no serious adverse events occurred.
CONCLUSION: In this real-world study, telitacicept combined with conventional therapy was associated with improvements in disease activity and organ functions in SLE with favorable safety.
METHODS: This retrospective study included SLE patients treated with telitacicept for at least 3 months at Mianyang Central Hospital between January 2022 and December 2025. Baseline characteristics and clinical outcomes at 12, 24, and 52 weeks were assessed.
RESULTS: A total of 139 patients were enrolled in this study. The SLE Disease Activity Index 2000 (SLEDAI-2K) score significantly decreased from a baseline of 11.42 ± 4.68 to 4.623 ± 3.65, 2.42 ± 2.98, and 1.48 ± 2.58 at 12, 24, and 52 weeks, respectively (P < 0.0001). The anti-dsDNA positivity rate declined from 35.25% at baseline to 7.94% by week 52, accompanied by an upward trend in complement 3 (C3) and complement 4 (C4) levels. Among the 74 patients with lupus nephritis, the baseline 24-hour urine protein was 1.59 ± 1.68 g/24h, which significantly decreased to 1.12 ± 1.41 g/24h, 0.42 ± 0.46 g/24h, and 0.39 ± 0.64 g/24h at 12 weeks, 24 weeks, and 52 weeks, respectively (P < 0.001). The serum albumin level significantly increased (P < 0.0001), while the serum estimated glomerular filtration rate (eGFR) showed significant reductions (P < 0.05). Furthermore, white blood cell and platelet count also improved significantly in patients with leukopenia and thrombocytopenia (P < 0.0001). The mean daily glucocorticoids dose (equivalent to prednisone) was successfully tapered from 39.98 ± 10.09 mg/d at baseline to 18.35 ± 7.87 mg/d at 12 weeks, 9.752 ± 4.72 mg/d at 24 weeks, and 5.69 ± 2.95 mg/d at 52 weeks (P < 0.0001). Adverse events occurred in 28 (20.14%) patients, with upper respiratory tract infections being the most common (53%), and no serious adverse events occurred.
CONCLUSION: In this real-world study, telitacicept combined with conventional therapy was associated with improvements in disease activity and organ functions in SLE with favorable safety.