Efficacy and safety of telitacicept in the treatment of systemic lupus erythematosus: A retrospective real-world study

Objectives To assess the real-world efficacy and safety of telitacicept in Chinese systemic lupus erythematosus (SLE) patients. Methods This retrospective single-center observational study enrolled 41 SLE patients treated with telitacicept between April 2021 and March 2022. Baseline characteristics and 24-week follow-up clinical outcomes were collected for analysis. Results A total of 41 SLE patients who received telitacicept at least once were included. Compared with baseline (10.0 ± 6.85), SLEDAI-2K scores significantly decreased at 12 weeks (6.25 ± 5.46, p < .001) and 24 weeks (4.18 ± 4.78, p < .001). The proportion of organ involvement, as assessed by SLEDAI-2K, significantly decreased in skin/mucosa and musculoskeletal involvement. The mean glucocorticoid dose (prednisone equivalent) was significantly reduced at 12 weeks (14.19 ± 8.88 mg/d, p < .001) and 24 weeks (9.86 ± 4.25 mg/d, p = .001) compared with baseline (20.87 ± 16.71 mg/d). C3 and C4 levels showed an increasing trend. In patients with lupus nephritis, 24-h urinary protein levels significantly reduced from 2.81 ± 3.83 g/day at baseline to 1.00 ± 1.32 g/day after 24 weeks of treatment ( p = .005), with a 68.66% decline (IQR, 35.61%, 76.30%). Albumin levels also significantly improved ( p = .003). Nine treatment-emergent adverse events (TEAEs) were recorded in six patients, all of which were mild and moderate. Conclusions In this real-world study, telitacicept combined with conventional therapy showed good onset efficacy and safety for treating SLE patients.