Efficacy and Safety of Telitacicept in Systemic Lupus Erythematosus.

Telitacicept, a biological agent, was approved by the National Medical Products Administration (NMPA) for the treatment of systemic lupus erythematosus (SLE). This meta-analysis aims to evaluate the efficacy and safety of telitacicept in SLE. A systematic search was conducted for relevant studies from Web of Science, PubMed, the Cochrane Library, Embase, China National Knowledge Infrastructure (CNKI), and Wanfang, covering the period up to January 7, 2025. Randomized controlled trials (RCTs) and observational studies (OSs) were included. Ninety studies were included in this study, including three RCTs and 16 OSs. The result from RCTs showed that telitacicept significantly improved the Systemic Lupus Erythematosus Respondent Index-4 (SRI4) response (RR = 2.23, 95% CI: 1.92~2.59, p<0.00001) and the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score (RR = 1.95, 95% CI: 1.69~2.24, p<0.00001). The pooled results of OSs showed that the SRI-4 response rate increased to 75% (95% CI: 70%~80%), and the SLEDAI score decreased by 7.00 (95% CI: -7.36~-6.64) compared to baseline. Compared with belimumab, telitacicept significantly improved the SRI-4 response rate and SLEDAI score and facilitated early attainment of Lupus Low Disease Activity State (LLDAS) (RR = 1.20, 95% CI: 1.00~1.43, p=0.048; WMD = -1.38, 95% CI: -2.75~-0.01, p=0.048; RR = 1.47, 95% CI: 1.07~2.01, p=0.017). Compared with the control group, the telitacicept group significantly improved the total renal response rates (RR=1.23, 95% CI: 1.11~1.37, p<0.001) and complete renal response rates (RR=2.04, 95% CI: 1.55~2.69, p < 0.001). Regarding safety, the most common adverse events (AEs) reported were infections, such as respiratory infections, urinary tract infections, and herpes. The overall incidence of AEs with telitacicept was 41% (95% CI: 25%~58%), and the incidence of serious AEs was 10% (95% CI: 7%~13%). There was no significant difference in AE incidence compared with belimumab (RR = 0.99, 95% CI: 0.70 ~ 1.40, p=0.949). Telitacicept significantly improves SRI-4 response and reduces SLEDAI scores in SLE/LN patients, with 160 mg showing optimal efficacy. Telitacicept outperformed belimumab, likely due to dual BAFF/APRIL inhibition. Safety profiles were acceptable with mostly mild-to-moderate adverse events. However, limited RCTs and geographic restrictions to Chinese populations necessitate further multicenter trials for broader validation. Telitacicept is an effective and safe treatment for SLE. However, more clinical studies should be conducted to confirm it.