Shenglan Gao ¹ Chunlong Yang ¹ Bitang Huang ¹ Lawei Yang ¹ Lu Lu ¹ Huiting Yang ¹ TING LI ^2* Qingjun Pan ^1*

• ¹ Affiliated Hospital of Guangdong Medical University, Zhanjiang, China
• ² Faculty of Chinese Medicine, Macau University of Science and Technology, Macau, Macau Region, China

Background: Telitacicept, a new biological agent, was approved in China for treating systemic lupus erythematosus (SLE) in 2021. Its optimal dosing for treating SLE remains unclear. Therefore, the aim of this meta-analysis is to evaluate the efficacy and safety of various telitacicept doses in SLE treatment. Methods: PubMed, EMBASE, Cochrane libraries, Web of science, China National Knowledge Infrastructure (CNKI), VIP, Wanfang, and Sinomed were searched for the controlled trials that studied the efficacy and safety of telitacicept on SLE patients from their initiation to April 30, 2024. The analysis included three two randomized controlled trials (RCT) and one cohort study with 606 participants. We used fixed-effects models for meta-analyses and the risk ratios (RRs) and corresponding 95% confidence intervals (CIs) were used to evaluate the effectiveness and safety.Heterogeneity was assessed and quantified using I 2 . Results: All telitacicept dosages (80 mg, 160 mg, 240 mg) significantly improved SLE Responder Index 4 (SRI4) responses compared to the control group (RR = 2.20, 95%CI:1.50-3.21, p < 0.0001; RR = 2.18, 95%CI: 1.82-2.62, p < 0.00001; RR = 2.44, 95%CI: 1.67-3.56, p < 0.00001, respectively). The 80 mg and 240 mg groups also showed better improvement on SELENA-SLE Disease Activity Index (SELENA-SLEDAI) scores (RR = 1.63, 95%CI:1.23-2.17, p = 0.0008; RR = 1.73, 95%CI: 1.30-2.30, p = 0.0002, respectively) and Physician Global Assessment (PGA) scores (RR = 1.25, 95%CI: 1.09-1.44, p = 0.002; RR = 1.24, 95%CI: 1.09-1.42, p = 0.002, respectively). However, the 160 mg group showed less improvement on SELENA-SLEDAI and PGA scores (RR = 0.82, 95%CI: 0.70-0.97, p = 0.02; RR = 0.81, 95%CI: 0.73-0.91, p = 0.0002, respectively). Furthermore, 160 mg group exhibited higher British Isles Lupus Assessment Group (BILAG) score than the control group (RR = 1.11, 95%CI: 1.01-1.22, p = 0.03). Overall, no significant differences in adverse events (AEs) and serious adverse events (SAEs) were observed between all dosages of telitacicept groups and the control group (all p > 0.05). Conclusion: Telitacicept combined with standard therapy presents potential benefits and a comparable safety profile to placebo, warranting further investigation for optimal dosing strategies in SLE management.