关键词: 系统性红斑狼疮, 贝利尤单抗, 阿尼鲁单抗, 泰它西普, 疗效, 不良反应事件, 网状meta分析

Abstract: Background: Systemic lupus erythematosus is a chronic multisystem autoimmune disease that is prone to multiple system damage. After treatment, it is prone to recurrence, reducing the quality of life of patients, and in severe cases, endangering their lives. The development and research of biological agents have brought dawn to SLE patients. Currently, three biological agents have been approved for use in SLE patients, namely belimumab, anifrolumab, and telitacicept, However, there is currently a lack of research that directly compares the efficacy and safety of the three drugs. Therefore, in this study, a network meta-analysis method was used to indirectly compare the efficacy and safety of the three. Objective: To analyze the clinical efficacy and safety of belimumab, anifrolumab, and telitacicept in the treatment of patients with SLE using a mesh meta-analysis. Methods: A randomized controlled study was conducted on PubMed, Web of Science, Cochrane Library, and EMBASE to investigate the effects of belimumab, anifrolumab, and telitacicept on SLE. The search was conducted from the establishment of the database until August 2023. By incorporating exclusion criteria to screen literature and obtaining data, direct or mesh meta-analysis was performed on the data using RevMan5.4.1 software, R language 4.3.1, and ADDIS1.16.8 software. The effects were expressed as OR values and their 95% CI. Compare the efficacy and safety of data related to three drugs. Results: After screening, a total of 4 789 patients were included in 12 randomized controlled studies, including 2 721 patients in the experimental group and 2 068 patients in the placebo group. Direct meta-analysis results showed that in terms of clinical efficacy, three drugs, belimumab, anifrolumab, and telitacicept, significantly improved the SLE Responder Index 4(SRI4) compared to the placebo group, Effectively improve the clinical symptoms of patients [(OR=1.62, 95% CI: 1.40-1.88, P<0.001); (OR=2.39, 95% CI: 1.70-3.37, P<0.001); (OR=6.28, 95% CI: 3.20-12.33, P<0.001)]; Compared with the placebo group, belimumab, anifrolumab can reduce oral corticosteroid doses [(OR=1.48, 95% CI: 1.09-2.02, P<0.001); (OR=2.45, 95% CI: 1.69-3.54, P<0.001)] and reduce severe flare rates (Severe flare, SF) [(OR=0.59, 95% CI: 0.49-0.71, P<0.001); (OR=0.52, 95% CI: 0.39-0.69, P<0.001)]; In terms of safety, although the incidence of Total adverse events (TAEs) was higher in the anifrolumab, and telitacicept groups compared to the placebo group (OR=1.80, 95% CI: 1.25-2.59, P=0.001); (OR=2.13, 95% CI: 1.18-3.83, P=0.01) (P<0.05), anifrolumab can reduce the incidence of serious adverse events (SAEs) (OR=0.67, 95% CI: 0.46-0.97, P=0.04), and telitacicept also has similar advantages; Compared with the placebo group, the incidence of Total adverse events (OR=0.89, 95% CI: 0.72-1.08, P=0.24) and the incidence of serious adverse events (OR=0.82, 95% CI: 0.59-1.12, P=0.25) in the belimumab group were not statistically significant ; The indirect results of network meta-analysis showed that the remission rate of SRI4 after treatment with three drugs was higher than that of anifrolumab and belimumab , and the incidence of TAEs was higher than that of belimumab ; Similar efficacy and safety were observed in both intravenous and subcutaneous injections of belimumab. Conclusion: All three drugs have good clinical efficacy in the treatment of SLE patients, among which the efficacy of telitacicept is more significant. Although anifrolumab and telitacicept increase the overall incidence of adverse events after medication, they reduce the incidence of serious adverse events. belimumab is more stable in terms of safety.

Key words: Systemic lupus erythematosus, Belimumab, Anifrolumab, Telitacicept, Efficacy, Adverse reaction events, Network meta-analysis