中国系统性红斑狼疮患者中不同推荐剂量泰它西普的疗效和安全性比较：一项系统评价和荟萃分析
Comparative efficacy and safety of different recommended doses of telitacicept in patients with systemic lupus erythematosus in China: a systematic review and meta-analysis.
作者信息
Gao Shenglan, Yang Chunlong, Huang Bitang, Yang Lawei, Lu Lu, Yang Huiting, Li Ting, Pan Qingjun
机构信息
State Key Laboratory of Quality Research in Chinese Medicine, Macau Institute for Applied Research in Medicine and Health, Macau University of Science and Technology, Macao, Macao SAR, China.
Clinical Research Center, Affiliated Hospital of Guangdong Medical University, Zhanjiang, China.
出版信息
Front Immunol. 2025 Jan 10;15:1472292. doi: 10.3389/fimmu.2024.1472292. eCollection 2024.
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 randomized controlled trials (RCT) with 606 participants. We used fixed-effects models for meta-analyses and the risk ratios (RRs) and corresponding 95% confidence intervals (CIs) to evaluate the effectiveness and safety. Heterogeneity was assessed and quantified using I.
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, < 0.0001; RR = 2.18, 95%CI: 1.82-2.62, < 0.00001; RR = 2.44, 95%CI: 1.67-3.56, < 0.00001, respectively). The 80 mg, 160 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, = 0.0008; RR = 1.72, 95%CI: 1.45-2.04, < 0.00001; RR = 1.73, 95%CI: 1.30-2.30, = 0.0002, respectively) and Physician Global Assessment (PGA) scores (RR = 1.25, 95%CI: 1.09-1.44, = 0.002; RR = 1.39, 95%CI: 1.25-1.55, < 0.00001; RR = 1.24, 95%CI: 1.09-1.42, = 0.002, 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, = 0.03). As for security, 160 mg telitacicept group had higher incidence of adverse events (AEs) than the control group (RR = 1.10, 95%CI: 1.03-1.18, = 0.007).
CONCLUSION
Telitacicept combined with standard therapy presents potential benefits but there are certain safety concerns with certain dosages of telitacicept, warranting further investigation for optimal dosing strategies in SLE management.
SYSTEMATIC REVIEW REGISTRATION
INPLASY.COM, identifier INPLASY202440101.
背景
新型生物制剂泰它西普于2021年在中国获批用于治疗系统性红斑狼疮（SLE）。其治疗SLE的最佳剂量仍不清楚。因此，本荟萃分析的目的是评估不同剂量泰它西普治疗SLE的疗效和安全性。
方法
检索了PubMed、EMBASE、Cochrane图书馆、Web of science、中国知网（CNKI）、维普（VIP）、万方和中国生物医学文献数据库（Sinomed），以查找从开始至2024年4月30日研究泰它西普对SLE患者疗效和安全性的对照试验。该分析纳入了3项随机对照试验（RCT），共606名参与者。我们使用固定效应模型进行荟萃分析，并采用风险比（RR）和相应的95%置信区间（CI）来评估有效性和安全性。使用I²评估和量化异质性。
结果
与对照组相比，所有泰它西普剂量（80毫克、160毫克、240毫克）均显著改善了SLE应答者指数4（SRI4）反应（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）。80毫克、160毫克和240毫克组在SELENA - SLE疾病活动指数（SELENA - SLEDAI）评分（RR = 1.63，95%CI：1.23 - 2.17，P = 0.0008；RR = 1.72，95%CI：1.45 - 2.04，P < 0.00001；RR = 1.73，95%CI：1.30 - 2.30，P = 0.0002）和医生整体评估（PGA）评分（RR = 1.25，95%CI：1.09 - 1.44，P = 0.002；RR = 1.39，95%CI：1.25 - 1.55，P < 0.00001；RR = 1.24，95%CI：1.09 - 1.42，P = 0.002）方面也显示出更好的改善。此外，160毫克组的不列颠群岛狼疮评估组（BILAG）评分高于对照组（RR = 1.11，95%CI：1.01 - 1.22，P = 0.03）。至于安全性，160毫克泰它西普组的不良事件（AE）发生率高于对照组（RR = 1.10，95%CI：1.03 - 1.18，P = 0.007）。
结论
泰它西普联合标准治疗具有潜在益处，但某些剂量的泰它西普存在一定的安全问题，需要进一步研究SLE管理中的最佳给药策略。
系统评价注册
INPLASY.COM，标识符INPLASY202440101。
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