Tocilizumab的有效性及其与肿瘤坏死因子α拮抗剂在 Takayasu动脉炎治疗中的比较: 一项系统性综述和荟萃分析。
The effectiveness of tocilizumab and its comparison with tumor necrosis factor alpha inhibitors for Takayasu Arteritis: A systematic review and meta-analysis.
发表日期:2023 Mar
作者:
Durga Prasanna Misra, Kritika Singh, Upendra Rathore, Pallavi Patro, Alessandro Tomelleri, Corrado Campochiaro, Vikas Agarwal, Aman Sharma
来源:
AUTOIMMUNITY REVIEWS
摘要:
高松氏动脉炎(TAK)对传统疾病修饰抗风湿药(DMARD)具有抵抗性,常用生物制剂DMARD,如托珠单抗或肿瘤坏死因子-α抑制剂(TNFi)进行治疗。2021年美国风湿病学会(ACR)推荐优先使用TNFi而非托珠单抗。因此,我们进行系统性综述和荟萃分析,通过对MEDLINE、Pubmed Central、Scopus、重要国际风湿病学会议摘要和临床试验数据库,更新先前对TAK中DMARD的系统性综述进行搜索,以评估托珠单抗在TAK中的证据基础,时间跨度为2021年1月至2022年11月。共有35项涉及1082名TAK患者的研究[1个随机对照试验(RCT),11项对照和21项无对照研究,大多数是中等到高质量的]评估了托珠单抗在TAK中的应用。托珠单抗与安慰剂的RCT未能在意向治疗分析(风险比0.41,95%CI 0.15-1.10)中实现其主要终点的卓越性,但在符合方案分析(风险比0.34,95%CI 0.11-1.00)上成功实现了次要终点的卓越性。6项研究的荟萃分析发现,托珠单抗和TNFi的临床缓解率(风险比[R.R.]托珠单抗vs TNFi 1.03,95%CI 0.91-1.17),血管造影稳定率(R.R. 1.00,95%CI 0.72-1.40)或不良事件(R.R. 0.84,95%CI 0.54-1.31)相似。3项研究的荟萃分析显示,托珠单抗优于环磷酰胺的临床反应(R.R. 1.55,95%CI 1.15-2.10)和副作用资料(R.R. 0.45,95%CI 0.25-0.80)。无对照研究的汇总数据显示,临床反应率为85%(95%CI 79-91%),血管造影稳定率为82%(95%CI 68-94%)。我们的研究显示,与ACR 2021年的建议相反,使用托珠单抗或TNFi治疗TAK具有相似的证据。版权所有©2023 Elsevier B.V.。
Takayasu arteritis (TAK) refractory to conventional disease-modifying anti-rheumatic drugs (DMARDs) is commonly treated with biologic DMARDs such as tocilizumab or tumor necrosis factor-alpha inhibitors (TNFi). The 2021 American College of Rheumatology (ACR) recommendations preferred TNFi to tocilizumab. Therefore, we conducted a systematic review with meta-analysis to assess the evidence base for tocilizumab in TAK by updating a previous systematic review on DMARDs in TAK through searches on MEDLINE, Pubmed Central, Scopus, major international Rheumatology conference abstracts, and clinical trial databases from January 2021 to November 2022. Thirty-five studies involving 1082 TAK [one randomized controlled trial (RCT), eleven controlled and twenty-one uncontrolled studies, most of moderate to high quality] had evaluated tocilizumab in TAK. The RCT of tocilizumab versus placebo failed to meet its primary end-point of superiority of tocilizumab on an intention-to-treat analysis (hazard ratio 0.41, 95%CI 0.15-1.10) but successfully met the secondary end-point of superiority on per-protocol analysis (hazard ratio 0.34, 95%CI 0.11-1.00). A meta-analysis of six studies identified similar rates of clinical remission [risk ratio (RR) tocilizumab vs TNFi 1.03, 95%CI 0.91-1.17)], angiographic stabilization (RR 1.00, 95%CI 0.72-1.40) or adverse events (RR 0.84, 95%CI 0.54-1.31) with tocilizumab or TNFi. A meta-analysis of three studies identified superior clinical response (RR 1.55, 95%CI 1.15-2.10) and adverse effect profile (RR 0.45, 95%CI 0.25-0.80) with tocilizumab than cyclophosphamide. Pooled data from uncontrolled studies identified clinical response in 85%(95%CI 79-91%) and angiographic stabilization in 82% (95%CI 68-94%). Our study suggests similar evidence for treating TAK with tocilizumab or TNFi, contrary to the ACR 2021 recommendations.Copyright © 2023 Elsevier B.V. All rights reserved.