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在澳大利亚的风湿性关节炎患者中,阿达利穆马布与托法西提尼布的有效性比较
Claire T Deakin1,2,3, Bianca L De Stavola4, Geoffrey Littlejohn1,5
1OPAL Rheumatology Ltd, Sydney, New South Wales, Australia.
JAMA network open
|June 29, 2023
概括
这项研究发现,托法西提尼布 (TOF) 与阿达利姆巴 (ADA) 相比,在3个月内,对类风湿性关节炎疾病活动的适度,统计学显著减少. 在9个月后没有观察到任何显著差异,两种治疗都实现了临床相关的减少.
科学领域:
- 类风湿病学 类风湿病学
- 相对有效性研究研究比较
- 观察性研究 观察性研究
背景情况:
- 随机临床试验 (RCT) 提供了强有力的证据,但观察性研究对于真实世界的数据至关重要.
- 目标试验模拟 (TTE) 框架通过应用RCT设计原则来最大限度地减少观察性研究的偏差.
- 在类风湿性关节炎 (RA) 中,阿达利穆马布 (ADA) 和托法西提尼布 (TOF) 的疗效已确立,但使用真实数据进行对比是有限的.
研究的目的:
- 在RA患者中模拟RCT比较ADA与TOF,以启动生物或向合成疾病修饰性抗风湿药物 (b/tsDMARDs).
- 通过使用TTE框架在现实环境中评估ADA和TOF的比较有效性.
主要方法:
- 一项模拟RCT的比较有效性研究,使用澳大利亚风湿病学 (OPAL) 优化患者结果数据集.
- 包括在2015年10月至2021年4月期间启动ADA或TOF的RA的澳大利亚成年人,是新的b/tsDMARD用户,并记录了DAS28-CRP.
- 使用稳定的平衡权重来解决非随机治疗的分配,缺失的数据被多次归因.
主要成果:
- 包括842名患者:569名在ADA,273名在TOF.
- 在3个月后,TOF与ADA相比,对DAS28-CRP平均值呈现了统计学上显著的,适度的降低 (影响估计: -0.2;95%CI, -0.4至 -0.03;P=0.02).
- 在9个月后,在ADA和TOF之间没有观察到平均DAS28-CRP的显著差异 (影响估计: -0.03;95%CI, -0.2至0.1;P=0.60).
结论:
- 托法西提尼布在3个月后,在减少类风湿性关节炎疾病活动方面,比阿达利穆马布 (adalimumab) 具有适度但统计学上显著的优势.
- 无论是ADA还是TOF,都导致疾病活性的临床相关减少3个月,与缓解一致.
- 在9个月后,两种治疗方法之间没有发现有效性的显著差异.
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