生物和向合成DMARD在风湿性关节炎患者中的比较安全性:一个多数据库真实世界队列研究
Yinzhu Jin1, Jun Liu1, Rishi J Desai1
1Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Pharmacoepidemiology and drug safety
|July 27, 2025
概括
在类风湿性关节炎患者中,利图西马布的使用与恶性瘤,VTE和心力衰竭的风险增加有关. 与 abatacept 相比,联素-6 抑制剂显示恶性瘤风险较低.
科学领域:
- 类风湿病学 类风湿病学
- 药物监督 药物监督 药物监督
- 流行病学 流行病学
背景情况:
- 生物和向合成修饰疾病的抗风湿药物 (b/t DMARDs) 对于治疗类风湿性关节炎 (RA) 至关重要.
- 了解不同b/t DMARDs的比较安全性,包括恶性瘤,静脉血栓栓塞 (VTE) 和心力衰竭 (HF) 的风险,对于临床决策至关重要.
研究的目的:
- 为了比较与各种b/t相关的恶性瘤,VTE和HF风险,在RA患者中使用DMARD.
- 为了评估阿巴塞普的相对安全性,瘤坏死因子抑制剂 (TNFi),利图西马布,介素-6抑制剂 (IL-6i) 和雅努斯激酶抑制剂 (JAKi) 在RA队列中.
主要方法:
- 一项观察性队列研究,利用美国三大保险索赔数据库 (医疗保险,市场扫描,Optum CDM) 从2009-2022年.
- 包括成人RA患者开始使用特定的b/t DMARDs: abatacept (参考),TNFi,rituximab,IL-6i,或JAKi.
- 采用以治疗权重的逆概率和Cox比例危险模型的as-treated方法,然后进行元分析以估计危险比率 (HR) 和95%置信区间 (CI).
主要成果:
- 超过16万名RA患者在不同的b / t DMARD发起者中被分析.
- 与阿巴cept相比,Rituximab启动者显示恶性瘤 (HR 1.30;95% CI 1.14-1.49) 和HF (HR 1.52;95% CI 1.04-2.22) 的风险显著增加.
- 干白素-6 抑制剂与恶性瘤风险降低有关 (HR 0.73; 95% CI 0.60-0.88),而TNFi 发起者患高血压风险增加 (HR 1.54; 95% CI 1.22-1.94).
结论:
- 在RA患者中使用瑞图西马布与恶性瘤,VTE和HF的风险增加有关.
- 干白素-6抑制剂在恶性瘤风险方面表现出潜在的有利安全性.
- 随着TNFi的使用,观察到HF风险增加,这强调了需要仔细选择和监测患者的必要性.
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