Tofacitinib and risk of cardiovascular outcomes: results from the Safety of TofAcitinib in Routine care patients with Rheumatoid Arthritis (STAR-RA) study.
Tofacitinib and risk of cardiovascular outcomes: results from the Safety of TofAcitinib in Routine care patients with Rheumatoid Arthritis (STAR-RA) study.
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DOI：
10.1136/annrheumdis-2021-221915
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发表时间：
2022-06
影响因子：
27.4
通讯作者：
Desai, Rishi J.
中科院分区：
文献类型：
--
作者：
Khosrow-Khavar, Farzin;Kim, Seoyoung C.;Lee, Hemin;Lee, Su Been;Desai, Rishi J.
最近的“口服监测”试验结果引起了对托法替尼在类风湿关节炎（RA）患者中的心血管安全性的担忧。我们在现实世界中进一步研究了这一安全问题。我们使用Optum Clinformatics的去识别数据创建了两个开始接受托法替尼或肿瘤坏死因子抑制剂（TNFI）治疗的RA患者队列（2012-2020），IBM MarketScan（2012-2018），医疗保险（A、B和D部分，2012-2017）索赔数据库：1）由常规护理患者组成的“真实世界证据（RWE）队列”;和2）模拟口腔监测试验的纳入和排除标准的“RCT重复队列”，以根据试验结果校准结果。采用倾向评分精细分层加权的考克斯比例风险模型估计心肌梗死和卒中复合结局的风险比（HR）和95%置信区间（CI），并考虑76个潜在混杂因素。使用具有逆方差加权的固定效应模型合并数据库特定效应估计值。在RWE队列中，确定了102，263例患者，其中12，852例（12.6%）开始接受托法替尼治疗。RWE队列中托法替布与TNFI比较的汇总加权HR（95% CI）为1.01（0.83 - 1.23），RCT重复队列中为1.24（0.90 - 1.69），与ORAL监测结果密切一致（HR：1.33，95% CI：0.91 - 1.94）。我们没有发现托法替尼在真实环境中治疗的RA患者中心血管结局风险增加的证据;然而，托法替尼与心血管结局风险增加相关，尽管在有心血管风险因素的RA患者中无统计学显著性。
Recent results from “ORAL Surveillance” trial have raised concerns regarding the cardiovascular safety of tofacitinib in patients with rheumatoid arthritis (RA). We further examined this safety concern in the real-world setting. We created two cohorts of RA patients initiating treatment with tofacitinib or tumor necrosis factor inhibitors (TNFI) using de-identified data from Optum Clinformatics (2012–2020), IBM MarketScan (2012–2018), and Medicare (parts A, B, and D, 2012–2017) claims databases: 1) A “real-world evidence (RWE) cohort” consisting of routine care patients; and 2) A “RCT-duplicate cohort” mimicking inclusion and exclusion criteria of the ORAL surveillance trial to calibrate results against the trial findings. Cox proportional hazards models with propensity score fine stratification weighting were used to estimate hazard ratios (HR) and 95% confidence intervals (CI) for composite outcome of myocardial infarction and stroke and accounting for 76 potential confounders. Database-specific effect estimates were pooled using fixed effects models with inverse-variance weighting. In the RWE cohort, 102,263 patients were identified of whom 12,852 (12.6%) initiated tofacitinib. The pooled weighted HR (95% CI) comparing tofacitinib with TNFI was 1.01 (0.83 to 1.23) in RWE cohort and 1.24 (0.90 to 1.69) in RCT-duplicate cohort which aligned closely with ORAL-surveillance results (HR: 1.33, 95% CI: 0.91 to 1.94). We did not find evidence for an increased risk of cardiovascular outcomes with tofacitinib in RA patients treated in the real-world setting; however, tofacitinib was associated with an increased risk of cardiovascular outcomes, albeit statistically non-significant, in RA patients with cardiovascular risk factors.
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影响因子：
4
作者：
Kume, Kensuke;Amano, Kanzo;Kuwaba, Noriko
通讯作者：
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影响因子：
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影响因子：
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作者：
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影响因子：
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作者：
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影响因子：
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通讯作者：
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