Cardiovascular Safety of Tocilizumab Versus Tumor Necrosis Factor Inhibitors in Patients With Rheumatoid Arthritis: A Multi-Database Cohort Study
Cardiovascular Safety of Tocilizumab Versus Tumor Necrosis Factor Inhibitors in Patients With Rheumatoid Arthritis: A Multi-Database Cohort Study
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DOI：
10.1002/art.40084
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发表时间：
2017-06-01
影响因子：
13.3
通讯作者：
Schneeweiss, Sebastian
中科院分区：
文献类型：
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作者：
Kim, Seoyoung C.;Solomon, Daniel H.;Schneeweiss, Sebastian
虽然已知tocilizumab （TCZ）可增加低密度脂蛋白（LDL）胆固醇水平，但尚不清楚TCZ是否会增加类风湿关节炎（RA）患者的心血管风险。这项研究是为了比较接受TCZ和肿瘤坏死因子抑制剂（TNFi）的心血管风险。方法为了比较心血管安全性，我们使用来自Medicare、IMS PharMetrics和MarketScan的索赔数据，对新开始TCZ或TNFi的RA患者进行了一项队列研究。所有患者之前都需要使用不同的TNFi， abataccept或tofacitinib。主要结局指标是因心肌梗死或中风住院治疗的复合心血管终点。TCZ启动者倾向得分与TNFi启动者匹配，在每个数据库中以1:3的可变比例匹配，控制bbb65基线特征。固定效应模型结合了数据库特定风险比（hr）。结果我们在所有3个数据库中纳入了9,218名TCZ启动者倾向评分与18,810名TNFi启动者匹配。Medicare的平均年龄为72岁，PharMetrics的平均年龄为51岁，MarketScan的平均年龄为53岁。14.3%的TCZ启动者和13.5%的TNFi启动者基线时存在心血管疾病。在研究期间（平均0.9±0.7年，最长4.5年），共发生125例复合心血管事件，导致TCZ起始剂的发病率为0.52 / 100人年，TNFi起始剂的发病率为0.59 / 100人年。在所有3个数据库中，使用TCZ与使用TNFi相关的心血管事件风险相似，总风险比为0.84（95%可信区间为0.56-1.26）。结论：这项基于多数据库人群的队列研究显示，从不同的生物药物或托法替尼切换到TCZ而不是TNFi的RA患者中，没有证据表明心血管风险增加。
ObjectiveWhile tocilizumab (TCZ) is known to increase low-density lipoprotein (LDL) cholesterol levels, it is unclear whether TCZ increases cardiovascular risk in patients with rheumatoid arthritis (RA). This study was undertaken to compare the cardiovascular risk associated with receiving TCZ versus tumor necrosis factor inhibitors (TNFi).MethodsTo examine comparative cardiovascular safety, we conducted a cohort study of RA patients who newly started TCZ or TNFi using claims data from Medicare, IMS PharMetrics, and MarketScan. All patients were required to have previously used a different TNFi, abatacept, or tofacitinib. The primary outcome measure was a composite cardiovascular end point of hospitalization for myocardial infarction or stroke. TCZ initiators were propensity score matched to TNFi initiators with a variable ratio of 1:3 within each database, controlling for >65 baseline characteristics. A fixed-effects model combined database-specific hazard ratios (HRs).ResultsWe included 9,218 TCZ initiators propensity score matched to 18,810 TNFi initiators across all 3 databases. The mean age was 72 years in Medicare, 51 in PharMetrics, and 53 in MarketScan. Cardiovascular disease was present at baseline in 14.3% of TCZ initiators and 13.5% of TNFi initiators. During the study period (meanSD 0.9 +/- 0.7 years; maximum 4.5 years), 125 composite cardiovascular events occurred, resulting in an incidence rate of 0.52 per 100 person-years for TCZ initiators and 0.59 per 100 person-years for TNFi initiators. The risk of cardiovascular events associated with TCZ use versus TNFi use was similar across all 3 databases, with a combined HR of 0.84 (95% confidence interval 0.56-1.26).ConclusionThis multi-database population-based cohort study showed no evidence of an increased cardiovascular risk among RA patients who switched from a different biologic drug or tofacitinib to TCZ versus to a TNFi.