托珠单抗与阿巴西普治疗类风湿关节炎的心血管风险无差异：一项多数据库队列研究。
No difference in cardiovascular risk of tocilizumab versus abatacept for rheumatoid arthritis: A multi-database cohort study.
机构信息
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, 1620 Tremont Street, Suite 3030, Boston, MA 02120; Division of Rheumatology, Immunology and Allergy; Brigham and Women's Hospital, Boston, MA 02115.
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, 1620 Tremont Street, Suite 3030, Boston, MA 02120; Division of Rheumatology, Immunology and Allergy; Brigham and Women's Hospital, Boston, MA 02115.
出版信息
Semin Arthritis Rheum. 2018 Dec;48(3):399-405. doi: 10.1016/j.semarthrit.2018.03.012. Epub 2018 Mar 22.
OBJECTIVES
While tocilizumab may increase serum lipid levels, recent studies do not suggest a link between tocilizumab use and clinical cardiovascular risk in patients with rheumatoid arthritis (RA).
METHODS
To compare cardiovascular safety of tocilizumab with abatacept, we conducted a cohort study using data from Medicare (2010-2013), IMS PharMetrics (2011-2014) and MarketScan (2011-6/2015). RA patients aged ≥18 years who newly started tocilizumab or abatacept entered the cohort on the day of their first use of tocilizumab or abatacept after a continuous enrollment period for ≥365 days. The primary outcome was a composite cardiovascular endpoint of hospitalization for myocardial infarction or stroke. To control for more than 60 confounders, tocilizumab starters were propensity score (PS)-matched to abatacept starters with a variable ratio of 1:3 within each database. A fixed-effects model combined database-specific hazard ratios (HR).
RESULTS
We included 6237 tocilizumab starters PS-matched to 14,685 abatacept starters in all three databases. Mean age was 72 years in Medicare, 51 in PharMetrics and 53 in MarketScan. The incidence rate of the composite cardiovascular events per 100 person-years ranged from 0.37 (PharMetrics) to 1.64 (Medicare) in the tocilizumab group and from 0.59 (PharMetrics) to 1.69 (Medicare) in the abatacept group. The risk of the composite cardiovascular events was similar between the two groups across all three databases, with a combined HR of 0.82 (95% CI: 0.55-1.22) in tocilizumab versus abatacept starters.
CONCLUSIONS
This multi-database cohort study found no difference in the risk of cardiovascular events in RA patients who newly started tocilizumab versus abatacept.
目的
虽然托珠单抗可能会升高血清脂质水平，但最近的研究并未表明类风湿关节炎（RA）患者使用托珠单抗与临床心血管风险之间存在关联。
方法
为了比较托珠单抗与阿巴西普的心血管安全性，我们使用了来自 Medicare（2010-2013 年）、IMS PharMetrics（2011-2014 年）和 MarketScan（2011-6/2015 年）的数据进行了一项队列研究。年龄≥18 岁且新开始使用托珠单抗或阿巴西普的 RA 患者，在经过≥365 天的连续入组期后，在首次使用托珠单抗或阿巴西普的当天进入队列。主要结局是心肌梗死或卒中住院的复合心血管终点。为了控制 60 多个混杂因素，托珠单抗起始者与阿巴西普起始者按照倾向评分（PS）进行了 1:3 的变量比例匹配，每个数据库内均匹配。固定效应模型合并了数据库特异性风险比（HR）。
结果
我们纳入了 Medicare、PharMetrics 和 MarketScan 三个数据库中总计 6237 名托珠单抗起始者和 14685 名阿巴西普起始者的 PS 匹配数据。在 Medicare、PharMetrics 和 MarketScan 中，患者的平均年龄分别为 72 岁、51 岁和 53 岁。托珠单抗组每 100 人年的复合心血管事件发生率为 0.37（PharMetrics）至 1.64（Medicare），阿巴西普组为 0.59（PharMetrics）至 1.69（Medicare）。在三个数据库中，两组间复合心血管事件的风险相似，托珠单抗与阿巴西普起始者的合并 HR 为 0.82（95%CI：0.55-1.22）。
结论
这项多数据库队列研究发现，新开始使用托珠单抗与阿巴西普的 RA 患者的心血管事件风险无差异。
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