Comparative Risk of Thrombotic and Cardiovascular Events with Tofacitinib and Anti-TNF Agents in Patients with Inflammatory Bowel Diseases.
Comparative Risk of Thrombotic and Cardiovascular Events with Tofacitinib and Anti-TNF Agents in Patients with Inflammatory Bowel Diseases.
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托法替布和抗 TNF 药物在炎症性肠病患者中血栓和心血管事件的比较风险。
DOI：
10.1007/s10620-022-07404-z
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发表时间：
2022
影响因子：
3.1
通讯作者：
Ananthakrishnan,AshwinN
中科院分区：
文献类型：
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作者：
Kochar,BharatiD;Cheng,David;Cai,Tianxi;Ananthakrishnan,AshwinN
BackgroundTofacitinib和炎症性肠病（IBD）已与血栓栓塞和心血管事件的风险增加，但药物归因的风险是unknow.MethodsWe进行了一项回顾性队列研究，在美国索赔数据库。我们通过国际疾病分类（ICD）代码识别IBD患者，规定在开始托法替尼或抗肿瘤坏死因子（TNF）治疗前连续入组180天，以确定新的使用者。主要结局为静脉血栓栓塞（VTE）和心血管（CV）事件的ICD代码。我们构建了倾向评分（PS）加权考克斯比例风险模型，以估计托法替尼和抗TNF治疗的风险比（HR）和至事件发生时间结局。我们进行了一个亚组分析的患者≥ 50 years.ResultsWe确定了305例IBD患者开始托法替尼，并将其与19,096开始抗肿瘤坏死因子。加权后，所有人口统计学协变量均达到平衡。5%的托法替尼治疗患者和4%的抗TNF使用者发生VTE;在PS加权队列中，与抗TNF治疗相比，托法替尼未导致VTE风险显著升高（HR：1.72，95% CI：0.74-3.01）。2%的托法替布使用者和1%的抗TNF使用者发生了重大CV事件（MACE）;托法替布也未导致MACE风险显著升高（HR：2.50，95% CI：0.37-6.18）。Charlson合并症指数≥ 2的患者发生血栓栓塞和心血管事件的风险更高。在≥ 50 years.ConclusionsIn this large，active comparator，study中，我们证明了在IBD患者中，与抗TNF相比，托法替尼与不良血栓事件的更高风险无关。
BackgroundTofacitinib and inflammatory bowel disease (IBD) have been associated with increased risks for thromboembolic and cardiovascular events, but drug attributable risk is unknown.MethodsWe conducted a retrospective cohort study in a US claims database. We identified patients with IBD by International Classification of Disease (ICD) codes, stipulated 180 days of continuous enrollment prior to tofacitinib or anti-tumor necrosis factor (TNF) initiation to determine new users. Primary outcomes were ICD codes for venous thromboembolism (VTE) and cardiovascular (CV) events. We constructed propensity score (PS)-weighted Cox proportional hazard models to estimate hazard ratios (HRs) and time-to-event outcomes comparing tofacitinib and anti-TNF. We conducted a subgroup analysis of patients ≥ 50 years.ResultsWe identified 305 patients with IBD initiating tofacitinib and compared them with 19,096 initiating anti-TNFs. After weighting, balance was achieved across all demographic covariates. VTE occurred in 5% of patients treated with tofacitinib and 4% of anti-TNF users; in a PS-weighted cohort, tofacitinib did not confer a significantly elevated VTE risk compared with anti-TNF therapy (HR: 1.72, 95% CI: 0.74–3.01). A major CV event (MACE) occurred in 2% of tofacitinib users and 1% of anti-TNF users; tofacitinib also did not confer a significantly elevated risk for MACE (HR: 2.50, 95% CI: 0.37–6.18). Those with a Charlson comorbidity index ≥ 2 had greater risks for thromboembolic and cardiovascular events. Similar findings were noted in patients ≥ 50 years.ConclusionsIn this large,active comparator, study, we demonstrate that tofacitinib was not associated with a higher risk of adverse thrombotic events compared with anti-TNFs in patients with IBD.