Tofacitinib and Risk of Malignancy: Results From the Safety of Tofacitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA) Study.
Tofacitinib and Risk of Malignancy: Results From the Safety of Tofacitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA) Study.
复制标题
DOI：
10.1002/art.42250
复制
发表时间：
2022-10
影响因子：
13.3
通讯作者：
Kim, Seoyoung C.
中科院分区：
文献类型：
--
作者：
Khosrow-Khavar, Farzin;Desai, Rishi J.;Lee, Hemin;Lee, Su Been;Kim, Seoyoung C.
“口服监测”安全性试验的结果表明，与肿瘤坏死因子抑制剂（TNFI）相比，托法替尼的恶性肿瘤风险增加。我们进一步研究了现实世界中类风湿关节炎（RA）患者的这种安全性问题。使用Optum Clinformatics（2012-2020）、IBM MarketScan（2012-2018）和Medicare（A、B、D部分，2012-2017）的美国保险索赔数据，我们创建了两个开始接受托法替尼或TNFI治疗的RA患者队列。第一个队列“真实世界证据（RWE）”包括常规护理的患者。第二个队列，“RCT重复队列”，模仿口腔监测试验的纳入和排除标准，以评估我们的结果与试验的可比性。使用倾向评分精细分层加权的考克斯比例风险模型估计任何恶性肿瘤（不包括非黑色素瘤皮肤癌）风险的风险比（HR）和95%置信区间（CI）。使用具有逆方差加权的固定效应模型对数据库特定估计值进行荟萃分析。RWE队列包括83，295例患者，其中10，504例（12.6%）开始接受托法替尼治疗。与TNFI相比，托法替布相关的主要任何恶性肿瘤结局的汇总加权HR（95% CI）在RWE队列中为1. 01（0. 83，1. 22），在RCT重复队列中为1. 17（0. 85，1. 62）（与口服监测试验相比，1. 48 [1. 04，2. 09]）。我们没有发现证据表明，与TNFI相比，在现实世界中接受治疗的RA患者中，托法替尼会增加恶性肿瘤的风险。然而，我们的研究结果不能排除风险增加的可能性，这可能会随着治疗时间的延长而增加。
Results from “ORAL Surveillance” safety trial have indicated an increased risk of malignancy with tofacitinib when compared with tumor necrosis factor inhibitors (TNFI). We further examined this safety concern in rheumatoid arthritis (RA) patients in the real-world setting. Using U.S. insurance claims data from Optum Clinformatics (2012–2020), IBM MarketScan (2012–2018), and Medicare (parts A, B, D, 2012–2017), we created two cohorts of RA patients initiating treatment with tofacitinib or TNFI. The first cohort, “Real-world evidence (RWE)” included patients from routine care. The second cohort, “RCT-duplicate cohort”, emulated the inclusion and exclusion criteria of the ORAL surveillance trial to assess comparability of our results with the trial. Cox proportional hazards models with propensity score fine-stratification weighting were used to estimate hazard ratios (HR) and 95% confidence intervals (CI) for risk of any malignancy (excluding non-melanoma skin cancer). Database-specific estimates were meta-analyzed using fixed effects models with inverse-variance weighting. The RWE cohort included 83,295 patients of whom 10,504 (12.6%) initiated tofacitinib. The pooled weighted HR (95% CI) for the primary any malignancy outcome associated with tofacitinib compared with TNFI was 1.01 (0.83, 1.22) in the RWE cohort and 1.17 (0.85, 1.62) in the RCT-duplicate cohort (versus ORAL Surveillance trial, 1.48 [1.04, 2.09]). We did not find evidence for an increased risk of malignancy with tofacitinib, in comparison with TNFI, in RA patients treated in the real-world setting. However, our results cannot rule out a possibility of an increase in risk that may accrue with a longer treatment duration.
登录
查看更多内容
影响因子：
3.4
作者：
Kremer JM;Bingham CO 3rd;Cappelli LC;Greenberg JD;Madsen AM;Geier J;Rivas JL;Onofrei AM;Barr CJ;Pappas DA;Litman HJ;Dandreo KJ;Shapiro AB;Connell CA;Kavanaugh A
通讯作者：
Kavanaugh A
DOI：
10.1093/gerona/glz224
发表时间：
2020-06-01
影响因子：
5.1
作者：
Kim, Dae Hyun;Patorno, Elisabetta;Glynn, Robert J.
通讯作者：
Glynn, Robert J.
影响因子：
4.7
作者：
Fraenkel, Liana;Bathon, Joan M.;England, Bryant R.;St Clair, E. William;Arayssi, Thurayya;Carandang, Kristine;Deane, Kevin D.;Genovese, Mark;Huston, Kent Kwas;Kerr, Gail;Kremer, Joel;Nakamura, Mary C.;Russell, Linda A.;Singh, Jasvinder A.;Smith, Benjamin J.;Sparks, Jeffrey A.;Venkatachalam, Shilpa;Weinblatt, Michael E.;Al-Gibbawi, Mounir;Baker, Joshua F.;Barbour, Kamil E.;Barton, Jennifer L.;Cappelli, Laura;Chamseddine, Fatimah;George, Michael;Johnson, Sindhu R.;Kahale, Lara;Karam, Basil S.;Khamis, Assem M.;Navarro-Millan, Iris;Mirza, Reza;Schwab, Pascale;Singh, Namrata;Turgunbaev, Marat;Turner, Amy S.;Yaacoub, Sally;Akl, Elie A.
通讯作者：
Akl, Elie A.
DOI：
10.5414/cp203964
发表时间：
2021-10-01
影响因子：
0.8
作者：
Park, So-Hee;Jeon, Ha-Lim;Pratt, Nicole
通讯作者：
Pratt, Nicole
影响因子：
158.5
作者：
Lee, Eun Bong;Fleischmann, Roy;van Vollenhoven, Ronald F.
通讯作者：
van Vollenhoven, Ronald F.