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巴瑞替尼对于静脉血栓栓塞风险的安全性特征

接受巴瑞替尼（BARI）的患者中已报告深静脉血栓形成（DVT）和肺栓塞（PE）事件。深静脉血栓形成和 PE 是 BARI 偶见（≥0.1% 且 <1%）的药物不良反应。1

在一项类风湿关节炎（RA）患者使用 BARI 的回顾性观察研究中，观察到静脉血栓栓塞事件的发生率高于接受肿瘤坏死因子（TNF）抑制剂治疗的患者。这些事件中使用了其他 Janus 激酶（JAK）抑制剂。1

存在 DVT/PE 风险因素的患者应慎用巴瑞替尼。如果出现 DVT/PE 的临床特征，应停止巴瑞替尼治疗，立即对患者进行评估，并给予适当治疗。1

发表的文献和索赔数据库中的静脉血栓栓塞发生率

已发表的住院和门诊 RA 患者的静脉血栓栓塞（VTE）发生率（IR）范围为每 100 暴露患者年（PYE）0.33-0.79。 BARI 的总体 VTE IR 为每 100 PYE 0.5，处于文献报道的 RA 人群范围内。2-5

为了进一步表征 BARI 的 VTE IR，评估了来自食品药品监督管理局（FDA）Sentinel 项目与 Truven Marketscan 行政索赔数据中的 RA 人群的 VTE IR。 Sentinel 和 Truven 行政索赔数据库中都包含有关参加美国健康计划的患者的信息。Sentinel 项目一个代表 7500 万患者的子集中确认有超过 69,000 名患者使用 RA 药物。 Truven 代表超过 1.1 亿名患者，经确认使用 RA 药物的患者超过 205,000 名。2,6-8

虽然无法直接与 BARI 临床研究项目的结果比较，但 Sentinel（IR 范围 = 0.76 – 3.08）和 Truven（IR 范围 = 0.76 – 2.96）中使用传统和生物制剂改善病情抗风湿药（DMARD）治疗的 RA 患者的静脉血栓栓塞 IR 似乎在类似的范围，包括按年龄比较的 50 至 59 岁年龄组的数据。6,7,9

上次审阅日期：2021年10月14日

参考文献

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Eli Lilly and Company. Lilly FDA Advisory Committee Meeting NDA 207924 Briefing Document. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM605062.pdf. Accessed April 19, 2018.

3Genovese MC, Smolen JS, Takeuchi T, et al. Safety profile of baricitinib for the treatment of rheumatoid arthritis up to 8.4 years: an updated integrated safety analysis. Ann Rheum Dis. 2020;79(suppl 1):638. European League Against Rheumatism abstract FRI0123. https://ard.bmj.com/content/79/Suppl_1/642.1

4Choi HK, Rho YH, Zhu Y, et al. The risk of pulmonary embolism and deep vein thrombosis in rheumatoid arthritis: a UK population-based outpatient cohort study. Ann Rheum Dis. 2013;72(7):1182-1187. http://dx.doi.org/10.1136/annrheumdis-2012-201669

5Ogdie A, Kay McGill N, Shin DB, et al. Risk of venous thromboembolism in patients with psoriatic arthritis, psoriasis and rheumatoid arthritis: a general population-based cohort study. Eur Heart J. 2018;39(39):3608-3614. http://dx.doi.org/10.1093/eurheartj/ehx145

6Maro JC, Menzin T, Hornbuckle J, et al. Risk of thromboembolism in rheumatoid arthritis patients treated with biologic and non-biologic DMARDs. Poster presented at: European League Against Rheumatism (EULAR) Annual Meeting; June 13-16, 2018; Amsterdam, Netherlands.

7Maro JC, Menzin T, Hornbuckle J, et al. Risk of thromboembolism in rheumatoid arthritis patients treated with biologic and non-biologic DMARDs. Poster presented at: American College of Rhuematology (ACR) Annual Meeting; October 19-24, 2018; Chicago, IL.

8Salinas CA, Mitchell L, Giles JT, et al. Risk of Venous Thromboembolism in Rheumatoid Arthritis Patients in Truven Marketscan Data (Jan 2010–Sept 2015) Treated with Biologic or Conventional Dmards [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/risk-of-venous-thromboembolism-in-rheumatoid-arthritis-patients-in-truven-marketscan-data-jan-2010-sept-2015-treated-with-biologic-or-conventional-dmards/

9Salinas CA, Mitchell L, Giles JT, et al. Risk of Venous Thromboembolism in Rheumatoid Arthritis Patients in Truven Marketscan Data (Jan 2010–Sept 2015) Treated with Biologic or Conventional Dmards. American College of Rhuematology (ACR) Annual Meeting; October 19-24, 2018; Chicago, IL. https://acrabstracts.org/abstract/risk-of-venous-thromboembolism-in-rheumatoid-arthritis-patients-in-truven-marketscan-data-jan-2010-sept-2015-treated-with-biologic-or-conventional-dmards/

艾乐明®（巴瑞替尼片）

回复：

巴瑞替尼对于静脉血栓栓塞风险的安全性特征

发表的文献和索赔数据库中的静脉血栓栓塞发生率

参考文献

艾乐明^®（巴瑞替尼片）