为了评估欧洲药品管理局（EMA）的建议对实际使用JAK抑制剂（JAKis）的类风湿性关节炎（RA）患者以及使用扩展性风险评分（ERS-RA）来量化主要不良心脏事件（MACE）的影响，我们进行了一项回顾性分析。我们对接受JAKis治疗的实际RA患者进行了回顾性分析。如果患者符合EMA标准（年龄>65岁，恶性肿瘤史，或增加静脉血栓栓塞事件[VTE]或MACE包括吸烟）则将其分为不适合接受JAKis的类别中。根据ORAL Surveillance试验的纳入标准（ORALSURV）或使用ERS-RA来定义MACE风险。共有194名患者纳入研究，其中57.9％根据EMA定义（ORALSURV标准）被分类为不合格。被认定为不合格的原因最常见的是增加的MACE风险（70.2％），其次是年龄>65岁（34.2％），吸烟（30.7％），增加的VTE风险（20.2％）或恶性肿瘤（7％）。使用ERS-RA将携带增加心血管风险的患者的比例降低到18.6％（p<0.001，与ORALSURV相比），导致46.4％的总不合格患者。在337患者/年的药物暴露期内，我们观察到2例VTE，一例MACE（非致命性中风）和一例实体恶性肿瘤（都在根据两个定义分类为不合格的患者组中）。严格遵守EMA在临床实践中的指示，可能导致RA患者的大部分被排除在接受JAKis治疗之外。借助ERS-RA等专用工具对MACE风险进行适当量化，以更好地定制RA的管理方法是值得推荐的。版权所有©2023 Favalli, Cincinelli, Germinario, Di Taranto, Orsini, Maioli, Biggioggero, Ferrito and Caporali.

To evaluate in patients with rheumatoid arthritis (RA) the impact of EMA recommendations on the real-life prescription of JAK inhibitors (JAKis) and the use of the Expanded Risk Score in RA (ERS-RA) to quantify the risk of major adverse cardiac events (MACE).We conducted a retrospective analysis of real-life RA patients treated with JAKis. Patients were classified as ineligible for JAKis if they fulfilled EMA criteria (>65 years-old, history of malignancy, or increased risk of venous thromboembolic events [VTE] or MACE including smoking). Risk of MACE was defined according to ORAL Surveillance trial inclusion criteria (ORALSURV) or by using the ERS-RA.Of 194 patients enrolled, 57.9% were classified as ineligible according to EMA definition (ORALSURV criteria). The most frequent reason for ineligibility was increased MACE risk (70.2%), followed by age>65 (34.2%), smoking (30.7%), and increased risk of VTE (20.2%) or malignancy (7%). The use of the ERS-RA reduced the rate of patients carrying an increased CV risk to 18.6% (p<0.001 versus ORALSURV), leading to 46.4% overall ineligible patients. Over a drug-exposure of 337 patient/years, we observed 2 VTE, one MACE (non-fatal stroke), and one solid malignancy (all in the group of patients classified as ineligible according to both the definitions).Rigorous application of EMA indications in clinical practice could result in the exclusion of a large proportion of RA patients from treatment with JAKis. A proper quantification of the risk for MACE by dedicated tools as ERS-RA is advocated to better tailor the management of RA.Copyright © 2023 Favalli, Cincinelli, Germinario, Di Taranto, Orsini, Maioli, Biggioggero, Ferrito and Caporali.