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register hereBackground: Safety recommendations for Janus kinase inhibitors (JAKi) issued by the European Medical Agency (EMA) in 2023 could potentially influence treatment patterns for rheumatoid arthritis (RA) drugs, but little is known about the impact of these recommendations in routine clinical care.We retrospectively analyzed the German RHADAR rheumatology database for adult patients with RA and documentation of a new therapy with a JAKi, tumour necrosis factor inhibitor (TNFi), or interleukin-6 receptor inhibitor (IL-6Ri).

注册背景：2023年欧洲医学局（EMA）发布的Janus激酶抑制剂（JAKi）安全建议可能会影响类风湿性关节炎（RA）药物的治疗模式，但对这些建议在常规临床护理中的影响知之甚少。我们回顾性分析了德国RHADAR风湿病数据库中的成年RA患者，并记录了JAKi，肿瘤坏死因子抑制剂（TNFi）或白细胞介素-6受体抑制剂（IL-6Ri）的新疗法。

Data were grouped into half-yearly intervals from quarter (Q)2/2020 to Q3/2023. The period from Q4/2022 to Q1/2023 immediately followed the initial EMA endorsement of Pharmacovigilance Risk Assessment Committee (PRAC) recommendations and Q2/2023-Q3/2023 immediately followed the direct healthcare provider communication (DHPC) containing the new safety JAKi recommendations.Results: Between April 1, 2020 and September 23, 2023, 3008 newly initiated therapies for TNFi (1499 [49.8%]), JAKi (1126 [37.4%]), and ) were documented by the treating physicians.

。2022年第4季度至2023年第1季度，EMA首次批准了药物警戒风险评估委员会（PRAC）的建议，2023年第2季度至2023年第3季度，直接医疗保健提供者沟通（DHPC）包含了新的安全JAKi建议。结果：在2020年4月1日至2023年9月23日期间，治疗医师记录了3008例新开始的TNFi治疗（1499例（49.8%），JAKi（1126例（37.4%）和）。

JAKi were increasingly used in the first two halfyear periods (from 29.7% of these therapies in Q2/2020-Q3/2020 to 46.7% in Q2/2021-Q3/2021; odds ratio [OR] 2.08; p<0.001). The proportion of initiated JAKi therapies decreased significantly after the PRAC recommendations (32.9%; OR vs peak 0.56; p=0.001) and the DHPC letter (26.1%; OR vs peak 0.40; p<0.001).

JAKi在前两个半年的使用率越来越高（从2020年第二季度至2020年第三季度的29.7%增加到2021年第二季度至2021年第三季度的46.7%；优势比（OR）2.08；p<0.001）。。

JAKi were more likely to be used as >3 rd -line therapy in later time periods.Conclusions: This exploratory study suggests that EMA safety recommendations for JAKi influenced treatment patterns of RA patients who received JAKi in Germany..

JAKi更有可能在后期被用作>3线治疗。结论：这项探索性研究表明，EMA对JAKi的安全性建议影响了在德国接受JAKi的RA患者的治疗模式。。