University Hospital of Würzburg, Department of Medicine II, Rheumatology/Clinical Immunology, Würzburg, Germany.
Medical School Hannover, Department of Rheumatology and Immunology, Hannover, Germany.
Front Immunol. 2024 Aug 22;15:1445680. doi: 10.3389/fimmu.2024.1445680. eCollection 2024.
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, tumor necrosis factor inhibitor (TNFi), or interleukin-6 receptor inhibitor (IL-6Ri). 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.
Between April 1, 2020 and September 23, 2023, 3008 newly initiated therapies for TNFi (1499 [49.8%]), JAKi (1126 [37.4%]), and IL-6Ri (383 [12.7%]) were documented by the treating physicians. JAKi were increasingly used in the first two half-year 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 were more likely to be used as >3-line therapy in later time periods.
This exploratory study suggests that EMA safety recommendations for JAKi influenced treatment patterns of RA patients who received JAKi in Germany. Additional studies will be needed to confirm these findings.
欧洲药品管理局（EMA）于 2023 年发布的针对 Janus 激酶抑制剂（JAKi）的安全性建议可能会影响类风湿关节炎（RA）药物的治疗模式，但对于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 风湿病数据库中接受 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）新治疗的成年 RA 患者的文档。数据按 2020 年第 2 季度（Q2）至 2023 年第 3 季度（Q3）的半年间隔分组。从 2022 年第 4 季度（Q4）至 2023 年第 1 季度（Q1），紧随 EMA 最初认可的药物警戒风险评估委员会（PRAC）建议，从 2023 年第 2 季度（Q2）至 2023 年第 3 季度（Q3）紧随包含新安全性 JAKi 建议的直接医疗保健提供者沟通（DHPC）。
在 2020 年 4 月 1 日至 2023 年 9 月 23 日期间，治疗医生记录了 3008 例新开始的 TNFi（1499 [49.8%]）、JAKi（1126 [37.4%]）和 IL-6Ri（383 [12.7%]）治疗。在前两个半年期间，JAKi 的使用逐渐增加（从 2020 年第 2 季度至第 3 季度的这些治疗方法的 29.7%增加到 2021 年第 2 季度至第 3 季度的 46.7%；优势比[OR] 2.08；p<0.001）。在 PRAC 建议（32.9%；与高峰相比，OR 0.56；p=0.001）和 DHPC 信函（26.1%；与高峰相比，OR 0.40；p<0.001）后，开始使用 JAKi 治疗的比例显著下降。JAKi 更有可能作为三线以上的治疗方法在后期使用。
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 治疗的 RA 患者的治疗模式。需要进一步研究来证实这些发现。
