German Rheumatism Research Centre Berlin, a Leibniz Institute, Berlin, Germany Charité Universitätsmedizin Berlin, Institute for Social Medicine, Epidemiology and Health Economics, Berlin, Germany.
German Rheumatism Research Centre Berlin, a Leibniz Institute, Berlin, Germany.
Ann Rheum Dis. 2016 May;75(5):855-61. doi: 10.1136/annrheumdis-annrheumdis-2014-206747. Epub 2015 Apr 29.
Published evidence on the long-term safety of etanercept (ETA) and adalimumab (ADA) in patients with polyarticular juvenile idiopathic arthritis (pJIA) is still limited.
To investigate the rates of serious adverse events (SAE) and of events of special interest (ESI) under ETA and ADA treatment.
DESIGN, SETTING AND PARTICIPANTS: Patients with pJIA were prospectively observed in the national JIA biological register, Biologika in der Kinderrheumatologie, and its follow-up register, Juvenile arthritis Methotrexate/Biologics long-term Observation.
We calculated the relative risks of SAE and ESI for ETA and ADA compared with methotrexate (MTX).
Among the 1414 patients treated with ETA (n=1414; 4461 exposure years (EY)) and ADA (n=320; 493 EY), significantly more SAE, infections and medically important infections were observed (ETA: 4.5, 5.7, 0.9; ADA: 4.7, 11.4, 0.4 per 100 EY) compared with those treated with MTX alone (n=1455; 2.907 EY; 2.6, 5.5, 0.5 per 100 EY). The risk for malignancies was not significantly increased for ETA and ADA compared with MTX (0.09, 0.27 and 0.07/100 person-years). Patients under ETA monotherapy developed more frequently incident inflammatory bowel disease (IBD) and incident uveitis (0.5 and 0.8/100 EY) than patients treated by ETA in combination with MTX (0.1 and 0.2/100 EY) or MTX alone (0.03 and 0.1/100 EY).
Our data confirm the acceptable long-term tolerability of ETA and ADA in pJIA. However, whether the onset of IBD and uveitis during ETA monotherapy is a paradoxical effect or an inadequate response to therapy remains unclear and requires further investigation in this growing cohort.
有关依那西普（ETA）和阿达木单抗（ADA）在多关节型幼年特发性关节炎（pJIA）患者中的长期安全性的已发表证据仍然有限。
研究 ETA 和 ADA 治疗下严重不良事件（SAE）和特别关注事件（ESI）的发生率。
设计、地点和参与者：前瞻性观察国家 JIA 生物登记处、儿科风湿病学生物制剂和其随访登记处、幼年特发性关节炎甲氨蝶呤/生物制剂长期观察中的 pJIA 患者。
我们计算了 ETA 和 ADA 与甲氨蝶呤（MTX）相比 SAE 和 ESI 的相对风险。
在接受 ETA（n=1414；4461 暴露年（EY））和 ADA（n=320；493 EY）治疗的 1414 名患者中，观察到更多的 SAE、感染和具有医学重要意义的感染（ETA：4.5、5.7、0.9；ADA：4.7、11.4、0.4/100 EY），与单独接受 MTX 治疗的患者（n=1455；2.907 EY；2.6、5.5、0.5/100 EY）相比。与 MTX 相比，ETA 和 ADA 发生恶性肿瘤的风险无显著增加（0.09、0.27 和 0.07/100 人年）。接受 ETA 单药治疗的患者发生炎症性肠病（IBD）和葡萄膜炎的发生率更高（0.5 和 0.8/100 EY），而接受 ETA 联合 MTX 治疗（0.1 和 0.2/100 EY）或 MTX 单药治疗（0.03 和 0.1/100 EY）的患者则较低。
我们的数据证实了 ETA 和 ADA 在 pJIA 中的长期可接受性。然而，ETA 单药治疗期间 IBD 和葡萄膜炎的发生是一种矛盾效应还是对治疗的反应不足仍不清楚，需要在这个不断增长的队列中进一步研究。
