接受生物制剂治疗的幼年特发性关节炎患者不良事件的发生情况：现实环境中的长期随访
Occurrence of adverse events in patients with JIA receiving biologic agents: long-term follow-up in a real-life setting.
作者信息
Tarkiainen Maarit, Tynjälä Pirjo, Vähäsalo Paula, Lahdenne Pekka
机构信息
Children's Hospital, Helsinki University Central Hospital, Institute of Clinical Medicine, University of Helsinki, Poison Information Center, Helsinki University Central Hospital, Helsinki, Finland, Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland Children's Hospital, Helsinki University Central Hospital, Institute of Clinical Medicine, University of Helsinki, Poison Information Center, Helsinki University Central Hospital, Helsinki, Finland, Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland
Children's Hospital, Helsinki University Central Hospital, Institute of Clinical Medicine, University of Helsinki, Poison Information Center, Helsinki University Central Hospital, Helsinki, Finland, Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland Children's Hospital, Helsinki University Central Hospital, Institute of Clinical Medicine, University of Helsinki, Poison Information Center, Helsinki University Central Hospital, Helsinki, Finland, Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.
出版信息
Rheumatology (Oxford). 2015 Jul;54(7):1170-6. doi: 10.1093/rheumatology/keu457. Epub 2014 Dec 10.
OBJECTIVE
The aim of this study was to carry out a safety evaluation of biologic agents in patients with JIA and associated uveitis.
METHODS
In three tertiary centres in Finland, all adverse events (AEs) in 348 consecutive patients were collected. AEs were classified according to the Common Terminology Criteria for AEs.
RESULTS
A total of 1516 patient-years (py) were included: 710 on etanercept, 591 on infliximab, 188 on adalimumab, 8 on rituximab, 5 on anakinra, 6 on tocilizumab, 6 on abatacept and 1 on golimumab. The median follow-up of an individual patient was 51 months (range 1-155). The most common of the 2902 AEs (191/100 py) observed were mild infections, infusion or injection site reactions and alanine aminotransferase elevations. At least one AE occurred in 319 (92%) patients and 121 (35%) had at least one serious AE (SAE). The rate of SAEs was 11.4/100 py on etanercept, 11.8 on infliximab, 10.1 on adalimumab, 15.7 on abatacept, 31.2 on tocilizumab and 87.5 on rituximab, higher than with most anti-TNF agents (P = 0.005). No cases of malignant neoplasms or tuberculosis were detected. New-onset uveitis occurred in 9 patients, psoriasis or psoriasiform lesions in 13 and IBD in 6.
CONCLUSION
Mild and moderate AEs in patients with JIA treated with biologics were more frequent than previously reported. SAEs were observed in one-third of the patients, but SAEs seldom led to drug discontinuation.
目的
本研究旨在对幼年特发性关节炎（JIA）及相关葡萄膜炎患者使用生物制剂进行安全性评估。
方法
在芬兰的三个三级医疗中心，收集了348例连续患者的所有不良事件（AE）。不良事件根据不良事件通用术语标准进行分类。
结果
共纳入1516患者年（py）：710例使用依那西普，591例使用英夫利昔单抗，188例使用阿达木单抗，8例使用利妥昔单抗，5例使用阿那白滞素，6例使用托珠单抗，6例使用阿巴西普，1例使用戈利木单抗。个体患者的中位随访时间为51个月（范围1 - 155个月）。观察到的2902例不良事件中最常见的（191/100 py）是轻度感染、输液或注射部位反应以及丙氨酸转氨酶升高。319例（92%）患者发生至少1次不良事件，121例（35%）患者发生至少1次严重不良事件（SAE）。依那西普的严重不良事件发生率为11.4/100 py，英夫利昔单抗为11.8，阿达木单抗为10.1，阿巴西普为15.7，托珠单抗为31.2，利妥昔单抗为87.5，高于大多数抗TNF药物（P = 0.005）。未检测到恶性肿瘤或结核病病例。9例患者出现新发葡萄膜炎，13例出现银屑病或银屑病样病变，6例出现炎症性肠病。
结论
使用生物制剂治疗的JIA患者中，轻度和中度不良事件比先前报道的更频繁。三分之一的患者观察到严重不良事件，但严重不良事件很少导致停药。
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