Swart Joost F, de Roock Sytze, Wulffraat Nico M
Arthritis Res Ther. 2013;15(3):213. doi: 10.1186/ar4213.
This review summarizes the immunological consequences of biological therapies used in juvenile idiopathic arthritis (JIA). For every frequently used biological agent the characteristics are clearly specified (molecular target, isotype, registered indication for JIA, route of administration, half-life, contraindication, very common side effects, expected time of response and average cost in the first year). The emphasis of this review is on the immunological side effects that have been encountered for every separate agent in JIA populations. For each agent these adverse events have been calculated as incidence per 100 patient-years for the following categories: serious infections, tuberculosis, malignancies, response to vaccination, new-onset autoimmune diseases and development of anti-drug antibodies. There are large differences in side effects between various agents and there is a clear need for an international and standardized collection of post-marketing surveillance data of biologicals in the vulnerable group of JIA patients. Such an international pharmacovigilance database, called Pharmachild, has now been started.
本综述总结了用于幼年特发性关节炎（JIA）的生物疗法的免疫后果。对于每种常用的生物制剂，都明确规定了其特性（分子靶点、免疫球蛋白类型、JIA的注册适应症、给药途径、半衰期、禁忌症、非常常见的副作用、预期反应时间和第一年的平均费用）。本综述的重点是JIA患者群体中每种单独制剂所出现的免疫副作用。对于每种制剂，这些不良事件按以下类别计算为每100患者年的发生率：严重感染、结核病、恶性肿瘤、疫苗接种反应、新发自身免疫性疾病和抗药物抗体的产生。不同制剂之间的副作用存在很大差异，显然需要对JIA这一弱势群体中的生物制剂进行国际标准化的上市后监测数据收集。现在已经启动了一个名为Pharmachild的国际药物警戒数据库。
