Pediatric Rheumatology Unit, Department of Pediatrics, Shaare Zedek Medical Center, Jerusalem 91031, Israel.
Nat Rev Rheumatol. 2010 Oct;6(10):561-71. doi: 10.1038/nrrheum.2010.142. Epub 2010 Aug 31.
The treatment of juvenile idiopathic arthritis (JIA) has been revolutionized by the use of novel biologic agents that have much improved patients' short-term and, according to early evidence, long-term outcomes. Currently available biologic agents used to treat patients with JIA include tumor necrosis factor (TNF) blockers, various agents that target interleukin (IL)-1 and the IL-6 receptor, T-cell co-stimulation inhibitors and antibodies to B-lymphocyte antigen CD20. These agents are increasingly used early in the course of the disease (often in combination with other immunosuppressive medications) and often for long periods of time, as patients can be difficult to wean from their use. Safety concerns (especially the long-term effects of biologic therapy) are, therefore, being examined more closely. For instance, in 2009, the FDA issued a warning related to the development of malignancies in patients with JIA who had used anti-TNF medications for >2.5 years. In this Review, data related to the safety profile of all currently available biologic agents used to treat JIA are examined, with a particular focus on anti-TNF therapy, the most studied biologic agent for JIA. Safety issues that need further study, including the implementation of registries to monitor long-term drug safety, are also discussed.
新型生物制剂的应用彻底改变了幼年特发性关节炎（JIA）的治疗方法，极大地改善了患者的短期预后，而且根据早期证据，长期预后也得到了改善。目前可用于治疗 JIA 患者的生物制剂包括肿瘤坏死因子（TNF）阻滞剂、靶向白细胞介素（IL）-1 和 IL-6 受体的各种制剂、T 细胞共刺激抑制剂以及针对 B 淋巴细胞抗原 CD20 的抗体。这些药物在疾病早期（通常与其他免疫抑制剂联合使用）越来越多地使用，而且通常使用很长时间，因为患者很难停止使用这些药物。因此，正在更密切地检查安全性问题（尤其是生物治疗的长期影响）。例如，2009 年，FDA 发布了一项警告，涉及使用抗 TNF 药物超过 2.5 年的 JIA 患者发生恶性肿瘤的情况。在这篇综述中，检查了所有目前可用于治疗 JIA 的生物制剂的安全性概况数据，特别关注抗 TNF 治疗，这是针对 JIA 研究最多的生物制剂。还讨论了需要进一步研究的安全性问题，包括实施登记处以监测长期药物安全性。
