关联导致的内疚 - 使用依那西普治疗幼年特发性关节炎的儿童发生恶性肿瘤的真实风险是多少？
Guilt by association - what is the true risk of malignancy in children treated with etanercept for JIA?
机构信息
Department of Pediatrics, Division of Rheumatology, University of Alabama at Birmingham, Birmingham, AL 35294, USA.
出版信息
Pediatr Rheumatol Online J. 2010 Aug 16;8:23. doi: 10.1186/1546-0096-8-23.
Recently, the Food and Drug Administration placed a "black box" label on etanercept, and other tumor necrosis factor inhibitors used to treat childhood arthritis, warning of the risk of malignancies. The Food and Drug Administration made their decision based on a review of 48 cases of malignancies identified worldwide in children treated with tumor necrosis factor inhibitors for inflammatory bowel disease, sarcoidosis, and juvenile idiopathic arthritis. Recently, an article in Pediatric Rheumatology demonstrated that there may not be an increased risk of cancer in children with juvenile idiopathic arthritis treated specifically with the tumor necrosis factor receptor fusion protein, etanercept. There are many confounding issues regarding whether or not etanercept increases the risk of malignancy, specifically lymphomas, above the background rate of cancer in children with juvenile idiopathic arthritis who are not being treated with biologic agents. Whether or not it was appropriate for the Food and Drug Administration to lump cancer patients with underlying granulomatous diseases (inflammatory bowel disease and sarcoidosis) with children with juvenile idiopathic arthritis is explored herein. Moreover, the amalgamation of etanercept with anti-tumor necrosis factor monoclonal antibodies (adalimumab and infliximab) is another point of contention. What is clear is that there is much that is currently unknown to be able to convincingly demonstrate a substantial risk of cancer in children with juvenile idiopathic arthritis treated with etanercept. Conversely, there is ample evidence demonstrating remarkable benefit of etanercept in treating juvenile idiopathic arthritis. Physicians treating childhood arthritis should weigh these potential risks and benefits with patients and their families discussing the current limitations in available data regarding the risk of cancer in children treated with etanercept for juvenile idiopathic arthritis.
最近，美国食品和药物管理局在依那西普（etanercept）和其他用于治疗儿童关节炎的肿瘤坏死因子抑制剂上加贴了“黑框”标签，警告其存在恶性肿瘤风险。美国食品和药物管理局基于对全球范围内 48 例接受肿瘤坏死因子抑制剂治疗炎症性肠病、结节病和幼年特发性关节炎的儿童恶性肿瘤病例的审查做出了这一决定。最近，一篇发表在《儿科风湿病学》（Pediatric Rheumatology）上的文章表明，在专门接受肿瘤坏死因子受体融合蛋白依那西普治疗的幼年特发性关节炎儿童中，癌症风险可能不会增加。在未接受生物制剂治疗的幼年特发性关节炎儿童中，依那西普是否会增加恶性肿瘤（尤其是淋巴瘤）的风险，存在许多混杂因素。美国食品和药物管理局将患有潜在肉芽肿性疾病（炎症性肠病和结节病）的癌症患者与患有幼年特发性关节炎的儿童归为一类是否恰当，这一点值得探讨。此外，将依那西普与抗肿瘤坏死因子单克隆抗体（阿达木单抗和英夫利昔单抗）合并使用也是另一个争议点。目前尚不清楚的是，有多少证据能够令人信服地表明接受依那西普治疗的幼年特发性关节炎儿童存在实质性的癌症风险。相反，有大量证据表明依那西普在治疗幼年特发性关节炎方面具有显著益处。治疗儿童关节炎的医生应权衡这些潜在的风险和益处，与患者及其家属讨论目前有关接受依那西普治疗的幼年特发性关节炎儿童癌症风险的数据存在局限性的问题。
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