Department of Pediatric Immunology, University Medical Centre Utrecht, Utrecht, The Netherlands.
J Rheumatol. 2011 Jul;38(7):1441-6. doi: 10.3899/jrheum.100809. Epub 2011 Apr 1.
With the increasing use of etanercept for juvenile idiopathic arthritis (JIA) new possible adverse events are reported including new autoimmune diseases. Our purpose was to examine if the incidence of inflammatory bowel disease (IBD) in patients with JIA using etanercept is higher than in the healthy age-matched population. We give the clinical characteristics of the IBD in patients with JIA using etanercept.
The national JIA registries for etanercept of The Netherlands, Germany, Finland, Denmark, and Italy were searched for patients with JIA and IBD. The total number of patient-years was used to calculate incidence. The physicians of the identified patients were asked to give clinical details.
Thirteen cases of IBD in JIA patients were identified in the registries between 1999 and 2008. The IBD incidence in JIA patients while using etanercept was 362 per 100,000 patient-years under etanercept, about 43 times higher than in the general pediatric population. Clinical presentation of IBD in JIA patients using etanercept was similar to that in non-JIA patients. The median time between onset of JIA and onset of IBD was 6 years and 10 months. The time between the start of etanercept and the first appearance of IBD symptoms was between 9 days and 4.5 years.
The incidence of IBD in JIA patients using etanercept seems to be markedly increased, analyzing data from European registries. This incidence of IBD in the etanercept registries cannot be compared to the incidence of IBD in JIA patients using other treatment without etanercept, because such registries do not exist yet in all European countries. These findings are in keeping with a report of 8 new IBD cases occurring in French children with JIA using etanercept. These findings illustrate the need for large international disease-specific registries focused on outcome and pharmacovigilance.
随着依那西普在幼年特发性关节炎（JIA）中的应用越来越广泛，新的可能的不良反应包括新的自身免疫性疾病。我们的目的是研究接受依那西普治疗的 JIA 患者发生炎症性肠病（IBD）的发生率是否高于健康年龄匹配人群。我们给出了接受依那西普治疗的 JIA 患者 IBD 的临床特征。
我们检索了荷兰、德国、芬兰、丹麦和意大利的 JIA 依那西普国家登记处，以寻找患有 JIA 和 IBD 的患者。使用患者人数-年计算发病率。我们要求确定的患者的医生提供临床细节。
在 1999 年至 2008 年期间，登记处共发现 13 例 JIA 患者的 IBD。接受依那西普治疗的 JIA 患者 IBD 的发病率为每 100,000 患者-年 362 例，是一般儿科人群的 43 倍左右。接受依那西普治疗的 JIA 患者的 IBD 临床表现与非 JIA 患者相似。JIA 发病和 IBD 发病之间的中位时间为 6 年 10 个月。依那西普开始使用和 IBD 症状首次出现之间的时间为 9 天至 4.5 年。
分析来自欧洲登记处的数据，使用依那西普治疗的 JIA 患者发生 IBD 的发病率似乎明显增加。欧洲登记处中接受依那西普治疗的 JIA 患者的 IBD 发病率与未使用依那西普治疗的 JIA 患者的 IBD 发病率无法相比，因为并非所有欧洲国家都有此类登记处。这些发现与法国儿童接受依那西普治疗后发生 8 例新的 IBD 病例的报告一致。这些发现表明需要针对特定疾病的大型国际登记处，重点关注结果和药物警戒。
