Department of Paediatric Rheumatology, Institute of Child Health, 4th Floor Laboratories Block, Birmingham Children's Hospital-NHS Foundation Trust, University of Birmingham, Whittall Street, Birmingham, B4 6NH, UK.
Rheumatology (Oxford). 2011 Jan;50(1):189-95. doi: 10.1093/rheumatology/keq308. Epub 2010 Nov 3.
Since 2004, juvenile idiopathic arthritis (JIA) patients treated with etanercept and/or MTX have been monitored in the British Society for Paediatric and Adolescent Rheumatology Biologics and New Drug Register. Here, we report the duration of etanercept use for the first 5 years of the register and reasons for discontinuation.
Disease subtype and activity, comorbidity, treatment efficacy and safety data were recorded. Etanercept discontinuation was defined as stopping the drug because of disease remission or treatment failure. Time to discontinuation was explored using Kaplan-Meier survival analysis with remaining patients censored at 5-year follow-up.
A total of 483 etanercept-treated JIA patients were enrolled from 30 UK centres, representing 941 patient-years of follow-up. A total of 100 (20.7%) patients discontinued etanercept; 9 due to disease control, 88 because of treatment failure, 2 for unknown reasons and 1 because of a change in diagnosis. Of the 53 patients in whom etanercept was perceived to be ineffective at controlling the inflammation, 48 were prescribed other biologic drugs [26/48 (54%) infliximab]. In 21 patients with intolerance, infections, CNS events and a few isolated events were associated with discontinuation. Using Kaplan-Meier analysis, at 5 years 69% (95% CI 61, 77%) had not experienced treatment failure. Discontinuation of etanercept for inefficacy was associated with systemic arthritis subtype [odds ratio (OR) 2.55, 95% CI 1.27, 5.14], chronic anterior uveitis (OR 2.39, 95% CI 1.06, 5.35) and inefficacy of MTX before starting etanercept (OR 8.3, 95% CI 1.14, 60.58).
In a cohort of JIA patients treated with etanercept and followed for a median of 2 years (maximum 5 years), the majority (69%) remain on the drug.
自 2004 年以来，在英国儿科和青少年风湿病学会生物制剂和新药注册处，接受依那西普和/或 MTX 治疗的青少年特发性关节炎（JIA）患者接受了监测。在此，我们报告了登记处前 5 年依那西普的使用时间以及停药原因。
记录疾病亚型和活动、合并症、治疗效果和安全性数据。依那西普停药定义为因疾病缓解或治疗失败而停止用药。使用 Kaplan-Meier 生存分析探索停药时间，对 5 年随访时仍存活的患者进行删失。
从英国 30 个中心共纳入 483 例接受依那西普治疗的 JIA 患者，随访时间为 941 患者年。共有 100（20.7%）例患者停用依那西普；9 例因疾病控制，88 例因治疗失败，2 例因不明原因，1 例因诊断改变。在 53 例依那西普被认为对炎症控制无效的患者中，48 例患者处方了其他生物药物[26/48（54%）英夫利昔单抗]。在 21 例不耐受的患者中，感染、CNS 事件和少数孤立事件与停药有关。使用 Kaplan-Meier 分析，5 年时 69%（95%CI 61，77%）未发生治疗失败。依那西普因疗效不佳而停药与全身关节炎亚型[比值比（OR）2.55，95%CI 1.27，5.14]、慢性前葡萄膜炎（OR 2.39，95%CI 1.06，5.35）和依那西普治疗前 MTX 疗效不佳（OR 8.3，95%CI 1.14，60.58）有关。
在接受依那西普治疗并随访中位数为 2 年（最长 5 年）的 JIA 患者队列中，大多数（69%）患者仍在使用该药。
