近期发病的非系统性幼年特发性关节炎三种治疗策略的比较：儿童最佳治疗研究的最初3个月结果
A comparison of three treatment strategies in recent onset non-systemic Juvenile Idiopathic Arthritis: initial 3-months results of the BeSt for Kids-study.
作者信息
Hissink Muller P C E, Brinkman D M C, Schonenberg D, Koopman-Keemink Y, Brederije I C J, Bekkering W P, Kuijpers T W, van Rossum M A J, van Suijlekom-Smit L W A, van den Berg J M, Allaart C F, Ten Cate R
机构信息
Department of Pediatrics/Pediatric Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
Department of Pediatrics/Pediatric Rheumatology, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands.
出版信息
Pediatr Rheumatol Online J. 2017 Feb 6;15(1):11. doi: 10.1186/s12969-017-0138-4.
BACKGROUND
Combination therapy with prednisone or etanercept may induce earlier and/or more improvement in disease activity in Disease Modifying Anti Rheumatic Drug (DMARD) naïve non-systemic Juvenile Idiopathic Arthritis (JIA) patients. Here we present three months clinical outcome of initial treatments of the BeSt-for-Kids study.
METHODS
Included patients were randomized to either: 1. initial DMARD-monotherapy (sulfasalazine (SSZ) or methotrexate (MTX)), 2. Initial MTX / prednisolone-bridging, 3. Initial combination MTX/etanercept. Percentage inactive disease, adjusted (a) ACR Pedi30, 50 and 70 and JADAS after 6 and 12 weeks of treatment (intention to treat analysis) and side effects are reported.
RESULTS
94 patients (67% girls, 32 (arm 1), 32 (arm 2) and 30 (arm 3) with median (InterQuartileRange) age of 9.1 (4.7-12.9) years were included. 38% were ANA positive, 10 had oligo-articular disease, 68 polyarticular JIA and 16 psoriatic arthritis. Baseline median (IQR) ACRpedi-scores: VAS physician 49 (40-58) mm, VAS patient 54 (37-70) mm, ESR 6.5 (2-14.8)mm/hr, active joint count 8 (5-12), limited joint count 3 (1-5), CHAQ score 0.88 (0.63-1.5). In arm 1, 17 started with MTX, 15 with SSZ. After 3 months, aACR Pedi 50 was reached by 10/32 (31%), 12/32(38%) and 16/30 (53%) (p = 0.19) and aACR Pedi 70 was reached by 8/32 (25%), 6/32(19%) and 14/30(47%) in arms 1-3 (p = 0.04). Toxicity was similar. Few serious adverse events were reported.
CONCLUSION
After 3 months of treatment in a randomized trial, patients with recent-onset JIA achieved significantly more clinical improvement (aACRPedi70) on initial combination therapy with MTX / etanercept than on initial MTX or SSZ monotherapy.
TRIAL REGISTRATION
NTR1574 . Registered 3 December 2008.
背景
对于初治的非系统性幼年特发性关节炎（JIA）患者，联合使用泼尼松或依那西普进行治疗可能会更早和/或更大程度地改善疾病活动度。在此，我们展示了“儿童最佳治疗方案”研究初始治疗的三个月临床结果。
方法
纳入的患者被随机分为以下几组：1. 初始使用缓解病情抗风湿药（DMARD）单药治疗（柳氮磺胺吡啶（SSZ）或甲氨蝶呤（MTX））；2. 初始使用MTX/泼尼松龙桥接治疗；3. 初始联合使用MTX/依那西普。报告了治疗6周和12周后（意向性分析）的疾病非活动百分比、调整后的（a）美国风湿病学会儿科30%、50%和70%改善标准（ACR Pedi30、50和70）以及幼年特发性关节炎疾病活动度评分（JADAS）和副作用。
结果
共纳入94例患者（67%为女孩），第1组、第2组和第3组分别有32例、32例和例30，中位（四分位间距）年龄为9.1（4.7 - 12.9）岁。38%的患者抗核抗体（ANA）呈阳性，10例为少关节型疾病，68例为多关节型JIA，16例为银屑病关节炎。基线时中位（IQR）ACR儿科评分：医生视觉模拟评分（VAS）为49（（40 - 58）mm，患者VAS为54（37 - 70）mm，红细胞沉降率（ESR）为6.5（2 - 14.8）mm/小时，活动关节计数为8（5 - 12），受限关节计数为3（1 - 5），儿童健康评估问卷（CHAQ）评分为0.88（0.63 - 1.5）。在第1组中，17例起始使用MTX，15例起始使用SSZ。3个月后，第1 - 3组达到aACR Pedi 50的比例分别为10/32（31%）、12/32（38%）和16/30（53%）（p = 0.19），达到aACR Pedi 70的比例分别为8/32（25%）、6/32（19%）和14/30（47%）（p = 0.04）。毒性反应相似。报告的严重不良事件较少。
结论
在一项随机试验中治疗3个月后，新发病的JIA患者在初始联合使用MTX/依那西普治疗时，比初始使用MTX或SSZ单药治疗取得了显著更多的临床改善（aACR Pedi70）。
试验注册
NTR1574。于2008年12月3日注册。
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