Infliximab (REMICADE) therapy in the treatment of pediatric Crohn's disease
Infliximab (REMICADE) therapy in the treatment of pediatric Crohn's disease
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DOI：
10.1016/s0002-9270(03)00007-8
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发表时间：
2003-04-01
影响因子：
9.8
通讯作者：
Winter, HS
中科院分区：
文献类型：
--
作者：
Baldassano, R;Braegger, CP;Winter, HS
目的：本研究的目的是评估单次输注英夫利西单抗治疗小儿克罗恩病（CD）的疗效和安全性。共有21名儿童CD患者在7个研究中心入组，并随机接受英夫利西单抗1 mg/kg（n = 6）、5 mg/kg（n = 7）、或10 mg/kg（n = 8），在该多中心、开放标签、剂量设盲试验中，在第0周至少给药2小时。在筛选时和第1、2、4、8周进行疗效评估，包括儿童克罗恩病活动指数（PCDAI）、改良CDAI、C反应蛋白浓度（CRP）和红细胞沉降率（ESR）测定。和12.不良事件进行了评估整个研究participation.Results：改善PCDAI，修改CDAI，ESR和CRP观察所有英夫利西单抗剂量，开始，在第1周。平均而言，所有接受治疗的患者在第2周时PCDAI改善约50%。到第12周，PCDAI较基线改善约30%。研究期间，所有21例患者（100%）均达到临床应答，10例患者（48%）达到临床缓解。有没有输液反应，在任何治疗arms.CONCLUSIONS：这项试验的结果表明，英夫利西单抗可能是安全和有效的短期治疗医学难治性中度至重度CD在儿科人群。
OBJECTIVES: The aim of this study was to assess the efficacy and safety of a single infusion of infliximab in the treatment of pediatric Crohn's disease (CD).METHODS: A total of 21 pediatric CD patients were enrolled at seven study centers and randomized to receive a single infusion of infliximab 1 mg/kg (n = 6), 5 mg/kg (n = 7), or 10 mg/kg (n = 8) over at least 2 hrs at week 0 in this multicenter, open-label, dose-blinded trial. Efficacy assessments, including the Pediatric Crohn's Disease Activity Index (PCDAI), modified CDAI, C-reactive protein concentration (CRP), and erythrocyte sedimentation rate (ESR) determinations, were made at screening and at weeks 1, 2, 4, 8. and 12. Adverse events were assessed throughout study participation.RESULTS: Improvements in the PCDAI, modified CDAI, ESR, and CRP were observed with all infliximab doses, beginning, at week 1. On average, all treated patients experienced approximately 50% improvement in the PCDAI by week 2. By week 12, the PCDAI remained approximately 30% improved from baseline. During the study, all 21 patients (100%) achieved a clinical response, and 10 patients (48%) achieved clinical remission. There were no infusion reactions in any of the treatment arms.CONCLUSIONS: The results of this trial suggest that infliximab may be safe and effective as short-term therapy of medically refractory moderate to severe CD in a pediatric population.