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英夫利昔单抗用于儿童克罗恩病的长期疗效:加拿大多中心临床实践经验

Long-term Outcomes of Infliximab Use for Pediatric Crohn Disease: A Canadian Multicenter Clinical Practice Experience.

作者信息

deBruyn Jennifer C, Jacobson Kevan, El-Matary Wael, Carroll Matthew, Wine Eytan, Wrobel Iwona, Van Woudenberg Mariel, Huynh Hien Q

机构信息

Department of Pediatrics, University of Calgary, Calgary.

Department of Pediatrics, University of British Columbia, Vancouver.

出版信息

J Pediatr Gastroenterol Nutr. 2018 Feb;66(2):268-273. doi: 10.1097/MPG.0000000000001672.

Abstract

BACKGROUND

Data on long-term real-world outcomes of infliximab in pediatric Crohn disease are limited.

AIM

The aim of the study was to evaluate infliximab optimization and durability in children with Crohn disease.

METHODS

We performed a retrospective review of children with Crohn disease who started infliximab from January 2008 to December 2012 in 4 Canadian tertiary care centers. A priori factors associated with optimization and discontinuation from loss of response were evaluated using logistic regression and Cox proportional hazards model, respectively.

RESULTS

One hundred eighty children (54.4% boys) started infliximab; all completed induction. Median age at infliximab start was 14.3 years (Q1, Q3: 12.8, 15.9 years) and median time from diagnosis to infliximab start was 1.5 years (Q1, Q3: 0.6, 3.5 years). At last follow-up, 87.1% were maintained on infliximab (median duration follow-up 85.9 weeks [Q1, Q3: 43.8, 138.8 weeks]). Infliximab optimization occurred in 57.3% (dose escalation 15.2%, interval shortening 3.9%, both 38.2%), primarily due to loss of response. Younger age at diagnosis (<10 years old) and nonstricturing, nonpenetrating behavior were associated with optimization (odds ratio 6.5, 95% confidence interval [CI] 2.0-21.1 and odds ratio 2.1, 95% CI 1.0-4.2, respectively). The 1- and 2-year durability of infliximab (percentage in follow-up who were continuing on infliximab) were 95.5% (95% CI 90.4-98.3) and 91.0% (95% CI 82.4-96.3), respectively. Annual discontinuation due to loss of response occurred at 3.2% per year (95% CI 1.1-5.2).

CONCLUSIONS

Children with Crohn disease maintain a durable response to infliximab. Optimization occurs frequently and allows for continued use. Younger age at diagnosis and nonstricturing, nonpenetrating behavior are associated with increased need for infliximab optimization.

摘要

背景

英夫利昔单抗治疗儿童克罗恩病的长期实际疗效数据有限。

目的

本研究旨在评估英夫利昔单抗在儿童克罗恩病中的优化使用情况及疗效持久性。

方法

我们对2008年1月至2012年12月在加拿大4家三级医疗中心开始使用英夫利昔单抗的克罗恩病患儿进行了回顾性研究。分别使用逻辑回归和Cox比例风险模型评估与优化使用及因反应丧失而停药相关的先验因素。

结果

180名儿童(54.4%为男孩)开始使用英夫利昔单抗;均完成诱导治疗。开始使用英夫利昔单抗时的中位年龄为14.3岁(四分位间距:12.8,15.9岁),从诊断到开始使用英夫利昔单抗的中位时间为1.5年(四分位间距:0.6,3.5年)。在最后一次随访时,87.1%的患儿持续使用英夫利昔单抗(中位随访时间85.9周[四分位间距:43.8,138.8周])。57.3%的患儿进行了英夫利昔单抗优化(剂量增加15.2%,用药间隔缩短3.9%,两者均有38.2%),主要原因是反应丧失。诊断时年龄较小(<10岁)以及非狭窄、非穿透性病变行为与优化使用相关(优势比分别为6.5,95%置信区间[CI]2.0 - 21.1;优势比2.1,95%CI 1.0 - 4.2)。英夫利昔单抗1年和2年的疗效持久性(继续使用英夫利昔单抗的随访患儿百分比)分别为95.5%(95%CI 90.4 - 98.3)和91.0%(95%CI 82.4 - 96.3)。每年因反应丧失而停药的发生率为3.2%(95%CI 1.1 - 5.2)。

结论

克罗恩病患儿对英夫利昔单抗保持持久反应。优化使用情况频繁出现,使得药物能够持续使用。诊断时年龄较小以及非狭窄、非穿透性病变行为与英夫利昔单抗优化使用需求增加相关。

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