Abstract：
BACKGROUND: The phase 3 VOYAGE (NCT02948959) and open-label extension EXCURSION (NCT03560466) studies evaluated dupilumab in children (6-11 years) with uncontrolled moderate-to-severe asthma. This post hoc analysis assessed the efficacy and safety of add-on dupilumab 200 mg every 2 weeks (q2w), the largest dose cohort in both studies, in children from VOYAGE who participated in EXCURSION.
METHODS: Annualized rate of severe asthma exacerbations (AERs), change in prebronchodilator percent predicted forced expiratory volume in 1 s (ppFEV1), and treatment-emergent adverse events were assessed in children with moderate-to-severe asthma who received dupilumab 200 mg q2w in VOYAGE and EXCURSION (dupilumab/dupilumab arm) and those who received placebo in VOYAGE and dupilumab 200 mg q2w in EXCURSION (placebo/dupilumab arm). These endpoints were also assessed in children with moderate-to-severe type 2 asthma (defined as blood eosinophil count ≥150 cells/µL or FeNO ≥20 ppb at the parent study baseline [PSBL]).
RESULTS: In the overall population, dupilumab reduced AER and improved prebronchodilator ppFEV1 in the dupilumab/dupilumab arm (n = 158) for up to 2 years. Children receiving placebo/dupilumab (n = 85) showed similar reductions after initiation of dupilumab 200 mg q2w in EXCURSION. Similar results were observed for children with type 2 asthma at PSBL. The safety profile was consistent with the known safety profile of dupilumab.
CONCLUSIONS: In children (6-11 years) with uncontrolled moderate-to-severe type 2 asthma, dupilumab 200 mg reduced exacerbation rates and improved lung function for up to 2 years and showed safety consistent with the known dupilumab safety profile.
METHODS: Annualized rate of severe asthma exacerbations (AERs), change in prebronchodilator percent predicted forced expiratory volume in 1 s (ppFEV1), and treatment-emergent adverse events were assessed in children with moderate-to-severe asthma who received dupilumab 200 mg q2w in VOYAGE and EXCURSION (dupilumab/dupilumab arm) and those who received placebo in VOYAGE and dupilumab 200 mg q2w in EXCURSION (placebo/dupilumab arm). These endpoints were also assessed in children with moderate-to-severe type 2 asthma (defined as blood eosinophil count ≥150 cells/µL or FeNO ≥20 ppb at the parent study baseline [PSBL]).
RESULTS: In the overall population, dupilumab reduced AER and improved prebronchodilator ppFEV1 in the dupilumab/dupilumab arm (n = 158) for up to 2 years. Children receiving placebo/dupilumab (n = 85) showed similar reductions after initiation of dupilumab 200 mg q2w in EXCURSION. Similar results were observed for children with type 2 asthma at PSBL. The safety profile was consistent with the known safety profile of dupilumab.
CONCLUSIONS: In children (6-11 years) with uncontrolled moderate-to-severe type 2 asthma, dupilumab 200 mg reduced exacerbation rates and improved lung function for up to 2 years and showed safety consistent with the known dupilumab safety profile.
摘要：
背景：3期VOYAGE（NCT02948959）和开放标签延伸EXCURSION（NCT03560466）研究评估了dupilumab在儿童（6-11岁）未控制的中度至重度哮喘中的治疗。此事后分析评估了每2周（q2w）添加的dupilumab200mg的疗效和安全性，两项研究中最大的剂量队列，参加旅行的VOYAGE儿童。
方法：重度哮喘急性发作（AERs）的年化发生率，1s内支气管扩张剂前预测用力呼气量百分比的变化（ppFEV1），在VOYAGE和EXCURSION(dupilumab/dupilumab组)中接受dupilumab200mgq2w治疗的中重度哮喘儿童,以及在VOYAGE中接受安慰剂和在EXCURSION中接受dupilumab200mgq2w治疗的儿童(安慰剂/dupilumab组),我们对因治疗引起的不良事件进行在患有中度至重度2型哮喘的儿童中也评估了这些终点（定义为在父母研究基线[PSBL]时血液嗜酸性粒细胞计数≥150个细胞/µL或FeNO≥20ppb）。
结果：在总体人口中，dupilumab在dupilumab/dupilumab组(n=158)中降低了AER并改善了支气管扩张剂前ppFEV1,持续2年.接受安慰剂/dupilumab的儿童（n=85）在EXCURSION中开始使用dupilumab200mgq2w后显示出类似的减少。对于PSBL的2型哮喘儿童也观察到了类似的结果。安全性与dupilumab的已知安全性一致。
结论：在未控制的中度至重度2型哮喘的儿童（6-11岁）中，dupilumab200mg可在长达2年的时间内降低加重率并改善肺功能,其安全性与已知的dupilumab安全性一致.
方法：重度哮喘急性发作（AERs）的年化发生率，1s内支气管扩张剂前预测用力呼气量百分比的变化（ppFEV1），在VOYAGE和EXCURSION(dupilumab/dupilumab组)中接受dupilumab200mgq2w治疗的中重度哮喘儿童,以及在VOYAGE中接受安慰剂和在EXCURSION中接受dupilumab200mgq2w治疗的儿童(安慰剂/dupilumab组),我们对因治疗引起的不良事件进行在患有中度至重度2型哮喘的儿童中也评估了这些终点（定义为在父母研究基线[PSBL]时血液嗜酸性粒细胞计数≥150个细胞/µL或FeNO≥20ppb）。
结果：在总体人口中，dupilumab在dupilumab/dupilumab组(n=158)中降低了AER并改善了支气管扩张剂前ppFEV1,持续2年.接受安慰剂/dupilumab的儿童（n=85）在EXCURSION中开始使用dupilumab200mgq2w后显示出类似的减少。对于PSBL的2型哮喘儿童也观察到了类似的结果。安全性与dupilumab的已知安全性一致。
结论：在未控制的中度至重度2型哮喘的儿童（6-11岁）中，dupilumab200mg可在长达2年的时间内降低加重率并改善肺功能,其安全性与已知的dupilumab安全性一致.
