VOYAGE研究：度普利尤单抗可更好地控制儿童哮喘和生活质量
2023/10/25
摘要
背景：度普利尤单抗可在哮喘未控制的儿童中显示出长期治疗益处。我们更详细地评估了度普利尤单抗对儿童及其护理人员哮喘控制和健康相关生活质量（HRQoL）的影响。
方法：在VOYAGE研究中，患有不受控制的中度至重度2型哮喘（基线血嗜酸性粒细胞≥150个细胞·μL-1或呼出的一氧化氮[FeNO]≥20 ppb;n = 350）的6-11岁儿童接受度普利尤单抗或安慰剂治疗52周。这些分析的主要结局是哮喘控制（与访谈者管理的7项哮喘控制问卷[ACQ-7-IA]的基线相比变化，并取得了≥0.5的临床有意义的反应;哮喘控制良好或更好的患者比例 [ACQ-7-IA ≤0.75]）、对患者的影响（标准化儿科哮喘生活质量问卷 [PAQLQ[S]-IA]）和护理人员（儿科哮喘护理人员生活质量问卷 [PACQLQ] 评分）HRQoL，以及过敏性鼻炎相关的生活质量。
结果：与安慰剂相比，度普利尤单抗在第4周显著改善了儿童的ACQ-7-IA评分，并在第52周持续改善（第52周的最小二乘均差：-0.44,95%CI -0.59至-0.30;p<0.0001）;获得临床意义缓解的比例较高（第52周：86% vs 75%;p=0.0051）。在第24周和第52周，更多接受度普利尤单抗治疗的儿童哮喘得到良好控制（ACQ-7-IA ≤0.75：61% vs 43%，p=0.0001;70% vs 46%，p<0.0001）。到第52周时，观察到PAQLQ[S]-IA和PACQLQ评分显着改善。
结论：在6-11岁的中度至重度2型哮喘儿童中，度普利尤单抗治疗与哮喘控制的速度、持续改善有关。儿童及其照顾者的HRQoL得到了显着改善。
Dupilumab leads to better-controlled asthma & quality of life in children: the VOYAGE study.
Fiocchi AG, Phipatanakul W, Zeiger RS,
Abstrast
Background: Dupilumab has shown long-term treatment benefits in children with uncontrolled asthma. We assessed in more detail the impact of dupilumab on asthma control and health-related quality of life (HRQoL) in children and their caregivers.
Methods: Children aged 6-11 years with uncontrolled moderate-to-severe type 2 asthma (baseline blood eosinophils ≥150 cells·µL-1 or fractional exhaled nitric oxide [FeNO] ≥20 ppb; n=350) were treated with dupilumab or placebo for 52 weeks in the VOYAGE study. Primary outcomes of these analyses were asthma control (change from baseline in Interviewer-Administered 7-item Asthma Control Questionnaire [ACQ-7-IA] and achieving a clinically meaningful response of ≥0.5]; proportion of patients achieving well-controlled asthma or better [ACQ-7-IA ≤0.75]), effect on patients' (Standardised Paediatric Asthma Quality of Life Questionnaire [PAQLQ[S]-IA]), and caregivers' (Paediatric Asthma Caregiver's Quality of Life Questionnaire [PACQLQ] score) HRQoL; and allergic rhinitis-related QoL.
Results：Dupilumab versus placebo significantly improved children's ACQ-7-IA scores by week 4 with sustained improvements through week 52 (least-squares mean difference at week 52: -0.44, 95% CI -0.59 to -0.30; p<0.0001); a higher proportion achieved a clinically meaningful response (week 52: 86% versus 75%; p=0.0051). At weeks 24 and 52, more children who received dupilumab achieved well-controlled asthma (ACQ-7-IA ≤0.75: 61% versus 43%, p=0.0001; 70% versus 46%, p<0.0001, respectively). Significant improvements in PAQLQ[S]-IA and PACQLQ scores were observed by week 52.
Conclusions: In children aged 6-11 years with moderate-to-severe type 2 asthma, dupilumab treatment was associated with rapid, sustained improvements in asthma control. HRQoL was significantly improved for children and their caregivers.
背景：度普利尤单抗可在哮喘未控制的儿童中显示出长期治疗益处。我们更详细地评估了度普利尤单抗对儿童及其护理人员哮喘控制和健康相关生活质量（HRQoL）的影响。
方法：在VOYAGE研究中，患有不受控制的中度至重度2型哮喘（基线血嗜酸性粒细胞≥150个细胞·μL-1或呼出的一氧化氮[FeNO]≥20 ppb;n = 350）的6-11岁儿童接受度普利尤单抗或安慰剂治疗52周。这些分析的主要结局是哮喘控制（与访谈者管理的7项哮喘控制问卷[ACQ-7-IA]的基线相比变化，并取得了≥0.5的临床有意义的反应;哮喘控制良好或更好的患者比例 [ACQ-7-IA ≤0.75]）、对患者的影响（标准化儿科哮喘生活质量问卷 [PAQLQ[S]-IA]）和护理人员（儿科哮喘护理人员生活质量问卷 [PACQLQ] 评分）HRQoL，以及过敏性鼻炎相关的生活质量。
结果：与安慰剂相比，度普利尤单抗在第4周显著改善了儿童的ACQ-7-IA评分，并在第52周持续改善（第52周的最小二乘均差：-0.44,95%CI -0.59至-0.30;p<0.0001）;获得临床意义缓解的比例较高（第52周：86% vs 75%;p=0.0051）。在第24周和第52周，更多接受度普利尤单抗治疗的儿童哮喘得到良好控制（ACQ-7-IA ≤0.75：61% vs 43%，p=0.0001;70% vs 46%，p<0.0001）。到第52周时，观察到PAQLQ[S]-IA和PACQLQ评分显着改善。
结论：在6-11岁的中度至重度2型哮喘儿童中，度普利尤单抗治疗与哮喘控制的速度、持续改善有关。儿童及其照顾者的HRQoL得到了显着改善。
(中日友好医院呼吸与危重症医学科 万静萱 摘译 林江涛 审校)
(Eur Respir J 2023 Sep 21;doi: 10.1183/13993003.00558-2023. IF：12.339.)
(Eur Respir J 2023 Sep 21;doi: 10.1183/13993003.00558-2023. IF：12.339.)
Dupilumab leads to better-controlled asthma & quality of life in children: the VOYAGE study.
Fiocchi AG, Phipatanakul W, Zeiger RS,
Abstrast
Background: Dupilumab has shown long-term treatment benefits in children with uncontrolled asthma. We assessed in more detail the impact of dupilumab on asthma control and health-related quality of life (HRQoL) in children and their caregivers.
Methods: Children aged 6-11 years with uncontrolled moderate-to-severe type 2 asthma (baseline blood eosinophils ≥150 cells·µL-1 or fractional exhaled nitric oxide [FeNO] ≥20 ppb; n=350) were treated with dupilumab or placebo for 52 weeks in the VOYAGE study. Primary outcomes of these analyses were asthma control (change from baseline in Interviewer-Administered 7-item Asthma Control Questionnaire [ACQ-7-IA] and achieving a clinically meaningful response of ≥0.5]; proportion of patients achieving well-controlled asthma or better [ACQ-7-IA ≤0.75]), effect on patients' (Standardised Paediatric Asthma Quality of Life Questionnaire [PAQLQ[S]-IA]), and caregivers' (Paediatric Asthma Caregiver's Quality of Life Questionnaire [PACQLQ] score) HRQoL; and allergic rhinitis-related QoL.
Results：Dupilumab versus placebo significantly improved children's ACQ-7-IA scores by week 4 with sustained improvements through week 52 (least-squares mean difference at week 52: -0.44, 95% CI -0.59 to -0.30; p<0.0001); a higher proportion achieved a clinically meaningful response (week 52: 86% versus 75%; p=0.0051). At weeks 24 and 52, more children who received dupilumab achieved well-controlled asthma (ACQ-7-IA ≤0.75: 61% versus 43%, p=0.0001; 70% versus 46%, p<0.0001, respectively). Significant improvements in PAQLQ[S]-IA and PACQLQ scores were observed by week 52.
Conclusions: In children aged 6-11 years with moderate-to-severe type 2 asthma, dupilumab treatment was associated with rapid, sustained improvements in asthma control. HRQoL was significantly improved for children and their caregivers.
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墨旱莲甲醇提取物通过抑制NF-kappa-B途径降低慢性过敏性哮喘小鼠模型炎症
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重度哮喘患者的烟草暴露和生物治疗的疗效:来自丹麦重度哮喘登记的一项全国性研究
