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度普利尤单抗治疗中度至重度哮喘合并2型炎症性疾病儿童的评估。

The assessment of dupilumab in children with moderate-to-severe asthma and comorbid type 2 inflammatory diseases.

作者信息

Shi Tingting, Wu Shuning, Chen Rongshan, Xie Yaping, Yin Genquan, He Chunhui, Liang Cuiping, Lu Gen

机构信息

Department of respiratory, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.

BSL-3 Laboratory (Guangdong), Guangdong Provincial Key Laboratory of Tropical Disease Research, School of Public Health, Southern Medical University, Guangzhou, China.

出版信息

BMC Pulm Med. 2024 Dec 16;24(1):607. doi: 10.1186/s12890-024-03414-x.

DOI:10.1186/s12890-024-03414-x
PMID:39681861
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11650844/
Abstract

BACKGROUND

Dupilumab inhibiting the signaling of interleukin(IL)-4 and IL-13 was recommended for the treatment of severe asthma in children ≥ 6 years old according to the Global Initiative for Asthma (GINA,2024).This study aimed to analyse the efficacy and safety of dupilumab in paediatric patients with moderate-to-severe asthma and comorbid type 2 inflammatory disease in a real-world population.

METHODS

We evaluated the medical records of paediatric patients with moderate-to-severe asthma and comorbid type 2 inflammatory diseases, such as atopic dermatitis (AD) and allergic rhinitis (AR), receiving dupilumab treatment.

RESULTS

Twenty-five children (16 boys; mean age, 9.32 ± 2.58 years) were included. All the patients were diagnosed with moderate-to-severe asthma, 92% (23/25) with AR, and 64.0% (16/25) with AD. Among the 25 patients, no severe adverse reactions occurred, the times of severe asthma exacerbation were significantly lower, and the Asthma Control Test (ACT) / Child-Asthma Control Test (C-ACT) scores were significantly higher than those before the 24-week dupilumab treatment (all P = 0.00). The Patient-Oriented Eczema Measure(POEM) and Peak Pruritus Numerical Rating Scale(NRS), Rhinitis Four-point, and Rhinitis Visual Analogue Scale(VAS) scores were significantly lower than those at baseline (all P < 0.05). After receiving 24-week dupilumab treatment, the serum total immunoglobulin E (tIgE) and fractional exhaled nitric oxide (FeNO) level were reduced by 56.54% and 70.47% respectively at the 24th week (P = 0.00); the lung function parameters including large airways such as percent predicted forced expiratory volume in one second (FEV% pred) and small airways like percent predicted forced expiratory flow at , were significantly higher than those before dupilumab (all P < 0.05).

CONCLUSIONS

Dupilumab reduced asthma exacerbations and improved symptom control without severe adverse reactions in paediatric patients with moderate-to-severe asthma and comorbid type 2 inflammatory diseases. It also decreased biomarkers of type 2 inflammation and improved lung function parameters, including both large and small airways. Considering the racial diversity, a large real-world study in China is required to confirm the role of dupilumab in paediatric patients with moderate-to-severe asthma and comorbid type 2 inflammatory diseases.

摘要

背景

根据全球哮喘防治创议(GINA,2024),度普利尤单抗可抑制白细胞介素(IL)-4和IL-13信号传导,被推荐用于治疗6岁及以上儿童的重度哮喘。本研究旨在分析度普利尤单抗在患有中度至重度哮喘且合并2型炎症性疾病的真实世界儿科患者中的疗效和安全性。

方法

我们评估了接受度普利尤单抗治疗的患有中度至重度哮喘且合并2型炎症性疾病(如特应性皮炎(AD)和变应性鼻炎(AR))的儿科患者的病历。

结果

纳入25名儿童(16名男孩;平均年龄9.32±2.58岁)。所有患者均被诊断为中度至重度哮喘,92%(23/25)患有AR,64.0%(16/25)患有AD。在这25名患者中,未发生严重不良反应,重度哮喘加重次数显著减少,哮喘控制测试(ACT)/儿童哮喘控制测试(C-ACT)得分显著高于度普利尤单抗治疗24周前(所有P=0.00)。患者导向性湿疹评估量表(POEM)、瘙痒峰值数字评定量表(NRS)、鼻炎四分法及鼻炎视觉模拟量表(VAS)得分均显著低于基线水平(所有P<0.05)。接受度普利尤单抗24周治疗后,第24周时血清总免疫球蛋白E(tIgE)和呼出一氧化氮分数(FeNO)水平分别降低了56.54%和70.47%(P=0.00);包括一秒用力呼气容积预测值百分比(FEV%pred)等大气道以及如等小气道的肺功能参数均显著高于度普利尤单抗治疗前(所有P<0.05)。

结论

度普利尤单抗可减少患有中度至重度哮喘且合并2型炎症性疾病的儿科患者的哮喘加重次数,并改善症状控制,且无严重不良反应。它还降低了2型炎症的生物标志物水平,改善了包括大气道和小气道在内的肺功能参数。考虑到种族差异,需要在中国开展一项大型真实世界研究,以确认度普利尤单抗在患有中度至重度哮喘且合并2型炎症性疾病的儿科患者中的作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0312/11650844/aec5771f7136/12890_2024_3414_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0312/11650844/4a9af6a33708/12890_2024_3414_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0312/11650844/404aae7ec550/12890_2024_3414_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0312/11650844/aec5771f7136/12890_2024_3414_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0312/11650844/4a9af6a33708/12890_2024_3414_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0312/11650844/404aae7ec550/12890_2024_3414_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0312/11650844/aec5771f7136/12890_2024_3414_Fig3_HTML.jpg

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