Abstract

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. 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. 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 (FEV1% pred) and small airways like percent predicted forced expiratory flow at 25-75%, were significantly higher than those before dupilumab (all P < 0.05). 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.

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