Targeted therapy with dupilumab for children in the Astrakhan region: a clinical study

Background. Based on the central role of interleukin-4 (IL-4) and -13 in the pathogenesis of allergic inflammation, monoclonal antibodies to immunoglobulin G4 that bind to IL-4Ra (dipilumab) and block both IL-4 and -13 signaling pathways are effective pathogenetic tool for controlling allergic inflammation in patients with bronchial asthma (BA). Objective. Evaluation of the efficacy and safety of dupilumab for 52 weeks in children with severe BA. Methods. In our study, the main criteria for initiation of dipilumab therapy were severe BA, age over 12 years for BA patients and/or over 6 years for patients with moderate-to-severe atopic dermatitis, treatment with medium- or high-dose inhaled glucocorticosteroids (IGCS) in combination with 1 or 2 add-on therapies (LABA, LTRA, LAMA); pre-bronchodilatory FEV1 ≤90% of expected values: c-ACT ≤19 points, FEV1 reversibility ≥12%. The study main endpoints included absolute change in pre-bronchodilatory FEV1 at 12 and 52 weeks from baseline; change in Children Asthma Control test (c-ACT) score at 12 and 52 weeks from baseline; annualized frequency of severe BA exacerbations leading to hospitalization or emergency call. Results. The results of study demonstrated the high therapeutic efficacy of the drug, proven by the dynamics of key indicators at the study endpoint. All three patients achieved control of the disease and a confident trend towards growth in indicators to the standard FEV1 values. After a year of therapy with dupilumab, there was a reduction in the volume of basic anti-inflammatory therapy to the second stage, characterized by the use of low-dose glucocorticosteroids as monotherapy. Conclusion. The experience of using pathogenetic therapy with dupilumab in children with severe BA in the Astrakhan region showed a positive effect both on the clinical picture of the disease and the risk of side effects that could lead to drug withdrawal. However, this is the first experience and it requires further monitoring of both existing and treated patients, as well as new ones, which will help to objectify the assessment of the effectiveness and safety of the drug.

bronchial asthma, dupilumab