Evaluation of Dupilumab Therapy of Children with Multimorbid Atopic Phenotype: Preliminary Data from an Observational Study

Background. The genetically engineered biological drug dupilumab, which blocks the IL-4 and IL-13 signaling pathways, has demonstrated high efficacy in the treatment of Atopic Eczema (AE) in children and adults. However, there are no studies in Russia that evaluate the clinical response and the dynamics of biomarkers in children of different ages with a multimorbid atopic phenotype who receive therapy with this drug. The aim of the study is to evaluate the efficacy and safety of dupilumab, as well as to analyze the dynamics of inflammation biomarkers in children with a multimorbid atopic phenotype, including patients with moderate to severe AE.

Methods. A prospective observational study included 15 children aged 6 months to 17 years 11 months. All patients received dupilumab for at least 16 weeks. Clinical efficacy was assessed using the SCORAD and EASI scales (with SCORAD-50/75/90 and EASI-50/75/90), quality of life (CDLQI), and control of concomitant diseases (ACT, VAS). Biomarkers (periostin, VEGF, DPP4, eosinophils, and FeNO) were determined before and 16 weeks after the start of therapy.

Results. By the 16th week, all patients had reached SCORAD-50 and EASI-50, 80% had reached SCORAD-75, 100% had reached EASI-75, 60% had reached SCORAD-90, and 87% had reached EASI-90. During the treatment, there was a decrease in the levels of periostin (median change of –8%), VEGF (–9.7%), and a tendency towards a decrease in the number of eosinophils and FeNO, while the levels of DPP4 remained stable. The quality of life improved in most patients, and the accompanying manifestations (bronchial asthma, allergic rhinitis) were under full control. Side effects were limited to local reactions and conjunctivitis.

Conclusion. Dupilumab therapy in children with a multimorbid atopic phenotype, including patients with moderate to severe AE, provides rapid and persistent clinical improvement, a decrease in the severity of inflammatory markers, and an improvement in quality of life. The data obtained confirm the efficacy and safety of the drug and indicate the prospects for using biomarkers to predict the individual response to therapy.

1. Atopicheskii dermatit: Clinical guidelines. Ministry of Health of the Russian Federation; 2024. 100 p. (In Russ). Доступно по: https://cr.minzdrav.gov.ru/viewcr/265_3. Ссылка активна на 26.08.2025.

2. Schmitt J, Spuls PI, Thomas KS, et al. The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials. J Allergy Clin Immunol. 2014;134(4):800–807. doi: https://doi.org/10.1016/j.jaci.2014.07.043

3. Lewis-Jones MS, Finlay AY, Dykes PJ. The Infants’ Dermatitis Quality of Life Index. Br J Dermatol. 2001;144(1):104–110. doi: https://doi.org/10.1046/j.1365-2133.2001.03960.x

4. Simpson EL, Bieber T, Guttman-Yassky E, et al. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335–2348. doi: https://doi.org/10.1056/NEJMoa1610020

5. Park CO, Kim SM, Lee KH, Bieber T. Biomarkers for phenotypeendotype relationship in atopic dermatitis: a critical review. EBioMedicine. 2024;103:105121. doi: https://doi.org/10.1016/j.ebiom.2024.105121

6. Ebisawa M, Kataoka Y, Tanaka A, et al. Efficacy and safety of dupilumab with concomitant topical corticosteroids in Japanese pediatric patients with moderate-to-severe atopic dermatitis: A randomized, double-blind, placebo-controlled phase 3 study. Allergol Int. 2024;73(4):532–542. doi: https://doi.org/10.1016/j.alit.2024.04.006

7. Chopra R, Vakharia PP, Sacotte R, et al. Relationship between EASI and SCORAD severity assessments for atopic dermatitis. J Allergy Clin Immunol. 2017;140(6):1708–1710.e1. doi: https://doi.org/10.1016/j.jaci.2017.04.052

8. Beck LA, Muraro A, Boguniewicz M, et al. Dupilumab reduces inflammatory biomarkers in pediatric patients with moderate-tosevere atopic dermatitis. J Allergy Clin Immunol. 2025;155(1):135–143. doi: https://doi.org/10.1016/j.jaci.2024.08.005

9. Kamphuis E, Boesjes CM, Loman L, et al. Dupilumab in daily practice for the treatment of pediatric atopic dermatitis: 28-week clinical and biomarker results from the BioDay registry. Pediatr Allergy Immunol. 2022;33(12):e13887. doi: https://doi.org/10.1111/pai.13887