Dynamics of laboratory blood parameters in children with atopic dermatitis who received biological therapy with AN IL-4, IL-13 inhibitor in combination with topical therapy methods
L.L. Rusakova, N.N. Murashkin
Objective: Evaluation of the dynamics of laboratory blood parameters and the safety of using an IL-4, IL-13 inhibitor (dupilumab) in combination with topical therapy methods in children over 2 years of age with moderate and severe atopic dermatitis in the aspect of 2-year follow-up.
Materials and methods: A 2-year observational study was conducted in 120 children aged 2 to 17 years with atopic dermatitis who received biological therapy with dupilumab in combination with topical therapy methods. Patients were divided into 3 groups by the nature of the therapy. At the 16th, 28th, 52nd, 64th, 104th week of follow-up, all patients underwent laboratory clinical blood and urine tests, a biochemical blood test, and a study of the total IgE level.
Results: The effect of the IL-4, IL-13 inhibitor (dupilumab) in combination with various methods of topical therapy in children with AD during a 2-year follow-up showed that the dynamics of blood biochemical parameters did not undergo statistically significant changes (p>0.05). In all groups, these parameters were within the reference values throughout the follow-up period. Laboratory parameters of the complete blood count showed minor eosinophilia, which decreased to normal values with continued treatment. No statistically significant changes were found in the complete urine analysis either. And when assessing the IgE level, a stable statistically significant (p<0.05) decrease in laboratory parameters was observed from period to period.
Conclusion: Long-term assessment of the dynamics of laboratory parameters in children over 2 years old with moderate and severe AD in the context of 2-year follow-up who received dupilumab in combination with complex methods of topical therapy demonstrated no need for laboratory monitoring and confirmed the safety and efficacy of this therapy and prevention of AD exacerbations, which indicates the advisability of supplementing the complex treatment algorithm.
For citations: Rusakova L.L., Murashkin N.N. Dynamics of laboratory blood parameters in children with atopic dermatitis who received biological therapy with AN IL-4, IL-13 inhibitor in combination with topical therapy methods. Farmateka. 2025;32(1 suppl. 1):40-49. (In Russ.). doi: 10.18565/pharmateca.2025.1-s1.40-49
Authors’ contribution: Article concept development – N.N. Murashkin, material collection and analysis – N.N. Murashkin, L.L. Rusakova, text writing – L.L. Rusakova, article editing – N.N. Murashkin. All authors are responsible for the content and integrity of the entire article.
Conflicts of interest: N.N. Murashkin – receiving research grants from Janssen, Eli Lilly, Novartis, AbbVie, Pfizer, Amryt Pharma plc. pharmaceutical companies, receiving fees for scientific consulting from Galderma, L’Oreal, NAOS, Pierre Fabre, Bayer, LEO Pharma, Pfizer, Sanofi, Novartis, AbbVie, Glenmark, Janssen, Invar, Librederm, Viatris, JGL, B.Braun, Swixx BioPharma.
The remaining authors have confirmed that they have no conflict of interests to report.
Funding: The study was conducted without any sponsorship.
Ethical Approval: The study was approved by the Local Scientific Ethics Committee at the National Medical Research Center for Children’s Health of the Ministry of Health of the Russian Federation – extract from protocol No. 2 dated 02/20/2023.
Patient Consent for Publication: All patients provided informed consent for the publication of their data.
Authors’ Data Sharing Statement: The data supporting the findings of this study are available upon request from the corresponding author after approval from the principal investigator.
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About the Authors
Lyudmila Leonidovna Rusakova, Junior Researcher, Laboratory of Skin Pathology in Children, National Medical Research Center for Children’s Health (Moscow); Deputy Chief Physician for Medical Affairs, Bryansk Regional Skin and Venereal Diseases Dispensary (Bryansk); Chief Specialist in Dermatovenereology and Cosmetology, Bryansk Regional Health Department, Russia; ORCID: https://orcid.org/0000-0003-4297-4631Nikolay N. Murashkin, Dr. Sci. (Med.), Professor, Head of the Research Institute of Pediatric Dermatology, Head of the Department of Dermatology and Allergology, Head of the Laboratory of Skin Pathology in Children, Department of Scientific Research in Pediatrics, National Medical Research Center for Children’s Health; Professor, Department of Dermatovenereology and Cosmetology, Central State Medical Academy of the Administrative Directorate of the President of the Russian Federation, Professor, Department of Pediatrics and Pediatric Rheumatology, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia; m_nn2001@mail.ru, ORCID: https://orcid.org/0000-0003-2252-8570 (corresponding author)