Observational study of pimecrolimus 1% cream for prevention of transcutaneous sensitization in children with atopic dermatitis during their first year of life

Nikolay N Murashkin; Leyla S Namazova-Baranova; Svetlana G Makarova; Roman A Ivanov; Stepan G Grigorev; Dmitri V Fedorov; Eduard T Ambarchian; Roman V Epishev; Alexander I Materikin; Leonid A Opryatin; Alena A Savelova

doi:10.3389/fped.2023.1102354

Observational study of pimecrolimus 1% cream for prevention of transcutaneous sensitization in children with atopic dermatitis during their first year of life

Front Pediatr. 2023 Apr 25:11:1102354. doi: 10.3389/fped.2023.1102354. eCollection 2023.

Authors

Nikolay N Murashkin^{1

2

3

4}, Leyla S Namazova-Baranova^{4

5}, Svetlana G Makarova¹, Roman A Ivanov¹, Stepan G Grigorev^{6

7}, Dmitri V Fedorov¹, Eduard T Ambarchian^{1

4}, Roman V Epishev^{1

4}, Alexander I Materikin¹, Leonid A Opryatin¹, Alena A Savelova¹

Affiliations

¹ National Medical Research Center for Children's Health, Moscow, Russia.
² Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
³ Central State Medical Academy of the Presidential Administration of the Russian Federation, Moscow, Russia.
⁴ Research Institute for Pediatrics and Children's Health Protection, Federal National Public Healthcare Institution "Central Clinical Hospital of the Russian Academy of Sciences", Ministry of Science and Higher Education, Moscow, Russia.
⁵ Pirogov Russian National Research Medical University, Moscow, Russia.
⁶ Kirov Military Medical Academy, St Petersburg, Russia.
⁷ Pediatric Infectious Disease Clinical Research Center of the Federal Medical Biological Agency, St Petersburg, Russia.

Abstract

Introduction: Epidermal barrier dysfunction in children with atopic dermatitis can cause transcutaneous sensitization to allergens and allergic diseases. We evaluated the effectiveness of an early-intervention algorithm for atopic dermatitis treatment, utilizing pimecrolimus for long-term maintenance therapy, in reducing transcutaneous sensitization in infants.

Method: This was a single-center cohort observational study that enrolled children aged 1-4 months with family history of allergic diseases, moderate-to-severe atopic dermatitis, and sensitization to ≥ 1 of the investigated allergens. Patients who sought medical attention at atopic dermatitis onset (within 10 days) were group 1 "baseline therapy with topical glucocorticoids with subsequent transition to pimecrolimus as maintenance therapy"; patients who sought medical attention later were group 2 "baseline and maintenance therapy with topical glucocorticoids, without subsequent use of pimecrolimus". Sensitization class and level of allergen-specific immunoglobulin E were determined at baseline, and 6 and 12 months of age. Atopic dermatitis severity was evaluated using the Eczema Area and Severity Index score at baseline and 6, 9 and 12 months of age.

Results: Fifty-six and 52 patients were enrolled in groups 1 and 2, respectively. Compared with group 2, group 1 demonstrated a lower level of sensitization to cow's milk protein, egg white and house dust mite allergen at 6 and 12 months of age, and a more pronounced decrease in atopic dermatitis severity at 6, 9 and 12 months of age. No adverse events occurred.

Discussion: The pimecrolimus-containing algorithm was effective in treating atopic dermatitis and prophylaxis of early forms of allergic diseases in infants.

Trial registration: https://clinicaltrials.gov/ NCT04900948, retrospectively registered, 25 May 2021.

Keywords: atopic dermatitis; children; food allergens; indoor allergens; pimecrolimus; sensitization.

Associated data

ClinicalTrials.gov/NCT04900948

Grants and funding

Medical writing assistance in the preparation of this manuscript was funded by Meda Pharma S.p.A., a Viatris company.