Real-life retrospective multicentre study to describe the use of dupilumab in paediatric patients with atopic dermatitis in Spain: Patient profile, effectiveness and safety

BackgroundDupilumab, inhibiting interleukin 4 and 13, is the first monoclonal antibody licensed for atopic dermatitis (AD) since 6 months of age.ObjectivesThe study describes the patients' profile, the effectiveness and safety in real life of dupilumab in adolescents with moderate-severe AD and...

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Detalles Bibliográficos
Autores: Torres, EB, Ivars, M, Prat, C, Vicente, A, Rodríguez, MF, Pedrero, RM, Santiago, AM, Giacaman, A, Fernández, AT, Noguera-Morel, L, Mas, IB, Gracia, LD, Buselli, MÉ, Ruiz, MP, Wittel, JB, García, MTM, Domínguez, MC, Osuna, CG, Jiménez, JSJ, Martínez, AE, Ninet, VZ, Andreu, MC, Pérez, SIP, Hernández, JS, Alom, SD, Divasson, LF, Cebey, AB, Gutiérrez, MG, Laguna, RD
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Fundació Sant Joan de Déu
Repositorio:r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
OAI Identifier:oai:fsjd.fundanetsuite.com:p27449
Acceso en línea:https://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=27449
Access Level:acceso abierto
Palabra clave:anti-IL13
atopic dermatitis
anti-IL14, eczema
dupilumab
paediatric
Descripción
Sumario:BackgroundDupilumab, inhibiting interleukin 4 and 13, is the first monoclonal antibody licensed for atopic dermatitis (AD) since 6 months of age.ObjectivesThe study describes the patients' profile, the effectiveness and safety in real life of dupilumab in adolescents with moderate-severe AD and children with severe AD.MethodsNational, multicentre, observational, and retrospective study, based on medical records' data extracted in September 2023. Patients included were adolescents (12-17 years) with moderate-severe AD (Eczema Area and Severity Index [EASI] >= 16) and children (6-11 years) with severe AD (EASI >= 21) at the start of dupilumab therapy and treated with dupilumab for at least 3 months.ResultsAmong the 211 analysed patients, at dupilumab treatment onset, 69.6% registered an Investigator's Global Assessment (IGA) = 4, a median Dermatology Life Quality Index (DLQI) = 17, and a median Peak Pruritus Numerical Rating Scale (PP-NRS) = 8. Atopic comorbidities were present in 69.7% of the patients. Overall, 97.1% of the patients had received systemic treatments before dupilumab, being oral corticosteroids (75.5%) the most frequent. At 16 and 52 weeks, the mean EASI percentage reductions from baseline were -77.5% and -84.7%, respectively, and 71.8% and 82.4% of the patients achieved EASI <= 7. A total of 70.5% and 36.5% (16 weeks), and 78% and 48.4% (52 weeks) of the patients had EASI-75 and EASI-90, respectively. At week 52, 70% and 87% of the patients achieved a reduction of >= 4 PP-NRS points and of >= 6 DLQI points, respectively. No serious dupilumab-related adverse events were reported; 6.2% presented treatment-related conjunctivitis and 1.4% reported eosinophilia, but without treatment discontinuation.ConclusionsThe study population had a pronounced disease burden as defined by signs, symptoms, quality of life, atopic comorbidities, and the systemic treatments' use prior dupilumab. In a short time (16 weeks), dupilumab treatment demonstrated clinically relevant improvement with an acceptable safety profile, continued over 52 weeks.

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