Background Moderate-to-severe atopic dermatitis (AD) in the adolescence is a high burden disease, and its treatment can be very challenging due to paucity of approved systemic drugs for this age and their side-effects. Dupilumab was recently approved for treatment of adolescent AD. Objectives A multicentre, prospective, real-world study on the effectiveness and safety of dupilumab in adolescents (aged from >= 12 to <18 years) with moderate-to-severe AD was conducted. The main AD clinical phenotypes were also examined. Methods Data of adolescents with moderate-to-severe AD treated with dupilumab at label dosage for 16 weeks were collected. Treatment outcome was assessed by EASI, NRS itch, NRS sleep loss and CDLQI scores at baseline and after 16 weeks of treatment. The clinical scores were also evaluated according to clinical phenotypes. Results One hundred and thirty-nine adolescents were enrolled in the study. Flexural eczema and head and neck eczema were the most frequent clinical phenotypes, followed by hand eczema and portrait-like dermatitis. Coexistence of more than 1 phenotype was documented in 126/139 (88.5%) adolescents. Three patients (2.1%) contracted asymptomatic SARS-CoV-2 infection and 1 of the discontinued dupilumab treatment before the target treatment period. A significant improvement in EASI, NRS itch, NRS sleep loss and CDLQI was observed after 16 weeks of treatment with dupilumab. This outcome was better than that observed in clinical trials. Dupilumab resulted effective in all AD phenotypes, especially in diffuse eczema. Twenty-eight (20.1%) patients reported adverse events, conjunctivitis and flushing being the most frequent. None of patients discontinued dupilumab due to adverse event. Conclusions Dupilumab in adolescent AD showed excellent effectiveness at week 16 with consistent improvement of all clinical scores. Moreover, dupilumab showed a good safety profile also in this COVID-19 pandemic era.

Stingeni, L., Bianchi, L., Antonelli, E., Caroppo, E.s., Ferrucci, S.m., Ortoncelli, M., et al. (2022). Moderate-to-severe atopic dermatitis in adolescents treated with dupilumab: A multicentre Italian real-world experience. JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY, 36(8), 1292-1299 [10.1111/jdv.18141].

Moderate-to-severe atopic dermatitis in adolescents treated with dupilumab: A multicentre Italian real-world experience

Bianchi, L;
2022-08

Abstract

Background Moderate-to-severe atopic dermatitis (AD) in the adolescence is a high burden disease, and its treatment can be very challenging due to paucity of approved systemic drugs for this age and their side-effects. Dupilumab was recently approved for treatment of adolescent AD. Objectives A multicentre, prospective, real-world study on the effectiveness and safety of dupilumab in adolescents (aged from >= 12 to <18 years) with moderate-to-severe AD was conducted. The main AD clinical phenotypes were also examined. Methods Data of adolescents with moderate-to-severe AD treated with dupilumab at label dosage for 16 weeks were collected. Treatment outcome was assessed by EASI, NRS itch, NRS sleep loss and CDLQI scores at baseline and after 16 weeks of treatment. The clinical scores were also evaluated according to clinical phenotypes. Results One hundred and thirty-nine adolescents were enrolled in the study. Flexural eczema and head and neck eczema were the most frequent clinical phenotypes, followed by hand eczema and portrait-like dermatitis. Coexistence of more than 1 phenotype was documented in 126/139 (88.5%) adolescents. Three patients (2.1%) contracted asymptomatic SARS-CoV-2 infection and 1 of the discontinued dupilumab treatment before the target treatment period. A significant improvement in EASI, NRS itch, NRS sleep loss and CDLQI was observed after 16 weeks of treatment with dupilumab. This outcome was better than that observed in clinical trials. Dupilumab resulted effective in all AD phenotypes, especially in diffuse eczema. Twenty-eight (20.1%) patients reported adverse events, conjunctivitis and flushing being the most frequent. None of patients discontinued dupilumab due to adverse event. Conclusions Dupilumab in adolescent AD showed excellent effectiveness at week 16 with consistent improvement of all clinical scores. Moreover, dupilumab showed a good safety profile also in this COVID-19 pandemic era.
Pubblicato
Rilevanza internazionale
Articolo
Esperti anonimi
Settore MED/35
English
Antibodies, Monoclonal, Humanized
Double-Blind Method
Humans
Pandemics
Prospective Studies
Pruritus
SARS-CoV-2
Severity of Illness Index
Treatment Outcome
COVID-19
Dermatitis, Atopic
Eczema
Stingeni, L., Bianchi, L., Antonelli, E., Caroppo, E.s., Ferrucci, S.m., Ortoncelli, M., et al. (2022). Moderate-to-severe atopic dermatitis in adolescents treated with dupilumab: A multicentre Italian real-world experience. JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY, 36(8), 1292-1299 [10.1111/jdv.18141].
Stingeni, L; Bianchi, L; Antonelli, E; Caroppo, Es; Ferrucci, Sm; Ortoncelli, M; Fabbrocini, G; Nettis, E; Schena, D; Napolitano, M; Gola, M; Bonzano, L; Rossi, M; Belloni Fortina, A; Balato, A; Peris, K; Foti, C; Guarneri, F; Romanelli, M; Patruno, C; Savoia, P; Fargnoli, Mc; Russo, F; Errichetti, E; Bianchelli, T; Bianchi, L; Pellacani, G; Feliciani, C; Offidani, A; Corazza, M; Micali, G; Milanesi, N; Malara, G; Chiricozzi, A; Tramontana, M; Hansel, K
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2108/304581
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