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author Napolitano, Maddalena
Fabbrocini, Gabriella
Neri, Iria
Stingeni, Luca
Boccaletti, Valeria
Piccolo, Vincenzo
Amoruso, Giuseppe Fabrizio
Malara, Giovanna
De Pasquale, Rocco
Di Brizzi, Eugenia Veronica
Diluvio, Laura
Bianchi, Luca
Chiricozzi, Andrea
Di Guida, Adriana
Del Duca, Elisabetta
Moschese, Viviana
Di Lernia, Vito
Dragoni, Federica
Gruber, Michaela
Hansel, Katharina
Licari, Amelia
Manti, Sara
Leonardi, Salvatore
Mastorino, Luca
Ortoncelli, Michela
Provenzano, Eugenio
Palermo, Antonino
Patella, Vincenzo
Peduto, Tiziana
Pezzolo, Elena
Piras, Viviana
Potestio, Luca
Battista, Teresa
Satta, Rosanna
Termine, Stefania
Palma, Paolo
Zangari, Paola
Patruno, Cataldo
author_facet Napolitano, Maddalena
Fabbrocini, Gabriella
Neri, Iria
Stingeni, Luca
Boccaletti, Valeria
Piccolo, Vincenzo
Amoruso, Giuseppe Fabrizio
Malara, Giovanna
De Pasquale, Rocco
Di Brizzi, Eugenia Veronica
Diluvio, Laura
Bianchi, Luca
Chiricozzi, Andrea
Di Guida, Adriana
Del Duca, Elisabetta
Moschese, Viviana
Di Lernia, Vito
Dragoni, Federica
Gruber, Michaela
Hansel, Katharina
Licari, Amelia
Manti, Sara
Leonardi, Salvatore
Mastorino, Luca
Ortoncelli, Michela
Provenzano, Eugenio
Palermo, Antonino
Patella, Vincenzo
Peduto, Tiziana
Pezzolo, Elena
Piras, Viviana
Potestio, Luca
Battista, Teresa
Satta, Rosanna
Termine, Stefania
Palma, Paolo
Zangari, Paola
Patruno, Cataldo
author_sort Napolitano, Maddalena
collection PubMed
description BACKGROUND: The management of paediatric atopic dermatitis (AD) is challenging, mostly relying on emollients and topical corticosteroids. Dupilumab, a fully human monoclonal antibody, has been recently approved for the treatment of children aged 6–11 years with moderate-to-severe AD not adequately controlled with topical therapies or when those therapies are not advisable. OBJECTIVES: The aim of this study was to evaluate in real life the effectiveness and safety of dupilumab in the treatment of children aged from 6 to 11 years. METHODS: Demographic and clinical data of children aged 6–11 years, affected by moderate-to-severe AD and treated with dupilumab, were retrospectively collected from 24 dermatological and paediatric referral centres. Dupilumab was administered subcutaneously at an induction dose of 300 mg on day (D) 1, followed by 300 mg on D15 and 300 mg every 4 weeks. Disease severity was assessed at baseline and after week 2 (W2), W4 and W16 of dupilumab therapy using Eczema Area Severity Index (EASI), Pruritus Numerical Rating Scale (P-NRS) and Sleep NRS (S-NRS) and Children’s Dermatology Life Quality Index (c-DLQI) score. RESULTS: A total of 55 AD children (24 males [43.64%], 31 females [56.36%]; mean age 9.35 ± 1.75 years) were included. A significant improvement in EASI score, P-NRS, S-NRS and c-DLQI was observed from baseline to W16 of treatment with dupilumab. In particular, at W16 the proportion of patients achieving EASI75 was 74.54%. Moreover, at the same timepoint a significant mean percentage reduction for P-NRS, S-NRS and c-DLQI was also observed (68.39%, 70.22% and 79.03%, respectively). CONCLUSIONS: Our real-life data seem to confirm the effectiveness of dupilumab in paediatric patients on all disease aspects, including extent and severity of signs, intensity of symptoms, sleep and QoL, with a good safety profile.
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spelling pubmed-94179302022-08-30 Dupilumab Treatment in Children Aged 6–11 Years With Atopic Dermatitis: A Multicentre, Real-Life Study Napolitano, Maddalena Fabbrocini, Gabriella Neri, Iria Stingeni, Luca Boccaletti, Valeria Piccolo, Vincenzo Amoruso, Giuseppe Fabrizio Malara, Giovanna De Pasquale, Rocco Di Brizzi, Eugenia Veronica Diluvio, Laura Bianchi, Luca Chiricozzi, Andrea Di Guida, Adriana Del Duca, Elisabetta Moschese, Viviana Di Lernia, Vito Dragoni, Federica Gruber, Michaela Hansel, Katharina Licari, Amelia Manti, Sara Leonardi, Salvatore Mastorino, Luca Ortoncelli, Michela Provenzano, Eugenio Palermo, Antonino Patella, Vincenzo Peduto, Tiziana Pezzolo, Elena Piras, Viviana Potestio, Luca Battista, Teresa Satta, Rosanna Termine, Stefania Palma, Paolo Zangari, Paola Patruno, Cataldo Paediatr Drugs Original Research Article BACKGROUND: The management of paediatric atopic dermatitis (AD) is challenging, mostly relying on emollients and topical corticosteroids. Dupilumab, a fully human monoclonal antibody, has been recently approved for the treatment of children aged 6–11 years with moderate-to-severe AD not adequately controlled with topical therapies or when those therapies are not advisable. OBJECTIVES: The aim of this study was to evaluate in real life the effectiveness and safety of dupilumab in the treatment of children aged from 6 to 11 years. METHODS: Demographic and clinical data of children aged 6–11 years, affected by moderate-to-severe AD and treated with dupilumab, were retrospectively collected from 24 dermatological and paediatric referral centres. Dupilumab was administered subcutaneously at an induction dose of 300 mg on day (D) 1, followed by 300 mg on D15 and 300 mg every 4 weeks. Disease severity was assessed at baseline and after week 2 (W2), W4 and W16 of dupilumab therapy using Eczema Area Severity Index (EASI), Pruritus Numerical Rating Scale (P-NRS) and Sleep NRS (S-NRS) and Children’s Dermatology Life Quality Index (c-DLQI) score. RESULTS: A total of 55 AD children (24 males [43.64%], 31 females [56.36%]; mean age 9.35 ± 1.75 years) were included. A significant improvement in EASI score, P-NRS, S-NRS and c-DLQI was observed from baseline to W16 of treatment with dupilumab. In particular, at W16 the proportion of patients achieving EASI75 was 74.54%. Moreover, at the same timepoint a significant mean percentage reduction for P-NRS, S-NRS and c-DLQI was also observed (68.39%, 70.22% and 79.03%, respectively). CONCLUSIONS: Our real-life data seem to confirm the effectiveness of dupilumab in paediatric patients on all disease aspects, including extent and severity of signs, intensity of symptoms, sleep and QoL, with a good safety profile. Springer International Publishing 2022-08-27 2022 /pmc/articles/PMC9417930/ /pubmed/36028611 http://dx.doi.org/10.1007/s40272-022-00531-0 Text en © The Author(s), under exclusive licence to Springer Nature Switzerland AG 2022, Springer Nature or its licensor holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Original Research Article
Napolitano, Maddalena
Fabbrocini, Gabriella
Neri, Iria
Stingeni, Luca
Boccaletti, Valeria
Piccolo, Vincenzo
Amoruso, Giuseppe Fabrizio
Malara, Giovanna
De Pasquale, Rocco
Di Brizzi, Eugenia Veronica
Diluvio, Laura
Bianchi, Luca
Chiricozzi, Andrea
Di Guida, Adriana
Del Duca, Elisabetta
Moschese, Viviana
Di Lernia, Vito
Dragoni, Federica
Gruber, Michaela
Hansel, Katharina
Licari, Amelia
Manti, Sara
Leonardi, Salvatore
Mastorino, Luca
Ortoncelli, Michela
Provenzano, Eugenio
Palermo, Antonino
Patella, Vincenzo
Peduto, Tiziana
Pezzolo, Elena
Piras, Viviana
Potestio, Luca
Battista, Teresa
Satta, Rosanna
Termine, Stefania
Palma, Paolo
Zangari, Paola
Patruno, Cataldo
Dupilumab Treatment in Children Aged 6–11 Years With Atopic Dermatitis: A Multicentre, Real-Life Study
title Dupilumab Treatment in Children Aged 6–11 Years With Atopic Dermatitis: A Multicentre, Real-Life Study
title_full Dupilumab Treatment in Children Aged 6–11 Years With Atopic Dermatitis: A Multicentre, Real-Life Study
title_fullStr Dupilumab Treatment in Children Aged 6–11 Years With Atopic Dermatitis: A Multicentre, Real-Life Study
title_full_unstemmed Dupilumab Treatment in Children Aged 6–11 Years With Atopic Dermatitis: A Multicentre, Real-Life Study
title_short Dupilumab Treatment in Children Aged 6–11 Years With Atopic Dermatitis: A Multicentre, Real-Life Study
title_sort dupilumab treatment in children aged 6–11 years with atopic dermatitis: a multicentre, real-life study
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9417930/
https://www.ncbi.nlm.nih.gov/pubmed/36028611
http://dx.doi.org/10.1007/s40272-022-00531-0
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