Dupilumab Treatment in Children Aged 6–11 Years With Atopic Dermatitis: A Multicentre, Real-Life Study

• Published in: Paediatric drugs Vol. 24; no. 6; pp. 671 - 678
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: Auckland Springer 01.11.2022; Springer Nature B.V; Springer International Publishing
• Subjects: Age; Asthma; Atopic dermatitis; Children; Children & youth; Demographic aspects; Dermatitis; Dermatology; Disease; Drug dosages; Drug therapy; Eczema; FDA approval; Health aspects; Light therapy; Monoclonal antibodies; Original; Patient outcomes; Pediatrics; Pruritus; Quality of life; Skin care products; Sleep; Software; Steroids; Italy; United States > US
• ISSN: 1174-5878; 1179-2019
• DOI: 10.1007/s40272-022-00531-0

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.