Background: Dupilumab has been shown to be a safe and effective drug for the treatment of atopic dermatitis (AD) in children from 6 months to 11 years in randomized clinical trials. Aim: The aim of this real-life study was to determine the effectiveness in disease control and safety of dupilumab at W52 in moderate-to-severe AD children aged 6-11 years. Methods: All data were collected from 36 Italian dermatological or paediatric referral centres. Dupilumab was administered at label dosage with an induction dose of 300 mg on day 1 (D1), followed by 300 mg on D15 and 300 mg every 4 weeks (Q4W). Treatment effect was determined as overall disease severity, using EASI, P-NRS, S-NRS and c-DLQI at baseline, W16, W24, and W52. Ninety-six AD children diagnosed with moderate-to-severe AD and treated with dupilumab were enrolled. Results: Ninety-one (94.8%) patients completed the 52-week treatment period and were included in the study. A significant improvement in EASI score, P-NRS, S-NRS and c-DLQI was observed from baseline to weeks 16, 24 and 52. Conclusions: Our real-life data seem to confirm dupilumab effectiveness and safety in paediatric patients. Moreover, our experience highlighted that patients achieving clinical improvement at W16 preserved this condition over time.
A 52-week multicenter retrospective real-world study on effectiveness and safety of dupilumab in children with atopic dermatitis aged from 6 to 11 years / Patruno, Cataldo; Fabbrocini, Gabriella; Lauletta, Giuseppe; Boccaletti, Valeria; Colonna, Cristiana; Cavalli, Riccardo; Neri, Iria; Ortoncelli, Michela; Schena, Donatella; Stingeni, Luca; Hansel, Katharina; Piccolo, Vincenzo; Di Brizzi, Eugenia Veronica; Potenza, Concetta; Tolino, Ersilia; Bianchi, Luca; Manti, Sara; De Pasquale, Rocco; Di Lernia, Vito; Caminiti, Lucia; Galli, Elena; Coppo, Paola; Chiricozzi, Andrea; De Simone, Clara; Guerriero, Cristina; Amoruso, Fabrizio Giuseppe; Provenzano, Eugenio; Leonardi, Salvatore; Licari, Amelia; Marseglia, Gian Luigi; Palermo, Antonino; Di Pillo, Sabrina; Russo, Daniele; Moschese, Viviana; Patella, Vincenzo; Peduto, Tiziana; Ferreli, Caterina; Zangari, Paola; Veronese, Federica; Berti, Samantha Federica; Gruber, Michaela; Pezzolo, Elena; Termine, Stefania; Satta, Rosanna; Dragoni, Federica; Esposito, Maria; Fargnoli, Maria Concetta; Chiodini, Paolo; Vallone, Ylenia; di Vico, Francesca; Picone, Vincenzo; Napolitano, Maddalena. - In: THE JOURNAL OF DERMATOLOGICAL TREATMENT. - ISSN 0954-6634. - 34:1(2023), p. 2246602. [10.1080/09546634.2023.2246602]
A 52-week multicenter retrospective real-world study on effectiveness and safety of dupilumab in children with atopic dermatitis aged from 6 to 11 years
Piccolo, Vincenzo;Satta, Rosanna;
2023-01-01
Abstract
Background: Dupilumab has been shown to be a safe and effective drug for the treatment of atopic dermatitis (AD) in children from 6 months to 11 years in randomized clinical trials. Aim: The aim of this real-life study was to determine the effectiveness in disease control and safety of dupilumab at W52 in moderate-to-severe AD children aged 6-11 years. Methods: All data were collected from 36 Italian dermatological or paediatric referral centres. Dupilumab was administered at label dosage with an induction dose of 300 mg on day 1 (D1), followed by 300 mg on D15 and 300 mg every 4 weeks (Q4W). Treatment effect was determined as overall disease severity, using EASI, P-NRS, S-NRS and c-DLQI at baseline, W16, W24, and W52. Ninety-six AD children diagnosed with moderate-to-severe AD and treated with dupilumab were enrolled. Results: Ninety-one (94.8%) patients completed the 52-week treatment period and were included in the study. A significant improvement in EASI score, P-NRS, S-NRS and c-DLQI was observed from baseline to weeks 16, 24 and 52. Conclusions: Our real-life data seem to confirm dupilumab effectiveness and safety in paediatric patients. Moreover, our experience highlighted that patients achieving clinical improvement at W16 preserved this condition over time.File | Dimensione | Formato | |
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