Journal of Dermatological Treatment (Dec 2023)
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
- Cataldo Patruno,
- Gabriella Fabbrocini,
- Giuseppe Lauletta,
- Valeria Boccaletti,
- Cristiana Colonna,
- Riccardo Cavalli,
- Iria Neri,
- Michela Ortoncelli,
- Donatella Schena,
- Luca Stingeni,
- Katharina Hansel,
- Vincenzo Piccolo,
- Veronica Di Brizzi,
- Concetta Potenza,
- Ersilia Tolino,
- Luca Bianchi,
- Sara Manti,
- Rocco De Pasquale,
- Vito Di Lernia,
- Lucia Caminiti,
- Elena Galli,
- Paola Coppo,
- Andrea Chiricozzi,
- Clara De Simone,
- Cristina Guerriero,
- Fabrizio Giuseppe Amoruso,
- Eugenio Provenzano,
- Salvatore Leonardi,
- Amelia Licari,
- Gian Luigi Marseglia,
- Antonino Palermo,
- Sabrina Di Pillo,
- Daniele Russo,
- Viviana Moschese,
- Vincenzo Patella,
- Tiziana Peduto,
- Caterina Ferreli,
- Paola Zangari,
- Federica Veronese,
- Samantha Federica Berti,
- Michaela Gruber,
- Elena Pezzolo,
- Stefania Termine,
- Rosanna Satta,
- Federica Dragoni,
- Maria Esposito,
- Maria Concetta Fargnoli,
- Paolo Chiodini,
- Ylenia Vallone,
- Francesca di Vico,
- Vincenzo Picone,
- Maddalena Napolitano
Affiliations
- Cataldo Patruno
- Department of Health Sciences, University Magna Graecia of Catanzaro
- Gabriella Fabbrocini
- Department of Clinical Medicine and Surgery, Section of Dermatology, University of Naples Federico II
- Giuseppe Lauletta
- Department of Clinical Medicine and Surgery, Section of Dermatology, University of Naples Federico II
- Valeria Boccaletti
- Department of Medicine, Section of Dermatology, University of Brescia
- Cristiana Colonna
- Pediatric Dermatology Unit, Department of Clinical Sciences and Community Health, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico
- Riccardo Cavalli
- Pediatric Dermatology Unit, Department of Clinical Sciences and Community Health, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico
- Iria Neri
- Unit of Dermatology, IRCCS AOU di Policlinico S Orsola, University of Bologna
- Michela Ortoncelli
- Department of Medical Sciences, Division of Dermatology, University of Turin
- Donatella Schena
- Department of Medicine, Section of Dermatology and Venereology, University of Verona
- Luca Stingeni
- Department of Medicine and Surgery, Dermatology Section, University of Perugia
- Katharina Hansel
- Department of Medicine and Surgery, Dermatology Section, University of Perugia
- Vincenzo Piccolo
- Dermatology Unit, University of Campania Luigi Vanvitelli
- Veronica Di Brizzi
- Dermatology Unit, University of Campania Luigi Vanvitelli
- Concetta Potenza
- Department of Medical-Surgical Sciences and Biotechnologies, Dermatology Unit "Daniele Innocenzi", Sapienza University of Rome
- Ersilia Tolino
- Department of Medical-Surgical Sciences and Biotechnologies, Dermatology Unit "Daniele Innocenzi", Sapienza University of Rome
- Luca Bianchi
- Dermatology Unit, Policlinico Tor Vergata, System Medicine Department, University of Tor Vergata
- Sara Manti
- Dermatology Unit, Policlinico Tor Vergata, System Medicine Department, University of Tor Vergata
- Rocco De Pasquale
- U.O. Dermatologia, Ospedale San Marco
- Vito Di Lernia
- Dermatology Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia
- Lucia Caminiti
- Policlinico Hospital-University of Messina
- Elena Galli
- UOS Immuno Allergologia dell’Età evolutiva, Ospedale San Pietro-Fatebenefratelli
- Paola Coppo
- Pediatric Endocrinology Unit, Regina Margherita Children’s Hospital, Città Della Salute e Della Scienza di Torino
- Andrea Chiricozzi
- Dermatologia, Dipartimento Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli IRCCS
- Clara De Simone
- Dermatologia, Dipartimento Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli IRCCS
- Cristina Guerriero
- Dermatologia, Dipartimento Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli IRCCS
- Fabrizio Giuseppe Amoruso
- Dermatology Unit, Azienda Ospedaliera di Cosenza
- Eugenio Provenzano
- Dermatology Unit, Azienda Ospedaliera di Cosenza
- Salvatore Leonardi
- Pediatric Respiratory Unit, Department of Clinical and Experimental Medicine, San Marco Hospital, University of Catania
- Amelia Licari
- Department of Pediatrics, Pediatric Clinic, Fondazione IRCCS Policlinico San Matteo, University of Pavia
- Gian Luigi Marseglia
- Department of Pediatrics, Pediatric Clinic, Fondazione IRCCS Policlinico San Matteo, University of Pavia
- Antonino Palermo
- Department of Pediatrics, Garibaldi Hospital
- Sabrina Di Pillo
- Pediatric Allergy and Pulmonology Unit, Department of Pediatrics, University of Chieti-Pescara
- Daniele Russo
- Pediatric Allergy and Pulmonology Unit, Department of Pediatrics, University of Chieti-Pescara
- Viviana Moschese
- Pediatric Allergology and Immunology Unit, University of Rome Tor Vergata, Policlinico Tor Vergata
- Vincenzo Patella
- Department of Medicine, Division of Allergy and Clinical Immunology, "Santa Maria della Speranza" Hospital
- Tiziana Peduto
- Department of Medicine, Division of Allergy and Clinical Immunology, "Santa Maria della Speranza" Hospital
- Caterina Ferreli
- Department of Medical Sciences, and Public Health, Dermatology Clinic, University of Cagliari
- Paola Zangari
- Research Unit of Clinical Immunology and Vaccinology, Academic Department of Pediatrics (DPUO), Bambino Gesù Children’s Hospital, IRCCS
- Federica Veronese
- Dermatologic Clinic, AOU Maggiore della Carità Hospital
- Samantha Federica Berti
- Dermatology Unit, Department of Surgery and Translational Medicine, University of Florence
- Michaela Gruber
- Department of Pediatrics, Central Hospital of Bolzano
- Elena Pezzolo
- Dermatology Unit, Ospedale San Bortolo
- Stefania Termine
- Division of Dermatology, Santa Chiara Hospital
- Rosanna Satta
- Dipartimento Scienze Mediche, Chirurgiche e Sperimentali, Università di Sassari
- Federica Dragoni
- UOC Dermatologia Ospedale San Donato
- Maria Esposito
- Dermatology, Department of Biotechnological and Applied Clinical Sciences, University of L’Aquila
- Maria Concetta Fargnoli
- Dermatology, Department of Biotechnological and Applied Clinical Sciences, University of L’Aquila
- Paolo Chiodini
- Dermatology Unit, University of Campania Luigi Vanvitelli
- Ylenia Vallone
- Department of Clinical Medicine and Surgery, Section of Dermatology, University of Naples Federico II
- Francesca di Vico
- Department of Clinical Medicine and Surgery, Section of Dermatology, University of Naples Federico II
- Vincenzo Picone
- Department of Clinical Medicine and Surgery, Section of Dermatology, University of Naples Federico II
- Maddalena Napolitano
- Department of Clinical Medicine and Surgery, Section of Dermatology, University of Naples Federico II
- DOI
- https://doi.org/10.1080/09546634.2023.2246602
- Journal volume & issue
-
Vol. 34,
no. 1
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.
Keywords
