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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, 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.
Affiliation
  • Patruno C; Department of Health Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.
  • Fabbrocini G; Department of Clinical Medicine and Surgery, Section of Dermatology, University of Naples Federico II, Naples, Italy.
  • Lauletta G; Department of Clinical Medicine and Surgery, Section of Dermatology, University of Naples Federico II, Naples, Italy.
  • Boccaletti V; Department of Medicine, Section of Dermatology, University of Brescia, Brescia, Italy.
  • Colonna C; Pediatric Dermatology Unit, Department of Clinical Sciences and Community Health, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
  • Cavalli R; Pediatric Dermatology Unit, Department of Clinical Sciences and Community Health, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
  • Neri I; Unit of Dermatology, IRCCS AOU di Policlinico S Orsola, University of Bologna, Bologna, Italy.
  • Ortoncelli M; Department of Medical Sciences, Division of Dermatology, University of Turin, Turin, Italy.
  • Schena D; Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy.
  • Stingeni L; Department of Medicine and Surgery, Dermatology Section, University of Perugia, Perugia, Italy.
  • Hansel K; Department of Medicine and Surgery, Dermatology Section, University of Perugia, Perugia, Italy.
  • Piccolo V; Dermatology Unit, University of Campania Luigi Vanvitelli, Caserta, Italy.
  • Di Brizzi V; Dermatology Unit, University of Campania Luigi Vanvitelli, Caserta, Italy.
  • Potenza C; Department of Medical-Surgical Sciences and Biotechnologies, Dermatology Unit "Daniele Innocenzi", Sapienza University of Rome, Polo Pontino, Latina, Italy.
  • Tolino E; Department of Medical-Surgical Sciences and Biotechnologies, Dermatology Unit "Daniele Innocenzi", Sapienza University of Rome, Polo Pontino, Latina, Italy.
  • Bianchi L; Dermatology Unit, Policlinico Tor Vergata, System Medicine Department, University of Tor Vergata, Rome, Italy.
  • Manti S; Dermatology Unit, Policlinico Tor Vergata, System Medicine Department, University of Tor Vergata, Rome, Italy.
  • De Pasquale R; U.O. Dermatologia, Ospedale San Marco, Catania, Italy.
  • Di Lernia V; Dermatology Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
  • Caminiti L; Policlinico Hospital-University of Messina, Messina, Italy.
  • Galli E; UOS Immuno Allergologia dell'Età evolutiva, Ospedale San Pietro-Fatebenefratelli, Roma, Italy.
  • Coppo P; Pediatric Endocrinology Unit, Regina Margherita Children's Hospital, Città Della Salute e Della Scienza di Torino, Torino, Italy.
  • Chiricozzi A; Dermatologia, Dipartimento Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
  • De Simone C; Dermatologia, Dipartimento Universitario di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Rome, Italy.
  • Guerriero C; Dermatologia, Dipartimento Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
  • Amoruso FG; Dermatologia, Dipartimento Universitario di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Rome, Italy.
  • Provenzano E; Dermatologia, Dipartimento Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
  • Leonardi S; Dermatology Unit, Azienda Ospedaliera di Cosenza, Cosenza, Italy.
  • Licari A; Dermatology Unit, Azienda Ospedaliera di Cosenza, Cosenza, Italy.
  • Marseglia GL; Pediatric Respiratory Unit, Department of Clinical and Experimental Medicine, San Marco Hospital, University of Catania, Catania, Italy.
  • Palermo A; Department of Pediatrics, Pediatric Clinic, Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy.
  • Di Pillo S; Department of Pediatrics, Pediatric Clinic, Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy.
  • Russo D; Department of Pediatrics, Garibaldi Hospital, Catania, Italy.
  • Moschese V; Pediatric Allergy and Pulmonology Unit, Department of Pediatrics, University of Chieti-Pescara, Chieti, Italy.
  • Patella V; Pediatric Allergy and Pulmonology Unit, Department of Pediatrics, University of Chieti-Pescara, Chieti, Italy.
  • Peduto T; Pediatric Allergology and Immunology Unit, University of Rome Tor Vergata, Policlinico Tor Vergata, Rome, Italy.
  • Ferreli C; Department of Medicine, Division of Allergy and Clinical Immunology, "Santa Maria della Speranza" Hospital, Battipaglia, SA, Italy.
  • Zangari P; Department of Medicine, Division of Allergy and Clinical Immunology, "Santa Maria della Speranza" Hospital, Battipaglia, SA, Italy.
  • Veronese F; Department of Medical Sciences, and Public Health, Dermatology Clinic, University of Cagliari, Cagliari, Italy.
  • Berti SF; Research Unit of Clinical Immunology and Vaccinology, Academic Department of Pediatrics (DPUO), Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.
  • Gruber M; Dermatologic Clinic, AOU Maggiore della Carità Hospital, Novara, Italy.
  • Pezzolo E; Dermatology Unit, Department of Surgery and Translational Medicine, University of Florence, Florence, Italy.
  • Termine S; Department of Pediatrics, Central Hospital of Bolzano, Bolzano, Italy.
  • Satta R; Dermatology Unit, Ospedale San Bortolo, Vicenza, Italy.
  • Dragoni F; Division of Dermatology, Santa Chiara Hospital, Trento, Italy.
  • Esposito M; Dipartimento Scienze Mediche, Chirurgiche e Sperimentali, Università di Sassari, Sassari, Italy.
  • Fargnoli MC; UOC Dermatologia Ospedale San Donato, Arezzo, Italy.
  • Chiodini P; Dermatology, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
  • Vallone Y; Dermatology, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
  • di Vico F; Dermatology Unit, University of Campania Luigi Vanvitelli, Caserta, Italy.
J Dermatolog Treat ; 34(1): 2246602, 2023 Dec.
Article in En | MEDLINE | ID: mdl-37580895
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.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Dermatitis, Atopic Type of study: Diagnostic_studies / Observational_studies Limits: Child / Humans Language: En Journal: J Dermatolog Treat Journal subject: DERMATOLOGIA Year: 2023 Document type: Article Affiliation country:
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Dermatitis, Atopic Type of study: Diagnostic_studies / Observational_studies Limits: Child / Humans Language: En Journal: J Dermatolog Treat Journal subject: DERMATOLOGIA Year: 2023 Document type: Article Affiliation country: