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
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...
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| Format: | Article |
| Language: | English |
| Published: |
Taylor & Francis Group
2023-12-01
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| Series: | Journal of Dermatological Treatment |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/09546634.2023.2246602 |
| _version_ | 1797683514705969152 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Cataldo Patruno |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T00:15:33Z |
| format | Article |
| id | doaj.art-fb3f28510b7a41c6a5913518338704e4 |
| institution | Directory Open Access Journal |
| issn | 0954-6634 1471-1753 |
| language | English |
| last_indexed | 2024-03-12T00:15:33Z |
| publishDate | 2023-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Journal of Dermatological Treatment |
| spelling | doaj.art-fb3f28510b7a41c6a5913518338704e42023-09-15T14:40:43ZengTaylor & Francis GroupJournal of Dermatological Treatment0954-66341471-17532023-12-0134110.1080/09546634.2023.22466022246602A 52-week multicenter retrospective real-world study on effectiveness and safety of dupilumab in children with atopic dermatitis aged from 6 to 11 yearsCataldo Patruno0Gabriella Fabbrocini1Giuseppe Lauletta2Valeria Boccaletti3Cristiana Colonna4Riccardo Cavalli5Iria Neri6Michela Ortoncelli7Donatella Schena8Luca Stingeni9Katharina Hansel10Vincenzo Piccolo11Veronica Di Brizzi12Concetta Potenza13Ersilia Tolino14Luca Bianchi15Sara Manti16Rocco De Pasquale17Vito Di Lernia18Lucia Caminiti19Elena Galli20Paola Coppo21Andrea Chiricozzi22Clara De Simone23Cristina Guerriero24Fabrizio Giuseppe Amoruso25Eugenio Provenzano26Salvatore Leonardi27Amelia Licari28Gian Luigi Marseglia29Antonino Palermo30Sabrina Di Pillo31Daniele Russo32Viviana Moschese33Vincenzo Patella34Tiziana Peduto35Caterina Ferreli36Paola Zangari37Federica Veronese38Samantha Federica Berti39Michaela Gruber40Elena Pezzolo41Stefania Termine42Rosanna Satta43Federica Dragoni44Maria Esposito45Maria Concetta Fargnoli46Paolo Chiodini47Ylenia Vallone48Francesca di Vico49Vincenzo Picone50Maddalena Napolitano51Department of Health Sciences, University Magna Graecia of CatanzaroDepartment of Clinical Medicine and Surgery, Section of Dermatology, University of Naples Federico IIDepartment of Clinical Medicine and Surgery, Section of Dermatology, University of Naples Federico IIDepartment of Medicine, Section of Dermatology, University of BresciaPediatric Dermatology Unit, Department of Clinical Sciences and Community Health, Fondazione IRCCS Ca’ Granda Ospedale Maggiore PoliclinicoPediatric Dermatology Unit, Department of Clinical Sciences and Community Health, Fondazione IRCCS Ca’ Granda Ospedale Maggiore PoliclinicoUnit of Dermatology, IRCCS AOU di Policlinico S Orsola, University of BolognaDepartment of Medical Sciences, Division of Dermatology, University of TurinDepartment of Medicine, Section of Dermatology and Venereology, University of VeronaDepartment of Medicine and Surgery, Dermatology Section, University of PerugiaDepartment of Medicine and Surgery, Dermatology Section, University of PerugiaDermatology Unit, University of Campania Luigi VanvitelliDermatology Unit, University of Campania Luigi VanvitelliDepartment of Medical-Surgical Sciences and Biotechnologies, Dermatology Unit "Daniele Innocenzi", Sapienza University of RomeDepartment of Medical-Surgical Sciences and Biotechnologies, Dermatology Unit "Daniele Innocenzi", Sapienza University of RomeDermatology Unit, Policlinico Tor Vergata, System Medicine Department, University of Tor VergataDermatology Unit, Policlinico Tor Vergata, System Medicine Department, University of Tor VergataU.O. Dermatologia, Ospedale San MarcoDermatology Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio EmiliaPoliclinico Hospital-University of MessinaUOS Immuno Allergologia dell’Età evolutiva, Ospedale San Pietro-FatebenefratelliPediatric Endocrinology Unit, Regina Margherita Children’s Hospital, Città Della Salute e Della Scienza di TorinoDermatologia, Dipartimento Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli IRCCSDermatologia, Dipartimento Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli IRCCSDermatologia, Dipartimento Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli IRCCSDermatology Unit, Azienda Ospedaliera di CosenzaDermatology Unit, Azienda Ospedaliera di CosenzaPediatric Respiratory Unit, Department of Clinical and Experimental Medicine, San Marco Hospital, University of CataniaDepartment of Pediatrics, Pediatric Clinic, Fondazione IRCCS Policlinico San Matteo, University of PaviaDepartment of Pediatrics, Pediatric Clinic, Fondazione IRCCS Policlinico San Matteo, University of PaviaDepartment of Pediatrics, Garibaldi HospitalPediatric Allergy and Pulmonology Unit, Department of Pediatrics, University of Chieti-PescaraPediatric Allergy and Pulmonology Unit, Department of Pediatrics, University of Chieti-PescaraPediatric Allergology and Immunology Unit, University of Rome Tor Vergata, Policlinico Tor VergataDepartment of Medicine, Division of Allergy and Clinical Immunology, "Santa Maria della Speranza" HospitalDepartment of Medicine, Division of Allergy and Clinical Immunology, "Santa Maria della Speranza" HospitalDepartment of Medical Sciences, and Public Health, Dermatology Clinic, University of CagliariResearch Unit of Clinical Immunology and Vaccinology, Academic Department of Pediatrics (DPUO), Bambino Gesù Children’s Hospital, IRCCSDermatologic Clinic, AOU Maggiore della Carità HospitalDermatology Unit, Department of Surgery and Translational Medicine, University of FlorenceDepartment of Pediatrics, Central Hospital of BolzanoDermatology Unit, Ospedale San BortoloDivision of Dermatology, Santa Chiara HospitalDipartimento Scienze Mediche, Chirurgiche e Sperimentali, Università di SassariUOC Dermatologia Ospedale San DonatoDermatology, Department of Biotechnological and Applied Clinical Sciences, University of L’AquilaDermatology, Department of Biotechnological and Applied Clinical Sciences, University of L’AquilaDermatology Unit, University of Campania Luigi VanvitelliDepartment of Clinical Medicine and Surgery, Section of Dermatology, University of Naples Federico IIDepartment of Clinical Medicine and Surgery, Section of Dermatology, University of Naples Federico IIDepartment of Clinical Medicine and Surgery, Section of Dermatology, University of Naples Federico IIDepartment of Clinical Medicine and Surgery, Section of Dermatology, University of Naples Federico IIBackground: 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.http://dx.doi.org/10.1080/09546634.2023.2246602atopic dermatitischildrendupilumabreal-world data |
| spellingShingle | 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 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 Journal of Dermatological Treatment atopic dermatitis children dupilumab real-world data |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 52 week multicenter retrospective real world study on effectiveness and safety of dupilumab in children with atopic dermatitis aged from 6 to 11 years |
| topic | atopic dermatitis children dupilumab real-world data |
| url | http://dx.doi.org/10.1080/09546634.2023.2246602 |
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