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

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:

• Atopic dermatitis
• children
• dupilumab
• real-world data

Ethical approval

The patients in this manuscript have given written informed consent to publication of their case details.

Author contributions

Conceptualization: Cataldo Patruno, Gabriella Fabbrocini, 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, Ylenia Vallone, Giuseppe Lauletta, Vincenzo Picone, Maddalena Napolitano. Methodology: Cataldo Patruno, Maddalena Napolitano. Formal analysis and investigation: Cataldo Patruno, Giuseppe Lauletta, Vincenzo Picone, Maddalena Napolitano. Writing-review and editing: Cataldo Patruno, Gabriella Fabbrocini, 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, Ylenia Vallone, Giuseppe Lauletta, Vincenzo Picone, Maddalena Napolitano. Supervision: Cataldo Patruno. All authors read and approved the final version of the manuscript.

Disclosure statement

Cataldo Patruno acted as investigator, speaker, consultant and advisory board member for AbbVie, Amgen, Eli Lilly, LEO Pharma, Novartis, Pfizer, Pierre Fabre and Sanofi; Gabriella Fabbrocini has been principal investigator in clinical trials sponsored by and/or has received personal fees from AbbVie, Abiogen, Almirall, Celgene, Eli Lilly, LEO Pharma, Novartis, Sanofi and UCB; Luca Stingeni has been principal investigator in clinical trials sponsored by and/or and has received personal fees for participation in advisory boards from AbbVie, LEO Pharma, Novartis and Sanofi, outside the submitted work; Katharina Hansel reports personal fees from AbbVie and Novartis, outside the submitted work; Paola Coppo received support for attending meetings and/or travel from Pierre Fabre and Sanofi; Andrea Chiricozzi has served as advisory board member and consultant and has received fees and speaker’s honoraria or has participated in clinical trials for AbbVie, Almirall, Bristol Myers Squibb, Leo Pharma, Lilly, Janssen, Novartis, Pfizer and Sanofi Genzyme; Clara De Simone has served as advisory board member and has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Abbvie, Almirall,Eli Lilly, LeoPharma, Novartis, Janssen, Sanofi, UCB Pharma, Amgen, Boehringer Ingelheim; Viviana Moschese has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Sanofi-Genzyme; Caterina Ferreli has received support for meetings and/or travel from Novartis, Lilly, Abbvie, Almirall, Galderma, Leo Pharma, Pierre Fabre, Sanofi, Sun Pharma, Janssen; Maria Esposito acted as speaker, consultant and advisory board member for Sanofi, AbbVie, LEO Pharma; Maria Concetta Fargnoli has been principal investigator in clinical trials sponsored by and/or has received personal fees from AbbVie, Sanofi, Galderma, Pfizer; Maddalena Napolitano acted as speaker, consultant and advisory board member for Sanofi, AbbVie, LEO Pharma, Amgen, Pierre Fabre, and Eli Lilly. No potential conflict of interest was reported by the author(s).

Data availability statement

Data are reported in the current study.

Correction Statement

This article has been corrected with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.