E Nettis1, S M Ferrucci2, M Ortoncelli3, G Pellacani4, C Foti5, E Di Leo6, C Patruno7, F Rongioletti8, G Argenziano9, L Macchia1, S Tavecchio2, M Napolitano10, S Ribero3, L Bonzano11, P Romita5, D Di Bona1, S P Nisticò7, V Piras8, G Calabrese9, C Detoraki12, M Carbonara13, G Fabbrocini14. 1. Department of Emergency and Organ Transplantation, School and Chair of Allergology and Clini-cal Immunology, University of Bari - Aldo Moro, Bari, Italy. 2. UOC Dermatologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy; Dipartimento di Fisiopatologia Medico-Chirurgica e dei Trapianti, Università degli Studi di Milano, Milan, Italy. 3. Medical Sciences Department, Dermatologic Clinic, University of Turin, Turin, Italy. 4. Dermatology, University of Modena and Reggio Emilia, Modena, Italy. 5. Department of Biomedical Science and Human Oncology, Dermatological Clinic, University of Bari, Italy. 6. Section of Allergy and Clinical Immunology, Unit of Internal Medicine-"F. Miulli" Hospital, Ac-quaviva delle Fonti, (BA), Italy. 7. Unit of Dermatology, Department of Health Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy. 8. Unit of Dermatology, Department of Medical Sciences and Public Health, University of Cagliari, Italy. 9. Dermatology Unit, University of Campania, Naples, Italy. 10. Department of Health Sciences "Vincenzo Tiberio", University of Molise, Campobasso, Italy. 11. Allergology Service, AUSL Modena, Italy. 12. Department of Internal Medicine and Clinical Pathology, Azienda Ospedaliera Universitaria Fede-rico II, Naples, Italy. 13. National Institute of Statistics (ISTAT), Bari, Italy. 14. Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.
Abstract
BACKGROUND: Dupilumab has proven to be an effective treatment for patients with moderate-to-severe atopic dermatitis (AD) in clinical trials. However, real-world experience with dupilumab in a broader population is limited. METHODS: The study population comprised adult patients with moderate-to-severe AD, defined as an Eczema Area Severity Index (EASI) score of 24 or higher, treated with dupilumab at 10 Italian teaching hospitals. We analyzed physician-reported outcome measures (EASI), patient-reported outcome measures (pruritus and sleep score, Dermatology Life Quality Index [DLQI]), and serological markers (IgE and eosinophil count) after 16 weeks. RESULTS: We enrolled 543 patients with moderate-to-severe AD. Two patients (0.4%) discontinued treatment. The median (IQR) change from baseline to 16 weeks of treatment in the EASI score was -87.5 (22.0) (P<.001). The EASI-50, EASI-75, and EASI-90 response rates were 98.1%, 81.5%, and 50.8% after 16 weeks. At 16 weeks, 93.0% of the patients had achieved a 4-point or higher improvement in DLQI from baseline. During treatment with dupilumab, 12.2% of the patients developed conjunctivitis, and total IgE decreased significantly (P<.001). Interestingly, in the multivariate logistic regression model, the risk of developing dupilumab-related conjunctivitis was associated with early onset of AD (OR, 2.25; 95%CI, 1.07-4.70; P=.03) and presence of eosinophilia (OR, 1.91; 95%CI, 1.05-3.39; P=.03). CONCLUSION: This is the broadest real-life study in AD patients treated with dupilumab to date. We observed more significant improvements induced by dupilumab in adult patients with moderate-to-severe AD than those reported in clinical trials.
BACKGROUND: Dupilumab has proven to be an effective treatment for patients with moderate-to-severe atopic dermatitis (AD) in clinical trials. However, real-world experience with dupilumab in a broader population is limited. METHODS: The study population comprised adult patients with moderate-to-severe AD, defined as an Eczema Area Severity Index (EASI) score of 24 or higher, treated with dupilumab at 10 Italian teaching hospitals. We analyzed physician-reported outcome measures (EASI), patient-reported outcome measures (pruritus and sleep score, Dermatology Life Quality Index [DLQI]), and serological markers (IgE and eosinophil count) after 16 weeks. RESULTS: We enrolled 543 patients with moderate-to-severe AD. Two patients (0.4%) discontinued treatment. The median (IQR) change from baseline to 16 weeks of treatment in the EASI score was -87.5 (22.0) (P<.001). The EASI-50, EASI-75, and EASI-90 response rates were 98.1%, 81.5%, and 50.8% after 16 weeks. At 16 weeks, 93.0% of the patients had achieved a 4-point or higher improvement in DLQI from baseline. During treatment with dupilumab, 12.2% of the patients developed conjunctivitis, and total IgE decreased significantly (P<.001). Interestingly, in the multivariate logistic regression model, the risk of developing dupilumab-related conjunctivitis was associated with early onset of AD (OR, 2.25; 95%CI, 1.07-4.70; P=.03) and presence of eosinophilia (OR, 1.91; 95%CI, 1.05-3.39; P=.03). CONCLUSION: This is the broadest real-life study in AD patients treated with dupilumab to date. We observed more significant improvements induced by dupilumab in adult patients with moderate-to-severe AD than those reported in clinical trials.
Entities:
Keywords:
Atopic dermatitis; Dupilumab; Multicenter real-life study
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