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Use of Dupilumab in 543 Adult Patients With Moderate-to-Severe Atopic Dermatitis: A Multicenter, Retrospective Study

Nettis E1, Ferrucci SM2, Ortoncelli M3, Pellacani G4, Foti C5, Di Leo E6, Patruno C7, Rongioletti F8, Argenziano G9, Macchia L1, Tavecchio S2, Napolitano M10, Ribero S3, Bonzano L11, Romita P5, Di Bona D1, Nisticò SP7, Piras V8, Calabrese G9, Detoraki C12, Carbonara M13, Fabbrocini G14

1Department of Emergency and Organ Transplantation, School and Chair of Allergology and Clinical Immunology, University of Bari - Aldo Moro, Bari, Italy
2UOC 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
3Medical Sciences Department, Dermatologic Clinic, University of Turin, Turin, Italy
4Dermatology, University of Modena and Reggio Emilia, Modena, Italy
5Department of Biomedical Science and Human Oncology, Dermatological Clinic, University of Bari, Italy
6Section of Allergy and Clinical Immunology, Unit of Internal Medicine—“F. Miulli” Hospital, Acquaviva delle Fonti, (BA), Italy
7Unit of Dermatology, Department of Health Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy
8Unit of Dermatology, Department of Medical Sciences and Public Health, University of Cagliari, Italy
9Dermatology Unit, University of Campania, Naples, Italy
10Department of Health Sciences “Vincenzo Tiberio”, University of Molise, Campobasso, Italy.
11Allergology Service, AUSL Modena, Italy
12Department of Internal Medicine and Clinical Pathology, Azienda Ospedaliera Universitaria Federico II, Naples, Italy
13National Institute of Statistics (ISTAT), Bari, Italy
14Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy

J Investig Allergol Clin Immunol 2022; Vol 32(2) : 124-132
doi: 10.18176/jiaci.0641

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.

Key words: Atopic dermatitis, Dupilumab, Multicenter real-life study