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Use of Dupilumab for 543 Adult Patients with Moderate-To-Severe Atopic Dermatitis: A Multicenter, Retrospective Study

Nettis E1, Ferrucci SM2, Ortoncelli M3,4, Pellacani G5, Foti C6, Di Leo E7, Patruno C8, Rongioletti F9, Argenziano G10, Macchia L1, Tavecchio S2, Napolitano M11, Ribero S3, Bonzano L12, Romita P6, Di Bona D1, Nisticò SP8, Piras V9, Calabrese G10, Detoraki C13, Carbonara M14, Fabbrocini G15

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
3Dipartimento di Fisiopatologia Medico‐Chirurgica e dei Trapianti, Università degli Studi di Milano, Milan, Italy
4Medical Sciences Department, Dermatologic Clinic, University of Turin, Turin, Italy
5Dermatology, University of Modena and Reggio Emilia, Modena, Italy
6Department of Biomedical Science and Human Oncology, Dermatological Clinic, University of Bari, Italy
7Section of Allergy and Clinical Immunology, Unit of Internal Medicine - “F. Miulli” Hospital, AcquavivadelleFonti, (BA), Italy
8Unit of Dermatology, Department of Health Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy
9Unit of Dermatology, Department of Medical Sciences and Public Health, University of Cagliari, Italy
10Dermatology Unit, University of Campania, Naples, Italy
11Department of Health Sciences “Vincenzo Tiberio”, University of Molise, Campobasso, Italy
12 Allergology Service, AUSL Modena, Italy
13Department of Internal Medicine and Clinical Pathology, Azienda Ospedaliera Universitaria Federico II, Naples, Italy
14National Institute of Statistics (ISTAT), Bari, Italy
15Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy

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

Background: Dupilumab has been demonstrated to be an effective treatment for patients with moderate-to-severe atopic dermatitis (AD) in clinical trials. However, evidence of real-world experience with dupilumab in a broader population is limited to date.
Methods: Adult patients with moderate-to-severe AD, defined as an Eczema Area Severity Index (EASI) score of 24 or higher, treated with dupilumab at ten Italian academic centers, were included in the study. Physician-reported outcome measures (EASI), patient-reported outcome measures (pruritus and sleep score, Dermatology Life Quality Index, DLQI) and serological markers [immunoglobulin (Ig) E and eosinophil count] after 16 weeks were analyzed.
Results: We enrolled 543 patients with moderate-to-severe AD. Two patients (0.4%) discontinued treatment. The median ± interquartile percentage change from baseline to 16 weeks of treatment in the EASI score was -87.5±22.0 (p<0.001). 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 dupilumab treatment, 12.2% of the patients developed conjunctivitis, and total IgE significantly decreased (p<0.001). Interestingly, in the multivariate logistic regression model, the risk of developing dupilumab-related conjunctivitis was associated with early AD onset [OR, 2.25; 95%CI, 1.07–4.70; p=0.03] and presence of eosinophilia [OR, 1.91; 95%CI, 1.05–3.39; p=0.03].
Conclusion: To date, this is the broadest real-life study in AD patients treated with dupilumab. We observed significant improvements induced by dupilumab in adult patients with moderate-to-severe AD, to a greater extent than those reported in clinical trials.

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