M C Fargnoli1, M Esposito1, S Ferrucci2, G Girolomoni3, A Offidani4, A Patrizi5, K Peris6,7, A Costanzo8, G Malara9, G Pellacani10, M Romanelli11, P Amerio12, A Cristaudo13, M L Flori14, A Motolese15, P Betto16, C Patruno17, P Pigatto18, R Sirna19, G Stinco20, I Zalaudek21, L Bianchi22, V Boccaletti23, S P Cannavò24, F Cusano25, S Lembo26, R Mozzillo27, R Gallo28, C Potenza29, F Rongioletti30, R Tiberio31, T Grieco32, G Micali33, S Persechino34, M Pettinato35, S Pucci36, E Savi37, L Stingeni38, A Romano39, G Argenziano40. 1. Dermatology Unit, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy. 2. Unit of Dermatology, Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico, Milan, Italy. 3. Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy. 4. Dermatology Unit, Department of Clinical and Molecular Sciences, Polytechnic Marche University, Ancona, Italy. 5. Dermatology Unit, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy. 6. Institute of Dermatology, Catholic University, Rome, Italy. 7. Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. 8. Dermatology Unit, Department of Biomedical Sciences, Humanitas University and Humanitas Clinical and Research Center, Rozzano, Italy. 9. Dermatology Department, Grande Ospedale Metropolitano, Bianchi Melacrino Morelli, Reggio Calabria, Italy. 10. Department of Dermatology, University of Modena and Reggio Emilia, Modena, Italy. 11. Dermatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy. 12. Department of Medicine and Aging Science, Dermatologic Clinic, G. D'Annunzio University, Chieti, Italy. 13. Unit of Dermatology, San Gallicano Dermatological Institute-IRCCS, Rome, Italy. 14. Dermatology Section, Department of Clinical Medicine and Immunological Science, University of Siena, Hospital S. Maria Alle Scotte, Siena, Italy. 15. Department of Dermatology, Macchi Hospital, Varese, Italy. 16. Department of Dermatology, Ospedale San Bortolo, ULSS8 Berica, Vicenza, Italy. 17. Department of Health Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy. 18. Department of Biomedical, Surgical and Dental Sciences, Clinical Dermatology, IRCCS Galeazzi Orthopaedic Institute, University of Milan, Milan, Italy. 19. Unit of Dermatology, Ospedale Della Misericordia, Grosseto, Italy. 20. Department of Medicine, Institute of Dermatology, University of Udine, Udine, Italy. 21. Dermatology Clinic, Hospital Maggiore of Trieste, Trieste, Italy. 22. Department of Dermatology, University of Tor Vergata, Rome, Italy. 23. Section of Dermatology, Department of Clinical and Experimental Medicine, University Hospital, Parma. 24. Dermatology, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy. 25. Dermatology Unit, Gaetano Rummo Hospital Benevento, Benevento, Italy. 26. Unit of Dermatology, University Hospital San Giovanni di Dio e Ruggi di Salerno, Hospital Santa Maria Incoronata Dell'Olmo, Cava De' Tirreni, Salerno, Italy. 27. Dermatology and Venereology, "San Gennaro" Hospital, Naples, Italy. 28. Dermatology Section, Department of Health Science, University of Genoa, Polyclinic Hospital San Martino, Genoa, Italy. 29. Dermatology Unit, Department of Medical and Surgical Sciences and Biotechnologies, Daniele Innocenzi, Sapienza University of Rome - Polo Pontino, Rome, Italy. 30. Section of Dermatology, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy. 31. Department of Health Science, University of Eastern Piedmont, Novara, Italy. 32. Dermatology Clinic Umberto I, Sapienza University of Rome, Rome, Italy. 33. Dermatology Clinic, University of Catania, Catania, Italy. 34. Dermatology Unit, Sant'Andrea Hospital, NESMOS Department, Sapienza University of Rome, Rome, Italy. 35. Unit of Dermatology, University Hospital, Policlinico Vittorio Emanuele, Catania, Italy. 36. Allergology, Hospital of Civitanova Marche, Civitanova Marche, Italy. 37. Unit of Dermatology, Hospital Guglielmo da Saliceto, Piacenza, Italy. 38. Dermatology Section, Department of Medicine, University of Perugia, Perugia, Italy. 39. Allergology Unit, Columbus Presidium, Catholic University, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. 40. Dermatology Unit, University of Campania Luigi Vanvitelli, Naples, Italy.
Abstract
BACKGROUND: Dupilumab, a fully human monoclonal antibody targeting the alpha subunit of IL-4 was recently approved for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients. OBJECTIVE: To assess dupilumab effectiveness and safety in adults with moderate-to-severe AD in a real-life Italian multicentre retrospective cohort. METHODS: Adult moderate-to-severe AD patients, referring to 39 Italian centers, received dupilumab in the context of a national patient access program. Disease assessment was performed at baseline, after 4 and 16 weeks of treatment using Eczema-Area-and-Severity-Index (EASI) score, itch and sleep numerical-rating-score (itch-NRS, sleep-NRS) and Dermatology-Life-Quality-Index (DLQI). RESULTS: A total of 109 (71 M/38F) patients was studied. There was a significant reduction in EASI score, itch-NRS, sleep-NRS and DLQI from baseline to week 4 and a further significant decline to week 16. EASI 50, EASI75 and EASI90 were achieved by 59.6%, 28.4% and 9.3% of patients at 4 weeks and by 87.2%, 60.6% and 32.4% of them at 16 weeks, respectively. Adverse events were experienced by 19.2% (21/109) of the patients and they were all mild in intensity, being conjunctivitis the most common side effect. CONCLUSIONS: Dupilumab significantly improved disease severity, pruritus, sleep loss and quality of life with an acceptable safety profile.
BACKGROUND: Dupilumab, a fully human monoclonal antibody targeting the alpha subunit of IL-4 was recently approved for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients. OBJECTIVE: To assess dupilumab effectiveness and safety in adults with moderate-to-severe AD in a real-life Italian multicentre retrospective cohort. METHODS: Adult moderate-to-severe AD patients, referring to 39 Italian centers, received dupilumab in the context of a national patient access program. Disease assessment was performed at baseline, after 4 and 16 weeks of treatment using Eczema-Area-and-Severity-Index (EASI) score, itch and sleep numerical-rating-score (itch-NRS, sleep-NRS) and Dermatology-Life-Quality-Index (DLQI). RESULTS: A total of 109 (71 M/38F) patients was studied. There was a significant reduction in EASI score, itch-NRS, sleep-NRS and DLQI from baseline to week 4 and a further significant decline to week 16. EASI 50, EASI75 and EASI90 were achieved by 59.6%, 28.4% and 9.3% of patients at 4 weeks and by 87.2%, 60.6% and 32.4% of them at 16 weeks, respectively. Adverse events were experienced by 19.2% (21/109) of the patients and they were all mild in intensity, being conjunctivitis the most common side effect. CONCLUSIONS: Dupilumab significantly improved disease severity, pruritus, sleep loss and quality of life with an acceptable safety profile.