학술논문
Short-, mid- and long-term efficacy of dupilumab in moderate to severe atopic dermatitis: a real life multicenter Italian study on 2576 patients.
Document Type
Academic Journal
Author
Ferrucci S; I.R.C.C.S. Foundation Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.; Tavecchio S; I.R.C.C.S. Foundation Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.; Maronese CA; I.R.C.C.S. Foundation Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.; Balato A; Dermatology Unit, Universita degli Studi della Campania Luigi Vanvitelli, Naples, Italy.; Di Brizzi E; Dermatology Unit, Universita degli Studi della Campania Luigi Vanvitelli, Naples, Italy.; Ortoncelli M; Medical Sciences Department, Dermatologic Clinic, University of Turin, Turin, Italy.; Ribero S; Medical Sciences Department, Dermatologic Clinic, University of Turin, Turin, Italy.; Girolomoni G; Department of Medicine, Section of Dermatology, University of Verona, Verona, Italy.; Maurelli M; Department of Medicine, Section of Dermatology, University of Verona, Verona, Italy.; Belloni Fortina A; Department of Women and Children Health, University of Padua, Padova, Italy.; Caroppo F; Department of Women and Children Health, University of Padua, Padova, Italy.; Naldi L; Study Centre of the Italian Group for Epidemiological Research in Dermatology, Bergamo, Italy.; Pezzolo E; Department of Dermatology, San Bortolo Hospital of Vicenza, Vicenza, Italy.; Nettis E; Department of Emergency and Organ Transplantation, School and Chair of Allergology and Clinical Immunology, University of Bari, Aldo Moro, Bari, Italy.; Pugliese F; Department of Emergency and Organ Transplantation, School and Chair of Allergology and Clinical Immunology, University of Bari, Aldo Moro, Bari, Italy.; Stingeni L; Section of Dermatology, Department of Medicine, University of Perugia, Perugia, Italy.; Hansel K; Section of Dermatology, Department of Medicine, University of Perugia, Perugia, Italy.; Rubegni G; Department of Ophthalmology, University of Siena, Siena, Italy.; Calabrese L; Department of Medical Science, Surgical and Neuroscience, Section of Dermatology, University of Siena, Siena, Italy.; Russo F; I.R.C.C.S. Foundation Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.; Gola M; Section of Dermatology, Azienda Sanitaria and University of Florence, Piero Palagi Hospital, Viale Michelangiolo, Florence, Italy.; Magnaterra E; Section of Dermatology, Azienda Sanitaria and University of Florence, Piero Palagi Hospital, Viale Michelangiolo, Florence, Italy.; Rongioletti F; I.R.C.C.S. Foundation Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.; Mercuri SR; I.R.C.C.S. Foundation Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.; Paolino G; Department of Dermatology, San Raffaele Hospital, Milan, Lombardia, Italy.; Savoia P; Department of Health Science, University of Eastern Piedmont, Novara, Italy.; Veronese F; AOU Maggiore della Carità di Novara, Novara, Italy.; Foti C; Department of Dermatology, Universita Degli Studi di Bari Dipartimento di Scienze Biomediche ed Oncologia Umana, Bari, Puglia, Italy.; Ambrogio F; Section of Dermatology and Venereology, Department of Precision and Regenerative Medicine and Ionian Area (DiMePRe-J), University of Bari, Bari, Aldo Moro, Italy.; Scalvenzi M; Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.; Napolitano M; Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.; Patruno C; Magna Graecia University of Catanzaro, Catanzaro, Calabria, Italy.; Dastoli S; Magna Graecia University of Catanzaro, Catanzaro, Calabria, Italy.; Corazza M; Department of Medical Sciences, Section of Dermatology, University of Ferrara, Ferrara, Emilia-Romagna, Italy.; Borghi A; Department of Medical Sciences, Section of Dermatology, University of Ferrara, Ferrara, Emilia-Romagna, Italy.; Calzavara-Pinton PG; Dermatology Department, University of Brescia, Brescia, Italy.; Rossi M; Dermatology Department, University of Brescia, Brescia, Italy.; Offidani A; Department of Clinical and Surgical Specialties, Università Politecnica delle Marche Facoltà di Medicina e Chirurgia, Ancona, Marche, Italy.; Radi G; Department of Clinical and Surgical Specialties, Università Politecnica delle Marche Facoltà di Medicina e Chirurgia, Ancona, Marche, Italy.; Bonzano L; AUSL Modena, Allergology Service, Modena, Italy.; Ferreli C; Unit of Dermatology, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.; Piras V; Unit of Dermatology, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.; Satta R; Department of Medical, Surgical and Experimental Sciences, Dermatology Unit, University of Sassari, Sassari, Italy.; Sucato F; Department of Medical, Surgical and Experimental Sciences, Dermatology Unit, University of Sassari, Sassari, Italy.; Malagoli P; Istituto Policlinico San Donato, San Donato Milanese, Milan, Italy.; Gaiani F; Istituto Policlinico San Donato, San Donato Milanese, Milan, Italy.; Micali G; University of Catania, Catania, Italy.; Musumeci ML; University of Catania, Catania, Italy.; Fargnoli MC; Department of Dermatology, University of L'Aquila, L'Aquila, Italy.; Esposito M; Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.; Grieco T; Dermatology Unit, University of Rome 'Sapienza', Rome, Italy.; Chello C; Dermatology Unit, University of Rome 'Sapienza', Rome, Italy.; Casazza G; Università degli Studi di Milano, Milan, Italy.; Marzano A; I.R.C.C.S. Foundation Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.
Source
Publisher: Oxford University Press Country of Publication: England NLM ID: 7606847 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1365-2230 (Electronic) Linking ISSN: 03076938 NLM ISO Abbreviation: Clin Exp Dermatol Subsets: MEDLINE
Subject
Language
English
Abstract
Background: The efficacy and safety of dupilumab in atopic dermatitis (AD) have been defined in clinical trials but limited real-world evidence on long term treatment outcomes are currently available to inform clinical decisions.
Objectives: to describe long-term effectiveness and safety of dupilumab up to 48 months in patients with moderate-to-severe AD.
Methods: a multicenter, retrospective, dynamic cohort study was conducted to assess long term effectiveness and safety of dupilumab in patients with moderate to severe AD in a real-world setting. Predictors of minimal disease activity (MDA) optimal treatment target criteria (defined as the simultaneous achievement of EASI90, itch NRS score ≤1, sleep NRS score ≤1 and DLQI ≤1) were investigated.
Results: 2576 patients were enrolled from June 2018 to July 2022. MDA optimal treatment target criteria were achieved by 506 (21.91%), 769 (40.63%), 628 (50.36%), 330 (55.37%) and 58 (54.72%) of those that reached 4, 12, 24, 36 and 48 months of follow-up, respectively. Logistic regression revealed a negative effect on MDA achievement for conjunctivitis and food allergy at all timepoints. Adverse events (AE) were mild and were observed in 373 (15.78%), 166 (7.02%), 83 (6.43%), 27 (4.50%) and 5 (4.55%) of those that reached 4, 12, 24, 36 and 48 months of follow-up. Conjunctivitis was the most frequently reported AE during the available follow-up. AE led to treatment discontinuation in <1% of patients during the evaluated time periods.
Conclusion: High long-term effectiveness and safety of dupilumab were confirmed in this dynamic cohort of patients with moderate to severe AD, regardless of clinical phenotype and course at baseline. Further research will be needed to investigate the effect of Th2 comorbidities and disease duration on the response to dupilumab and other newer therapeutics for AD.
(© The Author(s) 2024. Published by Oxford University Press on behalf of British Association of Dermatologists.)
Objectives: to describe long-term effectiveness and safety of dupilumab up to 48 months in patients with moderate-to-severe AD.
Methods: a multicenter, retrospective, dynamic cohort study was conducted to assess long term effectiveness and safety of dupilumab in patients with moderate to severe AD in a real-world setting. Predictors of minimal disease activity (MDA) optimal treatment target criteria (defined as the simultaneous achievement of EASI90, itch NRS score ≤1, sleep NRS score ≤1 and DLQI ≤1) were investigated.
Results: 2576 patients were enrolled from June 2018 to July 2022. MDA optimal treatment target criteria were achieved by 506 (21.91%), 769 (40.63%), 628 (50.36%), 330 (55.37%) and 58 (54.72%) of those that reached 4, 12, 24, 36 and 48 months of follow-up, respectively. Logistic regression revealed a negative effect on MDA achievement for conjunctivitis and food allergy at all timepoints. Adverse events (AE) were mild and were observed in 373 (15.78%), 166 (7.02%), 83 (6.43%), 27 (4.50%) and 5 (4.55%) of those that reached 4, 12, 24, 36 and 48 months of follow-up. Conjunctivitis was the most frequently reported AE during the available follow-up. AE led to treatment discontinuation in <1% of patients during the evaluated time periods.
Conclusion: High long-term effectiveness and safety of dupilumab were confirmed in this dynamic cohort of patients with moderate to severe AD, regardless of clinical phenotype and course at baseline. Further research will be needed to investigate the effect of Th2 comorbidities and disease duration on the response to dupilumab and other newer therapeutics for AD.
(© The Author(s) 2024. Published by Oxford University Press on behalf of British Association of Dermatologists.)