Silvia Ferrucci, Simona Tavecchio, Carlo Alberto Maronese, Anna Balato, Eugenia Veronica Di Brizzi, Michela Ortoncelli, Simone Ribero, Giampiero Girolomoni, Martina Maurelli, Anna Belloni Fortina, Francesca Caroppo, Luigi Naldi, Elena Pezzolo, Eustachio Nettis, Francesco Pugliese, Luca Stingeni, Katharina Hansel, Giovanni Rubegni, Laura Calabrese, Filomena Russo, Massimo Gola, Elisabetta Magnaterra, Franco Rongioletti, Santo Raffaele Mercuri, Giovanni Paolino, Paola Savoia, Federica Veronese, Caterina Foti, Francesca Ambrogio, Massimiliano Scalvenzi, Maddalena Napolitano, Cataldo Patruno, Stefano Dastoli, Monica Corazza, Alessandro Borghi, Pier Giacomo Calzavara-Pinton, Mariateresa Rossi, Annamaria Offidani, Giulia Radi, Laura Bonzano, Caterina Ferreli, Viviana Piras, Rosanna Satta, Federica Sucato, Piergiorgio Malagoli, Francesca Gaiani, Giuseppe Micali, Maria Letizia Musumeci, Maria Concetta Fargnoli, Maria Esposito, Teresa Grieco, Camilla Chello, Giovanni Casazza, Angelo Valerio Marzano
{"title":"Short-, mid- and long-term efficacy of dupilumab in moderate-to-severe atopic dermatitis: a real-world multicentre Italian study of 2576 patients.","authors":"Silvia Ferrucci, Simona Tavecchio, Carlo Alberto Maronese, Anna Balato, Eugenia Veronica Di Brizzi, Michela Ortoncelli, Simone Ribero, Giampiero Girolomoni, Martina Maurelli, Anna Belloni Fortina, Francesca Caroppo, Luigi Naldi, Elena Pezzolo, Eustachio Nettis, Francesco Pugliese, Luca Stingeni, Katharina Hansel, Giovanni Rubegni, Laura Calabrese, Filomena Russo, Massimo Gola, Elisabetta Magnaterra, Franco Rongioletti, Santo Raffaele Mercuri, Giovanni Paolino, Paola Savoia, Federica Veronese, Caterina Foti, Francesca Ambrogio, Massimiliano Scalvenzi, Maddalena Napolitano, Cataldo Patruno, Stefano Dastoli, Monica Corazza, Alessandro Borghi, Pier Giacomo Calzavara-Pinton, Mariateresa Rossi, Annamaria Offidani, Giulia Radi, Laura Bonzano, Caterina Ferreli, Viviana Piras, Rosanna Satta, Federica Sucato, Piergiorgio Malagoli, Francesca Gaiani, Giuseppe Micali, Maria Letizia Musumeci, Maria Concetta Fargnoli, Maria Esposito, Teresa Grieco, Camilla Chello, Giovanni Casazza, Angelo Valerio Marzano","doi":"10.1093/ced/llae208","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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 is currently available to inform clinical decisions.</p><p><strong>Objectives: </strong>To describe the long-term effectiveness and safety of dupilumab up to 48 months in patients with moderate-to-severe AD.</p><p><strong>Methods: </strong>A multicentre, 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 a 90% reduction in Eczema Area and Severity Index score, itch-numeric rating scale (NRS) score ≤ 1, sleep-NRS score ≤ 1 and Dermatology Life Quality Index ≤ 1] were investigated.</p><p><strong>Results: </strong>In total, 2576 patients were enrolled from June 2018 to July 2022. MDA optimal treatment target criteria were achieved by 506/2309 (21.9%), 769/1959 (39.3%), 628/1247 (50.4%), 330/596 (55.4%) and 58/106 (54.7%) 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 (AEs) were mild and were observed in 373/2364 (15.8%), 166/2066 (8.0%), 83/1291 (6.4%), 27/601 (4.5%) and 5/110 (4.5%) 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. AEs led to treatment discontinuation in < 1% of patients during the evaluated time periods.</p><p><strong>Conclusions: </strong>The 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 (persisting or relapsing) at baseline. Further research will be needed to investigate the effect of T helper cell 2 comorbidities and disease duration on the response to dupilumab and other newer therapeutics for AD.</p>","PeriodicalId":10324,"journal":{"name":"Clinical and Experimental Dermatology","volume":" ","pages":"1561-1572"},"PeriodicalIF":3.7000,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical and Experimental Dermatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/ced/llae208","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
引用次数: 0
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 is currently available to inform clinical decisions.
Objectives: To describe the long-term effectiveness and safety of dupilumab up to 48 months in patients with moderate-to-severe AD.
Methods: A multicentre, 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 a 90% reduction in Eczema Area and Severity Index score, itch-numeric rating scale (NRS) score ≤ 1, sleep-NRS score ≤ 1 and Dermatology Life Quality Index ≤ 1] were investigated.
Results: In total, 2576 patients were enrolled from June 2018 to July 2022. MDA optimal treatment target criteria were achieved by 506/2309 (21.9%), 769/1959 (39.3%), 628/1247 (50.4%), 330/596 (55.4%) and 58/106 (54.7%) 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 (AEs) were mild and were observed in 373/2364 (15.8%), 166/2066 (8.0%), 83/1291 (6.4%), 27/601 (4.5%) and 5/110 (4.5%) 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. AEs led to treatment discontinuation in < 1% of patients during the evaluated time periods.
Conclusions: The 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 (persisting or relapsing) at baseline. Further research will be needed to investigate the effect of T helper cell 2 comorbidities and disease duration on the response to dupilumab and other newer therapeutics for AD.
期刊介绍：
Clinical and Experimental Dermatology (CED) is a unique provider of relevant and educational material for practising clinicians and dermatological researchers. We support continuing professional development (CPD) of dermatology specialists to advance the understanding, management and treatment of skin disease in order to improve patient outcomes.
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