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.
Short-, mid- and long-term efficacy of dupilumab in moderate to severe atopic dermatitis: a real life multicenter Italian study on 2576 patients / Ferrucci, Silvia; Tavecchio, Simona; Maronese, Carlo Alberto; Balato, Anna; Di Brizzi, Eugenia; Ortoncelli, Michela; Ribero, Simone; Girolomoni, Giampiero; Maurelli, Martina; Belloni Fortina, Anna; Caroppo, Francesca; Naldi, Luigi; Pezzolo, Elena; Nettis, Eustachio; Pugliese, Francesco; Stingeni, Luca; Hansel, Katharina; Rubegni, Giovanni; Calabrese, Laura; Russo, Filomena; Gola, Massimo; Magnaterra, Elisabetta; Rongioletti, Franco; Mercuri, Santo Raffaele; Paolino, Giovanni; Savoia, Paola; Veronese, Federica; Foti, Caterina; Ambrogio, Francesca; Scalvenzi, Massimiliano; Napolitano, Maddalena; Patruno, Cataldo; Dastoli, Stefano; Corazza, Monica; Borghi, Alessandro; Calzavara-Pinton, Pier Giacomo; Rossi, Mariateresa; Offidani, Annamaria; Radi, Giulia; Bonzano, Laura; Ferreli, Caterina; Piras, Viviana; Satta, Rosanna; Sucato, Federica; Malagoli, Piergiorgio; Gaiani, Francesca; Micali, Giuseppe; Musumeci, Maria Letizia; Fargnoli, Maria Concetta; Esposito, Maria; Grieco, Teresa; Chello, Camilla; Casazza, Giovanni; Marzano, Angelo. - In: CLINICAL AND EXPERIMENTAL DERMATOLOGY. - ISSN 0307-6938. - 00:(2024), pp. 1-12. [10.1093/ced/llae208]
Short-, mid- and long-term efficacy of dupilumab in moderate to severe atopic dermatitis: a real life multicenter Italian study on 2576 patients
Piras, Viviana;Satta, Rosanna;Sucato, Federica;
2024-01-01
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
