Short-, mid- and long-term efficacy of dupilumab in moderate-to-severe atopic dermatitis: a real-world multicentre Italian study of 2576 patients

Ferrucci, Silvia;Tavecchio, Simona;Maronese, Carlo Alberto;Balato, Anna;Di Brizzi, Eugenia Veronica;Ortoncelli, Michela;Ribero, Simone;Girolomoni, Giampiero;Maurelli, Martina;Fortina, Anna Belloni;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 Valerio

2024-01-01

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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 48months 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 48months 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 48months 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.