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