TY - JOUR
T1 - Short-, mid- and long-term efficacy of dupilumab in moderate-to-severe atopic dermatitis
T2 - a real-world multicentre Italian study of 2576 patients
AU - Ferrucci, Silvia
AU - Tavecchio, Simona
AU - Maronese, Carlo Alberto
AU - Balato, Anna
AU - Di Brizzi, Eugenia Veronica
AU - Ortoncelli, Michela
AU - Ribero, Simone
AU - Girolomoni, Giampiero
AU - Maurelli, Martina
AU - Fortina, Anna Belloni
AU - Caroppo, Francesca
AU - Naldi, Luigi
AU - Pezzolo, Elena
AU - Nettis, Eustachio
AU - Pugliese, Francesco
AU - Stingeni, Luca
AU - Hansel, Katharina
AU - Rubegni, Giovanni
AU - Calabrese, Laura
AU - Russo, Filomena
AU - Gola, Massimo
AU - Magnaterra, Elisabetta
AU - Rongioletti, Franco
AU - Mercuri, Santo Raffaele
AU - Paolino, Giovanni
AU - Savoia, Paola
AU - Veronese, Federica
AU - Foti, Caterina
AU - Ambrogio, Francesca
AU - Scalvenzi, Massimiliano
AU - Napolitano, Maddalena
AU - Patruno, Cataldo
AU - Dastoli, Stefano
AU - Corazza, Monica
AU - Borghi, Alessandro
AU - Calzavara-Pinton, Pier Giacomo
AU - Rossi, Mariateresa
AU - Offidani, Annamaria
AU - Radi, Giulia
AU - Bonzano, Laura
AU - Ferreli, Caterina
AU - Piras, Viviana
AU - Satta, Rosanna
AU - Sucato, Federica
AU - Malagoli, Piergiorgio
AU - Gaiani, Francesca
AU - Micali, Giuseppe
AU - Musumeci, Maria Letizia
AU - Fargnoli, Maria Concetta
AU - Esposito, Maria
AU - Grieco, Teresa
AU - Chello, Camilla
AU - Casazza, Giovanni
AU - Marzano, Angelo Valerio
N1 - Publisher Copyright:
© 2024 The Author(s).
PY - 2024/12/1
Y1 - 2024/12/1
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/85200777773
U2 - 10.1093/ced/llae208
DO - 10.1093/ced/llae208
M3 - Article
SN - 0307-6938
VL - 49
SP - 1561
EP - 1572
JO - Clinical and Experimental Dermatology
JF - Clinical and Experimental Dermatology
IS - 12
ER -