TY - JOUR
T1 - Effectiveness, Safety, and Health-Related Quality of Life in Moderate-to-Severe Atopic Dermatitis Treated with Lebrikizumab: A 16-Week Nationwide Retrospective Cohort Study
AU - Avallone, Gianluca
AU - Bombelli, Andrea
AU - Gargiulo, Luigi
AU - Foti, Caterina
AU - Trave, Ilaria
AU - Rossi, Mariateresa
AU - Magnaterra, Elisabetta
AU - Pigliacelli, Flavia
AU - Malagoli, Piergiorgio
AU - Giacalone, Serena
AU - Portarapillo, Antonio
AU - Patruno, Cataldo
AU - Schettini, Natale
AU - Bonzano, Laura
AU - Pezzolo, Elena
AU - Chello, Camilla
AU - Gori, Niccolò
AU - Brunasso, Giovanna
AU - Veronese, Federica
AU - Ortoncelli, Michela
AU - Tolino, Ersilia
AU - Azzolini, Alan
AU - Bellinato, Francesco
AU - Hansel, Katharina
AU - Di Brizzi, Eugenia Veronica
AU - Gurioli, Carlotta
AU - Esposito, Maria
AU - Giuffrida, Roberta
AU - Barei, Francesca
AU - Calzari, Paolo
AU - Burroni, Anna Graziella
AU - Gola, Massimo
AU - Mariano, Maria
AU - Fargnoli, Maria Concetta
AU - Napolitano, Maddalena
AU - Grieco, Teresa
AU - Peris, Ketty
AU - SAVOIA, Paola
AU - Ribero, Simone
AU - Girolomoni, Giampiero
AU - Stingeni, Luca
AU - Balato, Anna
AU - Costanzo, Antonio
AU - Marzano, Angelo Valerio
AU - Narcisi, Alessandra
AU - Ferrucci, Silvia Mariel
PY - 2025
Y1 - 2025
N2 - Introduction: Atopic dermatitis (AD) is a chronic inflammatory skin condition that significantly affects the quality of life (QoL). Lebrikizumab, a biologic drug targeting interleukin-13, demonstrated efficacy and safety in clinical trials. However, real-world data remain limited, largely restricted to Asian populations. Methods: This 16-week retrospective multicenter study included 78 adults from a predominantly white cohort with moderate-to-severe AD treated with lebrikizumab throughout 2024. Patients were both naïve and experienced with biologics or Janus kinase inhibitors (bio/JAKi-naïve or -experienced). The primary outcome for disease severity and therapeutic response was measured using the Eczema Area and Severity Index (EASI). Secondary outcomes included the Dermatology Life Quality Index (DLQI), itch- and sleep-numerical rating scales (NRS), body surface area (BSA), Investigator Global Assessment (IGA), SCORing Atopic Dermatitis (SCORAD), and Patient-Oriented Eczema Measure (POEM). Atopic Dermatitis Control Tool (ADCT) and minimal disease activity (MDA) were used to estimate disease control, and Hospital Anxiety and Depression Scales to monitor mental health status. Results: At week 16, benefits in disease severity were observed for EASI (− 15.8 ± 9.4, p < 0.0001) and EASI head and neck (− 2.0 ± 1.7, p < 0.0001). QoL significantly improved in 70% of patients (DLQI reduction of − 12.6 ± 9.3, p < 0.0001), accompanied by decreased pruritus (Itch-NRS reduction of − 4.6 ± 3.2, p < 0.0001) and better sleep quality (sleep-NRS reduction of − 4.1 ± 3.4, p < 0.0001). A 76% reduction in BSA score was recorded, 85% of subjects improved their IGA index, with 62% achieving a score of 0–1, and SCORAD and POEM assessments significantly improved (p < 0.0001). Patients perceived a better control of the disease (ADCT, − 10.9 ± 7.1, p < 0.0001), and 14% of patients achieved MDA. Anxiety and depression levels decreased. Four mild adverse events were registered. Conclusions: This is one of the first real-world multicenter studies in a predominantly adult white population showing that lebrikizumab is effective, safe and improves symptoms, QoL, and mental health in moderate-to-severe AD bio/JAKi-naïve and -experienced patients.
AB - Introduction: Atopic dermatitis (AD) is a chronic inflammatory skin condition that significantly affects the quality of life (QoL). Lebrikizumab, a biologic drug targeting interleukin-13, demonstrated efficacy and safety in clinical trials. However, real-world data remain limited, largely restricted to Asian populations. Methods: This 16-week retrospective multicenter study included 78 adults from a predominantly white cohort with moderate-to-severe AD treated with lebrikizumab throughout 2024. Patients were both naïve and experienced with biologics or Janus kinase inhibitors (bio/JAKi-naïve or -experienced). The primary outcome for disease severity and therapeutic response was measured using the Eczema Area and Severity Index (EASI). Secondary outcomes included the Dermatology Life Quality Index (DLQI), itch- and sleep-numerical rating scales (NRS), body surface area (BSA), Investigator Global Assessment (IGA), SCORing Atopic Dermatitis (SCORAD), and Patient-Oriented Eczema Measure (POEM). Atopic Dermatitis Control Tool (ADCT) and minimal disease activity (MDA) were used to estimate disease control, and Hospital Anxiety and Depression Scales to monitor mental health status. Results: At week 16, benefits in disease severity were observed for EASI (− 15.8 ± 9.4, p < 0.0001) and EASI head and neck (− 2.0 ± 1.7, p < 0.0001). QoL significantly improved in 70% of patients (DLQI reduction of − 12.6 ± 9.3, p < 0.0001), accompanied by decreased pruritus (Itch-NRS reduction of − 4.6 ± 3.2, p < 0.0001) and better sleep quality (sleep-NRS reduction of − 4.1 ± 3.4, p < 0.0001). A 76% reduction in BSA score was recorded, 85% of subjects improved their IGA index, with 62% achieving a score of 0–1, and SCORAD and POEM assessments significantly improved (p < 0.0001). Patients perceived a better control of the disease (ADCT, − 10.9 ± 7.1, p < 0.0001), and 14% of patients achieved MDA. Anxiety and depression levels decreased. Four mild adverse events were registered. Conclusions: This is one of the first real-world multicenter studies in a predominantly adult white population showing that lebrikizumab is effective, safe and improves symptoms, QoL, and mental health in moderate-to-severe AD bio/JAKi-naïve and -experienced patients.
KW - Atopic dermatitis
KW - Biologics
KW - IL-13 inhibitor
KW - Lebrikizumab
KW - Monoclonal antibodies
KW - Multi-failure
KW - Skin disease
KW - Atopic dermatitis
KW - Biologics
KW - IL-13 inhibitor
KW - Lebrikizumab
KW - Monoclonal antibodies
KW - Multi-failure
KW - Skin disease
UR - https://iris.uniupo.it/handle/11579/220667
U2 - 10.1007/s13555-025-01550-8
DO - 10.1007/s13555-025-01550-8
M3 - Articolo in rivista
SN - 2193-8210
VL - 15
SP - 3671
EP - 3688
JO - Dermatology and Therapy
JF - Dermatology and Therapy
IS - 12
ER -