Effectiveness, Safety, and Health-Related Quality of Life in Moderate-to-Severe Atopic Dermatitis Treated with Lebrikizumab: A 16-Week Nationwide Retrospective Cohort Study
Gianluca Avallone, Andrea Bombelli, Luigi Gargiulo, Caterina Foti, Ilaria Trave, Mariateresa Rossi, Elisabetta Magnaterra, Flavia Pigliacelli, Piergiorgio Malagoli, Serena Giacalone, Antonio Portarapillo, Cataldo Patruno, Natale Schettini, Laura Bonzano, Elena Pezzolo, Camilla Chello, Niccolò Gori, Alexandra Maria Giovanna Brunasso, Federica Veronese, Michela Ortoncelli, Ersilia Tolino, Alan Azzolini, Francesco Bellinato, Katharina Hansel, Eugenia Veronica Di Brizzi, Carlotta Gurioli, Maria Esposito, Roberta Giuffrida, Francesca Barei, Paolo Calzari, A. Burroni, Massimo Gola, Maria Mariano, Maria Concetta Fargnoli, Maddalena Napolitano, Teresa Grieco, Ketty Peris, Paola Savoia, Simone Ribero, Giampiero Girolomoni, Luca Stingeni, Anna Balato, Antonio Costanzo, Angelo Valerio Marzano, Alessandra Narcisi, Silvia Mariel Ferrucci
Abstract
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. 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. 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. 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. Atopic dermatitis is a chronic inflammatory skin condition that can impact quality of life. Lebrikizumab, a new biological drug, proved to be effective and safe. This is one of the first studies investigating the benefit of lebrikizumab use in routine clinical practice in predominantly white adults. The study included 78 adults who were treated with lebrikizumab for 16 weeks between January and December 2024. Some patients had never used biologic treatments before, while others had been treated using different therapies. Different evaluations of the benefit of treatment were performed by physicians and patients, assessing the severity of the disease, including skin appearance, itchiness, and how much of the body was affected. The impact on the quality of life and mental health, including itch levels, sleep quality, anxiety and depression states, and overall control over the disease was also evaluated. After 16 weeks, most patients reported major improvements. The severity of their skin symptoms and itch reduced significantly, and 76% had less body surface area affected. About 70% of patients reported an improvement in their quality of life. Itch and sleep improved, anxiety and depression levels decreased, and patients felt more in control of their condition. Only three mild side effects and one relapse were reported. Overall, this study shows that lebrikizumab is safe and effective for the treatment of moderate-to-severe atopic dermatitis in white patients.