Real-World Effectiveness and Safety of Lebrikizumab in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: A 52-Week Retrospective Italian Study Focusing on Head and Neck Involvement

Introduction: Lebrikizumab, a monoclonal antibody targeting interleukin (IL)-13, has demonstrated efficacy and safety in phase III trials for moderate-to-severe atopic dermatitis (AD). However, long-term real-world evidence, particularly in European populations and in difficult-to-treat areas such as the head and neck, remains limited. This study evaluated the 52-week real-world effectiveness and safety of lebrikizumab in patients with moderate-to-severe AD. Methods: This retrospective, two-center study included adults and adolescents treated with lebrikizumab according to the approved label. Clinical assessments were performed at baseline and weeks 16, 24, and 52. Effectiveness outcomes included the Eczema Area and Severity Index (EASI) 75/90/100, absolute EASI thresholds, Investigator’s Global Assessment (IGA) 0/1, patient-reported outcomes (Peak Pruritus Numerical Rating Scale [PP-NRS] and Sleep Disturbance Numerical Rating Scale [S-NRS]), and minimal disease activity (MDA) defined as the combined endpoint EASI 90 plus PP-NRS 0/1. Head and neck involvement was specifically analyzed. Safety was assessed by recording adverse events (AEs). Results: A total of 123 patients were included (116 adults, 7 adolescents). EASI 75 was achieved by 65.0%, 68.9%, and 82.6% of patients at weeks 16, 24, and 52, respectively. EASI 90 increased from 43.9% at week 16 to 69.6% at week 52, while EASI 100 was observed in 56.5% at week 52. IGA 0/1 was achieved by 82.6% of patients at week 52. Clinically meaningful pruritus improvement (ΔPP-NRS ≥ 4) was observed in 65.2% of patients at week 52, and MDA was achieved by 56.6%. Patients with head and neck AD showed comparable clinical responses to those without involvement of this area, with a marked reduction in head and neck EASI (H&N EASI) over time. Overall, 5.7% of patients reported at least one AE, most commonly mild-to-moderate conjunctivitis, with no new safety signals. Conclusions: In this real-world European cohort, lebrikizumab demonstrated sustained effectiveness and a favorable safety profile over 52 weeks, including in patients with head and neck involvement, supporting its long-term use in routine clinical practice.