Niccolò Gori, Marco Galluzzo, Elena Ippoliti, Benedetta Ambrosio, Elettra Antonelli, Alessandra Capo, Camilla Chello, Maria Mariano, Emanuela Martina, Gaia Moretta, Edoardo Mortato, Lina Maria Magnanimi, Nevena Skroza, Paolo Amerio, Anna Campanati, Ester Del Duca, Ornella De Pità, Maria Esposito, Maria Concetta Fargnoli, Luca Stingeni, Ersilia Tolino, Lucia Di Nardo, Ketty Peris
Lebrikizumab demonstrated favorable real-world effectiveness and safety in adults with moderate-to-severe AD after 16 weeks of treatment, with clinical and patient-reported improvements maintained through week 24.
BACKGROUND: Lebrikizumab has recently been approved for moderate-to-severe atopic dermatitis (AD), but real-world evidence across different patient subgroups remains limited.
OBJECTIVE: To evaluate the real-world effectiveness and safety of lebrikizumab in adults with moderate-to-severe AD.
METHODS: This multicenter observational study included adults with moderate-to-severe AD treated with lebrikizumab for at least 16 weeks at eight Italian university hospitals between March and December 2025. Outcomes were assessed at baseline and weeks 16 and 24. The primary endpoint was achievement of at least a 75% improvement in the Eczema Area and Severity Index (EASI75) at week 16. Secondary outcomes included EASI90, EASI100, pruritus and sleep Numeric Rating Scale scores, Dermatology Life Quality Index, and safety.
RESULTS: Ninety-one patients were included; 56% were male, mean age was 37.9 years, and mean baseline EASI was 21.2. At week 16, EASI75, EASI90, and EASI100 were achieved by 49.5%, 20.9%, and 9.9% of patients, respectively. At week 24, response rates increased to 58.6%, 32.8%, and 25.9%, respectively. Clinically meaningful improvements were also observed in pruritus, sleep disturbance, and quality of life. Biologic- and JAK inhibitor-naive patients showed numerically higher response rates than previously treated patients, whereas no significant differences were observed according to age, sex, atopic comorbidities, or disease duration. Treatment-emergent adverse events occurred in 23.1% of patients and were mainly mild to moderate. Conjunctivitis was the most frequent adverse event.
CONCLUSION: Lebrikizumab demonstrated favorable real-world effectiveness and safety in adults with moderate-to-severe AD after 16 weeks of treatment, with clinical and patient-reported improvements maintained through week 24.