Abstract
Tralokinumab is a monoclonal antibody selectively targeting IL-13, approved for moderate-to-severe atopic dermatitis (AD), for which real-world data are scarce. This prospective, observational, multicentric study aimed to assess the long-term effectiveness and safety of tralokinumab in patients with AD in a real-world setting. Primary outcomes included 50%, 75%, and 90% improvement in Eczema Area and Severity Index score (EASI50, EASI75, EASI90, respectively) and improvements in Dermatology Life Quality Index (DLQI) at 1 year. A total of 136 patients with AD were enrolled in the study; data at 1-year follow-up were available for 111 patients. After 1 year, 68.5% and 33.3% of patients achieved an EASI75 and EASI90, respectively. A significantly higher percentage of patients with than without foot involvement achieved EASI50 (p = 0.009) and EASI75 (p = 0.022). Similarly, hand involvement was significantly associated with higher EASI50 response (p = 0.005). Median DLQI score decreased from 9.00 (interquartile range (IQR): 6.00, 13.75) to 1.00 (IQR: 0.00, 4.00) after 1 year of treatment. Adverse events included blepharitis (n = 10), conjunctivitis (n = 6), and injection-site reactions (n = 2). Tralokinumab can be an effective and safe treatment for patients with moderate-to-severe AD. Involvement of certain body areas, such as hands and feet, might positively predict a clinical response to tralokinumab.