Background and Importance Atopic dermatitis (AD) is a chronic inflammatory skin disease characterised by severe pruritus, eczema and xerosis. A systemic treatment option for moderate-severe AD is tralokinumab, a human monoclonal antibody targeting IL-13.

Aim and Objectives The aim of the study is to evaluate the effectiveness and safety of tralokinumab in patients with moderate-severe AD in three tertiary hospitals.

Material and Methods Observational, retrospective, multicentred study of patients treated with tralokinumab from April 2022 to September 2023. Variables collected: age, sex, previous treatments, initiation and duration of treatment, adverse effects (AE) and the severity of AD was analysed using the scales: Eczema Area and Severity Index (EASI) and Body Surface Area (BSA).

Effectiveness was evaluated assessing the number of patients with a reduction of at least 50% or 75% in the values of EASI (EASI50 and EASI75, respectively) and number of patients with a reduction in BSA, during week 16 approximately. Sources of information: application of electronic prescription Prisma® and computerised clinical history Diraya®.

Results We included 39 patients, of whom 32 (18 women, 14 men) had reached week 16 of treatment or higher, with an average age of 37.63 years (range 16–66 years) and with a median follow-up of 26.6 weeks. All received previous treatment with topical corticosteroids and cyclosporine, 11 had received treatment with dupilumab and 6 with JAK inhibitors.

The basal medium of EASI was 27.05 and after the assessment carried out, 33% (13/39) achieved EASI50 and 23% (9/39) EASI75. With a median dermatologist assessment of 20 weeks, the number of patients remaining on EASI50 was 11 and on EASI75 9. The basal median of BSA was 21, where 3 (8%) patients suffered an increase and 17 (44%) reduced it, reaching 7 of them to values of 0–1. 15 patients (38%) discontinued treatment, 14 due to lack of efficacy and 1 due to AE.

Four patients with AD were reported: syncope, respiratory infection, headache and conjunctivitis together with generalised xerosis, whose patient had to discontinue treatment.

Conclusion and Relevance Tralokinumab is an innovative alternative in patients with moderate-severe AD refractory to other therapies. More data on long-term efficacy and safety are needed.

Conflict of Interest No conflict of interest.