Effectiveness and safety of tralokinumab treatment for moderate-to-severe atopic dermatitis in real-world clinical practice in Japan.

Tralokinumab is a human monoclonal anti-interleukin-13 antibody approved as systemic treatment for atopic dermatitis (AD). We aimed to evaluate effectiveness and safety of tralokinumab for AD in real-world clinical practice. We analysed Japanese patients with AD from October 2023 to March 2024. All patients were subcutaneously injected with tralokinumab, 300 mg every two weeks, after an initial injection of 600 mg and twice-daily topical corticosteroids of moderate to strongest class until week 12. In this study, 103 patients were analysed. At week 4 and 12, 54.7 % and 83.0 % achieved eczema area and severity index (EASI) 50, 22.7 % and 38.3 % achieved EASI 75, 90 8.0 % and 23.4 % achieved EASI, 32.0 % and 55.3 % achieved EASI ≤7, and 1.3 % and 14.0 % achieved Investigator's Global Assessment 0/1, respectively. At week 4 and 12, 52.9 % and 51.2 % achieved Peak Pruritus-Numerical Rating Scale (PP-NRS) 4, 16.5 % and 15.6 % achieved PP-NRS ≤1, and 57.9 % and 75.0 % achieved Atopic Dermatitis Control Tool 7, respectively. Serum levels of immunoglobulin E, thymus and activation-regulated chemokine, and lactate dehydrogenase significantly decreased at week 12 compared to baseline. Treatment-emergent adverse events occurred in 14.8 % of patients, which were mild and manageable. Notably, conjunctivitis occurred in 2.9 % of patients but was mild and resolved spontaneously. Tralokinumab for patients with AD was well-tolerated and provided favourable therapeutic effects in real-world clinical practice.