Effectiveness, biomarker transition, and safety of 48-week tralokinumab treatment for atopic dermatitis: real-world analyses stratified by age groups (15-17, 18-64, and ≥ 65 years).

Tralokinumab, an anti-interleukin-13 monoclonal antibody, is effective for atopic dermatitis (AD). However, long-term (one-year) clinical outcomes stratified by age groups have not been sufficiently studied. To evaluate the effectiveness of 48-week tralokinumab treatment for patients with AD, stratified by age groups (15-17, 18-64, and ≥65 years). We conducted a prospective study from October 2023 to May 2025 in 194 Japanese patients aged ≥15 years with moderate-to-severe AD. Patients received tralokinumab every two weeks for 48 weeks. Outcomes included transitions in total EASI, anatomical site-specific EASI, PP-NRS, and IGA, achievement rates of EASI50/75/90/100, IGA0/1, and PP-NRS4, transitions of blood biomarkers (total IgE, TARC, LDH, and TEC), and treatment-emergent adverse events. Mean scores of total and anatomical site-specific EASI and PP-NRS decreased similarly across all age groups through week 48. At week 48, the achievement rates of EASI 75 and PP-NRS 4 were 87.5% and 66.7% in patients aged 15-17 years, 92.5% and 63.1% in those aged 18-64 years, and 81.8% and 66.7% in those aged ≥65 years (p>0.05), respectively. Tralokinumab reduced both EASI and PP-NRS scores throughout 48 weeks in patients with AD across all age groups. These findings suggest that tralokinumab may be effective in a wide range of patients, from adolescents to the elderly.