Tralokinumab Passes Real-World Test in the Treatment of Moderate-to-Severe Atopic Dermatitis

Tralokinumab improved quality of life outcomes related to itch, sleep, and treatment satisfaction for individuals with moderate-to-severe atopic dermatitis (AD) followed for 52 weeks in a real-world study, regardless of prior dupilumab use. The final analysis of the prospective longitudinal study enrolling U.S.-based patients with AD from the Adbry® AdvocateTM Program was presented in a poster session at the 2025 Fall Clinical Dermatology Conference, in Las Vegas. 

Tralokinumab, a monoclonal antibody that precisely targets and neutralizes the interleukin-13 (IL-13) cytokine, is approved in the United States for the treatment of moderate-to-severe AD in patients aged 12 years and older. By inhibiting IL-13, tralokinumab helps disrupt the inflammatory pathways responsible for the signs and symptoms caused by atopic dermatitis. This biologic therapy was previously shown to improve patient-reported outcomes (PROs) in several pivotal clinical trials, as well as in the real-world setting, as early as 4 weeks after treatment initiation. 

The 52-week analysis included 243 participants who completed the mandatory surveys prior to initiating tralokinumab treatment, and subsequently at weeks 4, 24, and 52, by January 2025. The investigators collected and analyzed multiple PROs, including weekly itch numeric rating scale (NRS), worst weekly itch NRS, sleep interference NRS, Dermatology Life Quality Index (DLQI), and Treatment Satisfaction Questionnaire for Medication (TSQM-9). 

    Mean AD duration was 15.6 years, with dupilumab-experienced patients reporting an earlier mean onset and longer duration of disease. Only 2.1% of patients reported not having used any medications prior to tralokinumab initiation. Most patients had used topical corticosteroids (80.7%) and dupilumab (58.9%), while 46.1% had taken prescription oral corticosteroids and 37.5% of patients had used prescription topical calcineurin inhibitors. The analysis showed that the percentage of patients who were not using any concomitant medications increased from 29.2% at baseline to 40.3% at week 52, and the proportion of patients using topical corticosteroids decreased from 49.8% at baseline to 39.1% at week 52. 

    Participants treated with tralokinumab in the real-world setting showed improvements in symptom control, quality of life, and treatment satisfaction over 52 weeks. More than half of the participants achieved a minimal clinically important difference for itch and sleep parameters at week 52, and three-quarters had meaningful changes in DLQI. The TSQM-9 scores showed that mean global satisfaction with treatment increased by 17.8 points. The dupilumab-naïve patients showed markedly improved outcomes, however, in dupilumab-experienced patients, improvement in one outcome was frequently associated with improvements in other outcomes. Significant positive shifts were observed in sleep interference NRS and DLQI, indicating that better sleep was associated with improved quality of life. Peter Lio, MD, an assistant professor of dermatology and pediatrics at the Northwestern University Feinberg School of Medicine, and colleagues noted that these real-world data suggest that tralokinumab is an effective long-term option for managing moderate-to-severe AD, even in patients with prior dupilumab experience.