Interim results from the TRACE study, presented at the 2024 European Academy of Dermatology and Venereology Congress, reveal that nine months of treatment with tralokinumab (Adbry; LEO Pharma) leads to significant improvements in itch, sleep quality, and overall quality of life in adult patients with atopic dermatitis (AD). The study, a prospective, non-interventional trial involving 824 patients across 11 countries, suggests that tralokinumab provides consistent benefits in a real-world setting, regardless of prior dupilumab exposure.
The TRACE study enrolled adult patients aged 18 years and older with a diagnosis of AD who were tralokinumab-naive and expected to receive at least one dose during the study. Patients were enrolled between November 2021 and July 2023, with data cutoff on October 15, 2023. Baseline characteristics showed that 627 patients were dupilumab-naive, while 197 had prior dupilumab treatment. The average age of participants was 44.1 years, with 52.2% being male. The majority (75.7%) were White, with representation from Asian (5.3%), Black or African American (4.5%), and other ethnicities (14.4%).
Improvement in Patient-Reported Outcomes
Researchers assessed patients at 3, 6, and 9 months, observing gradual improvements in patient-reported outcomes. Average Peak Pruritus Numerical Rating Scale (PP-NRS) scores decreased from 6.6 to 3.3 in dupilumab-naive patients and from 5.5 to 3.3 in dupilumab-experienced patients over the nine months. Dermatology Life Quality Index (DLQI) scores also improved, decreasing from 13.4 to 5.4 and from 10.7 to 5.4 in the respective groups. Sleep NRS scores showed a similar pattern, decreasing from 5.2 to 2.2 and from 4.4 to 2.2.
The proportion of patients achieving PP-NRS scores ≤ 4 improved from 23% at baseline to 72% at month 9. Similarly, the proportion of patients achieving DLQI scores ≤ 5 increased from 20% to 64% over the same period, demonstrating sustained improvements in itch and quality of life.
Clinical Implications
According to the poster authors, "Treatment up to 9 months with tralokinumab improved AD patient-reported itch, QoL, and sleep quality in a real-world setting." These findings support the use of tralokinumab as an effective treatment option for adult patients with atopic dermatitis, offering sustained relief from key symptoms and improved quality of life. The consistent efficacy observed in both dupilumab-naive and dupilumab-experienced patients highlights the potential of tralokinumab to address unmet needs in AD management.
