TRACE: Tralokinumab Data for Atopic Dermatitis in Skin of Color, With April Armstrong, MD, MPH

A new post-hoc analysis from the TRACE study suggests 80.4% of patients with skin of color and atopic dermatitis who were involved in the study achieved at least 1 clinically meaningful disease control endpoint at 12 months of use.1,2

This post-hoc analysis was 1 of several from the TRACE study presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting. The data was authored by investigators such as April Armstrong, MD, MPH, of UCLA’s David Geffen School of Medicine, who spoke with HCPLive about these new findings on tralokinumab, providing important real-world insights into the long-term effectiveness of tralokinumab in adults with atopic dermatitis.

“The TRACE study is a real world study looking at patients with moderate to severe atopic dermatitis who started on tralokinumab, and the unique aspect about this particular study is that it recruited globally and [used] a patient population,” Armstrong explained.

The study is a prospective, non-interventional, international study designed to assess outcomes over 12 months in those using tralokinumab in routine clinical practice. In 1 piece of data highlighted at the meeting, patients with baseline head and neck involvement (n=495) saw substantial and sustained disease improvement over time.

Specifically, the proportion of those reporting any head and neck involvement dipped from baseline to 46.3% at Month 3 and dipped further to 31.6% at Month 12. The investigators noted such improvements were accompanied by early and clinically meaningful gains in symptom burden and disease severity, including reductions in Peak Pruritus and Sleep Numerical Rating Scale (PP/Sleep-NRS) scores, Investigator’s Global Assessment (IGA) scores, and Dermatology Life Quality Index (DLQI) score improvements.

In the separate subgroup analysis described by Armstrong, regarding 131 patients with skin of color (Fitzpatrick skin types IV–VI), 80.4% attained at least a single clinically meaningful disease control endpoint by the 12-month mark. These endpoints included IGA 0/1, EASI ≤7, or SCORAD <10, suggesting minimal to mild disease. Observance of quality of life improvements also took place in this population.

“What we found is that, among patients who were classified as skin of color, about 80% of them are able to achieve that stringent endpoint by 12 months,” Armstrong said. “And importantly, for that particular endpoint looking at the difference between, for example, patients who are skin of color with the overall population, the difference was actually very small.”

Across the overall study population (n=824), Armstrong et al found 91% of patients achieved at least 1 moderate treatment target after 12 months of tralokinumab use. Notably, approximately three-quarters met both clinician-reported and patient-reported moderate endpoints. The team also found nearly half attained optimal targets consistent with minimal disease activity.

For any additional information on these data, view Armstrong’s full interview posted above.

The quotes used in this summary were edited for clarity.

Armstrong has served as a consultant for and received honoraria from AbbVie, Almirall, Arcutis, ASLAN, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Dermira, EPI, Incyte, Janssen, LEO Pharma, Eli Lilly, Nimbus, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi, Sun, and UCB and has participated in advisory boards for Boehringer Ingelheim and Parexel.

References

1. LEO Pharma Presents New 12-Month Real-World Data for Tralokinumab at AAD 2026. LEO Pharma. May 30, 2026. https://www.businesswire.com/news/home/20260328143419/en/LEO-Pharma-Presents-New-12-Month-Real-World-Data-for-Tralokinumab-at-AAD-2026.

2. Armstrong AW, Rubin C, Jarell A, et al. Real-world effectiveness of 12 months tralokinumab treatment in patients with skin of color and moderate-to-severe atopic dermatitis: final data from the prospective, non-interventional, international TRACE study. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Poster ID: 77199. Oral Poster Presentation.