Tralokinumab Delivers Sustained 12-Month Relief in Skin of Color and Difficult-to-Treat AD

Three LEO Pharma posters presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting report final 12-month findings from the international, prospective, non-interventional TRACE program, evaluating real-world outcomes with tralokinumab in adults with moderate-to-severe atopic dermatitis (AD). Collectively, these analyses provide insight into treatment effectiveness across specific subpopulations and clinically meaningful endpoints, including patients with skin of color (SoC), those achieving minimal disease activity (MDA), and individuals with hand and/or foot (H&F) involvement.

“TRACE is a global, real-world study evaluating tralokinumab in clinical practice across diverse patient populations. These 12-month data build on our understanding from clinical trials and highlight the impact of tralokinumab treatment, helping to address important evidence gaps in high-burden areas such as the hands and feet,” Shannon Schneider, Vice President of North America Medical Affairs for LEO Pharma, told Dermatology Times.

Skin of Color Subgroup Analysis

A dedicated analysis examined outcomes among 131 patients with Fitzpatrick skin types IV to VI, out of a total cohort of 824.¹ Baseline characteristics were broadly comparable to the overall population, with a mean age of 40.9 years, mean disease duration of 16.1 years, and substantial baseline disease burden, including a mean Eczema Area and Severity Index (EASI) score of 20.3 and DLQI of 13.5.

Over 12 months of tralokinumab treatment, patients with SoC experienced marked and progressive improvements in clinician-reported outcomes. The proportion achieving an Investigator’s Global Assessment (IGA) score of 0/1 (clear or almost clear) increased to 60.7% by month 12. Composite endpoints incorporating IGA, EASI, and SCORAD similarly improved over time and were consistent with outcomes observed in the full analysis set.

Patient-reported outcomes (PROs) also improved substantially. Mean peak pruritus scores decreased from 6.8 at baseline to approximately 3.0 by month 12, while DLQI scores improved from 13.5 to 5.6, reflecting meaningful gains in quality of life. Sleep disturbance scores similarly declined.

Minimal Disease Activity Outcomes

A second poster evaluated the attainment of minimal disease activity using both clinician-reported outcomes (ClinROs) and patient-reported outcomes in the full TRACE cohort.² At baseline, patients exhibited substantial disease burden, with a mean EASI of 20.1, SCORAD of 47.1, and DLQI of 12.8, and all had prior systemic treatment exposure.

By month 12, 91% of patients achieved at least 1 moderate treatment target, while 78% reached at least 1 optimal target, reflecting MDA as defined by AHEAD recommendations. Commonly achieved moderate endpoints included EASI ≤7 (88%) and IGA ≤2 with ≥50% improvement in body surface area (84%). Among optimal targets, EASI ≤3 (74%) and sleep NRS ≤1 (57%) were most frequent.

Importantly, the proportion of patients achieving both ClinRO and PRO targets increased over time. Approximately three-quarters of patients met both moderate ClinRO and PRO thresholds, and nearly half achieved optimal thresholds for both domains by the 12th month.

Hand and Foot Involvement Subgroup

A final analysis focused on 495 patients (60% of the TRACE population) with AD affecting the hands and feet—areas known to be particularly burdensome and difficult to treat.³ Baseline characteristics indicated long-standing disease (mean duration 20.5 years) and significant severity.

After a year of treatment, 57.4% of patients had no remaining AD involvement on the hands and feet. Clinician-assessed outcomes showed substantial improvement, with 60% achieving IGA 0/1. Composite response rates (IGA 0/1, EASI ≤7, or SCORAD <10) increased steadily over time and were comparable to those in the full cohort.

PROs demonstrated parallel benefits. Mean peak pruritus scores decreased from 6.5 at baseline to 2.8 to 3.0 by the end of the trial, while DLQI scores improved from 13.8 to 4.6, indicating reduced symptom burden and enhanced quality of life.

Overall Implications

Across all 3 analyses, the TRACE study reinforces the real-world effectiveness of tralokinumab in diverse AD populations. Improvements were rapid, sustained, and consistent across clinician- and patient-reported measures. Notably, efficacy extended to traditionally underrepresented or difficult-to-treat groups, including patients with SoC and those with H&F involvement, while a majority of patients achieved clinically meaningful MDA targets. Together, these findings support the role of IL-13 inhibition with tralokinumab as a robust therapeutic option for long-term AD management in routine clinical practice.

References

1. Armstrong A, Rubin C, Jarell A, et al. Real-world effectiveness of 12 months tralokinumab treatment in patients with skin of color and atopic dermatitis: Final data from the prospective, non-interventional, international TRACE study. Poster presented at the 2026 American Academy of Dermatology Annual Meeting. Denver, Colorado. March 27-31, 2026.

2. Pink A, Pezzolo E, Jarell A, et al. Minimal disease activity with 12 months of tralokinumab treatment in adults with atopic dermatitis: Real-world data from the prospective, non-interventional, international TRACE study. Poster presented at the 2026 American Academy of Dermatology Annual Meeting. Denver, Colorado. March 27-31, 2026.

3. Armstrong A, Rodriguez A, Jarell A. Real-world effectiveness of 12 months tralokinumab in 495 adult atopic dermatitis patients with hand and feet involvement: Final data from the prospective, non-interventional, international TRACE study. Poster presented at the 2026 American Academy of Dermatology Annual Meeting. Denver, Colorado. March 27-31, 2026.