Tralokinumab Improves Atopic Dermatitis Across Subgroups in TRACE study

Twelve months of tralokinumab (Adbry) treatment improved clinician- and patient-reported outcomes across multiple difficult-to-treat atopic dermatitis subpopulations, according to final real-world data from the international TRACE study presented at the Revolutionizing Atopic Dermatitis (RAD) 2026 Conference.

“Tralokinumab demonstrated robust real-world effectiveness in US adults with AD, with improvements in both disease severity and itch observed by Month 3 and sustained up to Month 12, regardless of prior dupilumab history,” wrote April Armstrong, MD, MPH, and colleagues in their conclusion of the 12-month TRACE data. “The majority of both dupilumab-naïve and dupilumab-experienced patients achieved the composite response or ≥2-point improvement in IGA score.”

Tralokinumab effectiveness in TRACE subpopulations at 12 months

Tralokinumab is a high-affinity monoclonal antibody specifically targeting interleukin-13 (IL-13), approved for moderate-to-severe disease. Real-world evidence in high-burden anatomic regions and in skin of color has been limited, leaving gaps the TRACE final analyses and a parallel US registry readout aimed to address.1,2,3

TRACE was a prospective, non-interventional, international, single-cohort study of 824 adults (full analysis set) with atopic dermatitis prescribed tralokinumab per the approved label and followed for up to 12 months.1 Effectiveness was tracked using a composite response defined as IGA 0/1, EASI ≤7, or SCORAD <10.2

Among 654 participants with head and neck involvement, IGA 0/1 rose from 1.4% (9/619) at baseline to 64.7% (205/371) at month 12, and EASI ≤7 reached 89.3% (259/290).1 Improvements held regardless of prior dupilumab use.

In the 495 patients with hand and foot involvement, 57.4% had no atopic dermatitis on hands or feet by month 12, with gains in IGA, EASI, and SCORAD consistent with the overall cohort.1

Among 131 patients with skin of color (Fitzpatrick IV-VI), composite response climbed to 86% by month 12, and SCORAD ≤24 increased from 15.9% at baseline to 81.8%.1

Minimal disease activity, US outcomes, and tralokinumab safety

A separate TRACE analysis applied the AHEAD minimal disease activity (MDA) targets to the full cohort.1 After 12 months, 91% of patients met at least one moderate target and 78% met at least one optimal target, corresponding to MDA.1 The most commonly met moderate targets were EASI ≤7 (88%) and IGA ≤2 plus 50% BSA improvement (84%), while EASI ≤3 (74%) and Sleep NRS ≤1 (57%) were the most frequent optimal targets.1

In the US cohort (N = 137), composite response increased from 5.2% (7/135) at baseline to 61.5% (24/39) at month 12.2 Response was seen in both dupilumab-naive and dupilumab-experienced patients, at 64.0% and 57.1%, respectively, by month 12.2

Tralokinumab was well tolerated in the US cohort.2 Adverse events occurred in 13 patients (9.5%) and were primarily mild or moderate, and two serious adverse events (1.5%) were reported, none considered treatment related.2 Investigators identified no new safety signals.2

Tralokinumab in the PPD CorEvitas AD Registry

US real-world findings from the PPD CorEvitas AD Registry, presented earlier in 2026, complemented the TRACE data. Among 119 patients persistent on tralokinumab at 12 months, clear or almost clear skin (vIGA-AD ≤1) rose from 6.7% (8/119) at baseline to 63.9% (76/119), and EASI ≤7 increased from 36.1% (43/119) to 85.7% (102/119).3

Among patients with moderate-to-severe disease at baseline (EASI ≥7.1), 78.9% achieved EASI-75 at 12 months.3 Of the registry cohort, 36.1% were advanced systemic therapy (AST) experienced, and 93.0% of those patients had prior dupilumab.3

Improvements extended to quality of life and itch.3 Among patients with baseline DLQI ≥4, 74.7% achieved a four-point or greater improvement, and 66.7% of those with weekly mean pruritus NRS ≥3 achieved a three-point or greater improvement.3 Mean WPAI activity impairment fell by 17.1%, with benefits observed regardless of prior AST use.3

LEO Pharma markets tralokinumab as Adbry in the US and Adtralza in other regions for moderate-to-severe atopic dermatitis.4 The TRACE subpopulation analyses and the CorEvitas registry add real-world durability and tolerability evidence in patients with high-burden involvement and prior advanced systemic therapy exposure.1,3

References

1. Pink AE, 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 TRACE study. Presented at: 8th Annual Revolutionizing Atopic Dermatitis (RAD) Conference; June 17-19, 2026.

2. Armstrong AW, Rubin C, Jarell A, et al. Effectiveness and safety of 12-month tralokinumab treatment in US adults with atopic dermatitis in the TRACE study. Presented at: 8th Annual Revolutionizing Atopic Dermatitis (RAD) Conference; June 17-19, 2026.

3. Silverberg JI, Balu S, Choi CJ, et al. Real-world effectiveness of 12-month persistent tralokinumab use: data from the PPD CorEvitas Atopic Dermatitis Registry. Presented at: 4th Annual Winter Clinical Dermatology Conference; February 21-March 1, 2026; Miami, FL.

4. ADBRY (tralokinumab-ldrm). Prescribing information. LEO Pharma Inc.; 2024.