TRACE Study: Delayed Responses to Tralokinumab Observed in Atopic Dermatitis
Key Takeaways
In the prospective, international TRACE study, 65.3% of patients with atopic dermatitis achieved a composite clinical response after 3 months of tralokinumab treatment.
Among patients without an early response who had an assessment at month 12, 76% met composite response criteria by month 12.
Early responses were generally maintained through 12 months, while patients without an early response experienced progressive improvements in disease activity and patient-reported outcomes.
More than three-quarters of patients with atopic dermatitis (AD) who had not achieved a composite clinical response to tralokinumab after 3 months met response criteria by month 12, according to findings from the prospective, international TRACE study presented at the 2026 European Academy of Dermatology and Venereology (EADV) Congress.1
The 12-month, noninterventional study evaluated real-world treatment responses among adults with AD prescribed tralokinumab. The full analysis set included 824 patients across 149 international sites. Investigators assessed clinical outcomes every 3 months using the Eczema Area and Severity Index (EASI), Investigator Global Assessment (IGA), and SCORing Atopic Dermatitis (SCORAD).
Composite response was defined as achieving at least one of the following: EASI ≤7, IGA 0/1, or SCORAD <10.
Early and Delayed Treatment Responses
At month 3, 65.3% (430/659) of evaluable patients achieved composite response, while 34.7% (229/659) did not. Among early responders with available month 12 assessments, 91% (262/288) maintained composite response.
Among patients without an early response, 51% (83/162) met response criteria at month 6, increasing to 76% (81/107) at month 12.
Patients without an early response had greater baseline disease severity than early responders, with mean EASI scores of 24.0 versus 18.8, respectively. They were also more likely to have previously received biologic therapy (27.9% vs 20.0%).
Both groups experienced improvements in dermatology-related quality of life, pruritus, and sleep outcomes over 12 months.
The observational design, variable assessment availability, and declining evaluable sample sizes limit interpretation of the findings.
"These results support the early and long-term effectiveness of tralokinumab for up to 12 months in a real-world setting," the investigators concluded.¹
- Armstrong AW, Pereyra Rodriguez JJ, Ameen A, et al. Real-world characterization of early and delayed responses to tralokinumab among patients with atopic dermatitis: results from the prospective, international, non-interventional 12-month TRACE study. Poster presented at: 35th European Academy of Dermatology and Venereology Congress; September 30-October 3, 2026. The poster does not specify the presentation location.