Tralokinumab Clears High-impact AD Areas, TRACE Real-world Data Show
Updated

Real-world data presented at the 2026 European Academy of Dermatology and Venereology (EADV) Congress in Vienna show that tralokinumab (Adtralza/Adbry, LEO Pharma) reduces involvement of high-impact atopic dermatitis (AD) areas — the face and neck, the hands, or the genitals — and improves quality of life in adults and adolescents.
The findings come from a subgroup analysis of TRACE, a prospective, non-interventional study following patients treated with tralokinumab for up to 12 months. Of 824 enrolled patients, 742 had AD affecting one, two or three high-impact areas at baseline. Patients with more areas involved started with more severe disease and worse quality of life and sleep.
The analysis found consistent reductions in involvement across all three groups by Month 12. Of the 91 patients with all three high-impact areas involved at baseline, 48 remained in the study and were assessed at 12 months. Among these, 79.2% reported fewer affected areas, and 25.0% reported no involvement in any area.
Of the 349 patients with two affected areas at baseline, 193 were assessed at 12 months; 71.0% reported a reduction, including 28.0% who no longer reported involvement in either area. Among the 302 patients with one high-impact area at baseline, 178 were assessed at 12 months, and 43.3% no longer reported involvement in that area.
Quality of life improved in parallel: 76.9% of patients with a baseline Dermatology Life Quality Index (DLQI) score of 4 or higher achieved at least a 4-point reduction.
ADHAND: Hand eczema and sleep outcomes
Related analyses from the Phase 3 ADHAND trial showed that significantly more patients on tralokinumab monotherapy than placebo achieved at least a 4-point reduction in DLQI and at least a 1.3-point reduction in the Hand Eczema Impact Scale (HEIS) at Week 16. The treatment groups separated within two weeks. Under open-label treatment, response rates rose to 89.6% for the DLQI endpoint and 83.2% for the HEIS endpoint by Week 32.
Every HEIS domain favored tralokinumab, including the pre-specified sleep quality domain and the domain covering gripping or holding objects.
In predefined exploratory outcomes assessing efficacy beyond the hands, more patients achieved Eczema Area and Severity Index (EASI)-75 and EASI-90 at Week 16 with tralokinumab monotherapy versus placebo.
Adolescent durability out to 3 years
A separate post hoc analysis followed 88 adolescents aged 12-17 years treated for up to approximately 3 years across the ECZTRA and ECZTEND trials. Outcomes remained stable throughout most of the extension trial, with response rates of 80-85% for EASI-75, 65-75% for a Children's Dermatology Life Quality Index (CDLQI) score of 6 or below, and 50-60% for an Investigator's Global Assessment (IGA) score of 0/1 and for EASI-90.
Tralokinumab was well tolerated in adolescents. Most adverse events were non-serious, mild or moderate in severity, and assessed as unrelated to treatment. Common adverse events during ECZTEND included coronavirus infection, nasopharyngitis, atopic dermatitis and anxiety. Allergic conjunctivitis was the only adverse event of special interest, reported in one adolescent, and no new safety concerns were identified.
Taken together, the TRACE subgroup data, ADHAND quality-of-life results and long-term adolescent extension findings position tralokinumab as a durable option for AD in the anatomical sites that drive the greatest patient burden, with longer-term comparative data still needed to define its place among newer biologics and small molecules.
Original: thedermdigest.com
Olivia Hart
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News editor covering technology and product news in Clinical dermatology, inflammatory skin disease and biologics at Derm Field.