• New findings from a subgroup analysis of the 12-month TRACE study show that more than 70% of adults whose Atopic Dermatitis (AD) affected multiple high-burden areas – such as the head and neck, hands and feet, or genitals – had reduced involvement of those areas after 12 months of treatment with tralokinumab.¹
• New pre-specified and post hoc analyses from the phase 3 ADHAND trial show significantly greater improvements in quality of life, daily function and sleep at Week 16 with tralokinumab monotherapy than with placebo in adults with AD and moderate-to-severe hand involvement, with the two treatment groups separating within two weeks.^2,3
• In a post hoc analysis, adolescents aged 12-17 years treated across the phase 3 ECZTRA 6 trial and its ECZTEND extension, response rates remained high and stable through most of the extension period, and no new safety concerns were identified.⁵

LEO Pharma A/S, a global leader in medical dermatology, has presented new data on Adtralza® (tralokinumab) / Adbry® (tralokinumab-ldrm) in Atopic Dermatitis (AD) at the 35th European Academy of Dermatology and Venereology (EADV) Congress, held from 30 September to 3 October 2026 in Vienna, Austria.

Eight original tralokinumab abstracts feature in the company's programme at the congress, including two oral presentations and six ePosters. The analyses highlighted here span adults and adolescents, controlled clinical trials and routine clinical practice, and outcomes reported by physicians and by patients themselves.^1–5

AD is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions, and it rarely affects only one part of the body.^6,7 Disease involving high-burden areas such as the head and neck, the hands and feet, or the genitals is especially difficult for patients.^1,2

Real-world evidence when atopic dermatitis affects the head and neck, hands and feet or genitals

In an oral presentation, a subgroup analysis from TRACE — a prospective, non-interventional study following treatment with tralokinumab for up to 12 months — assessed 742 of 824 enrolled patients with atopic dermatitis affecting one, two or three high-burden areas at baseline. Those with more areas affected had more severe disease and worse quality of life and sleep to begin with.¹

Involvement was reduced across all three groups by Month 12: of the 91 patients with all three areas involved at baseline, 48 remained in the study and were assessed at 12 months. Among these patients, 79.2% reported fewer affected areas, and 25.0% no longer reported involvement in any area. Similarly, 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. Finally, of the 302 patients with one high-burden area involved at baseline, 178 were assessed at 12 months, of whom 43.3% no longer reported involvement in that area.¹ Quality of life also improved, with 76.9% of patients with a baseline Dermatology Life Quality Index (DLQI) score of 4 or higher achieving at least a 4-point reduction.¹

“The areas that matter most to patients can often be the hardest to treat – high burden areas such as the face and neck, the hands, or the genitals. In TRACE, patients with AD affecting more of these areas started with more severe disease and a larger impact on quality of life and sleep than those without high burden involvement. Improvements were seen from three months of treatment with tralokinumab, and the majority reported fewer areas affected after a year,” said Professor Diamant Thaçi, Director of the Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Germany, and study co-author.

Daily function and quality of life when atopic dermatitis affects the hands

In analyses from the phase 3 ADHAND trial, significantly more patients on tralokinumab monotherapy than placebo achieved at least a 4-point reduction in DLQI (76.6% vs 44.7%, pre-specified) and at least a 1.3-point reduction in the Hand Eczema Impact Scale (HEIS) (59.7% vs 22.8%, post hoc) at Week 16, both p<0.001 and considered clinically meaningful improvements.²,³ The groups separated within two weeks, and rates rose to 89.6% and 83.2% by Week 32 under open-label treatment.³ Every HEIS domain favoured tralokinumab, including the pre-specified sleep quality domain (-68.5% vs -24.3%) and gripping or holding objects (-74.6% vs -29.8%), all p<0.001.³

In predefined exploratory outcomes assessing efficacy beyond the hands, more patients achieved EASI-75 (47.6% vs 19.8%) and EASI-90 (27.9% vs 9.5%) at Week 16 with tralokinumab monotherapy vs placebo (both p<0.001).²

Supporting best practice in the use of biologics

In a second oral presentation, the AMAZE project, through experts in a steering committee, examined how biologics as a class are initiated and managed in AD, drawing on a global survey of 150 dermatologists across North America, Europe and Japan, regional expert discussions and a literature review.⁴ It found considerable regional variation in practice, and proposed best-practice recommendations including patient-centered long-term treatment goals and formal assessment of treatment response at approximately 12-16 weeks after initiation.⁴

“For a long time, the treatment ambition in AD was to settle a flare and see how long the quiet lasted. Now, the guidelines are clear on the need for advanced therapies for long-term treatment for moderate-to-severe AD patients, but the practical challenges on effectively transitioning to biologics are often overlooked. We must adopt personalized strategies – agreeing what control should mean for that particular patient and returning to it at three or four months to see whether it has been reached,” said Professor April W. Armstrong, David Geffen School of Medicine at the University of California, Los Angeles, and presenting author.

Long-term disease control and safety data in adolescents

In a separate post-hoc analysis, 88 adolescents aged 12-17 years were treated for up to approximately three years across ECZTRA 6 and ECZTEND.⁵ 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 EASI-90.⁵

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 (≥5%) during ECZTEND included coronavirus infection, nasopharyngitis, atopic dermatitis and anxiety; allergic conjunctivitis was the only adverse event of special interest, reported in one adolescent (1.1%). No new safety concerns were identified.⁵

"When treating young patients, it is important not only to treat the flare but to aim for sustained disease control over time. That is why long-term disease control can matter as much as an early response, giving young people stability at an otherwise tumultuous time," said Professor Jacob Thyssen, Chief Scientific Officer, LEO Pharma.

About the TRACE Study

TRACE was an international, prospective, observational, non-interventional study describing the real-world effectiveness of tralokinumab in adults with AD prescribed treatment at the treating physician's discretion and followed for up to 12 months. Assessments followed local clinical practice and were reported at baseline and every three months, and included the IGA, EASI and SCORAD, alongside the patient-reported DLQI, peak pruritus and sleep numerical rating scales. To date, TRACE is the largest non-interventional, real-world study of tralokinumab in adults with AD.¹

About the ADHAND Trial

ADHAND (NCT05958407) was a 32-week, phase 3b, randomized, double-blind, placebo-controlled, multi-site trial and the first phase 3 trial to evaluate targeted IL-13 inhibition in adults with AD and moderate-to-severe hand involvement. Participants were randomized 2:1 to tralokinumab monotherapy 300 mg or placebo every two weeks for 16 weeks, after which all received open-label tralokinumab every two weeks through Week 32. Participants were required to have AD affecting at least one body area beyond the hands. Primary results from the 32-week trial have been reported previously.^2,3,8

About the ECZTRA 6 and ECZTEND Trials

ECZTRA 6 (NCT03526861) was a randomized, double-blind, placebo-controlled, multi-site phase 3 trial of tralokinumab, with optional topical corticosteroids or topical calcineurin inhibitors, in adolescents 12-17 years of age with moderate-to-severe AD over 52 weeks. ECZTEND (NCT03587805) was an open-label, multi-site extension trial in patients who had completed previous tralokinumab trials; trial treatment ended in May 2022 for adolescent participants.⁵

About the AMAZE Project

AMAZE (Advancing Management of Atopic dermatitis and ecZEma) explored real-world approaches to the use of biologic therapies in AD in order to identify best practices to support dermatologists in optimizing patient care. It comprised a global online survey of 150 dermatologists with recent experience of prescribing biologics, four regional expert discussion meetings and a narrative literature review, chaired by a Global Steering Committee of six dermatologists and nurse practitioners. AMAZE addressed the use of biologics as a class and was not specific to any individual product.⁴

About Atopic Dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.⁶ Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.⁷ Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology.^6,7

About Adtralza® (tralokinumab) / Adbry® (tralokinumab-ldrm)

Adtralza® (tralokinumab), which is marketed under the tradename Adbry® in the U.S., is a high-affinity fully human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.^9,10

Adtralza® / Adbry® is approved for the treatment of moderate-to-severe atopic dermatitis in adults in Canada, Japan, Switzerland, Saudi Arabia, South Korea, United Arab Emirates (UAE), UK and US.

Adtralza® / Adbry® is furthermore approved for use in adolescent patients with moderate-to-severe AD in Canada, EU, South Korea, UAE, Saudi Arabia, UK, and US.

About LEO Pharma

LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people's lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. Headquartered in Denmark, LEO Pharma has a team of 4,300 people worldwide. Together, we reach far beyond the skin. For more information, visit www.leo-pharma.com

References

1. Armstrong AW, et al. Real-world use of tralokinumab in patients with atopic dermatitis involving high-burden areas: Effectiveness and impact on quality of life in the prospective, non-interventional 12-month TRACE study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September-3 October 2026. Oral presentation. AS-1845.

2. Ehst B, et al. Tralokinumab monotherapy improves atopic dermatitis severity in patients with moderate-to-severe atopic hand eczema. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September-3 October 2026. ePoster Presentation. P1575.

3. Volc S, et al. Tralokinumab monotherapy rapidly improves sleep, daily functions, and health-related quality of life in patients with atopic dermatitis and moderate-to-severe hand involvement. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September-3 October 2026. ePoster Presentation. P1595.

4. Armstrong AW, et al. Initiating biologics in atopic dermatitis: Global practices and recommendations from the AMAZE project. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September-3 October 2026. Oral presentation. AS-2446.

5. Paller AS, et al. Long-term efficacy and safety of tralokinumab in adolescents aged 12-17 years with moderate-to-severe atopic dermatitis. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September-3 October 2026. ePoster Presentation. P1513.

6. Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016;387(10023):1109-1122.

7. Boguniewicz M, Leung DY. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-246.

8. Ehst B, et al. Tralokinumab treatment in patients with atopic dermatitis and moderate-to-severe hand involvement: results from the 32-week phase 3b ADHAND trial. Poster presentation. J of Skin. 2026;10(2):s744. doi:10.25251/ppt8ep84.

9. Adtralza® (tralokinumab). Summary of Product Characteristics. LEO Pharma. May 2026.

10. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020;75:54-62.

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