LEO Pharma Presents Late-Breaking Data at EADV 2025 Showing Week 16 Tralokinumab Response Predicts Long-Term Response in Moderate-to-Severe Atopic Dermatitis

BALLERUP, Denmark, 19 September 2025 LEO Pharma A/S, a global leader in medical dermatology, today announced a late-breaking post hoc analysis of the European Academy of Dermatology and Venereology (EADV) Congress in Paris. The results demonstrate that a response to tralokinumab at Week 16 predicts long-term stability of response in patients.¹

The analysis grouped Week 16 responders of ECZTRA 3 (n=252) into patients treated with tralokinumab plus optional topical corticosteroids who achieved at least a 75% reduction in the Eczema Area and Severity Index from baseline (EASI-75), EASI-90, a Dermatology Life Quality Index score of 0 or 1 (DLQI 0/1), or a composite minimal disease activity endpoint of EASI-90 with DLQI 0/1. Patients who achieved EASI-90 at Week 16 were considered “super responders”. Week 16 results showed 56% of patients achieved EASI-75, 33% achieved EASI-90, 25% achieved DLQI 0/1, and 15% met the composite minimal disease activity endpoint of EASI-90 with DLQI 0/1.¹

A stable EASI predicted trend line of ≥90% improvement from baseline was maintained through Week 120 in the subsequent phase 3, open-label extension ECZTEND trial for both the EASI-75 responders and the super responders. In both groups, a lower absolute EASI at Week 16 was a strong predictor for improvements in EASI over 120 weeks (p<0.0001). The composite responder group (EASI-90 with DLQI 0/1 at Week 16) demonstrated a consistent response, with 58.8% of patients maintaining minimal disease activity across regular follow-up visits approximately every eight weeks throughout the 120-week ECZTEND study period.¹

Across all responder groups, discontinuation due to lack of efficacy or adverse events was low, occurring in fewer than 13% of patients.¹

“Unpredictable flares and symptom variability are common in atopic dermatitis, making long-term disease control a critical goal,” said Andrew Blauvelt, MD, MBA, lead author and Owner of Blauvelt Consulting, LLC. “These data show that early response to tralokinumab is not only achievable but also highly predictive of durable outcomes, offering reassurance in long-term treatment planning.”

“The data from ECZTRA 3 and ECZTEND reinforce the long-term value of tralokinumab in managing moderate-to-severe atopic dermatitis,” said Professor Alexander Egeberg, MD, PhD, Head of Global Medical Affairs at LEO Pharma. “Stability and predictability are essential for patients living with this chronic condition, and we are proud to present evidence that supports both. These findings underscore our commitment to advancing dermatology through rigorous science and patient-centred innovation.”

Alongside the late-breaking ECZTEND data, LEO Pharma presented three e-poster abstracts from the real-world TRACE study, a prospective, non-interventional, international cohort study evaluating tralokinumab in adult patients with AD.^2-4 A total of 824 patients were included with longitudinal data collected over up to 12 months.^2-4 The findings showed consistent reductions in disease severity, with 89% (n=354) of patients reaching EASI ≤7 and 66% (n=397) achieving clear or almost clear skin, defined as Investigator’s Global Assessment (IGA) 0/1, at Month 12.²

Quality of life also improved, with mean DLQI scores decreasing from 12.8 (n=452) at baseline to 7.1 (n=243) and 5.0 (n=170) at Months 3 and 12, while the proportion of patients reporting no or only small impact on daily life (DLQI ≤5) increased from 20% at baseline to 68% at Month 12. Itch and sleep disturbances were reduced, as measured by the Numeric Rating Scale (NRS), with mean itch NRS decreasing from 6.4 (n=490) at baseline to 4.3 (n=258) and 3.3 (n=171) at Months 3 and 12, and sleep NRS from 5.1 (n=377) at baseline to 2.8 (n=202) and 2.3 (n=130) at Months 3 and 12.³ Health-related work ability also improved over time.³

In a subgroup of 654 patients with head and neck involvement, the proportion of AD patients reporting H&N involvement decreased to 68.1% (n=565) and 51.8% (n=367) at Months 3 and 12. The proportion achieving IGA 0/1 also increased from 1.5% (n=619) to 64.7% (n=317), while the proportion of those with severe disease (IGA 4) decreased from 40.1% at baseline to 2.2% at Month 12. EASI ≤7 was achieved by 89.3% (n=290) of patients at Month 12, and the proportion of patients with DLQI ≤5 rose from 19.0% (n=373) at baseline to 67.8% (n=143) at Month 12. Improvements were observed regardless of prior dupilumab use.⁴

These real-world data complement the long-term clinical trial findings and reinforce tralokinumab’s role in delivering long-term disease control and improved patient outcomes in AD.

By delivering durable disease control and improved quality of life for patients with moderate-to-severe atopic dermatitis, tralokinumab is recommended as a first-line systemic treatment. LEO Pharma remains dedicated to transforming the standard of care in dermatology and supporting patients in achieving sustained skin health. LEO Pharma remains dedicated to transforming the standard of care in dermatology and supporting patients in achieving sustained skin health.

*ENDS*

About ECZTRA 3

ECZTRA 3 was a randomized, double-blind, placebo-controlled, multinational Phase 3 trial to evaluate the safety and efficacy of Adtralza^® (tralokinumab) / Adbry^® (tralokinumab-ldrm) in combination with topical corticosteroids (TCS) in adult patients with moderate-to-severe atopic dermatitis.⁵ The trial's primary objective was to demonstrate the superiority of tralokinumab plus TCS versus placebo plus TCS, assessed by Investigator's Global Assessment (IGA 0/1) and EASI-75 at week 16, with additional focus on itch, sleep disturbance, and quality-of-life outcomes.⁵

About the ECZTEND - Long-Term Extension (LTE) Trial

ECZTEND (Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials) is a Phase 3, long-term, five-year, open-label, single-arm extension trial to evaluate the safety and efficacy of Adtralza in patients with atopic dermatitis who participated in the previous Adtralza monotherapy trials (ECZTRA 1 and ECZTRA 2), the combination therapy Adtralza plus TCS trial (ECZTRA 3), the Drug-drug interaction (DDI) trial (ECZTRA 4), the vaccine trial (ECZTRA 5), the adolescent trial (ECZTRA 6), the oral cyclosporine A trial (ECZTRA 7), the combination therapy Adtralza plus TCS trial in Japanese subjects (ECZTRA 8), and the Adtralza monotherapy skin barrier function trial (TraSki). Patients were permitted to enter ECZTEND after completion of the parent trial regardless of their treatment response or whether they were treated with Adtralza or placebo.^6,7

About Atopic Dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.⁸ Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.⁹ Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology.^8,9 Excessive IL-22 production is also known to contribute to the pathogenesis of AD.¹⁰

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.¹¹

Adtralza^® / Adbry^® is approved for the treatment of moderate-to-severe atopic dermatitis in adult and adolescent patients 12 years and older in the European Union, United States, Canada, the United Arab Emirates and South Korea. Adtralza is approved for use in adults with moderate to severe atopic dermatitis in Switzerland, Saudi Arabia and Japan.

About TRACE

TRACE is a prospective, non-interventional, international, single-cohort study of adult patients with AD who were prescribed tralokinumab according to the national approved label at the treating physician’s discretion. Concomitant medications were allowed. 835 patients were enrolled between between November 2021 and July 2023 and followed for up to one year.^2-4

References

1. Blauvelt A, De Bruin-weller M, Katoh N, et al. Initial “Super Response” to Tralokinumab Leads to Stable Long-term Response in Patients with Moderate-to-Severe Atopic Dermatitis: Responder and Predictor Analysis from the ECZTRA 3 & ECZTEND Trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2025. Paris, France. 17-20 September. Late Breaking News Session. D3T01.3F.
2. Armstrong A, Ferrucci S, Rodriguez J, et al. Effectiveness and safety of 12-months tralokinumab treatment in 824 adults with atopic dermatitis: Final real-world data from the prospective, non-interventional, international, single-cohort TRACE study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2025. Paris, France. 17-20 September. E-poster Presentation. P2730.
3. Ameen A, Becherel P, Rubin C, et al. Patient-reported outcomes evaluations of 12-months tralokinumab treatment in 824 adults with atopic dermatitis: Real-world data from the prospective, non-interventional, international, single-cohort TRACE study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2025. Paris, France. 17-20 September. E-poster Presentation. P3225.
4. Wiseman M, Albreiki F, Pink A, et al. Effectiveness of 12-months tralokinumab treatment in 654 adults with atopic dermatitis with head & neck area involvement: Final real-world data from the prospective, non-interventional, international, single-cohort TRACE study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2025. Paris, France. 17-20 September. E-poster Presentation. P3435.
5. ClinicalTrials.gov. National Library of Medicine (U.S.). ECZTRA 3: A Study to Evaluate Tralokinumab in Combination with Topical Corticosteroids in Adults with Moderate-to-Severe Atopic Dermatitis. Identifier: NCT03363854. https://clinicaltrials.gov/ct2/show/NCT03363854
6. Blauvelt A, Langley RG, Lacour JP, et al. Long-term 2-year safety and efficacy of tralokinumab in adults with moderate-to-severe atopic dermatitis: Interim analysis of the ECZTEND open-label extension trial. J Am Acad Dermatol. 2022;87(4):815–824.
7. ClinicalTrials.gov. National Library of Medicine (U.S.). Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials – ECZTEND. Identifier: NCT03587805. https://clinicaltrials.gov/ct2/show/NCT03587805
8. Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016;387(10023):1109–1122.
9. Boguniewicz M, Leung DY. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233–246.
10. Dudakov JA, Hanash AM, van den Brink MR. Interleukin-22: immunobiology and pathology. Annu Rev Immunol. 2015;33:747–785.
11. Popovic B, et al. Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13Rα1 and IL-13Rα2. J Mol Biol. 2017;429:208–219.

 

 MAT-85580 September 2025