LEO Pharma Presents New 12-Month Real-World Data for Tralokinumab at AAD 2026

• The majority of atopic dermatitis (AD) patients with hand and/or foot (H&F) involvement experienced clearance over 12 months of treatment with ADBRY^® (tralokinumab-ldrm)/ADTRALZA® (tralokinumab).¹
• 12-month data demonstrated that treatment with tralokinumab reduced AD severity and provided improved quality of life among patients with skin of color.²
• Nearly all patients treated with tralokinumab achieved at least one moderate treatment target, including both clinician and patient reported outcomes.³

MADISON, N.J.--(BUSINESS WIRE)--LEO Pharma A/S, a global leader in medical dermatology, today announced the presentation of new post-hoc analyses of 12‑month real‑world data from the TRACE study of tralokinumab, at the 2026 American Academy of Dermatology (AAD) Annual Meeting. TRACE is a prospective, non-interventional, international study evaluating adult patients receiving tralokinumab, with analyses assessing minimal disease activity and outcomes in patient subgroups, including those with H&F involvement, or skin of color.^1-3

“LEO Pharma is committed to moving the science forward on our understanding of the pathogenesis of atopic dermatitis and how tralokinumab works in difficult to treat populations. These 12-month real-world results build on data from the tralokinumab clinical trial program and help address evidence gaps in specific patient populations and high burden areas, like the hands and feet,” said Shannon Schneider, Vice President of North America Medical Affairs for LEO Pharma.

Tralokinumab Treatment in AD Patients with H&F Involvement

In a post-hoc analysis of the TRACE patients with H&F involvement (n=495 of 824) at baseline treated with tralokinumab, the proportion of patients reporting any H&F involvement decreased markedly to 46.3% (n=430) at Month 3 and 31.6% (n=272) at Month 12. Early and clinically significant improvements in disease severity, patient reported outcomes, and quality of life were also observed, as measured by Investigator’s Global Assessment (IGA), Peak Pruritus/Sleep Numerical Rating Scale (PP/Sleep-NRS) scores, and Dermatology Life Quality Index (DLQI) scores, respectively.¹

Real-World Effectiveness of Tralokinumab Treatment in AD Patients with Skin of Color

In a post-hoc analysis among patients with skin of color (Fitzpatrick skin types IV–VI; n=131 of 824), 80.4% (n=56) achieved at least one clinically meaningful disease control endpoint at 12 months, defined as an IGA score of 0/1 (clear or almost clear), an Eczema Area and Severity Index (EASI) score of ≤7 (no to mild disease), or a SCORing Atopic Dermatitis (SCORAD) score of <10 (minimal to mild). Improvements in quality of life were also observed.²

“Atopic dermatitis affects people with all skin tones and frequently impacts high-burden areas such as the hands and feet,” said April Armstrong, MD, MPH, Professor and Chief of Dermatology, UCLA, and primary author of the study. “These results reinforce clinical experience, demonstrating that tralokinumab helps deliver meaningful benefits across diverse patient groups and challenging areas of the body.”

Disease Control Data with Tralokinumab Treatment in Adults with AD

Complementing these subgroup analyses, a third TRACE post-hoc analysis measured improvements in disease control across the study population (n=824). After 12 months of tralokinumab, 91% of patients achieved at least one moderate treatment target, which included clinical and patient reported outcomes (ClinRO and PRO). Three out of four achieved both a moderate ClinRO and PRO target, and nearly half achieved both an optimal ClinRO and PRO (minimal disease activity) target.³

In the pivotal clinical trials, the most common adverse events (incidence ≥1% and greater than placebo) were upper respiratory tract infections (mainly reported as common cold), conjunctivitis, injection site reactions, and eosinophilia.⁴

The TRACE study presentations are part of LEO Pharma’s extensive data program at AAD, which includes 17 accepted abstracts across the company’s medical dermatology portfolio and pipeline.

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 November 2021 and July 2023, of whom 824 were included in the full analysis set, and followed for up to one year.⁵

About Atopic Dermatitis

Atopic Dermatitis (AD) is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.⁶ AD 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 AD pathophysiology.^6,7 Excessive IL-22 production is also known to contribute to the pathogenesis of AD.⁸

About ADBRY^® (tralokinumab-ldrm)/ADTRALZA^® (tralokinumab)

ADBRY^® (tralokinumab-ldrm), which is marketed outside of the U.S. under the tradename ADTRALZA^® (tralokinumab), 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.^4,9 Tralokinumab specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).¹⁰

Tralokinumab is approved for the treatment of moderate-to-severe AD in adult and adolescent patients 12 years and older in the European Union, Canada, Great Britain, the United Arab Emirates, South Korea, the U.S., and Saudi Arabia. Tralokinumab is approved for use in adults with moderate- to-severe AD in Switzerland and Japan.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR ADBRY^® (TRALOKINUMAB)

What is ADBRY?

• ADBRY^® (tralokinumab) injection is a prescription medicine used to treat people 12 years of age and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. ADBRY can be used with or without topical corticosteroids.
• It is not known if ADBRY is safe and effective in children under 12 years of age.

Do not use ADBRY if you are allergic to tralokinumab or to any of its ingredients.

What should I discuss with my healthcare provider before starting ADBRY?

Tell your healthcare provider about all your medical conditions, including if you:

• have eye problems.
• have a parasitic (helminth) infection.
• are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with ADBRY.
• are pregnant or plan to become pregnant. It is not known whether ADBRY will harm your unborn baby. There is a pregnancy exposure registry for women who use ADBRY during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. You or your healthcare provider can get information and enroll you in this registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/.
• are breastfeeding or plan to breastfeed. It is not known whether ADBRY passes into your breast milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use ADBRY?

• See the detailed “Instructions for Use” that comes with ADBRY for information on how to prepare and inject ADBRY and how to properly store and throw away (dispose of) used ADBRY prefilled syringes and autoinjectors.
• Use ADBRY exactly as prescribed by your healthcare provider.
• Your healthcare provider will tell you how much ADBRY to inject and when to inject it.
• ADBRY comes as a single-dose prefilled syringe with needle guard or as an autoinjector.
• ADBRY is given as an injection under the skin (subcutaneous injection).
• If your healthcare provider decides that you or a caregiver can give the injections of ADBRY, you or your caregiver should receive training on the right way to prepare and inject ADBRY. Do not try to inject ADBRY until you have been shown the right way by your healthcare provider. In children 12 years of age and older, it is recommended that ADBRY be given by or under supervision of an adult.
• If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time.
• If you inject too much ADBRY than prescribed, call your healthcare provider or call Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
• Your healthcare provider may prescribe other medicines to use with ADBRY. Use the other prescribed medicines exactly as your healthcare provider tells you to.

What are the possible side effects of ADBRY?

ADBRY can cause serious side effects including:

• Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using ADBRY and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:
  • breathing problems
  • itching
  • skin rash
  • swelling of the face, mouth, and tongue
  • fainting, dizziness, feeling lightheaded (low blood pressure)
  • hives
• Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision.

The most common side effects of ADBRY include:

• upper respiratory tract infections
• Eye and eyelid inflammation, including redness, swelling, and itching
• Injection site reactions
• High count of a certain white blood cell (eosinophilia)

These are not all the possible side effects of ADBRY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please click here for full U.S. Prescribing Information, including Patient Information and Instructions for Use.

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 4,000 people worldwide. Together, we reach far beyond the skin. For more information, visit www.leo-pharma.com.

References

1. Armstrong AW, Rodriguez A, Jarell A, et al. Real-world effectiveness of 12 months tralokinumab in 495 adult patients with atopic dermatitis and hand and foot involvement: final data from the prospective, non-interventional, international TRACE study. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Poster ID: 77138. Oral Poster Presentation.
2. Armstrong AW, Rubin C, Jarell A, et al. Real-world effectiveness of 12 months tralokinumab treatment in patients with skin of color and moderate-to-severe atopic dermatitis: final data from the prospective, non-interventional, international TRACE study. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Poster ID: 77199. Oral Poster Presentation.
3. Pink A, 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 prospective, non-interventional, international TRACE study. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Poster ID: 74527. Online ePoster.
4. ADBRY^® (tralokinumab). Prescribing Information. FDA. December 2025.
5. 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 2025. E-poster Presentation. P3225.
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. Dudakov JA, Hanash AM, van den Brink MR. Interleukin-22: immunobiology and pathology. Annu Rev Immunol. 2015;33:747-785.
9. Bieber T. Interleukin-13: Targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020;75(1):54-62.
10. Popovic B, Breed J, Rees DG, 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(2):208-219.

MAT-93283 March 2026

Samantha Cranko
LEO Pharma External Communications, U.S.
Email: media@leo-pharma.com