MADISON, N.J.--()--LEO Pharma Inc., a global leader in medical dermatology, today presented the final results of the five-year extension study ECZTEND, showing the long-term safety and efficacy profile of Adbry® (tralokinumab-ldrm) in adults and adolescent patients (aged 12 years and over) with moderate-to-severe atopic dermatitis (AD).1 The findings were presented in a poster at the Fall Clinical Dermatology Conference in Las Vegas, Nevada, from October 24-27, 2024.

ECZTEND is a Phase 3, open-label, single-arm, multi-center, long-term, extension study. It evaluated the long-term safety and efficacy of tralokinumab-ldrm for up to five years in adult and adolescent patients (aged 12 years and over) with moderate-to-severe AD (N= 1672).1,2 Participants were invited to join ECZTEND after completing their treatment period with tralokinumab-ldrm in one of nine parent trials.1,2 Interim analyses have previously demonstrated the safety and efficacy of tralokinumab-ldrm in patients followed up to 4.5 years in ECZTEND.3,4

Results from the long-term use of tralokinumab-ldrm, up to one year in parent trials plus up to five years in ECZTEND, identified no new safety signals. The overall long-term safety profile was similar to the safety profile observed in the initial placebo-controlled treatment period of the parent trials. Adverse events (AEs) were reported at relatively lower rates in ECZTEND, with the majority being mild/moderate.1

Long-term treatment with tralokinumab-ldrm also demonstrated sustained efficacy after up to six years of treatment. A reduction of at least 75% in Eczema Area and Severity Index (EASI-75) from baseline to Week 248 was observed in 92.9% of patients. In the same period, 66.7% of patients achieved an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear) (IGA 0/1). Improvements in Itch, sleep, and quality of life were observed.1

"With the release of the final results from the ECZTEND open-label extension study, we are pleased to present robust evidence further supporting the long-term safety and efficacy of tralokinumab-ldrm in the treatment of moderate-to-severe atopic dermatitis," said Brian Hilberdink, EVP and President, Region North America, LEO Pharma. "This important milestone underscores our unwavering commitment to transforming the lives of the millions of Americans affected by this chronic condition. With this new evidence and a single-dose autoinjector now available for adults in the U.S., we are excited to empower patients to help manage their symptoms for the long term."

“These long-term findings are crucial for clinical practice, providing healthcare professionals with the data needed to prescribe tralokinumab-ldrm for sustained use confidently,” said Dr. Andrew Blauvelt, Blauvelt Consulting, LLC, Lake Oswego, U.S., and International Coordinating Investigator (ICI) of the ECZTEND trial. “Ultimately, these comprehensive results will help improve their ability to manage this debilitating condition and enhance patient care.”

The ECZTEND abstract and poster will also be published in the peer-reviewed journal Skin at a later date.

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INDICATION AND IMPORTANT SAFETY INFORMATION

What is ADBRY?

  • ADBRY® (tralokinumab-ldrm) 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 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 tralokinumab-ldrm in patients with atopic dermatitis who participated in the previous tralokinumab-ldrm monotherapy trials (ECZTRA 1 and ECZTRA 2), the combination therapy tralokinumab-ldrm 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 tralokinumab-ldrm plus TCS trial in Japanese subjects (ECZTRA 8), and the tralokinumab-ldrm 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 tralokinumab-ldrm or placebo.1-4

About Atopic Dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.5,6 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.8

About Adbry® (tralokinumab-ldrm)

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.8 Tralokinumab-ldrm specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).6

Tralokinumab-ldrm 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-ldrm is approved for use in adults with moderate to severe AD in Switzerland and Japan.

About LEO Pharma

LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 4,000 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion.

References

  1. Blauvelt A, Laquer V, Langley RG, et al. Long-term safety and efficacy of tralokinumab in adults and adolescents with moderate-to-severe atopic dermatitis treated for up to 6 years. Presented at the 2024 Fall Clinical Dermatology Conference. Las Vagas, Nevada. 24-27 October.
  2. 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.
  3. Reich K, Langley RG, Silvestre JF, et al. Safety of tralokinumab for the treatment of atopic dermatitis in patients with up to 4.5 years of treatment: an updated integrated analysis of eight clinical trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October.
  4. 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.
  5. Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016;387(10023):1109-1122.
  6. 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.
  7. Boguniewicz M, Leung DY. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-246.
  8. Bieber T. Interleukin-13: Targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020;75(1):54-62.

MAT-77346 October 2024