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LEO Pharma Presents New Long-Term Adbry® (tralokinumab-ldrm) Data in Adults with Moderate-to-Severe Atopic Dermatitis at the 2024 AAD Annual Meeting

March 8, 2024 Off By BusinessWire
  • A post hoc analysis showed that high proportions of patients maintained stable responses when continually treated with Adbry® (tralokinumab-ldrm) for up to four years.1
  • This data is the latest addition to an extensive clinical evidence portfolio for Adbry.
  • Analysis is the latest clinical trial data from ECZTEND, an ongoing open-label, 5-year extension trial investigating the long-term safety and efficacy of Adbry.2

MADISON, N.J.–(BUSINESS WIRE)–NOT FOR UK USE – NOT INTENDED FOR UK MEDIA


LEO Pharma A/S, a global leader in medical dermatology, today unveiled new data analyzing the long-term therapeutic response of treatment with Adbry® (tralokinumab-ldrm) in adults (18 years and above) with moderate-to-severe atopic dermatitis (AD). The findings are being shared via an e-poster at the 82nd American Academy of Dermatology (AAD) Congress in San Diego, California.1

The results are part of a wide-ranging data program from LEO Pharma at AAD, with eight abstracts accepted in total for the meeting, showcasing an ongoing commitment to advancing the standard of research in medical dermatology.

“The data presented for Adbry at AAD further builds upon an established, wide-ranging collection of clinical evidence that aims to improve the support for those living with moderate-to-severe AD,” said Brian Hilberdink, EVP and President, Region North America, LEO Pharma. “Following the expansion of our indication in the U.S. late last year for Adbry to encompass pediatric patients aged 12 to 17 years old, this data is the latest, positive step on our ongoing mission to maximize the treatment options available for as many people as possible who live with this condition.”

The post hoc analysis included 347 adults (18 years and above) with moderate-to-severe AD who were continuously treated with Adbry for 52 weeks in the phase 3 ECZTRA 1 and 2 trials and subsequently for up to 152 weeks in the ECZTEND open-label extension trial.1

Assessments in this analysis focused on timepoints after Week 16 in ECZTEND to allow for re-normalization of response rates due to variable time between the last treatment in the parent trial and the first treatment in ECZTEND.1 The analysis showed that more than 70% of patients who continued treatment with Adbry in ECZTEND maintained a stable Eczema Area and Severity Index (EASI) score (≤7, no to mild disease) at ≥80% of days and over half of responders maintained stable EASI ≤7 at 100% of days for up to three years.1

“For patients to gain genuine control over their AD, it is critical that disease fluctuations are controlled and safety is established for this long-term approach,” said Dr. Andrew Blauvelt, Blauvelt Consulting, LLC, Lake Oswego, U.S., and International Coordinating Investigator (ICI) of the ECZTEND trial. “This new analysis demonstrates the benefits of the long-term use of Adbry for adults who live with this chronic condition.”

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.3 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.4 Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology.3,4 Excessive IL-22 production is also known to contribute to the pathogenesis of AD.5

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.4,6 Adbry® specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).7

Adbry is approved for the treatment of adults and pediatric patients (12 years and above) with moderate-to-severe AD in the U.S., Canada, the European Union, the United Arab Emirates, Great Britain, and South Korea. Adtralza is approved for use in adults with moderate-to-severe AD in Saudi Arabia, Switzerland, and Japan.

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 an ongoing Phase 3, long-term, five-year, open-label, single-arm extension trial to evaluate the safety and efficacy of Adbry in patients with atopic dermatitis who participated in the previous Adbry monotherapy trials (ECZTRA 1 and ECZTRA 2), the combination therapy Adbry 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 Adbry plus TCS trial in Japanese subjects (ECZTRA 8), and the Adbry 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 Adbry or placebo.2,8

U.S. 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.
  • 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 (150 mg) prefilled syringe with needle guard.
  • ADBRY is given as an injection under the skin (subcutaneous injection).
  • If your healthcare provider decides that you or a caregiver can give the injection 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.
  • 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 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 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 4,300 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion.

References

  1. Blauvelt A, et al. Stability of long-term therapeutic responses to tralokinumab in adults with moderate-to-severe atopic dermatitis. Presented at the 2024 American Academy of Dermatology Annual Meeting; March 8-12 2024; San Diego, CA.
  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. Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016;387(10023):1109-1122.
  4. Boguniewicz M, Leung DY. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-246.
  5. Dudakov JA, Hanash AM, van den Brink MR. Interleukin-22: immunobiology and pathology. Annu Rev Immunol. 2015;33:747-785.
  6. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
  7. 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.
  8. 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.

MAT-71599 March 2024

Contacts

Jes Broe Frederiksen

LEO Pharma, Senior Manager, Global Product and Data Communications

Tel: +45 53 60 59 48

Email: [email protected]

Melissa Borland

LEO Pharma, Senior Manager, Communications – North America

Tel: + 1 647 241 1475

Email: [email protected]