LEO Pharma Announces British Journal of Dermatology Publication of Adbry™ (tralokinumab-ldrm) Pooled Safety Data in Moderate-to-Severe Atopic Dermatitis

• Data analyses help characterize the safety profile of Adbry™ (tralokinumab-ldrm) for the treatment of moderate-to-severe atopic dermatitis in adults by detailing the incidence and rate of adverse events from pooled observations of more than 2,000 patients who received Adbry or placebo¹

 

MADISON, N.J.--(BUSINESS WIRE)--LEO Pharma Inc, a global leader in medical dermatology, today announced that the British Journal of Dermatology published detailed results from a pooled safety analysis of Adbry™ (tralokinumab-ldrm) from three pivotal Phase 3 trials (ECZTRA 1, 2, and ECZTRA 3), Phase 2 (ECZTRA 5) and Phase 2b trials of adult patients with moderate-to-severe atopic dermatitis (AD). The analysis evaluated the safety profile of Adbry compared to placebo over the initial 16-week treatment period and up to 52 weeks, as measured by the overall frequency and severity of adverse events (AEs).¹ Initial study results were presented online at EADV Virtual 2020.²

“As the atopic dermatitis treatment landscape continues to rapidly evolve, we are committed to ensuring the timely communication of Adbry clinical findings to help inform physician treatment selection and disease management strategies,” said Jörg Möller, Executive Vice President, Global Research and Development, LEO Pharma A/S. “Our ongoing clinical program continues to reveal new learnings and insights on the safety profile of Adbry. Safety remains a top priority for people with moderate-to-severe atopic dermatitis and the clinicians who treat them, as well as for LEO Pharma.”

Adbry, a high-affinity human monoclonal antibody, was approved by the U.S. Food and Drug Administration (FDA) in December 2021 for the treatment of adults with moderate-to-severe AD and is the first and only FDA-approved biologic that specifically binds to and inhibits the interleukin (IL)-13 cytokine, one of the drivers of AD signs and symptoms. Adbry is approved for adult patients whose disease is not adequately controlled with topical prescription therapies or when those are not advisable. Adbry can be used with or without topical corticosteroids.^3,4,5

To view the published manuscript, please visit https://onlinelibrary.wiley.com/doi/10.1111/bjd.21867.

Manuscript authors include: Eric L. Simpson, Joseph F. Merola, Jonathan I. Silverberg, Kristian Reich, Richard B. Warren, Delphine Staumont-Sallé, Giampiero Girolomoni, Kim Papp, Marjolein de Bruin-Weller, Jacob P. Thyssen, Rebecca Zachariae, Christina K. Olsen, Andreas Wollenberg.

About the British Association of Dermatologists

The British Journal of Dermatology is owned by British Association of Dermatologists (BAD), the central association of practising UK dermatologists. BAD’s aim is to continually improve the treatment and understanding of skin disease. For further information about the charity, visit www.bad.org.uk.

Wiley is BAD’s publishing partner. They are the international scientific, technical, medical, and scholarly publishing business of John Wiley & Sons, with strengths in every major academic and professional field and partnerships with many of the world's leading societies. For more information, please visit www.wiley.com.

About ECZTRA 1, 2, ECZTRA 3, ECZTRA 5 and Phase 2b Trials

• ECZTRA 1 and ECZTRA 2 (ECZema TRAlokinumab trials Nos. 1 and 2) were randomized, double-blind, placebo-controlled, multinational 52-week trials, which included 802 and 794 adult patients, respectively, to evaluate the efficacy and safety of Adbry (300 mg every other week) as monotherapy in adults with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.⁶

• ECZTRA 3 (ECZema TRAlokinumab trial No. 3) was a double-blind, randomized, placebo-controlled, multinational 32-week trial, which included 380 adult patients, to evaluate the efficacy and safety of Adbry (300 mg every other week) in combination with topical corticosteroids (TCS) as needed in adults with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.⁷

• ECZTRA 5 (ECZema TRAlokinumab trial No. 5) was a randomized, double-blind, placebo-controlled, 30-week, Phase 2 trial which included 215 adult patients to evaluate the effect of Adbry (300 mg every other week) on vaccine antibody responses (Tdap and meningococcal vaccines) in adults with moderate-to-severe atopic dermatitis who were candidates for systematic therapy. Patients were treated with either Adbry or placebo for 16 weeks. The efficacy, safety and tolerability of Adbry when administered with the studied vaccines was also assessed.⁸

• Phase 2b was a randomized, double-blind, placebo-controlled, dose-ranging clinical trial to evaluate the efficacy and safety of Adbry in 204 adult patients with moderate-to-severe atopic dermatitis.⁹

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.¹⁰ Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.¹¹ Type 2 cytokines, including IL-13, play an important role in atopic dermatitis pathophysiology.⁴

About Adbry™ (tralokinumab-ldrm)

Adbry™ (tralokinumab-ldrm) is a high-affinity 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. 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).^4,5

INDICATION AND IMPORTANT SAFETY INFORMATION

What is ADBRY?

• ADBRY™ (tralokinumab-ldrm) injection is a prescription medicine used to treat adults 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.

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.
• 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 more ADBRY than prescribed, call Poison Control at 1-800-222-1222.
• 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:

• 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 the FDA at 1-800-FDA-1088.

Please click here for full 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 5,800 people, serving millions of patients across the world. In 2021, the company generated net sales of USD 1,539 million.

References

1. Simpson, E L, et al. Safety of Tralokinumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis: Pooled Analysis of Five Randomized, Double-blind, Placebo-controlled Phase 2 and Phase 3 Trials. British Journal of Dermatology. 2022.
2. Simpson E, et al. Safety of specifically targeting interleukin-13 with tralokinumab in adult patients with moderate-to-severe atopic dermatitis: pooled analysis of five randomised, double-blind, placebo-controlled Phase 3 and Phase 2 trials. E-poster at European Academy of Dermatology and Venereology (EADV) Virtual Congress; October 29-31, 2020. P0218; Abstract 1464.
3. Adbry™ (tralokinumab-ldrm) Prescribing Information. LEO Pharma; July 2022.
4. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
5. 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; 429:208–19.
6. Wollenberg, et al. Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2). British Journal of Dermatology. 2021;184(3):437–449.
7. Silverberg JI, et al. Tralokinumab plus topical corticosteroids for the treatment of moderate-to-severe atopic dermatitis: results from the double-blind, randomized, multicentre, placebo-controlled phase III ECZTRA 3 trial. British Journal of Dermatology. 2021;184(3):450–463.
8. Merola JF, et al. Tralokinumab does not impact vaccine-induced immune responses: Results from a 30-week, randomized, placebo-controlled trial in adults with moderate-to-severe atopic dermatitis. J Am Acad Dermatol. 2021 Jul;85(1):71-78. doi: 10.1016/j.jaad.2021.03.032.
9. Wollenberg A, Howell MD, Guttman-Yassky E, et al. Treatment of atopic dermatitis with tralokinumab, an anti-IL-13 mAb. J Allergy Clin Immunol. 2019;143(1):135-141.
10. Weidinger S, et al. Atopic dermatitis. Lancet. 2016;387:1109-1122.
11. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev 2011;242(1):233-46.

Adbry™ is a trademark of LEO Pharma A/S.

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MAT-60037 October 2022