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LEO Pharma Announces Publication of Adbry™ (tralokinumab-ldrm) Efficacy Data in Moderate-to-Severe Atopic Dermatitis in American Journal of Clinical Dermatology

July 20, 2022 Off By BusinessWire
  • Post-hoc analysis from ECZTRA 3 showed improvements in extent and severity of atopic dermatitis, sleep interference, and quality of life in adult patients treated with Adbry plus topical corticosteroids as needed over 32 weeks.1

MADISON, N.J.–(BUSINESS WIRE)–LEO Pharma A/S, a global leader in medical dermatology, today announced that American Journal of Clinical Dermatology published 32-week results from a post-hoc analysis of the Phase 3 ECZTRA 3 clinical trial (NCT03363854) in atopic dermatitis (AD). The analysis showed treatment with Adbry™ (tralokinumab-ldrm) plus topical corticosteroids (TCS) as needed demonstrated improvements in extent and severity of AD, sleep interference, and quality of life over 32 weeks in adults with moderate-to-severe AD.1

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.2,3

A prespecified analysis focusing on patients who achieved a response at Week 16 has been reported elsewhere.4 To reflect clinical practice, this post-hoc analysis pooled all patients treated with Adbry every other week (Q2W) in the initial treatment period irrespective of the response achieved at Week 16 and the dosing regimen (Q2W or every four weeks [Q4W]) received beyond Week 16.1 The post-hoc analysis found treatment with Adbry plus TCS as needed provided improvements in extent and severity of AD and in sleep interference and quality of life measures over 32 weeks.1

Specifically, results at Week 32 (n=252) demonstrated that patients treated with Adbry:1

  • Achieved improvement in AD extent and severity, with 70.2% achieving improvement of 75% or more in the Eczema Area and Severity Index score (EASI-75) and 50.4% achieving EASI-90.
  • Achieved a 70.8% improvement in weekly average Eczema-related Sleep Interference Numeric Rating Scale (NRS) compared to baseline.
  • Achieved a 66.8% improvement in Dermatology Life Quality Index (DLQI) compared to baseline.

At Week 16 (n=247), 89.9% of patients initiating treatment with Adbry achieved clinically meaningful improvements in at least one of three disease measures, including AD extent and severity (≥50% improvement in EASI score [EASI-50]), pruritus (≥3-point improvement in the weekly average Worst Daily Pruritus NRS), or quality of life (≥4-point reduction in DLQI score).1 Additionally, 75.3% of patients achieved EASI-50 as well as clinically meaningful improvements in either pruritus or quality of life.1

Safety outcomes were previously reported for ECZTRA 3. The most common adverse events with Adbry (incidence ≥1% and greater than placebo) were upper respiratory tract infections (mainly reported as common cold), conjunctivitis, injection site reactions, and eosinophilia.1,2

“This latest peer-reviewed publication adds to the body of research to support the efficacy and safety of Adbry,” said Adriana Guana, M.D., Vice President, U.S. Medical Affairs, LEO Pharma Inc. “The results provide additional context around the benefits of Adbry, including impact on measures that are important to clinicians and patients and, ultimately, may help inform clinical decisions.”

To view the published manuscript, please visit https://link.springer.com/article/10.1007/s40257-022-00702-2.

Manuscript authors include: Jonathan I. Silverberg, David N. Adam, Matthew Zirwas, Sunil Kalia, Jan Gutermuth, Andreas Pinter, Andrew E. Pink, Andrea Chiricozzi, Sebastien Barbarot, Thomas Mark, Ann-Marie Tindberg, and Stephan Weidinger.

About the ECZTRA 3 Trial

ECZTRA 3 (ECZema TRAlokinumab trial No. 3) was a double-blind, randomized, placebo-controlled, multinational 32-week study, which included 380 adult patients, to evaluate the efficacy and safety of tralokinumab-ldrm (300 mg) in combination with TCS in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.4

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.5 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.6 Type 2 cytokines, including IL-13, play an important role in atopic dermatitis pathophysiology.7

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).3,7

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. Silverberg, JI, et al. Tralokinumab Plus Topical Corticosteroids as Needed Provides Progressive and Sustained Efficacy in Adults with Moderate-to-Severe Atopic Dermatitis Over a 32-Week Period: An ECZTRA 3 Post Hoc Analysis. American Journal of Clinical Dermatology. 2022.
  2. Adbry™ (tralokinumab-ldrm) Prescribing Information. LEO Pharma; January 2022.
  3. 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.
  4. 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.
  5. Weidinger S, et al. Atopic dermatitis. Lancet. 2016;387:1109-1122.
  6. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev 2011;242(1):233-46.
  7. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.

MAT-58721 July 2022

Contacts

David Patti

LEO Pharma, Global Product Communications

973.796.7706

[email protected]