LEO Pharma Presents Adbry® (tralokinumab-ldrm) Data at 2023 Fall Clinical Dermatology Conference

LEO Pharma A/S, a global leader in medical dermatology, will present a catalog of new clinical and real-world data around tralokinumab-ldrm in the treatment of moderate-to-severe atopic dermatitis (AD). The drug is marketed in the U.S. as Adbry^® for adult patients (aged 18+ years) with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The findings are being presented across 12 posters at the 2023 Fall Clinical Dermatology Conference taking place in Las Vegas, Nevada, from October 19-22, 2023.^1-12

"We are thrilled to present such a wealth of tralokinumab-ldrm data, which will further develop our understanding of how to meet the needs of patients living with atopic dermatitis," says Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. "The breadth and depth of LEO Pharma data being presented at the Fall Clinical Dermatology Conference this year will showcase our leadership in the medical dermatology space and our continued commitment to the whole patient community. We look forward to continuing to drive critical innovations for the millions affected by atopic dermatitis globally."

Various post hoc analyses and real-world studies examining the efficacy and safety around tralokinumab-ldrm in the treatment of moderate-to-severe AD are being presented at the conference.^1-5 They aim to build on the evidence of several phase 3 clinical trials.

Health economics and outcomes research (HEOR), as well as real-world evidence (RWE) research, are also being presented during the conference.^6-12 They aim to assess the clinical burden and preferences of patients living with moderate-to-severe AD, as well as investigate any potential clinical and economic benefits of treating patients with tralokinumab-ldrm in relation to other treatments such as dupilumab.⁹

The company's full roster of accepted presentations at the 2023 Fall Clinical Dermatology Conference includes:

• Improvement of the head and neck regions with continuous tralokinumab treatment for up to 4 years in adults with moderate-to-severe atopic dermatitis
  Author: Raj Chovatiya
  Poster presentation
  
  
• Tralokinumab real-world use in adults with atopic dermatitis: baseline characteristics of the first 100 patients recruited to the TRACE study in the United States
  Author: April W. Armstrong
  Poster presentation
  
  
• Patient Preferences in Moderate-to-Severe Atopic Dermatitis (AD): A Discrete Choice Experiment (DCE)
  Author: Steven R. Feldman
  Poster presentation
  
  
• Clinical Burden and Impairment in Moderate-to-Severe Atopic Dermatitis
  Author: Steven R. Feldman
  Poster presentation
  
  
• Tralokinumab Real-World Patient-Reported Outcomes in Moderate-to-Severe Atopic Dermatitis Adult Patients in the United States: 6-Month Interim Analysis
  Author: Peter Lio
  Poster presentation
  
  
• Cost-per-responder analysis of Tralokinumab versus Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis in the US and Canada
  Author: Jashin J. Wu
  Poster presentation
  
  
• Matching-adjusted indirect comparison of the efficacy of tralokinumab and dupilumab in the treatment of moderate-to-severe atopic dermatitis beyond week 16
  Author: Tiago Torres
  Poster presentation
  
  
• Incremental risk of adverse events with oral Janus kinase inhibitor use in atopic dermatitis and other indications: a systematic review and meta-analysis
  Author: Lasse Ryttig
  Poster presentation
  
  
• Laboratory parameters in adolescent patients aged 12?17 with moderate-to-severe atopic dermatitis treated with tralokinumab up to week 52: results from the phase 3 ECZTRA 6 trial
  Author: Amy Paller
  Poster presentation
  
  
• Tralokinumab improves signs and symptoms of moderate-to-severe atopic dermatitis in patients aged 12 years and older with and without atopic comorbidities
  Author: Amy Paller
  Poster presentation
  
  
• Neutralizing interleukin-13 with tralokinumab reduces abundance of S. aureus in adolescents with atopic dermatitis
  Author: LA Beck
  Poster presentation
  
  
• Real-world evidence demonstrating tralokinumab onset of action and efficacy in two skin of color patients with moderate-to-severe atopic dermatitis
  Author: Daniel Tinker
  Poster presentation

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.¹³ Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.¹⁴ Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology.^14,15

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.^14,15 Adbry specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor ?1 and ?2 subunits (IL-13R?1 and IL-13R?2).¹⁶

In the U.S., Adbry is approved for the treatment of moderate-to-severe AD in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Outside of the U.S., Adtralza is approved for the treatment of moderate-to-severe AD in adult and adolescent patients 12 years and older who are candidates for systemic therapy in the European Union, Canada, Great Britain, the United Arab Emirates, and South Korea. It is also approved for use in adults with moderate-to-severe AD in Switzerland, Saudi Arabia, and Japan.

U.S. 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 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 4,700 people, serving millions of patients across the world. In 2022, the company generated net sales of DKK 10.6 billion.

References

1. Chovatiya R, et al. Improvement of the head and neck regions with continuous tralokinumab treatment for up to 4 years in adults with moderate-to-severe atopic dermatitis. Presented at the 2023 Fall Clinical Dermatology Conference. Las Vagas, Nevada. 19-22 October.
2. Paller A, et al. Laboratory parameters in adolescent patients aged 12?17 with moderate-to-severe atopic dermatitis treated with tralokinumab up to week 52: results from the phase 3 ECZTRA 6 trial. Presented at the 2023 Fall Clinical Dermatology Conference. Las Vagas, Nevada. 19-22 October.
3. Armstrong A, et al. Tralokinumab real-world use in adults with atopic dermatitis: baseline characteristics of the first 100 patients recruited to the TRACE study in the United States. Presented at the 2023 Fall Clinical Dermatology Conference. Las Vagas, Nevada. 19-22 October.
4. Paller A, et al. Tralokinumab improves signs and symptoms of moderate-to-severe atopic dermatitis in patients aged 12 years and older with and without atopic comorbidities. Presented at the 2023 Fall Clinical Dermatology Conference. Las Vagas, Nevada. 19-22 October.
5. Beck LA, et al. Neutralizing interleukin-13 with tralokinumab reduces abundance of S. aureus in adolescents with atopic dermatitis. Presented at the 2023 Fall Clinical Dermatology Conference. Las Vagas, Nevada. 19-22 October.
6. Feldman SR, et al. Patient Preferences in Moderate-to-Severe Atopic Dermatitis (AD): A Discrete Choice Experiment (DCE). Presented at the 2023 Fall Clinical Dermatology Conference. Las Vagas, Nevada. 19-22 October.
7. Feldman SR, et al. Clinical Burden and Impairment in Moderate-to-Severe Atopic Dermatitis. Presented at the 2023 Fall Clinical Dermatology Conference. Las Vagas, Nevada. 19-22 October.
8. Lio P, et al. Tralokinumab Real-World Patient-Reported Outcomes in Moderate-to-Severe Atopic Dermatitis Adult Patients in the United States: 6-Month Interim Analysis. Presented at the 2023 Fall Clinical Dermatology Conference. Las Vagas, Nevada. 19-22 October.
9. Wu JJ, et al. Cost-per-responder analysis of Tralokinumab versus Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis in the US and Canada. Presented at the 2023 Fall Clinical Dermatology Conference. Las Vagas, Nevada. 19-22 October.
10. Torres T, et al. Matching-adjusted indirect comparison of the efficacy of tralokinumab and dupilumab in the treatment of moderate-to-severe atopic dermatitis beyond week 16. Presented at the 2023 Fall Clinical Dermatology Conference. Las Vagas, Nevada. 19-22 October.
11. Ryttig L, et al. Incremental risk of adverse events with oral Janus kinase inhibitor use in atopic dermatitis and other indications: a systematic review and meta-analysis. Presented at the 2023 Fall Clinical Dermatology Conference. Las Vagas, Nevada. 19-22 October.
12. Tinker D, et al. Real-world evidence demonstrating tralokinumab onset of action and efficacy in two skin of color patients with moderate-to-severe atopic dermatitis. Presented at the 2023 Fall Clinical Dermatology Conference. Las Vagas, Nevada. 19-22 October.
13. Weidinger S, et al. Atopic dermatitis. Lancet. 2016;387:1109-1122.
14. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-46.
15. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
16. Popovic B, et al. Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13R?1 and IL-13R?2. J Mol Biol. 2017; 429:208-19.