Subjects: Conference, Product/Service

LEO Pharma Presents Data at 2024 Winter Clinical and Maui Derm Conferences

LEO Pharma A/S, a global leader in medical dermatology, will present a catalog of investigational delgocitinib cream and Adbry^® data across 10 posters at the upcoming Winter Clinical and Maui Derm conferences this month. The 2024 Winter Clinical Conference will take place Jan. 12-17 in Honolulu, Hawaii, while Maui Derm is being held from Jan. 22-26 in Maui, Hawaii.

LEO Pharma is currently developing delgocitinib cream for the treatment of moderate-to-severe chronic hand eczema (CHE) in adults. The safety and efficacy has not been evaluated by any health authority. Adbry is indicated for adult and pediatric patients (aged 12+ years) with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.¹¹

"We look forward to sharing such a large volume of data with the clinical community at the Winter Clinical and Maui Derm Conferences," said Kreesten Meldgaard Madsen, LEO Pharma's Chief Development Officer. "With these 10 presentations, we hope to demonstrate our leadership in the medical dermatology space and our continued commitment to patients with chronic hand eczema and atopic dermatitis."

Five poster presentations on investigational delgocitinib cream will focus on data from the DELTA 1 and DELTA 2 phase 3 clinical trials.^1-5 This includes a pooled analysis of the two trials evaluating the effect of delgocitinib cream on health-related quality of life versus cream vehicle, as measured by the Dermatology Life Quality Index (DLQI) in patients with moderate to severe CHE.¹

Five other posters will focus on Adbry data, covering both clinical and real-world results in adult (aged 18+ years) and pediatric (aged 12-17 years) patients.^6-10 One poster examines a six-month interim analysis of a real-world study of adult patients with moderate-to-severe AD living in the U.S. The analysis includes patient-reported quality of life outcomes relating to itch, sleep, and treatment satisfaction when Adbry is used either in dupilumab-naïve or in dupilumab-experienced patients.⁶

The company's full roster of accepted presentations at the 2024 Winter Clinical and Maui Derm Conferences is as follows:

Investigational Delgocitinib

• Effect of delgocitinib cream 20 mg/g on Dermatology Life Quality Index in patients with moderate-to-severe Chronic Hand Eczema: pooled data from the DELTA 1 and DELTA 2 phase 3 trials.
  Author: Marie Louise Schuttelaar
  Poster presentation

• Efficacy and safety of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema: results of the Phase 3 DELTA 2 trial.
  Author: Sibylle Schliemann
  Poster presentation

• Efficacy and safety of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema: results of the Phase 3 DELTA 1 trial.
  Author: Robert Bissonnette
  Poster presentation

• Patient-reported itch and pain are correlated with clinician-assessed outcomes in Chronic Hand Eczema (CHE).
  Author: Tove Agner
  Poster presentation

• Systemic exposure of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema in the phase 3 DELTA 2 trial.
  Author: Diamant Thaçi
  Poster presentation

Adbry^® (tralokinumab-ldrm)

• 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

• 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

• Progressive and sustained disease control in patients with atopic dermatitis (AD) aged 12-17 years treated with tralokinumab for 52 weeks.
  Author: Andreas Wollenberg
  Poster Presentation

• Continuous tralokinumab treatment over 4 years in adults with moderate-to-severe atopic dermatitis provides long-term disease control.
  Author: Andrew Blauvelt
  Poster Presentation

• 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.
  Author: Kristian Reich
  Poster presentation

About chronic hand eczema

Chronic hand eczema (CHE) is defined as hand eczema (HE) that lasts for more than three months or relapses twice or more within a year.^12,13 HE is the most common skin disorder of the hands¹⁴ with a one-year prevalence rate of approximately 9%.¹⁵ In a substantial number of patients, HE can develop into a chronic disease.¹⁴ CHE is a fluctuating disorder characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists.¹⁶

About atopic dermatitis

Atopic dermatitis (AD) is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.¹⁷ AD is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.¹⁸ The type 2 cytokine, IL-13, has been identified as a key cytokine in lesional and non-lesional skin and it plays an important role in atopic dermatitis pathophysiology, including immune dysregulation, skin-barrier dysfunction and itch.^19,20

About delgocitinib

Delgocitinib is an investigational topical pan-Janus kinase (JAK) inhibitor. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.²¹ The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.²² LEO Pharma is currently developing delgocitinib in a cream formulation for the treatment of moderate to severe chronic hand eczema (CHE) in adults. In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights.

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.^11,19 Adbry specifically binds to the IL-13 cytokine, thereby preventing the interaction with the IL-13 receptor ?1 subunit of the Type 2 receptor and inhibiting the subsequent downstream IL-13 signaling.^23,24

Adbry, which is marketed outside of the U.S. under the tradename Adtralza^® (tralokinumab), 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.

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 4,600 people, serving millions of patients across the world.

For more information, please visit www.leo-pharma.com/.

References

1. Schuttelaar ML, et al. Effect of delgocitinib cream 20 mg/g on Dermatology Life Quality Index in patients with moderate-to-severe Chronic Hand Eczema: pooled data from the DELTA 1 and DELTA 2 phase 3 trials. Presented at the 2024 Winter Clinical Dermatology Conference, Honolulu, Hawaii (12-17 January) and the 2024 Maui Derm Conference, Maui, Hawaii (22-26 January).
2. Schliemann S, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema: results of the Phase 3 DELTA 2 trial. Presented at the 2024 Winter Clinical Dermatology Conference, Honolulu, Hawaii (12-17 January) and the 2024 Maui Derm Conference, Maui, Hawaii (22-26 January).
3. Bissonnette R, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema: results of the Phase 3 DELTA 1 trial. Presented at the 2024 Winter Clinical Dermatology Conference, Honolulu, Hawaii (12-17 January) and the 2024 Maui Derm Conference, Maui, Hawaii (22-26 January).
4. Agner T, et al. Patient-reported itch and pain are correlated with clinician-assessed outcomes in Chronic Hand Eczema (CHE). Presented at the 2024 Winter Clinical Dermatology Conference, Honolulu, Hawaii (12-17 January) and the 2024 Maui Derm Conference, Maui, Hawaii (22-26 January).
5. Thaçi D, et al. Systemic exposure of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema in the phase 3 DELTA 2 trial. Presented at the 2024 Winter Clinical Dermatology Conference, Honolulu, Hawaii (12-17 January) and the 2024 Maui Derm Conference, Maui, Hawaii (22-26 January).
6. 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 2024 Winter Clinical Dermatology Conference, Honolulu, Hawaii (12-17 January) and the 2024 Maui Derm Conference, Maui, Hawaii (22-26 January).
7. 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 2024 Winter Clinical Dermatology Conference, Honolulu, Hawaii (12-17 January) and the 2024 Maui Derm Conference, Maui, Hawaii (22-26 January).
8. Wollenberg A, et al. Progressive and sustained disease control in patients with atopic dermatitis (AD) aged 12-17 years treated with tralokinumab for 52 weeks. Presented at the 2024 Winter Clinical Dermatology Conference, Honolulu, Hawaii (12-17 January) and the 2024 Maui Derm Conference, Maui, Hawaii (22-26 January).
9. Blauvelt A, et al. Continuous tralokinumab treatment over 4 years in adults with moderate-to-severe atopic dermatitis provides long-term disease control. Presented at the 2024 Winter Clinical Dermatology Conference, Honolulu, Hawaii (12-17 January) and the 2024 Maui Derm Conference, Maui, Hawaii (22-26 January).
10. Reich K, 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 2024 Winter Clinical Dermatology Conference, Honolulu, Hawaii (12-17 January) and the 2024 Maui Derm Conference, Maui, Hawaii (22-26 January).
11. Adbry^® (tralokinumab-ldrm) Prescribing Information. LEO Pharma; December 2023.
12. Lynde C, Guenther L, Diepgen TL, et al. Canadian hand dermatitis management guidelines. J Cutan Med Surg. 2010;14(6):267-284.
13. Diepgen TL, Andersen KE, Chosidow O, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015;13(1):e1-e22.
14. Bissonnette R, Diepgen TL, Elsner P, et al. Redefining treatment options in chronic hand eczema (CHE). J Eur Acad Dermatol Venereol. 2010;24 Suppl 3:1-20.
15. Thyssen JP, Johansen JD, Linneberg A, Menné T. The epidemiology of hand eczema in the general population?prevalence and main findings. Contact Dermatitis. 2010;62(2):75-87.
16. Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378.
17. Weidinger S, et al. Atopic dermatitis. Lancet. 2016;387:1109-1122.
18. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-46.
19. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
20. Tsoi LC, et al. Atopic dermatitis is an IL-13 dominant disease with greater molecular heterogeneity compared to psoriasis. J Invest Dermatol. 2019;139:1480?1489.
21. Dubin C, Del Duca E, Guttman-Yassky E. Drugs for the Treatment of Chronic Hand Eczema: Successes and Key Challenges. Ther Clin Risk Manag. 2020;16:1319-1332.
22. Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging therapies for hand eczema. Dermatol Ther. 2019;32(3):e12840.
23. 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(2):208-219.
24. Simpson EL, et al. Tralokinumab therapy for moderate-to-severe atopic dermatitis: Clinical outcomes with targeted IL-13 inhibition. Allergy. 2023;78:2875-2891.

News published on 12 january 2024 at 04:05 and distributed by: