LEO Pharma to Reveal New Findings in Moderate to Severe Atopic Dermatitis (AD) and Chronic Hand Eczema (CHE) at the 2023 EADV Congress

GLOBAL RELEASE - NOT FOR UK USE – NOT INTENDED FOR UK MEDIA

BALLERUP, Denmark, October 12, 2023 – LEO Pharma A/S, a global leader in medical dermatology, will present new data and insights into moderate to severe atopic dermatitis (AD) and chronic hand eczema (CHE) at the 32^nd European Academy of Dermatology and Venereology (EADV) Congress. The event is being held from the 11^th to the 14^th of October in Berlin, Germany, a country where skin diseases are among the most frequent reasons for seeking medical care.⁷

“We are eager to share the latest results from our work in skin conditions at the 2023 EADV Congress,” said Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. “The breadth of LEO Pharma’s clinical evidence on show this year demonstrates our commitment to advancing the standard of care in medical dermatology to help support various patient populations.”

Oral presentations will assess the long-term safety and efficacy data of Adtralza^® (tralokinumab) after over four years of treatment for moderate to severe AD in adults.^1,2 Additional Adtralza data, presented as an e-poster, will examine the initial findings from the tralokinumab real-world clinical use (TRACE) cohort study.³

Eight e-poster presentations on delgocitinib cream will be delivered during the congress.^4-5,8-13 These include key results from the DELTA 2 clinical trial, assessing the investigational topical pan-Janus kinase (JAK)-inhibitor for the potential treatment of adults with moderate to severe CHE.^4,5

One temtokibart (LEO 138559) presentation will be delivered as an e-poster during the congress.⁶ This explores the results from a Phase 2a monotherapy trial assessing the efficacy and safety of IL-22RA1 inhibition in patients with moderate to severe atopic dermatitis, as well as some mechanistic in vitro data increasing the understanding of this new mechanism of action targeting the IL-22 pathway.⁶

Finally, four Kyntheum^® (brodalumab) presentations will also be delivered as e-posters.^14-17 This includes 12-week effectiveness data of Kyntheum in patients with visible and/or stigmatizing psoriasis lesions.¹⁵

The company’s full roster of accepted presentations at the 2023 EADV Congress includes:

 

Adtralza^® (tralokinumab)

 

Continuous tralokinumab treatment over 4 years in adults with moderate-to-severe atopic dermatitis provides long-term disease control

Author: Andrew Blauvelt

Abstract #: 4551

Oral 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

Abstract #: 4553

Oral Presentation

A global, observational, cohort study of patients with atopic dermatitis to evaluate tralokinumab real-world clinical use (TRACE): baseline characteristics from the first 100 patients in Germany

Author: Diamant Thaçi

Abstract #: 2717

E-Poster Presentation

Delgocitinib

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

Abstract #: 1620

E-Poster Presentation

Minimal systemic exposure of delgocitinib cream in adults with moderate to severe chronic hand eczema in the phase 3 DELTA 2 trial

Author: Diamant Thaçi

Abstract #: 1621

E-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

Abstract #: 945

E-Poster Presentation

 

Delgocitinib cream 20 mg/g improves health-related quality of life (EQ-5D) in patients with moderate-to-severe chronic hand eczema: pooled results from two randomised, controlled phase 3 trials

Author: Andrea Bauer

Abstract #: 2475

E-Poster Presentation

 

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

Abstract #: 2466

E-Poster Presentation

Treatments in chronic hand eczema: A systematic literature review of randomised controlled trials

Author: Richard B Warren

Abstract #: 2611

E-Poster Presentation

Development and psychometric validation of a new patient-reported outcome measure to assess the signs and symptoms of chronic hand eczema (CHE): the Hand Eczema Symptom Diary (HESD)

Author: Sonja Molin

Abstract #: 1625

E-Poster Presentation

Psychometric Validation of the Investigator Global Assessment of Chronic Hand Eczema (IGA-CHE): a new clinician reported outcome measure

Author: Jonathan Silverberg

Abstract #: 1626

E-Poster Presentation

Temtokibart

 

Efficacy and safety of IL-22RA1 inhibition in patients with moderate-to-severe atopic dermatitis: results from a Phase 2a monotherapy trial

Author: Diamant Thaçi

Abstract #: 4607

E-Poster Presentation

 

Kyntheum^® (brodalumab)

 

LIBERO VISIBLE: Disease Characteristics of Patients with Visible and/or Stigmatizing Psoriasis Lesions and Impact on Quality of Life

Author: Ralph von Kiedrowski

Abstract #: 3567

E-Poster Presentation

 

LIBERO VISIBLE: 12 Week Effectiveness of Brodalumab in Patients with Visible and/or Stigmatizing Psoriasis Lesions

Author: Matthias Augustin

Abstract #: 3584

E-Poster Presentation

Short-term management outcome assessment of patients with moderate-to-severe plaque psoriasis treated with brodalumab in Greece: The ReSOLVE study interim analysis

Author: Pantelis Panagakis

Abstracts #: 4223

E-Poster Presentation

Observational study to assess the real-life descriptive effectiveness in patients with moderate to severe plaque psoriasis treated with brodalumab. The BROACTIVE Study. 1-year results

Author: Juan Escalas

Abstracts #: 4072

E-Poster Presentation

 

*Ends*

 

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.^18,19 HE is the most common skin disorder of the hands²⁰ with a one-year prevalence rate of approximately 9%.²¹ In a substantial number of patients, HE can develop into a chronic disease.²⁰ 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.²²

About atopic dermatitis

Atopic dermatitis (AD) is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.²³ Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.²⁴ Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology.^24,25 Excessive IL-22 production is also known to contribute to the pathogenesis of AD.²⁶

 

About psoriasis

Psoriasis is a chronic, systemic inflammatory disease that primarily affects the skin in 125 million people worldwide.^27,28 Psoriasis is the result of skin barrier cell proliferation and the activation of cytokines (a family of proteins involved in immune responses) that cause inflammation.²⁹ About 80% to 90% of patients are affected by plaque psoriasis, the most common clinical form of psoriasis.³⁰ The symptoms of plaque psoriasis are itchy or painful raised scaly and inflamed plaques. Plaques may appear anywhere on the body, but often appear on the scalp, knees, elbows and torso.³⁰

 

About delgocitinib

Delgocitinib is a first-in-class 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.³¹ The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.³² 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 Adtralza^® (tralokinumab)

Adtralza^® (tralokinumab), which is marketed under the tradename Adbry^® in the U.S., 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.^24,25 Adtralza specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).³³

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. Adtralza is approved for use in adults with moderate to severe AD in the U.S., Switzerland, Saudi Arabia, and Japan.

About temtokibart

Temtokibart (LEO 138559) is an investigational monoclonal antibody that targets the IL-22RA1 receptor subunit, currently in Phase 2 development for the potential treatment of moderate to severe atopic dermatitis.³⁴ It blocks the IL-22RA1 subunit and thereby inhibits the effects of the IL-22 cytokine, and potentially also to some extent the effects of IL-20 and IL-24.³⁴ Temtokibart does not bind to the IL-22 cytokine itself.³⁴ LEO Pharma has obtained a worldwide exclusive license to develop and commercialize temtokibart from argenx.

 

About Kyntheum^® (brodalumab)

Kyntheum^® (brodalumab) is a recombinant fully human monoclonal immunoglobulin IgG2 antibody that binds with high affinity to human IL-17RA and blocks the biological activities of the pro-inflammatory cytokines IL-17A, IL-17F, IL-17A/F heterodimer, IL-17C and IL-17E (also known as IL-25), resulting in inhibition of the inflammation and clinical symptoms associated with psoriasis. IL-17RA is a protein expressed on the cell surface and is a required component of receptor complexes utilized by multiple IL-17 family cytokines. IL-17 family cytokine levels have been reported to be increased in psoriasis. IL-17A, IL-17F and IL-17A/F heterodimer have pleiotropic activities including the induction of pro-inflammatory mediators such as IL-6, GROα, and G-CSF from epithelial cells, endothelial cells and fibroblasts that promote tissue inflammation. IL-17C has been shown to induce similar responses as IL-17A and IL-17F in keratinocytes. Blocking IL-17RA inhibits IL-17 cytokine-induced responses resulting in normalization of inflammation in the skin.³⁵

Kyntheum is indicated in the European Union, the United Arab Emirates, and Brazil for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.

 

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. 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 European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Oral Presentation.
2. 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 European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Oral Presentation.
3. Thaçi D, et al. A global, observational, cohort study of patients with atopic dermatitis to evaluate tralokinumab real-world clinical use (TRACE): baseline characteristics from the first 100 patients in Germany. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P0434.
4. 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 European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P0395.
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 European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P0396.
6. Thaçi D, et al. Efficacy and safety of IL-22RA1 inhibition in patients with moderate-to-severe atopic dermatitis: results from a Phase 2a monotherapy trial. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P0500.
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8. 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 European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P0369.
9. Bauer A, et al. Delgocitinib cream 20 mg/g improves health-related quality of life (EQ-5D) in patients with moderate-to-severe chronic hand eczema: pooled results from two randomised, controlled phase 3 trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P0421
10. 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 European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P0420.
11. Warren R, et. Al. Treatments in chronic hand eczema: A systematic literature review of randomised controlled trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P0433.
12. Molin S, et. Al. Development and psychometric validation of a new patient-reported outcome measure to assess the signs and symptoms of chronic hand eczema (CHE): the Hand Eczema Symptom Diary (HESD). Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P0398.
13. Silverberg J, et. Al. Psychometric Validation of the Investigator Global Assessment of Chronic Hand Eczema (IGA-CHE): a new clinician reported outcome measure. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P0399.
14. Kiedrowski R, et al. LIBERO VISIBLE: Disease Characteristics of Patients with Visible and/or Stigmatizing Psoriasis Lesions and Impact on Quality of Life. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P2507.
15. Augustin M, et al. LIBERO VISIBLE: 12 Week Effectiveness of Brodalumab in Patients with Visible and/or Stigmatizing Psoriasis Lesions. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P2509.
16. Panagakis P, et al. Short-term management outcome assessment of patients with moderate-to-severe plaque psoriasis treated with brodalumab in Greece: The ReSOLVE study interim analysis. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation # P2541.
17. Escalas J, et al. Observational study to assess the real-life descriptive effectiveness in patients with moderate to severe plaque psoriasis treated with brodalumab. The BROACTIVE Study. 1-year results. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October. Poster Presentation #P2526.
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34. Thaçi D, et al. Efficacy and safety of IL-22R inhibition in patients with moderate-to-severe atopic dermatitis: results from a phase 2a monotherapy trial. Presented at the 2023 American Academy of Dermatology Annual Meeting; March 17–21 2023; New Orleans, LA.
35. Electronic Medicines Compendium. SmPC. Kyntheum (brodalumab). 10 Jan 2023. https://www.ema.europa.eu/en/documents/product-information/kyntheum-epar-product-information_en.pdf Accessed October 9, 2023.

MAT-68783 October 2023