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

    Pressemeddelelse fra LEO Pharma

    GLOBAL EASE – 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 32nd European Academy of Dermatology and Venereology (EADV) Congress. The event is being held from the 11th to the 14th 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.
    7. Augustin M, Girbig G, Kis A, et al. Inpatient care for skin diseases in Germany: multi-source analysis on the current and future health care needs. J Dtsch Dermatol Ges. 2021;19 Suppl 5:25-53. Doi:10.1111/ddg.14620.
    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.
    18. Lynde C, Guenther L, Diepgen TL, et al. Canadian hand dermatitis management guidelines. J Cutan Med Surg. 2010;14(6):267-284.
    19. 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.
    20. 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.
    21. Thyssen JP, Johansen JD, Linneberg A, Menné T. The epidemiology of hand eczema in the general populationâ??prevalence and main findings. Contact Dermatitis. 2010;62(2):75-87.
    22. Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378.
    23. Weidinger S, et al. Atopic dermatitis. Lancet. 2016;387:1109-1122.
    24. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-46.
    25. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
    26. Dudakov JA, Hanash AM, van den Brink MR. Interleukin-22: immunobiology and pathology. Annu Rev Immunol. 2015;33:747-785.
    27. Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol 2009; 60: 643-659.
    28. Psoriasis Statistics. National Psoriasis Foundation website. https://www.psoriasis.org/content/statistics. Accessed October 6, 2023.
    29. Hawkes JE, Chan TC, Krueger JG. Psoriasis pathogenesis and the development of novel targeted immune therapies. J Allergy Clin Immunol. 2017;140(3):645-653.
    30. Plaque Psoriasis. National Psoriasis Foundation website. https://www.psoriasis.org/plaque/. Updated September 2020. Accessed October 6, 2023.
    31. 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.
    32. Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging therapies for hand eczema. Dermatol Ther. 2019;32(3):e12840.
    33. 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.
    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

    Kontakt:

    Henrik Heskjær tlf.: +45 3140 6180 email: hdtdk@leo-pharma.com

    Jes Broe Frederiksen tlf.: +45 5360 5948 email: jebfe@leo-pharma.com

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    Torsdag 12. okt 2023 / R57430