LEO Pharma will demonstrate true leadership in medical dermatology by presenting one of its largest ever scientific programs to date at this year’s EADV congress, with 5 late-breaking presentations and 23 scientific posters in total.1-28

New late-breaking Anzupgo® (delgocitinib) cream data will include the full results of the Phase 3 head-to-head DELTA FORCE trial, as well as a wide range of associated clinical and real-world findings on delgocitinib cream and moderate to severe chronic hand eczema (CHE).1-6

Additional late-breaking data includes a presentation of Adtralza® (tralokinumab)/Adbry® (tralokinumab-ldrm) interim data from the real-world TRACE study on the effectiveness of Adtralza/Adbry in adults with moderate to severe head and neck atopic dermatitis (AD).27

Finally, a late-breaking presentation will discuss the first randomized trial comparing clinical and molecular effects of temtokibart and dupilumab in moderate to severe AD.28

BALLERUP, Denmark–(BUSINESS WIRE)–NOT FOR UK USE – NOT INTENDED FOR UK MEDIA

LEO Pharma A/S, a global leader in medical dermatology, will present new clinical and real-world data from across its portfolio of products at the upcoming 33rd European Academy of Dermatology and Venereology (EADV) Congress.

The event will be held from the 25th to the 28th of September in Amsterdam, Netherlands, where LEO Pharma will present 5 coveted late-breaking presentations in addition to 23 scientific posters for a range of skin conditions, forming the largest collection of data LEO Pharma has ever shared at the EADV congress.1-28

“It is extraordinary to witness the breadth and variety of LEO Pharma’s scientific contribution at this year’s EADV Congress. It is a record-breaking presence for us – and we cannot wait to share this ground-breaking data with the medical dermatology community,” said Christophe Bourdon, CEO of LEO Pharma.

The first late-breaking presentation for Anzupgo® (delgocitinib) cream will provide data from the 24-week DELTA FORCE trial that compared the efficacy and safety of topical delgocitinib cream with oral alitretinoin capsules in adults with severe CHE.1 An additional late-breaking oral presentation will provide data from the matching-adjusted indirect comparison (MAIC) of the efficacy of delgocitinib and dupilumab in the treatment of moderate to severe atopic hand eczema.25 The third delgocitinib cream late-breaking presentation will provide information on biomarker and efficacy data from the randomized vehicle-controlled clinical trial with delgocitinib cream in patients with frontal fibrosing alopecia.26

A late-breaking presentation will also be presented for Adtralza/Adbry, highlighting the interim real-world effectiveness results of tralokinumab in adult patients with head and neck atopic dermatitis after up to 9 months of treatment in the TRACE real world evidence (RWE) study.27

Finally, a late-breaking presentation for temtokibart will also be presented, comparing clinical and molecular responses in the targeting of IL-22RA1 with temtokibart vs dupilumab in patients with moderate to severe atopic dermatitis.28

“The 2024 EADV Congress marks a pivotal moment for LEO Pharma as we unveil a wealth of new data,” said Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. “Our presentations at EADV showcase our most comprehensive research portfolio to date, underscoring our unwavering commitment to developing innovative dermatological therapies and helping to bring new hope to patients grappling with challenging skin conditions.”

The company’s full roster at the 2024 EADV Congress, encompassing new research, encore abstracts, and 3 symposiums,1-28 includes:

Anzupgo® (delgocitinib) cream

DELTA FORCE trial: A 24-week head-to-head phase 3 trial comparing the efficacy and safety of topical delgocitinib cream with oral alitretinoin capsules in adults with severe chronic hand eczema

Author: Ana Maria Giménez-Arnau

Presentation ID: D1T01.1F

LB presentation: Wednesday, 25 Sep, 15:30 – 15:45

Location: Auditorium

Matching-adjusted indirect comparison of the efficacy of delgocitinib and dupilumab in the treatment of moderate to severe atopic hand eczema

Author: David Cohen

Presentation ID: D3T01.4B

LB presentation: Friday, 27 Sep, 16:15 – 16:30

Location: Auditorium

Randomized vehicle-controlled clinical trial with the topical JAK inhibitor delgocitinib in patients with frontal fibrosing alopecia demonstrates biomarker and clinical efficacy

Author: Maryanne Makredes Senna

Presentation ID: D3T01.4F

LB presentation: Friday, 27 Sep, 17:15 – 17:30

Location: Auditorium

Treatment response of delgocitinib cream according to Chronic Hand Eczema (CHE) subtypes in adults with moderate to severe CHE: results from the Phase 3 DELTA 1, DELTA 2, and DELTA 3 trials

Author: Robert Bissonnette

Presentation ID: FC07.04

Oral presentation: Friday, 27 Sep, 14:45 – 14:55

Location: G104-G105

Topical pan-JAK inhibition with delgocitinib restores the molecular signature of lesional skin in patients with Chronic Hand Eczema

Author: Sonja Molin

Poster ID: P0572

ePoster presentation

Health-related quality of life in people with Chronic Hand Eczema – Findings from the multi-national CHECK study

Author: Anthony Bewley

Poster ID: P3443

ePoster presentation

Clinical trial exit interviews in patients with moderate to severe Chronic Hand Eczema: perspectives on disease burden and its impact on quality of life from participants in the phase 3 DELTA 1 trial

Author: Padma Mohandas

Poster ID: P0532

ePoster presentation

Patient characteristics and comorbidities in moderate-to-severe CHE: Results from the RWEAL study

Author: Maria Concetta Fargnoli

Poster ID: P2559

ePoster presentation

The multifactorial and heterogenous nature of Chronic Hand Eczema in clinical practice: Results from the RWEAL study

Author: Maria Concetta Fargnoli

Poster ID: P0608

ePoster presentation

Delgocitinib cream reduces itch and pain in adults with moderate to severe Chronic Hand Eczema: pooled analyses of the Phase 3 DELTA 1 and 2 trials

Author: Andrea Bauer

Poster ID: P0564

ePoster presentation

Efficacy and safety of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema: pooled results of the Phase 3 DELTA 1 and 2 trials

Author: Marie Louise Schuttelaar

Poster ID: P0569

ePoster presentation

Systemic exposure and safety profile of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema in the Phase 3 DELTA 2 trial

Author: Melinda Gooderham

Poster ID: P0581

ePoster presentation

Long-term safety and efficacy of delgocitinib cream for up to 36 weeks in adults with Chronic Hand Eczema: results of the Phase 3 open-label extension DELTA 3 trial

Author: Sonja Molin

Poster ID: P0565

ePoster presentation

Association and impact of Chronic Hand Eczema on occupational and household/leisure activities– results from the multinational CHECK study

Author: Marie Noelle Crepy

Poster ID: P1076

ePoster presentation

Prevalence of Chronic Hand Eczema in adults: A cross-sectional multi-national study of over 60,000 respondents in the general population

Author: Christian Apfelbacher

Poster ID: P1901

ePoster presentation

Treatment patterns in moderate to severe Chronic Hand Eczema – Results from the multinational RWEAL medical chart review

Author: Ana Maria Giménez-Arnau

Poster ID: P3568

ePoster presentation

Self-reported disease severity and treatment of Chronic Hand Eczema from the CHECK study – A multinational study in six countries

Author: Sonja Molin

Poster ID: P3526

ePoster presentation

Adtralza® (tralokinumab)/Adbry® (tralokinumab-ldrm)

Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in patients with head and neck atopic dermatitis after up to 9 months of treatment in the TRACE study

Author: April Armstrong

Presentation ID: D3T01.3C

LB presentation: Friday, 27 Sep, 14:45 – 15:00

Location: Auditorium

Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in physician-assessed disease severity after up to 9 months of follow-up in the TRACE study

Author: Elena Pezzolo

Poster ID: P0689

ePoster presentation

Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in patient-reported outcomes after up to 9 months of follow-up in the TRACE study

Author: Antonio Costanzo

Poster ID: P0690

ePoster presentation

Long-term safety and efficacy of tralokinumab in patients 65 years or older with moderate-to-severe atopic dermatitis

Author: Andrew Blauvelt

Poster ID: P0479

ePoster presentation

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 ID: P0595

ePoster presentation

Tralokinumab formulated as a pre-filled pen was efficacious and well-tolerated in adults and adolescents with moderate-to-severe atopic dermatitis

Author: Jennifer Soung

Poster ID: P0574

ePoster presentation

Stability of long-term therapeutic responses to tralokinumab in adults with moderate-to-severe atopic dermatitis

Author: Andrew Blauvelt

Poster ID: P0596

ePoster presentation

Kyntheum® (brodalumab)

Observational study to assess the real-life descriptive effectiveness in patients with moderate to severe plaque psoriasis treated with Brodalumab stratified by patients with BMI>30 and patients with BMI ≤ 30. The BROACTIVE Study. 2 years – results.

Author: Juan Escalas

Poster ID: P3205

ePoster presentation

Long-term management outcome assessment of adult patients with moderate-to-severe plaque psoriasis treated with brodalumab in Greece: The ReSOLVE study.

Author: Pantelis Panagakis

Poster ID: P3102

ePoster presentation

Temtokibart

Targeting IL-22RA1 with temtokibart in patients with moderate to severe atopic dermatitis induces fast clinical and molecular responses, distinct from dupilumab

Author: Christine Bangert

Presentation ID: D2T01.3A

LB presentation: Thursday, 26 Sep, 14:15 – 14:30

Location: Auditorium

Individual responses to IL-22RA1 inhibition in Asian patients with moderate-to-severe atopic dermatitis in Phase 1 and 2a clinical trials

Author: Diamant Thaçi

Poster ID: P0691

ePoster presentation

In addition to the abstracts and poster presentations, LEO Pharma will also present 3 symposiums at the meeting:

A New Era in Atopic Dermatitis

Speakers: Prof. Melinda Gooderham, Prof. April Armstrong and Prof. Marjolein de Bruin-Weller

17:45–19:15 CEST on Thursday the 26th of September in Room 7.1, RAI Amsterdam

Plaque psoriasis and obesity — a double burden for patients?

Speakers: Prof. Dr med. Khusru Asadullah and Dr Matteo Megna

11:15-12:00 CEST on Thursday the 26th of September in Amtrium 1, Hall 4, RAI Amsterdam

Chronic Hand Eczema Breaking the Silent Conversation

Speakers: Prof. Swen Malte John, Prof. April Armstrong, Dr Marie-Louise Schuttelaar

13:00-14:00 CEST on Friday the 27th of September in Room 7.3, RAI Amsterdam.

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.29,30 CHE is one the most common skin disorder of the hands with a prevalence rate of approximately 4.7%.31 In a substantial number of patients, HE can develop into a chronic condition.32 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.33

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,34 with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities, and suffering disruption in their daily life due to the condition.35 Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.36

About Atopic Dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.37 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.38 Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology.37,38 Excessive IL-22 production is also known to contribute to the pathogenesis of AD.39

About Psoriasis

Psoriasis is a chronic, systemic inflammatory disease that primarily affects the skin in 125 million people worldwide.40,41 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.42 About 80% to 90% of patients are affected by plaque psoriasis, the most common clinical form of psoriasis.43 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.43

About Anzupgo® (delgocitinib) cream

Anzupgo® (delgocitinib) cream 20 mg/g is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.44 The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.45 Anzupgo is currently approved in the European Union for the treatment of moderate to severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate. 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 cream for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights.

About Adtralza® (tralokinumab) / Adbry ® (tralokinumab-ldrm)

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.38,46 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).47

Adtralza® is approved for the treatment of moderate to severe AD in adult and adolescent patients 12 years and older 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 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.48

Kyntheum® is indicated in the European Union, Great Britain, 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 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.49 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-24.49 Temtokibart does not bind to the IL-22 cytokine itself.49 LEO Pharma has obtained a worldwide exclusive license to develop and commercialize temtokibart from argenx.

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 4,200 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion.

References

Giménez-Arnau AM, Pinter A, Sondermann W et al. DELTA FORCE trial: A 24-week head-to-head phase 3 trial comparing the efficacy and safety of topical delgocitinib cream with oral alitretinoin capsules in adults with severe chronic hand eczema. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. Oral Presentation. D1T01.1F.

Bisonnette R, Schliemann S, Gooderham M, et al. Treatment response of delgocitinib cream according to Chronic Hand Eczema (CHE) subtypes in adults with moderate to severe CHE: results from the Phase 3 DELTA 1, DELTA 2, and DELTA 3 trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. Oral Presentation. FC07.04

Giménez-Arnau AM, Bewley A, Molin S, et al. Patient characteristics and comorbidities in moderate-to-severe CHE: Results from the RWEAL study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P2559

Fargnoli MN, Molin S, Bewley A, et al. The multifactorial and heterogenous nature of Chronic Hand Eczema in clinical practice: Results from the RWEAL study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0608.

Worm M, Jiang L, Litman T, et al. Topical pan-JAK inhibition with delgocitinib restores the molecular signature of lesional skin in patients with Chronic Hand. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. Oral Presentation. P0572.

Bewley A, Molin S, Crepy MN, et al. Health-related quality of life in people with Chronic Hand Eczema – Findings from the multi-national CHECK study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P3443.

Mohandas P, Devani AR, Baranowski K, et al. Clinical trial exit interviews in patients with moderate to severe Chronic Hand Eczema: perspectives on disease burden and its impact on quality of life from participants in the phase 3 DELTA 1 trial. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0532.

Pezzolo E, Cork M, Beecker J, et al. Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in physician-assessed disease severity after up to 9 months of follow-up in the TRACE study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0689.

Costanzo A, Becherel PA, Serra E, et al. Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in patient-reported outcomes after up to 9 months of follow-up in the TRACE study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0690.

Escalas J, Armesto S, Abalde T, et al. Observational study to assess the real-life descriptive effectiveness in patients with moderate to severe plaque psoriasis treated with Brodalumab stratified by patients with BMI>30 and patients with BMI ≤ 30. The BROACTIVE Study. 2 years – results. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P3205.

Panagakis P, Chasapi V, Kalapothakou K, et al. Long-term management outcome assessment of adult patients with moderate-to-severe plaque psoriasis treated with brodalumab in Greece: The ReSOLVE study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P3102.

Thaçi D, Bangert C, Laquer V, et al. Individual responses to IL-22RA1 inhibition in Asian patients with moderate-to-severe atopic dermatitis in Phase 1 and 2a clinical trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0691.

Blauvelt A, Merola J, Carrascosa JM, et al. Long-term safety and efficacy of tralokinumab in patients 65 years or older with moderate-to-severe atopic dermatitis. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0479.

Bauer A, Schuttelaar ML, Baranowski K, et al. Delgocitinib cream reduces itch and pain in adults with moderate to severe Chronic Hand Eczema: pooled analyses of the Phase 3 DELTA 1 and 2 trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0564.

Schuttelaar ML, Bisonnette R, Worm M, et al. Efficacy and of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema: pooled results of the Phase 3 DELTA 1 and 2 trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0569.

Gooderham M, Thaçi D, Damgaard T, et al. Systemic exposure and safety profile 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 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0581.

Molin S, Gooderham M, Bisonnette R, et al. Long-term safety and efficacy of delgocitinib cream for up to 36 weeks in adults with Chronic Hand Eczema: results of the Phase 3 open-label extension DELTA 3 trial. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0565.

Crepy MN, Molin S, Giménez-Arnau AM, et al. Association and impact of Chronic Hand Eczema on occupational and household/leisure activities– results from the multinational CHECK study.
Contacts

Melissa Borland
LEO Pharma, Senior Manager Communications, North America

647.241.1475

MQBCA@leo-pharma.com

Jes Broe Frederiksen
LEO Pharma, Senior Manager, Global Product and Data Communications

Tel: +45 53 60 59 48

Email: jebfe@leo-pharma.com

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