LEO Pharma Presents Extensive Data at EADV

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LEO Pharma is showcasing extensive clinical and real-world data at the 33rd European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam this week, according to a news release from the company. This year, LEO Pharma presented its largest collection of findings, including 5 late-breaking presentations and 23 scientific posters focused on various skin conditions.¹

“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.

Key highlights include data on delgocitinib cream from the DELTA FORCE trial, comparisons of delgocitinib with dupilumab for atopic hand eczema, and biomarker insights for frontal fibrosing alopecia. Additionally, results from the TRACE study discuss the real-world effectiveness of tralokinumab and tralokinumab-ldrm in treating head and neck atopic dermatitis.

LEO Pharma's chief development officer, Kreesten Meldgaard Madsen, emphasized the significance of this event, marking a commitment to innovative therapies and patient care: "The 2024 EADV Congress marks a pivotal moment for LEO Pharma as we unveil a wealth of new data. 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."

Presentations and posters presented by LEO Pharma^2-29 included:

Delgocitinib Cream (Anzupgo; LEO Pharma)

• 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

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

Author: David Cohen

• 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

• 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

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

Author: Sonja Molin

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

Author: Anthony Bewley

• 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

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

Author: Maria Concetta Fargnoli

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

Author: Maria Concetta Fargnoli

• 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

• 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

• 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

• 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

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

Author: Marie Noelle Crepy

• 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

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

Author: Ana Maria Giménez-Arnau

• Self-reported disease severity and treatment of Chronic Hand Eczema from the CHECK study - A multinational study in 6 countries

Author: Sonja Molin

Tralokinumab/Tralokinumab-ldrm (Adtralza/Adbry; LEO Pharma)

• 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

• 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

• 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

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

Author: Andrew Blauvelt

• 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

• 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

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

Author: Andrew Blauvelt

Brodalumab (Kyntheum; LEO Pharma)

• 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

• 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

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

• 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

Other Presentations

• A New Era in Atopic Dermatitis

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

• Plaque psoriasis and obesity — a double burden for patients?

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

• Chronic Hand Eczema Breaking the Silent Conversation

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

References

1. LEO Pharma unveils most extensive EADV program to date with 5 late breaking abstracts and 23 posters sharing clinical and real-world data. News Release. Business Wire. September 25, 2024. Accessed September 27, 2024. https://www.businesswire.com/news/home/20240925802803/en/LEO-Pharma-Unveils-Most-Extensive-EADV-Program-To-Date-with-5-Late-Breaking-Abstracts-and-23-Posters-Sharing-Clinical-and-Real-World-Data
2. 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. September 25-28, 2024.
3. 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. September 25-28, 2024.
4. 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. September 25-28, 2024.
5. 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. September 25-28, 2024.
6. 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. September 25-28, 2024.
7. 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. September 25-28, 2024.
8. 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. September 25-28, 2024.
9. 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. September 25-28, 2024.
10. 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. September 25-28, 2024.
11. 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. September 25-28, 2024.
12. 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. September 25-28, 2024.
13. 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. September 25-28, 2024.
14. 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. September 25-28, 2024.
15. 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. September 25-28, 2024.
16. 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. September 25-28, 2024.
17. 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. September 25-28, 2024.
18. 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. September 25-28, 2024.
19. 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. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. September 25-28, 2024.
20. Apfelbacher C, Bewley A, Molin S, et al. Prevalence of Chronic Hand Eczema in adults: A cross-sectional multi-national study of over 60,000 respondents in the general population. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. September 25-28, 2024.
21. Giménez-Arnau AM, Bewley A, Apfelbacher C et al. Treatment patterns in moderate to severe Chronic Hand Eczema - Results from the multinational RWEAL medical chart review. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. September 25-28, 2024.
22. Molin S, Fargnoli MN, Crepy MN, et al. Self-reported disease severity and treatment of Chronic Hand Eczema from the CHECK study - A multinational study in six countries. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. September 25-28, 2024.
23. Chovatiya R, Wollenberg A, Ribero S, 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 European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. September 25-28, 2024.
24. Soung J, Laquer V, Zirwas M, et al. Tralokinumab formulated as a pre-filled pen was efficacious and well-tolerated in adults and adolescents with moderate-to-severe atopic dermatitis. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. September 25-28, 2024.
25. Blauvelt A, Hong HC, Peris K, et al. Stability of long-term therapeutic responses to tralokinumab in adults with moderate-to-severe atopic dermatitis. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. September 25-28, 2024.
26. Cohen D, Bewley A, Wollenberg A, et al. Matching-adjusted indirect comparison of the efficacy of delgocitinib and dupilumab in the treatment of moderate to severe atopic hand eczema. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. September 25-28, 2024.
27. Senna MM, Soerensen OE, Nielsen AB et al. Randomized vehicle-controlled clinical trial with the topical JAK inhibitor delgocitinib in patients with frontal fibrosing alopecia demonstrates biomarker and clinical efficacy. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. September 25-28, 2024.
28. Armstrong A, Ameen A, Bagel J et al. 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. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. September 25-28, 2024.
29. Bangert C, Berdyshev E, Alkon N et al. Targeting IL-22RA1 with temtokibart in patients with moderate to severe atopic dermatitis induces fast clinical and molecular responses, distinct from dupilumab. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. September 25-28, 2024.