LEO Pharma Presents Data from the Largest-Ever Multinational Real-World Studies of Chronic Hand Eczema (CHE) in Adults at the ESCD 2024 Congress

• The CHECK (patient-reported) and RWEAL (physician-reported) studies form the largest multinational CHE surveys conducted in the adult population.^1-5
• Findings show that CHE is common in the general population, with around 5.6% of study participants self-reporting the condition in the last 12 months.^1-5
• Among people self-reporting CHE, one in five (21.5%) attribute the condition to their occupation, and one in ten (12.2%) of those reporting CHE in relation to occupation or daily activities have changed work assignments or reduced their working hours.²

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

LEO Pharma A/S, a global leader in medical dermatology, has today presented a range of new population-level and physician-reported data on the prevalence, severity and treatment of moderate to severe chronic hand eczema (CHE). The data forms part of an expansive scientific program from LEO Pharma. Eight posters in total will be shared at the European Society of Contact Dermatitis (ESCD) congress, held in Dresden, Germany from the 4^th to the 7^th of September 2024.

Four posters present data from CHECK (Chronic Hand Eczema epidemiology, Care, and Knowledge of real-life burden), a large multinational, prevalence study of CHE.^1-4 CHECK was conducted among 60,131 adult participants from the general population in France, Spain, Italy, Germany, Canada, and the UK.^1-4 The data from CHECK is supported by the findings in the RWEAL (Real-World trEatment & mAnagement of chronic hand eczema in cLinical practice) study, which examined the physician-reported treatment patterns in CHE. It was a medical chart review of 1,939 patients, involving 292 physicians from Canada, Germany, France, Italy, Spain, and the UK.⁵ Historically, data relating to the prevalence of CHE and treatment options has been limited.^6,7

“It is a privilege to present the results from the largest real-world studies LEO Pharma has ever completed,” said Kreesten Meldgaard Madsen, LEO Pharma’s Chief Development Officer. “Our findings from the CHECK study are supported by the physician-reported outcomes of the RWEAL study and for the first time at this scale, the data from both studies can show the needs among people living with this debilitating disease, and the immense impact it can have on quality of life.”

CHECK results: Prevalence of CHE in adults and data from patient-reported outcomes

One poster shows that CHE is a common skin disease, with 5.6% of study participants self-reporting CHE in the last 12 months. Overall, 4.7% of participants reported physician-diagnosed CHE.¹

An additional CHECK poster concludes that CHE is a burdensome disease that can have a direct impact on occupation, leisure time, and overall daily life of individuals with CHE. Among participants who self-reported CHE (n=2,330), one in five (21.5%) attribute their disease to their occupation, and almost one in three (30.3%) to their household/leisure activities.²

“The heavy burden of chronic hand eczema is well understood but prevalence has been historically understudied in the general population,” said Professor Sonja Molin, chair of the Division of Dermatology, Queen’s University and lead author. “Large-scale, multinational studies like CHECK provide powerful insights to help us better understand this debilitating disease.”

Further analysis assessed participants with physician-reported CHE (n=1,948). It showed that, despite the majority of participants receiving treatment, symptoms persisted across all treatment groups, indicating an unmet treatment need in this population.³

RWEAL results: Data from physician-reported outcomes

The RWEAL poster presented at ESCD found that the use of medium, high or ultra-high potency topical corticosteroids (TCS) was reported in more than 90% of moderate to severe CHE patients. More than one-in-four patients (27.4%) with moderate to severe CHE had progressed to phototherapy or systemic therapy, oral immunosuppressants, and biologics.⁵

Finally, in addition to the new data presented at the congress, three encore posters were also presented on the latest phase 3 clinical trial results from the DELTA 1, 2, and 3 studies. A symposium titled “Dear Diary: Chronic Hand Eczema in the patients’ words*” is also scheduled to take place on the 5^th of September to shed more light on the CHE experience through the words of patients. ^8-10

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.^11,12 HE is the most common skin disorder of the hands¹³ with a one-year prevalence rate of approximately 9%.¹⁴ In a substantial number of patients, HE can develop into a chronic condition.¹³ 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.¹⁵

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,¹⁶ 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.¹⁷ Furthermore, work and earning potential have also been shown to be impacted by the burden of living with CHE.¹⁸

About the CHECK study

CHECK (Chronic Hand Eczema epidemiology, Care, and Knowledge of real-life burden) is a population-based study which recruited (n=60,131) participants in six countries including Canada, Germany, France, Italy, Spain, and the UK aged 18-69 via online panels. Participants were representative of the general population regarding sex, age, region, employment status, urban/rural setting, and, for the UK, ethnicity.^1-4

The objective of the CHECK study was to investigate and analyze self-reported disease severity, symptoms, and treatments in CHE. Furthermore, the study estimated and described the prevalence according to key socio-demographic characteristics. Association and impact of CHE on exposures and occupation or household/leisure activities were also investigated.^1-4

About the RWEAL study

The RWEAL (Real-World trEatment & mAnagement of chronic hand eczema in cLinical practice) study is a medical chart review which involved (n=292) physicians from Canada, Germany, France, Italy, Spain, and the UK. Patients ≥18 years of age with moderate to severe CHE treated with TCS in the past 12 months, or with TCS contraindication, were randomly selected from physician’s overall caseload in the preceding 12 months. Data on treatments used in the 12 months prior to the last visit was collected and analyzed descriptively.⁵

The objective of the RWEAL study was to investigate treatment patterns in patients with moderate to severe CHE over 12 months, focusing on topical corticosteroid (TCS) therapy. ⁵

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.

Disclaimers

*Accounts from actual patients living with CHE.

References

1. Apfelbacher C, Bewley A, Molin S, et al. Prevalence of Chronic Hand Eczema in adults: A cross-sectional multi-national study of 60,000 respondents in the general population. Presented at the 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #3
2. Crepy MN, Molin S, Gimenez-Arnau AM, et al. Exploring the relationship between Chronic Hand Eczema occupation, and household/leisure activities. Presented at the 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #19
3. Molin S, Fargnoli MC, 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 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #64
4. Molin S, Le Calve P, Daccache A, et al. Self-reported disease severity and treatment of Chronic Hand Eczema in Germany. Presented at the 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #65
5. Gimenez-Arnau AM, Bewley A, Apfelbacher C, et al. Physician-reported treatment patterns in Chronic Hand Eczema – results from the multinational RWEAL medical chart review. Presented at the 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #27
6. Quaade AS, Simonsen AB, Halling AS, Thyssen JP, Johansen JD. Prevalence, incidence, and severity of hand eczema in the general population - A systematic review and meta-analysis. Contact Dermatitis. 2021;84(6):361-374.
7. Christoffers WA, Coenraads PJ, Svensson Å, et al. Interventions for hand eczema. Cochrane Database Syst Rev. 2019;4(4):CD004055.
8. 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 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #8
9. Schuttelaar ML, Bissonnette R, Worm M, et al. 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. Presented at the 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #83
10. Molin S, Gooderham M, Bissonnette 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 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #63
11. Lynde C, Guenther L, Diepgen TL, et al. Canadian hand dermatitis management guidelines. J Cutan Med Surg. 2010;14(6):267-284. Erratum in: J Cutan Med Surg. 2011 Nov-Dec;15(6):360.
12. Diepgen TL, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015 Jan;13(1):e1–22.
13. Bissonnette R, et al. Redefining treatment options in chronic hand eczema (CHE). JEADV. 2010;24;1–20.
14. Thyssen, et al. The epidemiology of hand eczema in the general population – prevalence and main findings. Contact Dermatitis. 2010;62:75-87.
15. Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378.
16. Grant L, Seiding Larsen L, Burrows K, et al. Development of a Conceptual Model of Chronic Hand Eczema (CHE) Based on Qualitative Interviews with Patients and Expert Dermatologists. Adv Ther. 2020;37(2):692-706.
17. Cortesi PA, Scalone L, Belisari A, et al. Cost and quality of life in patients with severe chronic hand eczema refractory to standard therapy with topical potent corticosteroids. Contact Dermatitis. 2014;70(3):158-168.
18. Voorberg AN, Loman L, Schuttelaar MLA. Prevalence and Severity of Hand Eczema in the Dutch General Population: A Cross-sectional, Questionnaire Study within the Lifelines Cohort Study. Acta Derm Venereol. 2022;102:adv00626.

MAT-76002 September 2024