LEO Pharma presents new data on delgocitinib cream at EADV 2026 highlighting real-world outcomes in adults and new adolescent data in Chronic Hand Eczema (CHE)

• Interim results from the German REACHED study provide the first real-world evidence on the effectiveness of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema (CHE), with 28.6% of patients assessed as clear or almost clear after eight weeks of treatment, from none at baseline.¹
• New post hoc analyses from the phase 3 DELTA TEEN trial show greater reductions in daily HESD itch and pain scores with delgocitinib cream than with cream vehicle in adolescents aged 12-17 with moderate to severe CHE.²
• In an oral presentation, new post hoc analyses from DELTA TEEN show that a higher proportion of adolescents reported no impact on quality of life at Week 16 with delgocitinib cream than with cream vehicle (27.0% vs 0%)³

BALLERUP, Denmark--(BUSINESS WIRE)--LEO Pharma A/S, a global leader in medical dermatology, has presented new data on delgocitinib cream in Chronic Hand Eczema (CHE) at the 35th European Academy of Dermatology and Venereology (EADV) Congress, held from 30 September to 3 October 2026 in Vienna, Austria.

In total, six delgocitinib presentations feature in the company’s programme at the congress, including one oral presentation and five ePosters, spanning adults and adolescents, controlled clinical trials and routine clinical practice, and outcomes reported by physicians and by patients themselves.^1-6

CHE is one of the most common skin diseases of the hands, with an annual prevalence of 4.7% in Western populations, causing itch and pain alongside signs such as fissures, scaling and erythema.⁷,⁸,²⁴ Approximately 70% of adults living with severe CHE report problems with everyday activities.⁹

New data in adolescents

A post hoc analysis of the phase 3 DELTA TEEN trial assessed daily patient-reported itch and pain scores using the Hand Eczema Symptom Diary (HESD) in adolescents aged 12-17 with moderate to severe CHE. Mean changes from baseline in HESD itch and pain scores were greater with delgocitinib cream than with cream vehicle at Day 1, for both itch (-1.03±0.20 vs -0.20±0.35, p=0.040) and pain (-1.34±0.22 vs -0.39±0.36, p=0.019), and across the first two weeks of treatment.²

In an oral presentation, further DELTA TEEN analyses assessed the impact of CHE on health-related quality of life, using the Children’s Dermatology Life Quality Index (CDLQI), a validated patient-reported questionnaire covering symptoms and feelings, leisure, school, personal relationships and sleep.³ In post hoc analyses, the proportion of adolescents reporting a CDLQI score of 0 – indicating no impact of their skin disease on quality of life – was significantly higher with delgocitinib cream than with cream vehicle at Week 16 (27.0% vs 0%, p=0.005).³

The proportion of adolescents reporting a large or very large impact on quality of life (CDLQI 13–30) decreased from 21.6% at baseline to 4.1% at Week 16 with delgocitinib cream, compared with 25.0% to 16.7% with cream vehicle.³ In the symptoms and feelings domain, improvements from baseline were significantly greater with delgocitinib cream at Week 16 (–1.83±0.14 vs –0.82±0.25, p<0.001), and significantly more adolescents reported a domain score of 0 (48.6% vs 5.0%, p<0.001).³

"For an adolescent, chronic hand eczema is rarely only a matter of the skin. It shapes how they feel, how they sleep, and what they are willing to do in front of others," said Professor Lawrence F. Eichenfield, Chief of Pediatric and Adolescent Dermatology at Rady Children's Hospital-San Diego. "Capturing that alongside clinical severity is what these quality-of-life analyses set out to do, and it is an important part of assessing this condition in younger patients."

Real-world evidence in adults

Interim results from REACHED, an ongoing prospective, non-interventional study conducted at 79 sites in Germany, provide the first real-world evidence on the effectiveness of delgocitinib cream in adults with moderate to severe CHE.¹ At the interim data cut-off, Week 8 data were available for up to 97 patients, depending on the endpoint.¹ Almost all patients assessed had moderate or severe disease at baseline (63 of 68), with a mean Hand Eczema Severity Index (HECSI) score of 62.4 — within the severe range.¹

After eight weeks of treatment in routine clinical practice, 28.6% of patients were assessed as clear or almost clear (mPGA 0/1), from none at baseline.¹ Mean HECSI scores decreased from 62.4 to 30.8, a change of –28.6 points (95% CI: –37.6, –19.7), and 35.5% of patients achieved at least a 75% improvement in HECSI.¹ Mean Dermatology Life Quality Index (DLQI) scores decreased from 14.5 to 7.9, a change of –6.5 points (95% CI: –7.9, –5.1), and mean itch and pain numerical rating scale scores decreased by –2.1 and –2.7 points respectively.¹ All adverse events reported were non-serious, and all but one were mild or moderate in severity.¹

“Chronic hand eczema is a disease that affect all aspects of everyday life. It can be felt when someone gets dressed, are seen at school, or uses a tool at work, or holds another person’s hand” said Professor Jacob Thyssen, Chief Scientific Officer, LEO Pharma. “The data we are presenting in Vienna describe that experience across the course of the disease – in adults and in adolescents, in clinical trials and in everyday clinical practice, and increasingly in the words of patients themselves. Our commitment is to keep raising the standard of care for a condition that we know affects far more than just the skin.”

About the REACHED Study

REACHED is an ongoing prospective, observational, non-interventional study describing the real-world effectiveness and safety of delgocitinib cream 20 mg/g in patients with moderate to severe CHE deemed suitable for treatment. Patient enrolment in Germany began on 6 June 2025 and is expected to conclude on 30 June 2026. Effectiveness is evaluated by comparing baseline and follow-up values for the modified Physician Global Assessment (mPGA), Hand Eczema Severity Index (HECSI), Dermatology Life Quality Index (DLQI), and itch and pain numerical rating scales.¹

About the DELTA TEEN Trial

DELTA TEEN was a 16-week, phase 3, randomized, double-blind, vehicle-controlled, parallel group, multi-site trial to evaluate the efficacy and safety of twice-daily applications of delgocitinib cream compared with cream vehicle in adolescents 12–17 years of age with moderate to severe CHE.¹⁰

The primary endpoint of DELTA TEEN was the Investigator’s Global Assessment for chronic hand eczema Treatment Success (IGA-CHE TS) at Week 16. Treatment Success was defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a two-step improvement from baseline.¹⁰

About Chronic Hand Eczema

CHE is one of the most common skin diseases of the hands with a global prevalence rate of approximately 4.7%.^7,18 In a substantial number of patients, HE can develop into a chronic disease.⁷ 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.^16,17 CHE is a fluctuating disease characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists.⁸

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,^19,20 with approximately 70% of adults who live with severe CHE admitting to problems in performing everyday activities, and suffering disruption in their daily life due to the condition.⁹ Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.²¹

About Anzupgo® (delgocitinib) Cream

Anzupgo cream is a topical non-steroidal pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE in adults. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.²²

Anzupgo is approved in the European Union, United Kingdom, Switzerland, Canada, Australia, South Korea, and the United Arab Emirates for the treatment of moderate to severe Chronic Hand Eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate.

Anzupgo (delgocitinib) cream is FDA approved in the U.S. for moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable.

In 2014, LEO Pharma obtained the exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where Shionogi & Co., Ltd. owns the rights.

About LEO Pharma

LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. Headquartered in Denmark, LEO Pharma has a team of 4,300 people worldwide. Together, we reach far beyond the skin. For more information, visit www.leo-pharma.com.

References

1. Molin S, et al. Real-world effectiveness of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema: interim analysis after 8 weeks of treatment in the German REACHED study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September–3 October 2026. ePoster Presentation. P1613.
2. Molin S, et al. Delgocitinib cream provides rapid improvements in itch and pain symptoms in adolescents with moderate to severe chronic hand eczema: Results from DELTA TEEN. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September–3 October 2026. ePoster Presentation. P2395.
3. Molin S, et al. Treatment with delgocitinib cream improves health-related quality of life in adolescents with moderate to severe chronic hand eczema: Results from DELTA TEEN; a randomized, double-blind, vehicle-controlled phase 3 trial. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September–3 October 2026. Oral presentation. AS-1174.
4. Bewley A, et al. Delgocitinib cream reduces patient-reported disease severity in adults with moderate to severe Chronic Hand Eczema: pooled analysis of the Phase 3 DELTA 1 and DELTA 2 trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September–3 October 2026. ePoster Presentation. P1525.
5. Bauer A, et al. HRQoL and Work Productivity Improvements with Topical Delgocitinib vs Oral Alitretinoin in Chronic Hand Eczema: Phase 3 DELTA FORCE Results. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September–3 October 2026. ePoster Presentation. P1608. Previously presented at ESCD 2026.
6. Armstrong AW, et al. Sustained Health-Related Quality of Life improvements with Delgocitinib 20 mg/g Cream in Chronic Hand Eczema – Results from the Phase 3 Open-Label Extension DELTA 3 Trial. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026. Vienna, Austria. 30 September–3 October 2026. ePoster Presentation. P1576. Previously presented at AAD 2026.
7. Bissonnette R, et al. Redefining treatment options in chronic hand eczema (CHE). J Eur Acad Dermatol Venereol. 2010;24:1–20.
8. Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357–378.
9. 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.
10. ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy and Safety of Delgocitinib Cream in Adolescents 12–17 Years of Age With Moderate to Severe Chronic Hand Eczema (DELTA TEEN). Identifier: NCT05355818.
11. ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 1). Identifier: NCT04871711.
12. ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 2). Identifier: NCT04872101.
13. Bissonnette R, Warren RB, Pinter A, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials. Lancet. 2024;404(10451):461–473.
14. ClinicalTrials.gov. National Library of Medicine (U.S.). Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials (DELTA 3). Identifier: NCT04949841.
15. ClinicalTrials.gov. National Library of Medicine (U.S.). A 24 Week Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema. Identifier: NCT05259722.
16. 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;15(6):360.
17. Diepgen TL, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015;13(1):e1–22.
18. Apfelbacher C, Bewley A, Molin S, et al. Prevalence of chronic hand eczema in adults: a cross-sectional survey of over 60,000 respondents from the general population of Canada, France, Germany, Italy, Spain and the UK. Presented at the 2024 European Society of Contact Dermatitis Congress; September 4–7, 2024; Dresden, Germany. Poster presentation #3.
19. Grant L, Seiding Larsen L, Burrows K, et al. Development of a conceptual model of chronic hand eczema based on qualitative interviews with patients and expert dermatologists. Adv Ther. 2020;37(2):692–706.
20. Dalgard FJ, Gieler U, Tomas-Aragones L, et al. The psychological burden of skin diseases: a cross-sectional multicenter study among dermatological out-patients in 13 European countries. J Invest Dermatol. 2015;135(4):984–991.
21. 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.
22. 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. Erratum in: Ther Clin Risk Manag. 2021;17:233.
23. ANZUPGO (delgocitinib) cream. Prescribing Information. FDA. July 2025.
24. Apfelbacher C, Bewley A, Molin S, et al. Prevalence of chronic hand eczema in adults: a cross-sectional survey of over 60 000 respondents from the general population of Canada, France, Germany, Italy, Spain and the UK. Br J Dermatol. 2025;192(6):1047–1054.

Jeppe Ilkjær
Global Corporate Communications
+45 3050 2014
JEILK@leo-pharma.com

Christian Bundgaard
Global Corporate Communication
+45 53 74 88 49
chbun@leo-pharma.com

Jes Broe Frederiksen
Global Corporate Communication
+45 53 60 59 48
jebfe@leo-pharma.com