LEO Pharma Unveils New Data on Delgocitinib Cream at AAD 2025
LEO Pharma A/S, a global leader in medical dermatology, has presented new findings from the DELTA 1 and 2 trials at the 83rd Annual Meeting of the American Academy of Dermatology (AAD) 2025. This marks the third consecutive year LEO Pharma has shared cutting-edge data at the prestigious event. The new data focuses on patient subset responses and the systemic exposure of delgocitinib cream, a promising treatment for moderate to severe eczema.
Christophe Bourdon, CEO of LEO Pharma, expressed enthusiasm over the new findings, stating, “The data released today further enhances LEO Pharma’s body of scientific evidence for the treatment of moderate to severe eczema. Our research in chronic hand eczema demonstrates our commitment to maintaining the broadest portfolio of dermatological products. I am proud to share this latest analysis from our DELTA pivotal trials.”
The data presented at AAD 2025 further reinforces the potential of delgocitinib cream, which is currently undergoing trials in the United States. This breakthrough treatment has shown promising results in improving outcomes for patients suffering from chronic eczema.
Post-Hoc Data Analysis: A Deeper Look at Delgocitinib Cream’s Effectiveness
The new data presented focused on a post-hoc subgroup analysis from the DELTA 1 and 2 trials, which examined the treatment responses of patients with moderate to severe chronic hand eczema (MACE). Patients were treated with delgocitinib cream for 16 weeks, and their responses were compared to those receiving a vehicle (placebo) treatment. The subgroup analyzed consisted of patients who demonstrated a profound, consistent, and/or sustained treatment response.
The findings from the analysis highlighted that delgocitinib cream produced strong treatment responses in patients within this subgroup. Patients receiving delgocitinib cream showed superior outcomes in several key measures, including the Hand Eczema Symptom Diary (HESD) and the Dermatology Life Quality Index (DLQI).
At Week 16, the data revealed that:
- 30.0% of patients receiving delgocitinib cream achieved HESD itch 0/1, compared to only 9.4% of those treated with the vehicle.
- 35.2% of delgocitinib-treated patients reached HESD pain 0/1, in contrast to 16.0% of vehicle-treated patients.
- 33.3% of delgocitinib-treated patients achieved a DLQI score of 0/1, versus 13.9% in the vehicle group.
The analysis also highlighted that a higher percentage of patients treated with delgocitinib cream showed consistent responses. Specifically, 24.1% of delgocitinib-treated patients experienced a reduction of at least 4 points in itch compared to 6.6% of those in the vehicle group. Similarly, 25.0% of delgocitinib patients showed a reduction in pain, compared to 9.0% in the vehicle group. Additionally, 27.3% of patients treated with delgocitinib cream achieved at least a 75% improvement in the Hand Eczema Severity Index (HECSI-75), while only 8.1% of vehicle-treated patients reached this milestone.
A particularly encouraging finding was the sustained response observed in patients. In those who achieved a clear (score of 0) Investigator Global Assessment (IGA)-CHE score at Week 16, 32.9% maintained this score for 8 weeks, and 15.7% maintained it for 16 weeks without further treatment.
Dr. April W Armstrong, Professor and Chief of Dermatology at the University of California, Los Angeles (UCLA), commented on the results: “It is exciting to see such a strong response in a subset of patients treated with delgocitinib cream. The results across treatment parameters are promising and demonstrate the potential of delgocitinib cream as a new treatment option for people with this unique and burdensome disease.”
Systemic Exposure Data: Delgocitinib’s Safety Profile
In addition to the patient response data, LEO Pharma presented new systemic exposure data from the DELTA 2 trial. This data, presented as an e-poster, explored the systemic exposure of delgocitinib cream under high-use conditions. The trial involved adults with moderate-to-severe chronic hand eczema (CH) who applied delgocitinib cream twice daily.
The systemic exposure data from this study was compared to pharmacokinetic data from a Phase 1 trial in patients with moderate to severe atopic dermatitis (AD) and to oral administration of the lowest tested dose in a pharmacokinetic study in healthy adults. The data from these trials provide crucial insights into the safety profile of delgocitinib cream, showing that delgocitinib has negligible systemic exposure even when used maximally for treating chronic hand eczema. This low systemic exposure is significant, as it suggests a favorable safety profile for long-term use of delgocitinib cream.
These findings underscore the potential of delgocitinib cream as a safe and effective treatment for patients suffering from chronic hand eczema, which is often difficult to manage and can significantly impact a patient’s quality of life.
“Super-Response” Subgroup: A Breakthrough in Treatment Efficacy
A key presentation at the meeting was titled “Super-response following treatment with delgocitinib cream 20 mg/g in a subgroup of patients with moderate to severe chronic hand eczema.” This session, presented by Dr. Armstrong, showcased the remarkable response seen in a specific patient subgroup after treatment with delgocitinib cream.
The findings, discussed during Session 1 on Saturday, March 8, demonstrated that a subset of patients experienced an extraordinary level of improvement, which was termed as a “super-response.” These patients not only showed significant reductions in symptoms but also achieved sustained improvements in quality of life.
This breakthrough represents a major step forward in the treatment of chronic hand eczema, offering hope for patients who have not responded adequately to other treatments.
Conclusion: LEO Pharma’s Continued Commitment to Dermatology
LEO Pharma’s consistent presence at the AAD and their ongoing research into delgocitinib cream underscore their commitment to advancing dermatological treatments. With promising new data on both patient responses and systemic exposure, LEO Pharma is poised to make a significant impact in the treatment of chronic hand eczema and other skin conditions.
As delgocitinib cream continues to undergo clinical studies, the dermatology community eagerly anticipates further findings that could solidify its place as a leading treatment option for patients suffering from moderate to severe eczema.
About DELTA 1, 2 and 3 trials
The primary objective of the multicenter, randomized, double-blind, vehicle-controlled phase 3 clinical trials (DELTA 1 and DELTA 2) was to evaluate the efficacy of twice-daily applications of delgocitinib cream compared with vehicle in the treatment of moderate-to-severe MCE in adults. 3-5
The primary endpoint of the trials was the investigator’s global assessment of chronic hand eczema treatment success (IGA-CHE TS) at 16 weeks. This was defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with an improvement of at least two grades from baseline. Additional IGA-CHE scores were 2 (mild), 3 (moderate), and 4 (severe). 3-5
Key secondary endpoints at Week 16 included a reduction in itch and pain scores of ≥4 points from baseline to Week 16 as measured by the Hand Eczema Symptom Diary (HESD), and at least a 75% improvement from baseline and at least a 90% improvement from baseline on the Hand Eczema Severity Index (HECSI) at Week 16. The number of treatment-emergent adverse events from baseline to Week 16 was the primary safety endpoint of the trials. 3-5
Subjects who completed 16 weeks of treatment with delgocitinib cream or vehicle twice daily in DELTA 1 or DELTA 2 were invited to participate in DELTA 3 (a 36-week, open-label, multisite extension study). The objective of this extension study was to evaluate the long-term safety of delgocitinib. 6
About Delgocitinib Cream
Delgocitinib cream is currently being studied in the United States and other markets. The cream is approved in the European Union, the United Kingdom, Switzerland, and the United Arab Emirates under the brand name Anzupgo ® for the treatment of moderate-to-severe chronic hand eczema (CHED) in adults for whom treatment with topical corticosteroids is inadequate or inappropriate.
Delgocitinib cream is a topical Janus kinase (JAK) inhibitor used in the treatment of moderate to severe hand eczema. This cream inhibits the activation of the JAK-STAT signaling pathway, which plays a key role in the pathogenesis of ECM. 7 The pathophysiology is marked by skin barrier dysfunction, skin inflammation, and alterations in the skin microbiome. 8
In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a licensing agreement under which LEO Pharma obtained exclusive rights to develop and commercialize delgocitinib topical cream for dermatological indications worldwide, excluding Japan, where JT retains the rights.
About Chronic Hand Eczema
Chronic hand eczema (CHE) is defined as hand eczema (HED) lasting more than three months or recurring two or more times within a year. 9,10 HED is the most common skin condition of the hands. 11 with a prevalence rate of approximately 4.7%. 12 In a large number of patients, HED may progress to a chronic condition. 11 HED is a fluctuating condition characterized by itching and pain; patients may present with signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on the hands and wrists. 13
Bovine spongiform encephalopathy has been shown to cause psychological and functional constraints that impact on patients’ quality of life, 14 and approximately 70% of people living with severe bovine spongiform encephalopathy report difficulty performing daily activities. They experience disruptions in their daily lives as a result of the disease.15 Furthermore, career and income prospects have also been shown to be affected by the burden of hand eczema.16
About LEO Pharma
LEO Pharma is a world leader in medical dermatology. We provide innovative skin health solutions with a century of experience and breakthrough medicines in healthcare. We are committed to fundamentally improving people’s lives, and our broad portfolio of treatments is used by nearly 100 million patients in more than 70 countries each year. Headquartered in Denmark, LEO Pharma has a team of 4,000 people spread across the world. LEO Pharma is owned by the LEO Foundation as majority shareholder and, since 2021, by Nordic Capital. For more information, visit www.leo-pharma.com .
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