LEO Pharma has announced the publication of results from its DELTA FORCE trial in The Lancet, one of the world's most prestigious medical journals. The phase 3 study compared the investigational delgocitinib cream with alitretinoin capsules for the treatment of chronic hand eczema (CHE).
The DELTA FORCE trial represents the first head-to-head phase 3 comparison between a topical JAK inhibitor and an oral systemic therapy for CHE. The 24-week study involved 513 participants with severe chronic hand eczema who were randomized to receive either twice-daily delgocitinib cream or once-daily alitretinoin capsules.
Superior Efficacy and Safety Profile
Delgocitinib cream achieved the primary outcome measure, demonstrating superior reduction in Hand Eczema Severity Index (HECSI) scores from baseline to Week 12 compared to alitretinoin capsules. Notably, all 14 North American clinical trial sites were located in Canada.
The topical treatment also met all key secondary endpoints, including:
- Investigator's Global Assessment (IGA)-CHE treatment success
- Reduction in HECSI scores from baseline to Week 24
- Improvement in health-related quality of life as measured by the Dermatology Life Quality Index (DLQI)
Patients receiving delgocitinib cream experienced fewer treatment-emergent adverse events compared to those taking alitretinoin capsules, suggesting a more favorable safety profile for the topical therapy.
"The discussion of delgocitinib and the presentation of DELTA FORCE data in The Lancet is an exciting moment for the LEO Pharma team," said Robert Spurr, EVP, LEO Pharma, North America and President, LEO Pharma, US. "We are proud to contribute to the overall understanding of moderate to severe chronic hand eczema, helping uncover potentially new treatment options for those living with skin conditions like CHE."
Understanding Chronic Hand Eczema
Chronic Hand Eczema is defined as hand eczema that persists for more than three months or relapses twice or more within a year. It is the most common skin disorder of the hands, with a prevalence rate of approximately 4.7%. In many patients, hand eczema can develop into a chronic condition.
CHE is characterized by symptoms including itch and pain, with visible signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists. The condition significantly impacts quality of life, with approximately 70% of individuals with severe CHE reporting problems performing everyday activities.
The condition also affects careers and earning potential, creating both psychological and functional burdens for patients. Currently, alitretinoin is the only treatment approved in Canada for severe CHE in patients who do not respond to topical corticosteroids.
Mechanism of Action and Regulatory Status
Delgocitinib cream is a topical pan-Janus kinase (JAK) inhibitor that works by inhibiting the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE. The pathophysiology of CHE is characterized by skin barrier dysfunction, inflammation, and alterations of the skin microbiome.
The investigational treatment is already approved and marketed under the trade name Anzupgo® in the European Union, United Kingdom, Switzerland, and the United Arab Emirates for the treatment of moderate to severe CHE in adults for whom topical corticosteroids are inadequate or inappropriate.
In Canada and the United States, delgocitinib cream remains under regulatory review and has not yet been approved by Health Canada or the FDA. The treatment originated from a 2014 license agreement between LEO Pharma A/S and Japan Tobacco Inc., giving LEO Pharma exclusive rights to develop and commercialize delgocitinib cream for topical use in dermatological indications worldwide, excluding Japan.
Clinical Trial Design
The DELTA FORCE trial was designed as a 24-week, randomized, assessor-blinded, active-controlled, parallel-group, phase 3 study. Participants assigned to the delgocitinib group applied the cream to affected areas twice daily for 16 weeks, while those in the alitretinoin group took oral capsules once daily for 12 weeks.
All participants were permitted to continue treatment for up to 24 weeks if their doctor considered they were benefiting from the therapy. The primary endpoint was the change in HECSI score from baseline to Week 12, with multiple secondary endpoints assessing longer-term efficacy and quality of life improvements.
The positive results from this landmark study suggest that delgocitinib cream could potentially offer a new topical treatment option for patients with moderate to severe chronic hand eczema who currently have limited therapeutic choices.
