Eczema, particularly chronic hand eczema, presents significant challenges in treatment due to its persistent and severe symptoms. In recent phase 3 trials, topical delgocitinib, a pan-Janus kinase inhibitor, demonstrated efficacy in reducing the severity and symptoms of moderate to severe chronic hand eczema (CHE).
The efficacy and safety of delgocitinib cream were evaluated in two randomized, multinational, double-blinded, vehicle-controlled phase 3 trials: DELTA 1 (n=487) and DELTA 2 (n=473). These trials enrolled adults with a mean age of 44 years, all suffering from moderate to severe chronic hand eczema. Participants were randomly assigned in a 2:1 ratio to receive either delgocitinib cream 20 mg/g or a cream vehicle twice daily for 16 weeks.
Investigator’s Global Assessment of Chronic Hand Eczema and Secondary Endpoints in Phase 3 Trials
The primary endpoint was the Investigator’s Global Assessment of Chronic Hand Eczema (IGA-CHE) treatment success at week 16, defined as an IGA-CHE score of 0 (clear) or 1 (almost clear). Secondary endpoints included reductions in the Hand Eczema Symptom Diary itch and pain scores, and at least 75% and 90% improvement in the Hand Eczema Severity Index (HECSI-75 and HECSI-90) scores from baseline at week 16.
A significantly higher number of patients receiving delgocitinib achieved IGA-CHE treatment success compared to the vehicle group in both DELTA 1 (20% vs. 10%; P = .0055) and DELTA 2 (29% vs. 7%; P < .0001). Delgocitinib also significantly reduced CHE itch and pain scores in both trials (P < .0001 for all comparisons). Additionally, the proportions of patients achieving HECSI-75 and HECSI-90 scores at week 16 were significantly higher in the delgocitinib groups compared to vehicle groups (P < .0001 for all comparisons).
Adverse event rates were similar in both trials, with most adverse events being mild to moderate and not considered related to treatment. The most common adverse events reported were COVID-19, nasopharyngitis, and headache.
Delgocitinib Cream Proves Efficacious and Safe for Chronic Hand Eczema in Adults
“Both trials indicate that the use of delgocitinib cream in adults with CHE is an efficacious and well-tolerated topical treatment, with no significant safety concerns,” the authors concluded. The study was led by Robert Bissonnette, MD, of Innovaderm Research in Montreal, Quebec, Canada, and was published online on July 18, 2024, in The Lancet.
The trials predominantly included a White patient population, which may limit the generalizability of the findings to more diverse populations. Additionally, the study duration of 16 weeks was relatively short, and the systemic effects of delgocitinib cream and its efficacy across different subtypes of CHE were not assessed.
The study was supported by LEO Pharma. Several authors reported ties with pharmaceutical companies, including LEO Pharma. Five authors were current or former employees of LEO Pharma. The article was created using several editorial tools, including AI, and reviewed by human editors before publication.
The findings from the DELTA 1 and DELTA 2 trials demonstrate that delgocitinib cream is a promising treatment for chronic hand eczema, offering significant improvements in disease severity and symptom relief with a favorable safety profile. Further studies with diverse populations and longer durations are necessary to fully establish the long-term efficacy and safety of delgocitinib cream across various subtypes of chronic hand eczema.
Resource: Med Scape, July 23, 2024
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