Delgocitinib Effective for Hand Eczema in Phase 3 Studies

TOPLINE:

Topical delgocitinib, a pan-Janus kinase inhibitor, was well tolerated and reduced the severity and symptoms of disease in patients with moderate to severe chronic hand eczema, in two phase 3 trials.

METHODOLOGY:

• Two randomized, multinational, double-blinded, vehicle-controlled, phase 3 trials, DELTA 1 (n = 487) and DELTA 2 (n = 473) enrolled adults (mean age, 44 years) with moderate to severe chronic hand eczema. Patients were randomly assigned in a 2:1 ratio to receive either delgocitinib cream 20 mg/g or cream vehicle twice daily for 16 weeks.
• 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 a reduction 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.

TAKEAWAY:

• A higher number of patients receiving delgocitinib achieved IGA-CHE treatment success vs vehicle in DELTA 1 (20% vs 10%; P = .0055) and 2 (29% vs 7%; P < .0001) trials.
• Delgocitinib significantly reduced eczema itch and pain scores in both the trials (P < .0001 for all comparisons).
• The proportions of patients achieving HECSI-75 and HECSI-90 scores at week 16 were significantly higher in the delgocitinib groups vs vehicle groups (P < .0001 for all comparisons).
• Adverse event rates were similar in both trials, and most adverse events were mild to moderate and not considered related to treatment. The most common adverse events were COVID-19, nasopharyngitis, and headache.

IN PRACTICE:

“Both trials indicate the use of delgocitinib cream in adults with chronic hand eczema is an efficacious and well-tolerated topical treatment, with no safety concerns,” the authors wrote.

SOURCE:

The study was led by Robert Bissonnette, MD, Innovaderm Research in Montreal, Quebec, Canada, and was published online on July 18, 2024, in The Lancet.

LIMITATIONS:

Both trials had a predominately White patient population, which may limit the generalizability of the findings to more diverse populations, and the study duration of 16 weeks was short. The systemic effects of delgocitinib cream and its efficacy across different subtypes of chronic hand eczema were not assessed.

DISCLOSURES:

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.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.