Delgocitinib cream: A promising treatment option for chronic hand eczema

A long-term extension of chronic hand eczema treatment with delgocitinib cream led to favourable safety and efficacy findings in the phase 3 DELTA 3 trial. New safety signals were not observed and, over time, more patients achieved clear or almost clear (0/1) skin in the Investigator’s Global Assessment of chronic hand eczema (IGA-CHE).

“Delgocitinib is a first-in-class topical pan-JAK inhibitor that targets the key mediators of chronic hand eczema pathogenesis,” Prof. Melinda Gooderham (Queens University, Canada) introduced the investigated study drug [1]. Following positive results in the phase 3 trials DELTA 1 (NCT04871711) and 2 (NCT04872101), DELTA 3 (NCT04949841) was designed as a long-term, open-label treatment assessment of topical delgocitinib on an as-needed regimen for chronic hand eczema. After completing week 16 in 1 of the parent trials, 801 participants rolled over to DELTA 3. Within the 36-week treatment period, delgocitinib cream 20 mg/g was used twice daily until an IGA-CHE of 0/1 indicated disease control. Subsequently, participants stayed off treatment unless the IGA-CHE increased to ≥2, in which case delgocitinib was re-started. Baseline characteristics in DELTA 3 included a mean age of 45 years, 63.9% women, 43.1% with mild and 30.3% with moderate disease. The primary objective of DELTA 3 was safety.

The analysis of treatment-emergent adverse events (TEAE) was in line with previous findings in the parent trials. “There were no safety concerns over this prolonged 36-week period,” underlined Prof. Gooderham. She also pointed out that the most frequent TEAE was COVID-19 (16.7% of the total cohort) as the study was performed during the pandemic. The second most frequent TEAE was nasopharyngitis in 16.0%.

The long-term, as-needed therapy regimen resulted in sustained improvement with, for example, the IGA-CHE 0/1 rate rising from 24.6% at baseline to 30.0% at week 36. Further, at week 36, a 4-point decrease in Hand Eczema Symptom Diary (HESD) itch/pain was observed in 41.3%/43.3% of the participants switching from vehicle and 52.4%/55.4% of those continuing delgocitinib.

Prof. Gooderham concluded that the DELTA 3 findings support the benefit of long-term, as-needed use of delgocitinib cream in moderate-to-severe chronic hand eczema.

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   1. Gooderham M. Long-term safety and efficacy of delgocitinib cream for up to 36 weeks in adults with Chronic Hand Eczema: results of the Phase 3 open-label extension DELTA-3 trial. LB1, 2024 AAD Annual Meeting, 8-12 March, San Diego, USA.

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Posted on 22 April 20241 May 2024