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On March 10, 2025, we reported on findings from a post hoc subgroup analysis of the DELTA 1 and DELTA 2 phase 3 clinical trials presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, FL.
The study
In the post hoc analysis, investigators reported on a subgroup analysis of 960 adults with moderate to severe chronic hand eczema (CHE) who were enrolled in the DELTA 1 and DELTA 2 phase 3 trials of delgocitinib. The analysis defined "super response" as one of three response levels to the treatment:
A deep response, defined as a Hand Eczema Symptom Diary (HESD) itch of 0 (clear) or 1 (almost clear); HESD pain 0 or 1, and/or a Dermatology Life Quality Index (DLQI) score of 0 or 1 at week 16.
A consistent response, defined as a ≥4 point reduction in HESD itch, HESD pain, or achievement of Hand Eczema Severity Index (HESCI)-75 at weeks 4, 8, 12, and 16.
A maintained response, defined as achieving an Investigator's Global Assessment (IGA)-CHE of 0 (clear) at week 16 and maintaining IGA-CHE 0 off treatment.
The findings
Results revealed a HESD itch of 0 or 1 for 30.0% of delgocitinib-treated participants vs 9.4% of those treated with vehicle; 35.2% vs 6.0% achieved HESD pain 0 or 1, and 33.3% vs 13.9% achieved a DLQI score of 0 or 1 at week 16 with delgocitinib and vehicle cream, respectively, reflecting a deep response to the treatment.
A greater proportion of participants receiving delgocitinib vs vehicle cream also achieved a consistent response: a 4-point or greater reduction from baseline in HESD itch (24.1% vs 6.6%) or pain (25.0% vs 9.0%) or at least 75% improvement on the HECSI-75 (27.3% vs. 8.1%). Among participants receiving delgocitinib cream who achieved an IGA-CHE score of 0 at Week 16, 32.9% maintained a score of 0 after 8 weeks and 15.7% after 16 weeks.
Author's comments
"It is so exciting to see such a strong response in a subgroup of patients treated with delgocitinib cream. The results across the various treatment metrics are promising and demonstrate the future potential that delgocitinib cream may have in offering a new treatment option for those living with this unique and burdensome disease."
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