TOPLINE:
Treatment with delgocitinib cream, a topical pan-Janus kinase inhibitor, resulted in a significant improvement in health-related quality of life in patients with moderate to severe chronic hand eczema (CHE), with those receiving delgocitinib cream 20 mg/g showed greater improvements in quality-of-life measures than those receiving vehicle cream over 16 weeks.
METHODOLOGY:
- This phase 2b, randomised, double-blind, five-arm, cream vehicle-controlled clinical trial evaluated the efficacy and safety of topical delgocitinib cream in 305 participants from November 2018 through April 2020.
- Participants with mild to severe CHE and an inadequate response to topical corticosteroids, or for whom topical corticosteroids were medically inadvisable, received delgocitinib cream or vehicle cream for 16 weeks.
- The primary endpoint was the Investigator’s Global Assessment for CHE treatment success. This study evaluated patient-reported outcomes (PROs) in patients with mild and moderate to severe CHE at screening and the impact of delgocitinib on PROs in patients with moderate to severe CHE.
- PROs were collected using the Dermatology Life Quality Index (DLQI), EuroQOL-5 Dimensions-5 Levels (EQ-5D-5L), and Hand Eczema Impact Scale (HEIS) at screening, baseline, and weeks 1, 4, 8, 12, and 16.
TAKEAWAY:
- Mean DLQI, EQ-5D-5L, and HEIS scores were 8.1, 0.788, and 1.7, respectively, for participants with mild CHE (n = 93) and 12.1, 0.689, and 2.3, respectively, for those with moderate to severe CHE (n = 202).
- Participants with moderate to severe CHE who received delgocitinib cream 20 mg/g (n = 41) showed a greater improvement in DLQI scores than those who received vehicle cream (n = 38) (least squares mean difference [LSMD], −2.5; P < .05).
- A superior improvement in EQ-5D-5L index scores was observed with delgocitinib vs vehicle cream (LSMD, 0.132; P < .01).
- Similarly, HEIS total scores were higher with delgocitinib cream than with vehicle cream (LSMD, −0.7; P < .01).
IN PRACTICE:
“The findings of the present study demonstrate that CHE is associated with a high patient burden, particularly for those patients with moderate to severe CHE. Furthermore, the results suggest that delgocitinib cream can potentially provide a new treatment option in a disease where there is a high unmet patient need,” the authors wrote.
SOURCE:
This study was led by Timo Buhl, Department of Dermatology, Venereology and Allergology, University Medical Center Göttingen, Göttingen, Germany. It was published online on April 05, 2025, in Dermatology and Therapy.
LIMITATIONS:
Participants included at screening may not be representative of patients under standard care in clinical practice. The analysis of delgocitinib cream included only a limited number of participants with moderate to severe CHE. Additionally, as this was a multinational study, cultural and country-specific differences may have affected patient responses, with samples being too small to investigate potential differences between countries.
DISCLOSURES:
This trial was sponsored by LEO Pharma A/S. Four authors reported being employees of LEO Pharma A/S. Several authors reported being speaker or advisor and having other ties with various sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Bong Latson
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