Subgroup with Chronic Hand Eczema See ‘Super Response’ with Delgocitinib Cream

Delgocitinib cream 20 mg/g treatment produced a “super-response” in a notable subgroup of patients with chronic hand eczema (CHE), recent data suggest, characterized by sustained improvements in itch, pain, quality of life, and severity.1

These findings on delgocitinib were presented in a poster session at the 2025 Fall Clinical Dermatology Conference in Las Vegas, Nevada. The research was authored by April W. Armstrong, MD, MPH, and a team of other investigators. Delgocitinib cream was previously approved by the US Food and Drug Administration (FDA) for CHE following the DELTA-1 and 2 trials.2

Armstrong et al's analysis looked into the durability, magnitude, and consistency of clinical responses to delgocitinib cream 20 mg/g in adult patients living with moderate to severe CHE. They drew on outcomes from the DELTA-1 and DELTA-2 phase 3 studies and their long-term extension, DELTA-3.

Prior DELTA-1 and DELTA-2 study findings demonstrated that delgocitinib therapy led to substantial improvements across a variety of efficacy endpoints. In their current investigation, Armstrong and colleagues set out to characterize the depth of response to delgocitinib treatment following 16 weeks of utilization. They also sought to explore how well patients' responses were maintained in the absence of ongoing therapy during the extension phase of up to 36 weeks.

Across DELTA-1 and DELTA-2, Armstrong and coauthors noted a total of 636 adults had been provided with delgocitinib cream on a twice daily basis for 16 weeks. There were also 319 individuals assigned to a cream vehicle control group. Subjects of these studies completing the initial treatment period were eligible to carry on into the DELTA-3 extension trial, during which they were examined for up to 36 weeks without the use of active therapy.

Armstrong and coauthors' main clinical measures evaluated in this extension included Hand Eczema Symptom Diary (HESD) scores for pain and pruritus, the Hand Eczema Severity Index (HECSI), the Dermatology Life Quality Index (DLQI), and the Investigator’s Global Assessment for CHE (IGA-CHE). By the 16-week point, those treated with delgocitinib cream were shown to have attained markedly better results than subjects assigned to vehicle.1

The investigative team found rates of little-to-no itch (HESD itch score 0 or 1) were more than triple among patients on active treatment, observing such responses in 30.0% of delgocitinib-treated subjects versus 9.4% of those in the vehicle-treated arm of the study.1 The team also noted little-to-no pain (HESD pain 0/1) reported by 35.2% of individuals given delgocitinib cream versus 16.0% in the vehicle arm.

In their assessment of quality-of-life impacts, as determined by a DLQI score of 0 or 1, Armstrong and colleagues identified comparable improvements: 33.3% of those in the delgocitinib group attained this threshold, compared with 13.9% of participants in the control group.1 In their assessment of the breadth of response across these 3 domains, 48.0% of delgocitinib recipients attained at least 1 of the “0/1” outcomes, representing minimal pain, minimal pruritus, or no quality of life impact.

This proportion was noted by the investigators as substantially higher than the 23.8% observed among vehicle-treated individuals in the analysis.1 The team additionally found 19.2% of delgocitinib-treated subjects attained all 3 favorable endpoints simultaneously, which Armstrong et al highlighted was more than triple the 5.4% rate observed with vehicle.

In this analysis, consistent clinical improvements were also evident across the treatment period.1 A higher proportion of delgocitinib-treated individuals met the threshold of at least a 4-point in HESD itch (24.1% versus 6.6%) or HESD pain (25.0% versus 9.0%), assessed repeatedly at the 4, 8, 12, and 16-week marks. In a similar conclusion, delgocitinib cream was shown to have yielded increased rates of disease extent and severity improvements, with 27.3% attaining a ≥75% reduction in their HECSI scores versus 8.1% of subjects in the vehicle group.

Durability of response following delgocitinib cessation was looked into over the course of the DELTA-3 extension study.1 The investigators found, among those who attained complete clearance (IGA-CHE 0) at the 16-week mark while on delgocitinib cream, 32.9% maintained full clearance following 8 weeks without using the topical. A meaningful subset, 15.7%, were shown to have continued to exhibit complete clearance 16 weeks post-therapy.

In all, the investigative team's conclusion pointed to a super-response to delgocitinib cream 20 mg/g produced among a notable subgroup of patients, characterized by profound, sustained improvements in various endpoints.1 They also identified a significant proportion of complete responders who preserved their CHE clearance well beyond the active treatment period.

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References

1. Armstrong A, Bernier C, Silverberg J, et al. “Super-response” following treatment with delgocitinib cream 20 mg/g in a subgroup of patients with moderate to severe Chronic Hand Eczema. Poster presented at the 2025 Fall Clinical Dermatology Conference, Las Vegas, Nevada, Oct 23-26, 2025.

2. LEO Pharma Announces FDA Approval of ANZUPGO® (delgocitinib) Cream in the U.S. LEO Pharma. Published July 23, 2025. Accessed July 23, 2025. https://www.leo-pharma.com/media-center/news/2025-fda-approval.