DELTA: Delgocitinib Cream Improves Health-Related Quality of Life in CHE

Delgocitinib cream twice-daily may lead to clinically significant improvements in health-related quality of life (HRQoL) among individuals with chronic hand eczema (CHE), new findings suggest.1

These recent findings resulted from the phase 3 DELTA 1 (NCT04871711) and DELTA 2 (NCT04872101) studies. Andrea Bauer, MD, MPH, of the University Hospital Carl Gustav Carus in Dresden, Germany, led a team of other investigators in authoring these data.

The phase 3 clinical trials DELTA 1 and DELTA 2 had been conducted using identical study designs to look into the efficacy of delgocitinib cream in adults with moderate-to-severe CHE. Bauer et al described the previous results of delogocitinib for CHE in the DELTA trial program before highlighting the latest assessment of the findings from these 2 studies.

“In two pivotal randomised, double-blind, multicentre phase 3 trials…twice-daily application of delgocitinib cream 20 mg/g resulted in superior efficacy versus cream vehicle and was well-tolerated over 16 weeks,” the investigators wrote.1,2 “Here, we report the effects of delgocitinib cream 20 mg/g versus cream vehicle on HRQoL in data pooled from the DELTA 1 and DELTA 2 trials.”

DELTA Trial Design Details

Those deemed eligible for inclusion in the DELTA trials had a score of 3 (moderate) or 4 (severe) on a modified Investigator’s Global Assessment for Chronic Hand Eczema (IGA-CHE). They were then randomly assigned in a 2:1 ratio to be treated either with delgocitinib cream 20 mg/g or a vehicle cream, applied twice each day for a total of 16 weeks under double-blind conditions. Outcomes related to HRQoL were assessed via several different patient-reported outcome measures.

Such measures included the Dermatology Life Quality Index (DLQI), the EQ-5D-5L questionnaire and its visual analogue scale (EQ VAS), and the Hand Eczema Impact Scale (HEIS). Additional HEIS components assessed Bauer and colleagues included the Proximal Daily Activity Limitations (PDAL) and Embarrassment (Emb) subscores. The EQ-5D-5L instrument was descibed as a preference-based, generic measure designed to capture an individual’s health status across 5 dimensions: self-care, mobility, usual activities, pain or discomfort, and anxiety or depression. Responses lead to a utility score anchored between 1, representing perfect health, and 0, representing death.

For their analysis, the investigative team pooled patient data from both of the DELTA studies and compared any shifts from the point of baseline in EQ-5D, DLQI, and HEIS outcomes, including the PDAL and Emb subsets. Across the pair of trials, there were 639 participants randomized to treatment with delgocitinib cream, whereas 321 were placed on the vehicle comparator.

Results of Delgocitinib for CHE

At 16-week mark, delgocitinib cream use was linked with significantly greater improvements in HRQoL measures compared with the vehicle cream. Specifically, Bauer and coauthors noted statistically significant differences favoring delgocitinib for DLQI scores, EQ-5D scores, overall HEIS scores, as well as the HEIS PDAL and HEIS Emb subscores. All comparisons reached P < .001.

Additionally, the investigative team found greater proportions of subjects in the delgocitinib arm attained clinically meaningful improvements in these patient-reported outcomes relative to those on the vehicle (all P < .001). The analysis also suggested individuals given delgocitinib spent a longer average duration in an improved HRQoL state during the study period.

Overall, Bauer et al concluded the use of twice-daily delgocitinib cream 20 mg/g produced clinically meaningful and statistically significant improvements in life quality outcomes versus the vehicle control across all patient-reported measures. Any distinctions between treatment arms emerged rapidly, with benefits favoring delgocitinib evident as early as the first week and increasing steadily throughout the 16-week treatment period.

“Given that HEIS was specifically developed to assess HRQoL in patients with CHE, it may have greater utility in clinical trials in CHE than more generic tools,” they concluded.1 “However, both EQ-5D and DLQI were also shown to correlate with clinical improvement, and all three measures should be considered complementary.”

Several limitations were acknowledged by the team when interpreting these findings, however, including the racial makeup of the trial population, consisting predominantly of White participants. This, Bauer and colleagues noted, may limit the generalizability of data to more diverse racial and ethnic groups. The treatment duration was also limited to 16 weeks, so the investigators pointed to ongoing research as necessary to evaluatw longer-term outcomes. Ongoing research included assessing the impact of delgocitinib cream on HRQoL up to 52 weeks in the DELTA 3 study.

References

1. Bauer A, Guenther L, Woolf R, et al. Effect of Delgocitinib Cream on Health-Related Quality of Life in Patients With Moderate to Severe Chronic Hand Eczema. Contact Dermatitis (2026): 1–9. https://doi.org/10.1111/cod.70114.

2. Bissonnette R, Warren RB, Schliemann S, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials. Lancet. 2024 Aug 3;404(10451):461-473. doi: 10.1016/S0140-6736(24)01027-4. Epub 2024 Jul 18. PMID: 39033766.