Twice-Daily Delgocitinib Improved Patient Reported Outcomes for Chronic Hand Eczema

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Twice-daily treatment with delgocitinib cream is effective in the improvement of both patient- and clinician-reported outcomes among adults with chronic hand eczema (CHE) versus the cream vehicle, according to recent findings, suggesting the drug’s potential as a new option for therapy adults with such a condition.¹

These conclusions were presented at the Revolutionizing Atopic Dermatitis (RAD) 2024 Annual Meeting and resulted from a pooled analysis of the DELTA-1 and -2 studies, assessing delgocitinib’s use among individuals with the common inflammatory skin condition known as chronic hand eczema. The condition results in pruritus, pain, and major impacts on patients’ daily life.

The drug itself is a topical pan-JAK inhibitor and was previously shown to have demonstrated dose-dependent efficacy among patients with chronic hand eczema in a phase 2b trial. Prior research indicated that delgocitinib-treated individuals were able to achieve treatment success per Investigator's Global Assessment scores (IGA-CHE) versus those given the vehicle cream at the 16-week mark.²

Design

The investigators set out to evaluate 20 mg/g of delgocitinib cream in terms of safety and efficacy in a twice-per-day regimen for adults with moderate to severe chronic hand eczema. The research team determined their primary outcome assessed would be success in drug treatment identified by the Investigator's Global Assessment (IGA-CHE).

Additionally, the analysis of DELTA-1 and 2 had a secondary outcome the team evaluated, which was ≥75%/≥90% improvement in subjects’ Hand Eczema Severity Index (HECSI) scores and the presence of a ≥4-point improvement in subjects’ Dermatology Life Quality Index (DLQI) scores. Both trials were phase 3 studies in which adult participants with moderate to severe disease were randomized in a 2:1 ratio to take either delgocitinib cream 20 mg/g or a cream vehicle, for a twice-per-day regimen through 16 weeks.

The investigators’ main endpoint was an improvement of ≥2-steps from the point of baseline at the 16-week mark and a score on the IGA-CHE of 0/1 (clear/almost clear). They determined that HECSI-75/90 and a noted ≥4-point improvement in subjects’ DLQI scores would be the secondary endpoints.

Findings

The research team’s pooled analysis concluded with a total of 639 participants who had been given delgocitinib therapy in the treatment arm and 321 in the vehicle arm.

Their findings by the 16-week mark showed that a significantly higher proportion of those in the treatment cohort saw success in achieving HECSI-75 compared to vehicle (49.4% compared 20.9%; P<.001), in their IGA-CHE scores (24.3% compared to 8.4%; P<.001), in achieving HECSI-90 (30.3% compared to 10.6%; P<.001), and in their DLQI ≥4-point improvement rates (73.3% compared to 47.8%; P<.001).

The investigators found that the adverse events which had been most common had been nasopharyngitis, COVID-19, and headaches, noting comparable rates in both arms of the study.and occurring in ≥5% of participants.

References

1. ^{Bissonnette R, Worm M, Schliemann S, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema: pooled results of the phase 3 DELTA-1 and -2 trials. Revolutionizing Atopic Dermatitis (RAD) 2024 Annual Meeting June 8 – 10, 2024. Chicago, IL.}
2. ^{Kunzmann K. Delgocitinib Significantly Improves Chronic Hand Eczema, Quality of Life at 16 Weeks. HCPLive. March 18, 2023. https://www.hcplive.com/view/delgocitinib-significantly-improves-chronic-hand-eczema-quality-of-life-at-16-weeks. Date accessed: June 14, 2024.}