Delgocitinib Superior to Oral Alitretinoin in Efficacy Findings for Chronic Hand Eczema

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Topical treatment of chronic hand eczema (CHE) using delgocitinib cream (Anzupgo) results in significantly greater efficacy than oral alitretinoin capsules among adults, according to recent data presented at the presented at the European Academy of Dermatology & Venereology (EADV) Congress in Amsterdam.¹

In a set of late-breaking presentations at EADV, the research team of the DELTA FORCE trial program had assessed delgocitinib cream as a potential medication for adults with moderate to severe CHE, specifically for those that find topical corticosteroids are inadequate or inappropriate.

“The completion of the DELTA FORCE study marks a significant milestone in our understanding of moderate to severe chronic hand eczema treatment,” Kreesten Meldgaard Madsen, Chief Development Officer of LEO Pharma, said in a statement. “With the full results now available, we have gained a new understanding of how topical treatment with delgocitinib cream compares to alitretinoin.”¹

Hand eczema which persists for over 3 months or recurs at least twice in a given year is known as CHE. Hand eczema is one of the most prevalent skin disorders impacting the hands and often progresses into a chronic condition.

The DELTA FORCE phase 3 clinical trial was a 12-week study evaluating 513 individuals with CHE, comparing delgocitinib cream against oral alitretinoin capsules in terms of safety and efficacy.

In DELTA FORCE, the investigators used a 24-week, randomized, assessor-blinded, active-controlled design for the phase 3 trial. They compared twice-per-day delgocitinib with once-per-day alitretinoin capsules among subjects with severe CHE.

The trial’s primary endpoint was the shift in HECSI scores from the point of baseline to the 12-week mark. The topical for a total of 16 weeks, and subjects on alitretinoin took capsules for 12 weeks. Continued treatment for up to 24 weeks was permitted if it was determined to be beneficial by subjects’ doctors.

By the research’s conclusion, the topical cream achieved the primary endpoint, with significantly greater reductions in subjects’ Hand Eczema Severity Index (HECSI) scores at the 12-week mark. Specifically, the research team reported a least squares (LS) mean decrease of 67.6 versus a decrease of 51.5 for alitretinoin (P < .001). In the study’s secondary endpoints, the results of delgocitinib were superior to alitretinoin.

The investigators found that at the 12-week mark, 27.2% of those treated with the topical reported treatment success according to the Investigator’s Global Assessment for CHE (IGA-CHE), contrasting with the 16.6% of those on alitretinoin (P = .004). Additionally, delgocitinib-treated subjects reported fewer treatment-emergent adverse events than those in the alitretinoin cohort (49.4% versus 76.1%).

The DELTA 1 and DELTA 2 phase 3 clinical studies looked at twice-per-day delgocitinib compared to a cream vehicle in adults with moderate to severe cases of CHE. The investigators’ main endpoints was success at the 16-week mark determined by IGA-CHE score of 0 (clear) or 1 (almost clear) achievement, with a 2-point improvement at least from the point of baseline.³

Reductions in subjects’ scores on itch and pain of at least 4 points were the secondary outcomes assessed in DELTA. Additionally, the team looked for 75% and 90% improvements on the HECSI by the 16-week mark and monitored the safety of the topical through assessment of adverse events.

In DELTA 1 and 2, the primary and secondary endpoints were met. It was noted that 20% of those treated achieved success in IGA-CHE compared to 10% of those in the vehicle cohort in DELTA 1. Additionally, 29% achieved IGA-CHE success compared to 7%, respectively, in the DELTA 2 study (P ≤ .0055).²

References

1. ^{LEO Pharma Presents Late-Breaking Anzupgo® (delgocitinib) Cream Presentation at EADV 2024 Highlighting Results of Head-to-Head DELTA FORCE Trial in Chronic Hand Eczema (CHE). LEO Pharma. September 25, 2024. https://www.leo-pharma.com/media-center/news/2024-leo-pharma-presents-late-breaking-anzupgo-cream-presentation-at-eadv-2024.}
2. ^{FDA Accepts LEO Pharma’s Filing of Delgocitinib Cream New Drug Application for the Treatment of Chronic Hand Eczema. Leo Pharma. September 23, 2024. https://www.businesswire.com/news/home/20240923600460/en/FDA-Accepts-LEO-Pharma%E2%80%99s-Filing-of-Delgocitinib-Cream-New-Drug-Application-for-the-Treatment-of-Chronic-Hand-Eczema. Date accessed: September 23, 2024.}