Delgocitinib Data Reveal "Super Responders" in CHE During AAD 2025 Late Breaker

_{April Armstrong, MD}

Late breaking data on delgocitinib cream presented at the American Academy of Dermatology Annual Meeting highlighted treatment response to the topical pan-Janus kinase (JAK)-inhibitor in a subgroup of adults with moderate to severe chronic hand eczema exhibiting a “super response” to the novel cream.¹

The post hoc subgroup analysis was based on the treatment response to delgocitinib cream used for 16 weeks in a group of participants with either a deep, consistent and/or maintained treatment response (Figure) compared to participants treated with the cream vehicle in the DELTA 1 and DELTA 2 phase 3 clinical trials.¹

The findings, presented by April Armstrong, MD, professor and chief of dermatology at the University of California-Los Angeles, revealed a HESD itch of 0 or 1 for 30.0% of delgocitinib-treated participants vs 9.4% of those treated with vehicle; 35.2% vs 6.0% achieved HESD pain 0 or 1, and 33.3% vs 13.9% achieved a DLQI score of 0 or 1 at week 16 with delgocitinib and vehicle cream, respectively, reflecting a deep response to the treatment.¹

A greater proportion of participants receiving delgocitinib vs vehicle cream also achieved a consistent response: a 4-point or greater reduction from baseline in HESD itch (24.1% vs 6.6%) or pain (25.0% vs 9.0%) or at least 75% improvement on the HECSI-75 (27.3% vs. 8.1%). Among participants receiving delgocitinib cream who achieved an IGA-CHE score of 0 at Week 16, 32.9% maintained a score of 0 after 8 weeks and 15.7% after 16 weeks.¹

"It is so exciting to see such a strong response in a subgroup of patients treated with delgocitinib cream," Armstrong said. "The results across the various treatment metrics are promising and demonstrate the future potential that delgocitinib cream may have in offering a new treatment option for those living with this unique and burdensome disease."²

LEO Pharma announced the submission of a New Drug Application to the FDA for delgocitinib for CHE in September 2024. A decision is expected during the second half of 2025, according to the company.³

The agency based its acceptance of the regulatory submission on review of findings from the multicenter, randomized, double-blind, vehicle-controlled phase 3 DELTA 1 and DELTA 2 clinical trials. The studies evaluated the safety and efficacy of delgocitinib 2% applied twice daily compared with a cream vehicle in adults with moderate-to-severe CHE over a 16-week treatment period. Both of the trials met their primary and all secondary endpoints.^3,4

In DELTA 1, 20% of study participants treated with delgocitinib met the study’s primary endpoint, Investigator’s Global Assessment for Chronic Hand Eczema treatment success (IGA-CHE TS) score of 0 or 1, compared with 10% of those using cream vehicle. In DELTA 2, 29% of those treated with the active study drug achieved IGA-CHE TS vs 7% of the placebo-treated group.^3,4

Participants who completed 16 weeks of treatment with either delgocitinib or placebo in either trial were eligible to continue in the 36-week open label DELTA 3 extension trial.³

“The data unveiled today further contributes to LEO Pharma’s ever-growing body of scientific evidence for the treatment of moderate to severe CHE," Christophe Bourdon, LEO Pharma CEO, said in a company statement.² "Our research and work in CHE is a testament to our ambition to maintain the broadest global product portfolio in dermatology, and I am proud we can share this latest analysis from our pivotal DELTA trials.”²

Separate data presented at the AAD 2025 evaluated systemic exposure in patients following high use of delgocitinib cream to treat moderate to severe CHE.

References

1. Armstrong AW. "Super-response” following treatment with delgocitinib cream 20 mg/g in a subgroup of patients with moderate to severe Chronic Hand Eczema. Abstract presented at: 2025 American Academy of Dermatology Annual Meeting. March 7-11, 2025; Orlando, FL.
2. LEO Pharma presents new late-braking delgocitinib cream data for the third consecutive year at AAD 2025. News release. LEO Pharma. March 8, 2025. Accessed March 9, 2025. https://www.leo-pharma.com/media-center/news/2025_aad-late-breaker-press-release
3. FDA accepts LEO Pharma’s filing of delgocitinib cream new drug application for the treatment of chronic hand eczema. News release. Leo Pharma. September 23, 2024. Accessed September 23, 2024. https://www.leo-pharma.com/media-center/news/2024-fda-accepts-leo-pharma-filing-of-delgocitinib
4. Bissonnette R, Warren RB, Pinter A, 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;202(10451):461-473. doi: 10.1016/S0140-6736(24)01027-4