Late-breaking data presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida, showcased responses in a subgroup of patients from the DELTA 1 and Delta 2 trials on lebrikizumab for chronic hand eczema.
Alongside this presentation, new systemic exposure data was also shared for delgocitinib cream at the meeting.
“The data unveiled … further contributes to LEO Pharma’s ever-growing body of scientific evidence for the treatment of moderate to severe CHE," Christophe Bourdon, Chief Executive Officer, LEO Pharma, said in a press release. "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.”
Delgocitinib cream is currently under investigation in the United States.
The subgroup analysis presented was based on the treatment response in patients with moderate-to-severe CHE treated with delgocitinib cream for 16 weeks compared to patients treated with the cream vehicle in the DELTA 1 and DELTA 2 trials. The subgroup in this analysis was defined as patients with either a deep, consistent and/or maintained treatment response.1
The findings from the post hoc analysis highlight that delgocitinib cream produced a strong treatment response across this subgroup of patients.
A deep response, defined as a Hand Eczema Symptom Diary (HESD) itch of 0 (clear) or 1 (almost clear), HESD pain 0/1, and/or a Dermatology Life Quality Index (DLQI) score of 0/1 at Week 16, was achieved by more patients receiving delgocitinib cream versus the cream vehicle. At Week 16, 30.0% vs 9.4% of patients achieved a HESD itch of 0/1, 35.2% vs 16.0% achieved HESD pain 0/1, and 33.3% vs 13.9% achieved a DLQI score of 0/1.1
Greater percentages of patients receiving delgocitinib cream versus the cream vehicle over the trial period achieved a consistent response of at least a 4-point 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 Hand Eczema Severity Index (HECSI-75) (27.3% vs. 8.1%).1
A maintained response was defined as achieving an Investigator’s Global Assessment (IGA)-CHE of 0 (clear) at Week 16 and maintaining IGA-CHE 0 off treatment. Among patients 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," April W. Armstrong, MD, Professor and Chief of Dermatology at the University of California-Los Angeles, said in the release. "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."
Alongside the late-breaker presentation, new systemic exposure data from the DELTA 2 trial were presented as an e-poster. The data was based on an investigation into the systemic exposure of twice-daily delgocitinib cream under high use conditions in the phase 3 DELTA 2 trial in adults with moderate-to-severe CHE.2
Additionally, the systemic exposure from the DELTA 2 trial was compared with adult pharmacokinetics (PK) data from a phase 1 trial in patients with moderate to severe AD, and with oral administration using the lowest dose tested in an oral PK study in healthy adults.2