OR WAIT null SECS
Delgocitinib Super Responders: New Insights from AAD 2025
An analysis of data from the DELTA program at AAD 2025 sheds light on the efficacy of delgocitinib for chronic hand eczema.
New data presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting highlight the potential of delgocitinib cream as a promising treatment for moderate to severe chronic hand eczema.
Data from the DELTA clinical program not only demonstrated statistically significant improvements in treatment success but also revealed improved outcomes among "super responders," showcasing deep, consistent, and maintained responses among this challenging patient population.1,2
“It is so exciting to see such a strong response in a subgroup of patients treated with delgocitinib cream,” said April W Armstrong, MD, professor and chief of Dermatology at the University of California-Los Angeles (UCLA).2 “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.”
Multicenter, randomized, double-blind, vehicle-controlled phase 3 trials, both the DELTA 1 and DELTA 2 studies were designed to evaluate twice-daily delgocitinib cream for treatment of moderate to severe chronic hand eczema. The trial’s had a primary endpoint of Investigator’s Global Assessment for chronic hand eczema treatment success (IGA-CHE TS) at Week 16. Upon completion, both trials had met their primary endpoint and demonstrated a statistically significant improvement in chronic hand eczema after 16 weeks of treatment with delgocitinib.1,2
Based on these data, LEO Pharma announced the submission of a New Drug Application to the US Food and Drug Administration for the agent in September 2024, with the decision expected sometime in the second half of 2025.3
At AAD 2025, Armstrong presented data from an analysis of “super responders” within the trials. For the purpose of analysis, “super-response” was defined as either a deep, consistent, and/or maintained treatment response.
- Deep Response: Hand Eczema Symptom Diary (HESD) score of 0 or 1, HESD pain score of 0 or 1, and/or Dermatology Life Quality Index (DLQI) of 0 or 1 at week 16.
- Consistent Response: 4-point or greater reduction in HESD itch, HESD pain, or achievement of Hand Eczema Severity Index (HECSI)-75 at weeks 4, 8, 12, and 16.
- Maintained Response: IGA-CHE 0 responders at week 16 and maintained of IGA-CHE 0 or 1 off treatment.
The AAD 2025 data revealed 30.0% and 9.4% of patients achieved a HESD itch of 0 or 1, 35.2% and 16.0% achieved HESD pain 0 or 1, and 33.3% and 13.9% achieved a DLQI score of 0 or 1 at week 16 with delgocitinib and vehicle cream groups, respectively. When assessing the prevalence of consistent responses, results revealed a greater proportion of patients receiving delgocitinib achieved 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%). When assessing maintained response among delgocitinib users, 32.9% maintained a score of 0 after 8 weeks and 15.7% after 16 weeks.1,2
“The data unveiled today further contributes to LEO Pharma’s ever-growing body of scientific evidence for the treatment of moderate to severe [chronic hand eczema],” said Christophe Bourdon, chief executive officer at LEO Pharma.2 “Our research and work in [chronic hand eczema] 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.”
