ORLANDO, Fla. — Up to half of all people with severe chronic hand eczema (CHE) who apply delgocitinib cream (Anzupgo) to their hands twice a day have had a profound response to treatment, and about a third of patients who stop treatment can maintain clear or almost clear hands for up 2 months, a subgroup analysis of phase 3 clinical trials found.
“When we’re looking at delgocitinib 20 mg/g cream and this super-response analysis, we learned that almost 50% of patients exhibited one of the three criteria of very little to no itch or pain, and also little or no effect on patients’ quality of life at week 16,” April Armstrong, MD, MPH, chief of dermatology at UCLA Health, Los Angeles, said at the 2025 annual meeting of the American Academy of Dermatology.
Armstrong reported on a subgroup analysis of 960 adults with moderate to severe CHE who were enrolled in the DELTA 1 and DELTA 2 phase 3 trials of delgocitinib. The analysis defined “super response” as one of three response levels to the treatment:
- A deep response, defined as a Hand Eczema Symptom Diary (HESD) itch of 0 (clear) or 1 (almost clear); HESD pain 0 or 1, and/or a Dermatology Life Quality Index (DLQI) score of 0 or 1 at week 16.
- A consistent response, defined as a ≥4 point reduction in HESD itch, HESD pain, or achievement of Hand Eczema Severity Index (HESCI)-75 at weeks 4, 8, 12, and 16.
- A maintained response, defined as achieving an Investigator’s Global Assessment (IGA)-CHE of 0 (clear) at week 16 and maintaining IGA-CHE 0 off treatment.
At week 16, Armstrong said, 30% of treated patients vs 9.4% of patients on placebo achieved an HESD itch of 0/1, 35.2% vs 16% achieved HESD pain of 0/1, and 33.3% vs 13.9% achieved a DLQI score of 0/1.
“When you look at achievement of any of these deep-treatment responses, nearly 50% of the patients will have achieved either one of those responses,” Armstrong said.
Consistent and Maintained Responses
In terms of a clinically meaningful improvement of a ≥4 point reduction in HESD scores, 24.1% of treated patients achieved that for itch vs 6.6% of patients on vehicle cream; 25% did so for pain vs 9% of vehicle; and 27.3% achieved HECSI-75 vs 8.1% on vehicle cream.
Among patients receiving delgocitinib cream who achieved an IGA-CHE score of 0 at week 16, one third (32.9%) maintained a score of 0 after 8 weeks and 15.7% after 16 weeks, Armstrong said.
“This is important because it shows us with this medication that when the patients are off treatment, there is still a therapeutic effect even though they’re not putting the medication twice daily on their hands,” she said.
“The concept of ‘super responders’ is an interesting one,” Kristina Callis Duffin, MD, chair of dermatology at the University of Utah, told Medscape Medical News.
“It always raises the question: Are there underlying phenotypic factors, such as genotype or phenotype biomarkers, that could take an analysis like that to predict who’s going to be a super responder to a drug?” Ruffin said.
That kind of predictability, she said, “is sort of the holy grail in our therapeutic world.”
There is also the question of how environmental factors may come into play when a patient has a robust response to treatment.
“Are there other environmental factors that that triggered that super response?” Duffin said. “There are always these confounders out there that bias results.”
Future studies might further explore whether patients with atopic dermatitis or allergic contact dermatitis are more likely to be super responders, the role of the mechanism of action of delgocitinib, and environmental factors patients may have modified during treatment.
Armstrong disclosed financial relationships with trial sponsor Leo Pharma, along with AbbVie, Amgen, Arcutis Biotherapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant Sciences, Eli Lilly, Galderma USA, Incyte, Janssen Biotech, Janssen-Ortho, Meiji, Novartis, Ortho Dermatologics, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, Sun Pharmaceutical, Takeda Pharmaceuticals USA, and UCB.
Duffin disclosed financial relationships with AbbVie, Alumis, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, FIDE, Janssen Pharmaceuticals, Novartis, and Pfizer.
Richard Mark Kirkner is a medical journalist based in Philadelphia.
Source link : https://www.medscape.com/viewarticle/analysis-takes-deep-dive-robust-response-delgocitinib-2025a10005qv?src=rss
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Publish date : 2025-03-09 21:17:00
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