Delgocitinib safe, efficacious in chronic hand eczema
March 19, 2023
1 min read
Bissonnette R. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema: Results of the Phase 3 DELTA 1 trial. Presented at: American Academy of Dermatology Annual Meeting; March 17-21, 2023; New Orleans.
Bissonnette reports having financial relationships with AbbVie, Arcutis, Arena Pharma, Asana BioSciences, BELLUS Health, Boehringer Ingelheim, CARA, Dermavant, Eli Lilly, EMD Serono, Galderma, Incyte, Kiniksa, Kyowa Kirin, LEO Pharma, Novan, Pfizer, RAPT, Regeneron, Sanofi Genzyme and Sienna. He also reports being an employee and shareholder of Innovaderm Research.
- 49.2% of patients with chronic hand eczema experienced a 75% improvement with 16 weeks of treatment with delgocitinib.
- 74.4% of patients in the treatment group had a 4-point improvement in DLQI.
NEW ORLEANS — Phase 3 trial results found delgocitinib cream to significantly improve patient and clinician-reported outcomes of hand eczema, according to a presenter at the American Academy of Dermatology Annual Meeting.
“Chronic hand eczema is one of the most frequent and chronic inflammatory disorders affecting hands,” Robert Bissonnette, MD, MSc, CEO and medical director of Innovaderm, said during his presentation.
Current chronic hand eczema (CHE) treatments often have unsatisfactory results, Bissonnette continued.
The phase 3 DELTA 1 trial included 487 adult patients with severe chronic hand eczema randomly assigned 2:1 to delgocitinib 20 mg/g cream or vehicle twice daily for 16 weeks. The primary endpoint was the proportion of patients reaching an IGA of clear or almost clear with a 2-grade difference from baseline; however, the scale for almost clear was different than in previous studies, according to Bissonnette.
“In order to be almost clear, the only sign that could be present on the skin was barely perceptible erythema,” he said.
At week 16, 19.7% of those in the treatment group reached this endpoint, compared with 9.9% of those in the vehicle group.
“When I look at this and I look at patients who have concluded this trial, I see a disconnect. I think this is not really representative of the efficacy of the drug,” Bissonnette said. “This is my personal opinion, but I think the reason why this is the case is because of the IGA scale that was used.”
The proportion of patients who met the secondary endpoint of a 75% and 90% improvement in Hand Eczema Severity Index (HECSI) and 4-point improvement in DLQI from baseline were 49.2%, 29.5% and 74.4% in the treatment group, respectively, compared with 23.5%, 12.3% and 50% in the vehicle group.
The most frequent adverse events were similar proportions between the study and vehicle group, and no major adverse cardia events were reported.
“Delgocitinib 20 mg/g provided significant improvement both in clinician assessment and DLQI and was well tolerated over a period of 16 weeks,” Bissonnette said.
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