Delgocitinib cream safe, effective for long-term use in chronic hand eczema

Long-term treatment with delgocitinib is well-tolerated and raises no major safety concerns among patients with chronic hand eczema (CHE), results of the DELTA 3 trial have shown. Its use also maintains disease control for up to 52 weeks. 

“Efficacy rates were maintained among patients treated with delgocitinib cream in the parent trials (DELTA 1 and 2) and further improved among patients previously treated with cream vehicle,” the investigators said. 

In DELTA 3, 801 patients who completed the 16-week treatment period in the DELTA 1 and 2 trials received delgocitinib cream twice daily on an as-needed basis for 36 weeks. Those with Investigator’s Global Assessment for CHE (IGA-CHE) ≥2 received treatment until they achieved IGA-CHE ≤1. 

The number of treatment-emergent adverse events (AEs) was the primary endpoint, while IGA-CHE 0/1 and ≥75 percent/≥90 percent improvement in Hand Eczema Severity Index (HECSI-75/90) scores served as key secondary endpoints. 

Delgocitinib was well-tolerated, with COVID-19 and nasopharyngitis being the most common AEs. In DELTA 3, the proportion of patients with IGA-CHE 0/1 (24.6 percent) and HECSI-75/90 (51.8 percent/31.8 percent) at baseline were maintained at week 36 (IGA-CHE 0/1: 30.0 percent; HECSI-75/90: 58.6 percent/36.6 percent). [J Am Acad Dermatol 2025;93:95-103] 

Among those who have been treated with cream vehicle, the response rates significantly improved from baseline (IGA-CHE 0/1: 9.1 percent; HECSI-75/90: 23.7 percent/12.0 percent) to week 36 (IGA-CHE 0/1: 29.5 percent; HECSI-75/90: 51.5 percent/ 35.7 percent). 

“Patients who stopped treatment due to disease remission (IGA-CHE 0/1) were able to regain response upon restart of treatment, thereby helping clinicians contextualize the potential benefits of delgocitinib cream to patients with CHE,” the investigators said. 

“These DELTA 3 data support the benefit of long-term, as-needed use of delgocitinib cream in patients with moderate to severe CHE,” they added. 

Treatment success 

DELTA 3 applied the same stringent definition of IGA-CHE treatment success used in the parent trials (ie, IGA-CHE 0: clear, no perceptible erythema; IGA-CHE 1: almost clear, barely perceptible erythema), with a ≥2-step improvement from baseline. [Lancet 2024;404:461-473]  

“The IGA-CHE instrument, as a single-item measure of CHE severity, is a strong, valid, and reliable measure of CHE severity and corresponding clinically meaningful changes, supporting its use as an endpoint in CHE clinical trials and practice,” the investigators said. [Arch Dermatol Res 2024;316:110] 

The current study was limited by its open-label design and the predominantly White patient pool (91.4 percent), which limits the generalization of the findings to other ethnic groups. On the other hand, the open-label, nonrandomized design of DELTA 3 reflected clinical practice with the treatment of flares until the skin is clear or almost clear, according to the investigators. 

“Real-world evidence data will be required to further assess the effectiveness and safety of delgocitinib cream 20 mg/g treatment in clinical practice, particularly for as-needed long-term use,” they said.  

“Delgocitinib cream is the only topical treatment that has been specifically developed and approved for moderate to severe CHE,” the investigators noted.