Twice-daily application of delgocitinib cream, a topical pan-Janus kinase inhibitor, works for adults with moderate-to-severe chronic hand eczema (CHE) compared with a vehicle cream, according to the pooled analysis of the phase III DELTA-1 and -2 trials presented at AAD 2024.
In this analysis, 960 patients (median age 44 years, 64.4 percent female) with moderate-to-severe CHE (median duration 5 years) were randomly assigned to receive either delgocitinib cream 20 mg/g twice daily (n=639) or a vehicle cream (n=321) for 16 weeks.
At week 16, Investigator’s Global Assessment for CHE (IGA-CHE) treatment success, defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline, was achieved by significantly more patients treated with delgocitinib than the vehicle cream (24.3 percent vs 8.4 percent; pnominal<0.001). [AAD 2024, abstract 52715]
Similarly, a significantly higher percentage of patients on delgocitinib achieved a ≥75- or ≥90-percent improvement in Hand Eczema Severity Index ([HECSI]; 49.4 percent vs 20.9 percent [HECSI-75] and 30.3 percent vs 10.6 percent [HECSI-90]; pnominal<0.001 for both) compared with those on the vehicle cream.
Significantly more patients treated with delgocitinib also had a ≥4-point improvement in Dermatology Life Quality Index (DLQI) from baseline to week 16 than those on the vehicle cream (73.3 percent vs 47.8 percent; pnominal<0.001).
In terms of safety, the overall rates of adverse events (AEs) were 45.6 percent in the delgocitinib arm and 47.7 percent in the vehicle arm, with only a few serious AEs reported (1.7 percent and 1.9 percent, respectively).
COVID-19 (11.1 percent vs 10.6 percent) and nasopharyngitis (6.9 percent vs 7.5 percent) were the most frequently reported AEs in the delgocitinib vs the vehicle cream group. However, none were related to the study drug or posed safety concerns.
“No changes or differences between the treatment groups in haematology, biochemistry, vital signs, physical examination, or electrocardiogram were assessed to be of clinical relevance,” the researchers noted.
“Overall, delgocitinib cream 20 mg/g was shown to be clinically effective in clinician- (IGA-CHE treatment success and HECSI) and patient-reported outcomes (DLQI) measured,” said the researchers.
“CHE is a frequent inflammatory skin disease associated with pain, pruritus, and a significant occupational, functional, social, and psychological burden … [The current] data suggest delgocitinib cream is efficacious and well-tolerated in patients with CHE where no topical treatments have specifically been developed and approved,” said the researchers.