In a phase III head-to-head trial, delgocitinib cream was more effective and safer compared with oral alitretinoin among adult patients with severe chronic hand eczema, according to results from the DELTA FORCE study.
In the trial, researchers randomly assigned 513 adult patients across 102 sites in 10 countries to receive either delgocitinib cream 20 mg/g twice daily or alitretinoin 30 mg capsules once daily for up to 24 weeks. The primary endpoint of the trial was the change in Hand Eczema Severity Index (HECSI) score from baseline to week 12.
Delgocitinib showed a significantly greater reduction in HECSI scores at week 12 (−67.6) compared with alitretinoin (−51.5), with a treatment difference of −16.1 points (95% CI, −23.3 to −8.9, P < .0001).
More patients in the delgocitinib group achieved at least a 90% improvement in HECSI scores (39% vs 26%) and were more likely to attain treatment success defined as “clear” or “almost clear” skin with at least a 2-point improvement in Investigator’s Global Assessment (27% vs 17%).
Delgocitinib also provided greater relief from itch and pain based on Hand Eczema Symptom Diary (HESD) scores. Mean reductions in itch and pain at week 12 were −3.0 and −2.9, respectively, compared with −2.4 and −2.3 in the alitretinoin group (P = .0051 and P = .018).
Improvements in quality of life, assessed by the Dermatology Life Quality Index (DLQI), were also greater with delgocitinib. At week 24, the cumulative reduction in DLQI scores was higher in the cream group (area under the curve difference = 334.0, 95% confidence interval = 195.7 to 472.3, P < .0001).
Fewer patients in the delgocitinib group reported adverse events (49% vs 76%). Headaches were reported in 4% of the patients in the delgocitinib group compared with 32% among the patients in the alitretinoin group. Nausea occurred in less than 1% of the patients in the delgocitinib group and 6% of those in the alitretinoin group. Treatment discontinuation as a result of adverse events was lower with delgocitinib (1% vs 10%), and serious adverse events were reported in 2% and 5% of patients, respectively.
All participants had severe chronic hand eczema unresponsive to topical corticosteroids or were deemed unsuitable for such treatment. Delgocitinib is a nonsteroidal topical pan–Janus kinase (JAK) inhibitor that targets multiple inflammatory pathways. Alitretinoin is a systemic retinoid and remains the only approved oral treatment for this condition in several countries.
The study was funded by LEO Pharma and registered under ClinicalTrials.gov (NCT05259722). The results support delgocitinib cream as a potential nonsystemic treatment alternative for patients with severe chronic hand eczema.
Full trial disclosures and safety data are available in the published report.
Source: The Lancet
