A RECENT phase 3 open-label extension study has demonstrated that delgocitinib cream is both safe and effective for long-term management of chronic hand eczema (CHE) in adults. The DELTA 3 trial, which followed the DELTA 1 and 2 studies, evaluated the safety and efficacy of delgocitinib cream 20 mg/g applied twice daily as needed over a 36-week period, extending the total treatment duration to 52 weeks.
The study included 801 patients who had completed the initial 16-week treatment periods in the DELTA 1 and 2 trials. Participants applied delgocitinib cream as needed, with those exhibiting an Investigator’s Global Assessment for CHE (IGA-CHE) score of ≥2 continuing treatment until achieving an IGA-CHE score of ≤1. The primary endpoint was the number of treatment-emergent adverse events (AEs), while key secondary endpoints included the proportion of patients achieving IGA-CHE 0/1 and at least 75% or 90% improvement in Hand Eczema Severity Index (HECSI-75/90) scores.
Delgocitinib cream was well tolerated, with the most frequently reported AEs being COVID-19 and nasopharyngitis. Among patients who had received delgocitinib in the parent trials, 24.6% had achieved IGA-CHE 0/1 at the start of DELTA 3, and this proportion increased to 30.0% by week 36. Similarly, HECSI-75 and HECSI-90 response rates improved from 51.8% and 31.8% at baseline to 58.6% and 36.6%, respectively, at week 36.
Notably, patients who had previously received the vehicle cream showed marked improvements during the DELTA 3 trial. At baseline, 9.1% had achieved IGA-CHE 0/1, increasing to 29.5% by week 36. HECSI-75 and HECSI-90 response rates also improved from 23.7% and 12.0% at baseline to 51.5% and 35.7%, respectively, at week 36.
The open-label design of the study is a limitation; however, the findings suggest that delgocitinib cream is a well-tolerated and effective long-term treatment option for maintaining disease control in patients with CHE.
Reference: Gooderham M et al. Long-term safety and efficacy of delgocitinib cream for up to 52 weeks in adults with Chronic Hand Eczema: results of the phase 3 open-label extension DELTA 3 trial following the DELTA 1 and 2 trials. JAAD. 2025. doi:10.1016/j.jaad.2025.03.008.
Anaya Malik | AMJ
