P120 Improvements in signs of chronic hand eczema with delgocitinib cream as assessed by the Hand Eczema Symptom Diary: pooled analysis of the phase III DELTA 1 and 2 trials

Abstract

The Hand Eczema Symptom Diary (HESD) is a validated chronic hand eczema (CHE)-specific, patient-reported outcome measure. In the DELTA 1 and 2 trials, patients with moderate-to-severe CHE reported significantly greater improvements in HESD itch and pain scores with delgocitinib cream compared with cream vehicle. This post hoc analysis of pooled data from DELTA 1 and 2 reports changes in the severity of other CHE signs that were also assessed by HESD. DELTA 1 and DELTA 2 were phase III trials of identical design in which adults with moderate-to-severe CHE were randomized (2 : 1) to double-blind treatment with delgocitinib cream 20 mg g−1 or cream vehicle twice daily for 16 weeks. HESD scores were used to assess the severity of skin cracking, redness, dryness and flaking over the past 24 h using an 11-point numerical rating scale, with 0 indicating no symptoms and 10 indicating severe symptoms. Data were pooled from both trials, and changes in weekly average HESD scores for CHE signs were compared between treatment groups. Across DELTA 1 and 2, 636 participants were treated with delgocitinib cream and 321 with cream vehicle and had baseline HESD values. At 16 weeks, treatment with delgocitinib cream was associated with significantly greater improvements from baseline (all P < 0.001) than cream vehicle in weekly average HESD scores (reported as the treatment difference and 95% confidence interval) for skin cracking (−1.7, −2.1 to −1.4), redness (−1.8, −2.1 to −1.4), dryness (−1.8, −2.2 to −1.5) and flaking (−1.8, −2.1 to −1.4). Significant treatment differences in favour of delgocitinib cream were evident from week 1 for all clinical signs assessed by HESD. Delgocitinib cream results in rapid and significant improvement in signs of CHE compared with cream vehicle as assessed by HESD, with reductions in skin cracking, redness, dryness and flaking, in addition to pain and itch.