Health-Related Quality of Life in Chronic Hand Eczema in a Phase 2b Trial of Delgocitinib Cream

INTRODUCTION: Chronic Hand Eczema (CHE) is a multifactorial, burdensome, inflammatory skin disease, with limited treatment options. In a double-blind dose-ranging phase 2b clinical trial, participants with CHE received delgocitinib cream, a topical pan-Janus kinase (JAK) inhibitor, or cream vehicle (clinical results published elsewhere). The objectives were to analyse patient-reported outcomes (PROs) in participants with mild and moderate to severe CHE at screening, and to investigate the impact on PROs during treatment in participants with moderate to severe CHE.

METHODS: Firstly, Dermatology Life Quality Index (DLQI), EQ-5D-5L, and Hand Eczema Impact Scale (HEIS) per severity were analysed at screening. Secondly, PROs were analysed in the subset of participants with moderate to severe CHE; participants receiving delgocitinib cream 20 mg/g were compared with participants receiving cream vehicle for 16 weeks.

RESULTS: At screening, mean (SD) DLQI, EQ-5D-5L, and HEIS were 8.1 (5.8), 0.788 (0.175), and 1.7 (0.8), respectively for mild CHE (n = 93), and 12.1 (6.9), 0.689 (0.236), and 2.3 (0.9) for participants with moderate to severe CHE (n = 202), respectively. Among the participants with moderate to severe CHE who received delgocitinib (n = 41), the least squares mean [SE] change from baseline to week 16 improved compared to cream vehicle (n = 38) in DLQI (- 7.1 [0.9] vs. - 4.6 [0.9]), EQ-5D-5L (0.228 [0.032] vs. 0.096 [0.034]), and HEIS (- 1.5 [0.2] vs. - 0.8 [0.2]) (P < 0.05).

CONCLUSIONS: Mild CHE had a moderate effect, whereas moderate to severe CHE had a very large effect on patients' Health-Related Quality of Life at screening. Treatment with delgocitinib cream was associated with considerable improvement in PROs and represents a potentially valuable treatment option.

TRIAL REGISTRATION: ClinicalTrials. gov identifier NCT03683719.