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The goal of this phase 2b clinical trial was to assess patient-reported outcomes (PROs) at screening in individuals with mild and moderate-to-severe chronic hand eczema (CHE), and to evaluate how treatment affected PROs in those with moderate-to-severe CHE.
People with moderate-to-severe chronic hand eczema report meaningful improvements in DLQI, EQ-5D-5L, and HEIS scores after delgocitinib treatment.
The goal of this phase 2b clinical trial was to assess patient-reported outcomes (PROs) at screening in individuals with mild and moderate-to-severe chronic hand eczema (CHE), and to evaluate how treatment affected PROs in those with moderate-to-severe CHE.
In this study, CHE-affected individuals were treated with either delgocitinib cream—a topical pan-Janus kinase (JAK) inhibitor—or a placebo cream. Initially, the Dermatology Life Quality Index (DLQI), EuroQol 5-Dimension 5-Level (EQ-5D-5L), and Hand Eczema Impact Scale (HEIS) scores were assessed at the time of screening procedure by disease intensity. Subsequently, PROs were determined in a subgroup of volunteers with moderate-to-severe CHE. Changes over 16 weeks in those treated with delgocitinib 20 mg/g cream were compared to those receiving placebo.
At screening, those with mild CHE (n=93) had mean (standard deviation) scores of 8.1 (5.8) for DLQI, 0.788 (0.175) for EQ-5D-5L, and 1.7 (0.8) for HEIS. In contrast, those with moderate-to-severe CHE (n=202) had scores of 12.1 (6.9), 0.689 (0.236), and 2.3 (0.9), respectively. In those with moderate-to-severe CHE, treatment with delgocitinib (n=41) resulted in greater improvements from baseline to week 16 when compared to placebo (n=38), as shown in Table 1:
Mild CHE exhibited a moderate impact, while moderate-to-severe CHE had a profound effect on health-related quality of life at baseline. Delgocitinib cream markedly improved PROs in those with more severe disease, suggesting its potential as an effective cure for this challenging ailment.
Dermatology and Therapy
Health-Related Quality of Life in Chronic Hand Eczema in a Phase 2b Trial of Delgocitinib Cream
Timo Buhl et al.
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