Buhl Timo, Bauer Andrea, Ehst Benjamin D, Thyssen Jacob P, Hahn-Pedersen Julie, Hagen Berith Fredsted, Apol Eydna D, Agner Tove
Department of Dermatology, Venereology and Allergology, University Medical Center Göttingen, Göttingen, Germany.
Department of Dermatology, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany.
Dermatol Ther (Heidelb). 2025 May;15(5):1181-1193. doi: 10.1007/s13555-025-01384-4. Epub 2025 Apr 5.
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.
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.
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).
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.
ClinicalTrials. gov identifier NCT03683719.
慢性手部湿疹（CHE）是一种多因素、负担沉重的炎症性皮肤病，治疗选择有限。在一项双盲剂量范围的2b期临床试验中，CHE患者接受了delgocitinib乳膏（一种局部泛Janus激酶（JAK）抑制剂）或乳膏赋形剂（临床结果已在其他地方发表）。目的是分析筛查时轻度和中度至重度CHE患者的患者报告结局（PROs），并调查对中度至重度CHE患者治疗期间PROs的影响。
首先，在筛查时分析每个严重程度的皮肤病生活质量指数（DLQI）、EQ-5D-5L和手部湿疹影响量表（HEIS）。其次，在中度至重度CHE患者亚组中分析PROs；将接受20mg/g delgocitinib乳膏的患者与接受乳膏赋形剂16周的患者进行比较。
在筛查时，轻度CHE患者（n = 93）的平均（SD）DLQI、EQ-5D-5L和HEIS分别为8.1（5.8）、0.788（0.175）和1.7（0.8），中度至重度CHE患者（n = 202）分别为12.1（6.9）、0.689（0.236）和2.3（0.9）。在接受delgocitinib的中度至重度CHE患者（n = 41）中，与乳膏赋形剂组（n = 38）相比，从基线到第16周的最小二乘均值[SE]变化在DLQI（-7.1[0.9]对-4.6[0.9]）、EQ-5D-5L（0.228[0.032]对0.096[0.034]）和HEIS（-1.5[0.2]对-0.8[0.2]）方面有所改善（P < 0.05）。
轻度CHE有中度影响，而中度至重度CHE在筛查时对患者的健康相关生活质量有非常大的影响。使用delgocitinib乳膏治疗与PROs的显著改善相关，是一种潜在有价值的治疗选择。
ClinicalTrials.gov标识符NCT03683719。
