Timo Buhl, Andrea Bauer, Benjamin D Ehst, Jacob P Thyssen, Julie Hahn-Pedersen, Berith Fredsted Hagen, Eydna D Apol, Tove Agner
{"title":"Delgocitinib霜治疗慢性手部湿疹患者健康相关生活质量的2b期试验","authors":"Timo Buhl, Andrea Bauer, Benjamin D Ehst, Jacob P Thyssen, Julie Hahn-Pedersen, Berith Fredsted Hagen, Eydna D Apol, Tove Agner","doi":"10.1007/s13555-025-01384-4","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials. gov identifier NCT03683719.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"1181-1193"},"PeriodicalIF":3.5000,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12033156/pdf/","citationCount":"0","resultStr":"{\"title\":\"Health-Related Quality of Life in Chronic Hand Eczema in a Phase 2b Trial of Delgocitinib Cream.\",\"authors\":\"Timo Buhl, Andrea Bauer, Benjamin D Ehst, Jacob P Thyssen, Julie Hahn-Pedersen, Berith Fredsted Hagen, Eydna D Apol, Tove Agner\",\"doi\":\"10.1007/s13555-025-01384-4\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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. 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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.
期刊介绍：
Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
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