D-CARE (Delgocitinib-Chronic hAnd Eczema Response Evaluation): A Retrospective, Multicenter, Real-World Study of Patients with Chronic Hand Eczema (CHE) Treated with Delgocitinib 2% Cream-Temporal Analysis of Symptom and Clinical Sign Response.

IF 4.6 3区 医学 Q1 DERMATOLOGY
Maddalena Napolitano, Martina Turco, Luca Potestio, Paolo Romita, Eustachio Nettis, Maria Carla Pisani, Maria Mariano, Mattia Cristallo, Martina Fico, Flavia Pigliacelli, Francesca di Vico, Maria Concetta Fargnoli, Cataldo Patruno
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引用次数: 0

Abstract

Introduction: Chronic hand eczema (CHE) is a frequent and often refractory inflammatory skin disease with a substantial impact on quality of life. Delgocitinib 2% cream has demonstrated efficacy in phase 3 trials, but real-world evidence remains limited. This study evaluated its effectiveness and the temporal dynamics of clinical and symptomatic response in patients with CHE.

Methods: This multicenter, retrospective observational study included 58 adults with CHE treated with delgocitinib 2% cream and followed for 16 weeks. Clinical severity and patient-reported outcomes were assessed at baseline, week 4, and week 16. Changes in the Hand Eczema Severity Index (HECSI), global assessment scores, pruritus, pain, and quality of life were analyzed, together with the evolution of individual HECSI components across anatomical regions.

Results: All clinical and patient-reported outcomes improved significantly during follow-up (all p < 0.001). Mean HECSI decreased from 71.5 ± 29.2 at baseline to 19.5 ± 15.1 at week 4 and 6.8 ± 8.9 at week 16. Pruritus and pain both showed marked reductions during follow-up. At week 4, mean vesicle and edema scores were 0.0-0.1 across anatomical regions, while desquamation remained 1.0 ± 1.1 at the fingertips and fingers; at week 16, fissure scores were 0.2 and 0.3 and desquamation scores were 0.4 and 0.3 at the fingertips and fingers, respectively. Quality of life also improved substantially. Two patients (3.4%) experienced adverse events leading to treatment discontinuation.

Conclusions: Delgocitinib 2% cream showed rapid and clinically meaningful real-world effectiveness in CHE. Inflammatory signs improved earlier than chronic structural features such as fissures and desquamation. These differential response kinetics may help clinicians interpret early partial responses and counsel patients regarding expected treatment timelines.

D-CARE (Delgocitinib-Chronic hAnd ecema Response Evaluation):一项对2% Delgocitinib乳膏治疗慢性手湿疹(CHE)患者的回顾性、多中心、真实世界研究——症状和临床体征反应的时间分析。
慢性手湿疹(CHE)是一种常见且难治性的炎症性皮肤病,对生活质量有重大影响。Delgocitinib 2%乳膏在3期试验中显示出疗效,但实际证据仍然有限。本研究评估了其有效性和CHE患者临床和症状反应的时间动态。方法:这项多中心、回顾性观察性研究纳入了58名成人CHE患者,接受2%德尔戈西替尼乳膏治疗,随访16周。在基线、第4周和第16周评估临床严重程度和患者报告的结果。分析了手湿疹严重程度指数(HECSI)、整体评估评分、瘙痒、疼痛和生活质量的变化,以及各个解剖区域HECSI成分的演变。结果:所有临床和患者报告的结果在随访期间显著改善(均p < 0.001)。平均HECSI从基线的71.5±29.2下降到第4周的19.5±15.1和第16周的6.8±8.9。瘙痒和疼痛在随访中均有明显减轻。第4周,各解剖区域的囊泡和水肿平均评分为0.0-0.1,而指尖和手指的脱屑仍为1.0±1.1;在第16周,指尖和手指的裂缝评分分别为0.2和0.3,脱屑评分分别为0.4和0.3。生活质量也大大提高。2例患者(3.4%)出现不良事件导致停药。结论:2% Delgocitinib乳膏对CHE具有快速和临床意义的实际疗效。炎症症状的改善早于慢性结构特征,如裂缝和脱屑。这些差异反应动力学可以帮助临床医生解释早期部分反应,并就预期的治疗时间表向患者提供建议。
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来源期刊
Dermatology and Therapy
Dermatology and Therapy Medicine-Dermatology
CiteScore
6.00
自引率
8.80%
发文量
187
审稿时长
6 weeks
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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