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Past, Present, and Future of Sodium Hypochlorite in Dermatology: A Scoping Review. 皮肤病学中次氯酸钠的过去、现在和未来:范围综述。
IF 8.8 1区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-22 DOI: 10.1007/s40257-025-00999-9
Christy H Chang, Maura Devine, Deborah Woo, Theresa Hopkins, Tiago Torres, Raj Chovatiya

Background: For over a century, dilute sodium hypochlorite (NaOCl), historically recognized as the antiseptic component of bleach, has been well established in wound care, primarily owing to its broad antimicrobial activity and ability to penetrate soft tissue and necrotic debris. NaOCl has been increasingly utilized and studied in clinical dermatology owing to its broad ranging antimicrobial, skin healing, and more recently described anti-inflammatory properties.

Objectives: This scoping review (Open Science Network; osf.io/6hyru) synthesizes current evidence of NaOCl's applications in skin care, highlighting mechanistic insights, clinical trends, and knowledge gaps.

Methods: A comprehensive search of PubMed, Embase, Web of Science, Cochrane Library, and ClinicalTrials.gov was conducted from inception through November 2024. This review was reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines.

Results: From 6959 deduplicated records, 225 studies published between 1915 and 2024 were identified for final inclusion. Four key clinical themes for NaOCl use emerged upon analysis of these publications: antimicrobial properties (n = 57), wound care (n = 64), eczematous skin disease (n = 78), and noneczematous inflammatory skin conditions (n = 23). NaOCl exhibits broad-spectrum activity against various organisms, notably Staphylococcus aureus and Pseudomonas aeruginosa, contributing to its effectiveness in treating chronically infected burns, ulcers, and other wounds. Limited studies also suggest NaOCl's potential role in modulating critical processes that support wound repair. In addition, the anti-inflammatory effects of NaOCl have supported its utility in treating eczematous and noneczematous skin disorders.

Conclusions: Current literature provides broad and extensive evidence supporting NaOCl's role in wound-healing, antimicrobial, and anti-inflammatory activity. However, considerable heterogeneity exists in recommended concentrations, preparation methods, and usage instructions across studies. There is a need for more randomized controlled trials and standardized protocols to better define the efficacy, safety, and optimal use of NaOCl in dermatologic practice.

背景:一个多世纪以来,稀次氯酸钠(NaOCl),历史上被认为是漂白剂的防腐成分,已经在伤口护理中得到了很好的应用,主要是因为它具有广泛的抗菌活性和穿透软组织和坏死碎片的能力。由于其广泛的抗菌、皮肤愈合和最近描述的抗炎特性,NaOCl在临床皮肤病学中越来越多地应用和研究。目的:本综述(开放科学网络;osf)。io/6hyru)综合了NaOCl在皮肤护理中的应用的当前证据,突出了机理见解,临床趋势和知识差距。方法:全面检索PubMed、Embase、Web of Science、Cochrane Library和ClinicalTrials.gov网站,检索时间从成立到2024年11月。本综述是根据系统评价和荟萃分析扩展范围评价(PRISMA-ScR)指南的首选报告项目进行报道的。结果:从6959条重复数据删除记录中,最终纳入了1915年至2024年间发表的225项研究。通过对这些出版物的分析,出现了使用NaOCl的四个关键临床主题:抗菌特性(n = 57)、伤口护理(n = 64)、湿疹性皮肤病(n = 78)和非湿疹性炎症性皮肤病(n = 23)。NaOCl对多种生物具有广谱活性,特别是金黄色葡萄球菌和铜绿假单胞菌,有助于治疗慢性感染烧伤、溃疡和其他伤口。有限的研究也表明NaOCl在调节支持伤口修复的关键过程中的潜在作用。此外,NaOCl的抗炎作用支持其治疗湿疹和非湿疹性皮肤病的效用。结论:目前的文献提供了广泛和广泛的证据支持NaOCl在伤口愈合,抗菌和抗炎活性中的作用。然而,各研究在推荐浓度、制备方法和使用说明上存在相当大的异质性。需要更多的随机对照试验和标准化方案,以更好地定义皮肤病学实践中NaOCl的疗效、安全性和最佳使用。
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引用次数: 0
Nutrition and Psoriasis: The Latest Evidence and How to Approach Nutrition in Clinical Practice 营养与牛皮癣:最新的证据和如何在临床实践中处理营养。
IF 8.8 1区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-10 DOI: 10.1007/s40257-025-00992-2
Andrea Leung, Allison Kranyak, Georgia Marquez-Grap, Tina Bhutani

Psoriasis is a chronic immune-mediated skin condition that is associated with cardiovascular disease, obesity, and other comorbidities. While highly linked to genetics, psoriasis is also significantly impacted by environmental and lifestyle factors. Nutrition and diet are areas of considerable interest for patients, providers, and researchers alike, as patient diets may have a significant impact on disease activity and severity. Diet is also a major modifiable lifestyle factor that patients are empowered to explore and optimize in the management of their psoriasis. In this Therapy in Practice, we summarize the most up-to-date research on various diets proposed to have benefits for patients with psoriasis and conclude with a discussion on how providers may integrate nutrition into clinical practice. The Mediterranean diet emphasizes whole fruits, vegetables, grains, and healthy fats. Given the anti-inflammatory effects and cardiovascular benefits of the Mediterranean diet, it is a good option for patients with psoriasis. A low-calorie diet is often recommended for individuals who are overweight or obese, and there is a strong association between obesity and psoriatic disease activity and progression. For patients with a diagnosis of celiac disease or seropositivity of immunoglobulin A or immunoglobulin G antigliadin antibodies, a gluten-free diet could be beneficial in reducing psoriasis severity. Diet can have a significant role in the management of psoriasis, and patients and providers should work collaboratively to create a sustainable, safe, and effective diet.

牛皮癣是一种慢性免疫介导的皮肤病,与心血管疾病、肥胖和其他合并症有关。牛皮癣虽然与遗传密切相关,但也受到环境和生活方式因素的显著影响。营养和饮食是患者、提供者和研究人员非常感兴趣的领域,因为患者的饮食可能对疾病的活动和严重程度有重大影响。饮食也是一个主要的可改变的生活方式因素,患者有权探索和优化他们的牛皮癣管理。在这篇治疗实践中,我们总结了最新的关于各种饮食对牛皮癣患者有益的研究,并讨论了提供者如何将营养纳入临床实践。地中海饮食强调完整的水果、蔬菜、谷物和健康的脂肪。考虑到地中海饮食的抗炎作用和心血管益处,它是牛皮癣患者的一个很好的选择。低热量饮食通常被推荐给超重或肥胖的人,肥胖与银屑病的活动和进展之间有很强的联系。对于诊断为乳糜泻或免疫球蛋白a或免疫球蛋白G抗麦胶蛋白抗体血清阳性的患者,无麸质饮食可能有助于减轻牛皮癣的严重程度。饮食可以在牛皮癣的管理中发挥重要作用,患者和提供者应该共同努力,创造一个可持续的,安全的,有效的饮食。
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引用次数: 0
Menopause and Common Dermatoses: A Systematic Review 更年期和常见皮肤病:系统综述。
IF 8.8 1区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-02 DOI: 10.1007/s40257-025-00994-0
Katie Roster, Lauren Fleshner, Turkan Banu Karatas, Anna Ecanow, Alyssa Sayegh, Banu Farabi, Shoshana Marmon

Background

Menopause is a universal physiological transition, marked by a decline in estrogen, which has important effects on skin and mucosal health. The impact of menopause and menopausal hormone therapy (MHT) on chronic dermatoses remains incompletely defined.

Objective

The aim was to investigate the relationship between menopause, MHT, and common dermatological conditions.

Methods

PubMed, Embase, and Web of Science were searched from inception to September 2024 in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Eligible studies evaluated menopause or MHT in relation to alopecia, psoriasis, acne, rosacea, melasma, and hidradenitis suppurativa (HS). Investigational cohorts largely consisted of menopausal women, although participant characteristics varied. Data on study design, population, hormonal status, and dermatological outcomes were extracted and synthesized.

Results

A total of 40 studies met inclusion criteria. Alopecia, particularly frontal fibrosing alopecia (FFA) and female pattern hair loss (FPHL), showed the strongest postmenopausal associations, with most cases presenting after menopause and earlier or surgical menopause conferring greater risk. Psoriasis frequently persisted or worsened after menopause, though objective assessments are limited. Acne and rosacea generally improved, whereas melasma showed mixed outcomes, including greater extra-facial involvement post menopause. HS responses to menopause were inconsistent. MHT was linked to increased risk of FFA and rosacea, whereas findings for other dermatoses were more variable or absent. Most of the studies involved MHT formulations that are less commonly used in current clinical practice.

Conclusion

Menopause influences the onset and course of several chronic dermatoses, while data on MHT remain more limited and inconsistent. Dermatologists should consider menopausal status and hormone therapy exposure when evaluating skin disease. Longitudinal, dermatology-focused studies—particularly those integrating diverse populations and updated hormone therapies—are needed to inform individualized care.

背景:绝经是一种普遍的生理转变,其特征是雌激素水平下降,对皮肤和粘膜健康有重要影响。绝经期和绝经期激素治疗(MHT)对慢性皮肤病的影响仍不完全明确。目的:探讨更年期、MHT和常见皮肤病之间的关系。方法:根据系统评价和荟萃分析(PRISMA)指南的首选报告项目,检索PubMed, Embase和Web of Science从成立到2024年9月。符合条件的研究评估了更年期或MHT与脱发、牛皮癣、痤疮、酒渣鼻、黄褐斑和化脓性汗腺炎(HS)的关系。研究队列主要由绝经期妇女组成,尽管参与者的特征各不相同。提取并综合研究设计、人群、激素状况和皮肤病学结果的数据。结果:共有40项研究符合纳入标准。脱发,尤其是额前部纤维化性脱发(FFA)和女性型脱发(FPHL),在绝经后表现出最强的相关性,大多数病例出现在绝经后,更早或手术绝经会增加风险。银屑病在绝经后经常持续或恶化,尽管客观评估有限。痤疮和酒糟鼻普遍得到改善,而黄褐斑则表现出不同的结果,包括绝经后更多的面部外受累。HS对更年期的反应不一致。MHT与FFA和酒糟鼻的风险增加有关,而其他皮肤病的发现则更不稳定或不存在。大多数研究涉及目前临床实践中不太常用的MHT配方。结论:更年期影响几种慢性皮肤病的发病和病程,而MHT的数据仍然比较有限和不一致。皮肤科医生在评估皮肤病时应考虑绝经状态和激素治疗暴露情况。纵向的、以皮肤病学为重点的研究——特别是那些整合不同人群和最新激素疗法的研究——需要为个性化护理提供信息。
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引用次数: 0
Cardiovascular Imaging in Psoriasis: A Critical Review of Current Evidence, Techniques, and Therapeutic Implications 银屑病的心血管影像学:当前证据、技术和治疗意义的重要回顾。
IF 8.8 1区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-01 DOI: 10.1007/s40257-025-00996-y
Jacopo Tartaglia, Monica Ponzano, Roberto Mazzetto, Alvise Sernicola, Christian Ciolfi, Francesco Tona, Stefano Piaserico

Psoriasis is a systemic inflammatory disease increasingly recognized for its association with elevated cardiovascular risk, driven by immune-mediated endothelial dysfunction and accelerated atherosclerosis. Non-invasive cardiovascular imaging has consistently demonstrated a spectrum of subclinical abnormalities in patients with moderate-to-severe psoriasis, including coronary microvascular dysfunction, high-risk plaque burden, vascular inflammation, myocardial remodeling, and increased arterial stiffness. This critical review summarizes the role of different imaging modalities in detecting psoriasis-associated cardiovascular alterations and evaluates emerging data on the impact of systemic therapies. Imaging abnormalities in psoriasis often precede clinical events and can support early risk reclassification and referral. Biologic therapy is associated with improved coronary microvascular function and with reductions in noncalcified plaque burden and high-risk plaque features on coronary computed tomography angiography (CCTA), and statins reduce vascular 18F-fluorodeoxyglucose (FDG) uptake on positron emission tomography (PET) in psoriasis cohorts. Outcome data that link these imaging changes to reduced events remain limited. Imaging should be used selectively, with coronary calcium scoring or carotid ultrasound for risk refinement in asymptomatic adults and targeted CCTA or transthoracic echocardiography (TTE) when symptoms, examination, or screening suggest cardiovascular involvement.

银屑病是一种全身性炎症性疾病,由于免疫介导的内皮功能障碍和动脉粥样硬化加速,银屑病与心血管风险升高相关,越来越得到认可。无创心血管影像学一致显示,中重度牛皮癣患者存在一系列亚临床异常,包括冠状动脉微血管功能障碍、高危斑块负担、血管炎症、心肌重构和动脉僵硬度增加。这篇重要的综述总结了不同成像方式在检测银屑病相关心血管改变中的作用,并评估了有关全身治疗影响的新数据。牛皮癣的影像学异常通常先于临床事件,可以支持早期风险重新分类和转诊。生物治疗可改善冠状动脉微血管功能,减少冠状动脉ct血管造影(CCTA)显示的非钙化斑块负担和高危斑块特征,他汀类药物可减少银屑病患者正电子发射断层扫描(PET)显示的血管18f -氟脱氧葡萄糖(FDG)摄取。将这些影像学改变与减少的事件联系起来的结果数据仍然有限。影像学检查应有选择性地使用,无症状的成人应使用冠状动脉钙化评分或颈动脉超声来改善风险,当症状、检查或筛查提示心血管受累时,应使用靶向CCTA或经胸超声心动图(TTE)。
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引用次数: 0
Real-World Evidence of Effectiveness and Safety of Abrocitinib, Baricitinib and Upadacitinib in Atopic Dermatitis: A Systematic Review and Meta-Analysis Abrocitinib, Baricitinib和Upadacitinib治疗特应性皮炎的有效性和安全性:一项系统综述和荟萃分析。
IF 8.8 1区 医学 Q1 DERMATOLOGY Pub Date : 2025-11-26 DOI: 10.1007/s40257-025-00997-x
Amalie Thorsti Møller Rønnstad, Daniel Isufi, Christopher G. Bunick, Raj Chovatiya, Mia-Louise Nielsen, Farzad Alinaghi, Simon F. Thomsen, Christian Vestergaard, Andreas Wollenberg, Alexander Egeberg, Jacob P. Thyssen, Nikolai Loft

Background

Oral Janus kinase inhibitors (JAKi) have proven effective in the treatment of atopic dermatitis (AD) in multiple clinical trials, providing rapid response, deep efficacy when given at the highest formulated dose, and in the case of abrocitinib and upadacitinib, superiority to biologics treatments in the first 4–16 weeks. However, it is unclear how this translates to real-world efficacy and safety.

Objectives

To assess the real-world effectiveness and safety of abrocitinib, baricitinib and upadacitinib in the treatment of AD.

Methods

PubMed and EMBASE were systematically searched from inception until 3 January 2025 for observational studies investigating effectiveness and safety of abrocitinib, baricitinib and upadacitinib for the treatment of AD. The primary outcomes were the proportion of patients achieving a ≥ 75% improvement in the Eczema Area and Severity Index (EASI-75) following treatment with abrocitinib, baricitinib or upadacitinib after 12 and 16 weeks. Secondary outcomes included the proportion of patients achieving EASI-50, EASI-90 and the proportion of patients experiencing adverse events (AE). Tertiary outcomes included the Dermatology Life Quality Index (DLQI) and the Peak-Pruritus Numerical rating scale (PP-NRS).

Results

A total of 63 studies including 517 patients treated with abrocitinib (50 mg [0.2%], 100 mg [50.9%], 200 mg [34.2%], mixed/unknown [14.7%]), 574 with baricitinib (2 mg [14.8%], 4 mg [71.9%], mixed/unknown [13.3%]) and 2779 with upadacitinib were included (15 mg [46.6%], 30 mg [33.3%], mixed/unknown [20.0%]). Most studies reported outcomes for doses combined. Across all doses, the proportion of patients achieving EASI-75 and -90 was 75% and 38% for abrocitinib, 51% and 24% for baricitinib and 83% and 55% for upadacitinib after 16 weeks, respectively. Acne and herpes simplex virus (HSV) were frequently reported across all doses of abrocitinib (21%, 2%), baricitinib (8%, 6%) and upadacitinib (15%, 6%), but patients treated with 100 mg abrocitinib and 30 mg upadacitinib reported the highest prevalence of acne and HSV, respectively. Few studies reported serious AEs across all treatments and doses.

Conclusions

Data from real-world studies of JAKis in AD show effectiveness and safety similar to clinical trials using the highest treatment doses. It is important to be aware of HSV and acne risk as these AEs are the most common reasons for discontinuation. Interpretation of results was complicated by the lack of studies reporting dosage information.

背景:在多个临床试验中,口服Janus激酶抑制剂(JAKi)已被证明在治疗特应性皮炎(AD)方面有效,在最高处方剂量下提供快速反应,深层疗效,并且在前4-16周内,阿布替尼和upadacitinib优于生物制剂治疗。然而,目前尚不清楚这如何转化为现实世界的有效性和安全性。目的:评价阿布替尼、巴西替尼和upadacitinib治疗AD的实际有效性和安全性。方法:系统检索PubMed和EMBASE从成立到2025年1月3日的观察性研究,调查阿布替尼、巴西替尼和upadacitinib治疗AD的有效性和安全性。主要结局是在接受阿布替尼、巴西替尼或upadacitinib治疗12周和16周后,湿疹面积和严重程度指数(EASI-75)改善≥75%的患者比例。次要结局包括达到EASI-50、EASI-90的患者比例和发生不良事件(AE)的患者比例。第三指标包括皮肤病生活质量指数(DLQI)和瘙痒峰数值评定量表(PP-NRS)。结果:共纳入63项研究,517例患者使用阿布替尼(50 mg [0.2%], 100 mg [50.9%], 200 mg[34.2%],混合/未知[14.7%]),574例患者使用巴西替尼(2 mg [14.8%], 4 mg[71.9%],混合/未知[13.3%]),2779例患者使用upadacitinib (15 mg [46.6%], 30 mg[33.3%],混合/未知[20.0%])。大多数研究报告了联合用药的结果。在所有剂量中,16周后,阿布替尼达到EASI-75和-90的患者比例分别为75%和38%,巴西替尼为51%和24%,更新达西替尼为83%和55%。痤疮和单纯疱疹病毒(HSV)在所有剂量的阿布替尼(21%,2%),巴西替尼(8%,6%)和upadacitinib(15%, 6%)中经常被报道,但服用100 mg阿布替尼和30 mg upadacitinib的患者分别报告了最高的痤疮和HSV患病率。很少有研究报告所有治疗和剂量的严重不良反应。结论:来自阿尔茨海默病中JAKis的实际研究数据显示,使用最高治疗剂量的临床试验的有效性和安全性相似。重要的是要意识到HSV和痤疮的风险,因为这些ae是停药的最常见原因。由于缺乏报告剂量信息的研究,结果的解释变得复杂。
{"title":"Real-World Evidence of Effectiveness and Safety of Abrocitinib, Baricitinib and Upadacitinib in Atopic Dermatitis: A Systematic Review and Meta-Analysis","authors":"Amalie Thorsti Møller Rønnstad,&nbsp;Daniel Isufi,&nbsp;Christopher G. Bunick,&nbsp;Raj Chovatiya,&nbsp;Mia-Louise Nielsen,&nbsp;Farzad Alinaghi,&nbsp;Simon F. Thomsen,&nbsp;Christian Vestergaard,&nbsp;Andreas Wollenberg,&nbsp;Alexander Egeberg,&nbsp;Jacob P. Thyssen,&nbsp;Nikolai Loft","doi":"10.1007/s40257-025-00997-x","DOIUrl":"10.1007/s40257-025-00997-x","url":null,"abstract":"<div><h3>Background</h3><p>Oral Janus kinase inhibitors (JAKi) have proven effective in the treatment of atopic dermatitis (AD) in multiple clinical trials, providing rapid response, deep efficacy when given at the highest formulated dose, and in the case of abrocitinib and upadacitinib, superiority to biologics treatments in the first 4–16 weeks. However, it is unclear how this translates to real-world efficacy and safety.</p><h3>Objectives</h3><p>To assess the real-world effectiveness and safety of abrocitinib, baricitinib and upadacitinib in the treatment of AD.</p><h3>Methods</h3><p>PubMed and EMBASE were systematically searched from inception until 3 January 2025 for observational studies investigating effectiveness and safety of abrocitinib, baricitinib and upadacitinib for the treatment of AD. The primary outcomes were the proportion of patients achieving a ≥ 75% improvement in the Eczema Area and Severity Index (EASI-75) following treatment with abrocitinib, baricitinib or upadacitinib after 12 and 16 weeks. Secondary outcomes included the proportion of patients achieving EASI-50, EASI-90 and the proportion of patients experiencing adverse events (AE). Tertiary outcomes included the Dermatology Life Quality Index (DLQI) and the Peak-Pruritus Numerical rating scale (PP-NRS).</p><h3>Results</h3><p>A total of 63 studies including 517 patients treated with abrocitinib (50 mg [0.2%], 100 mg [50.9%], 200 mg [34.2%], mixed/unknown [14.7%]), 574 with baricitinib (2 mg [14.8%], 4 mg [71.9%], mixed/unknown [13.3%]) and 2779 with upadacitinib were included (15 mg [46.6%], 30 mg [33.3%], mixed/unknown [20.0%]). Most studies reported outcomes for doses combined. Across all doses, the proportion of patients achieving EASI-75 and -90 was 75% and 38% for abrocitinib, 51% and 24% for baricitinib and 83% and 55% for upadacitinib after 16 weeks, respectively. Acne and herpes simplex virus (HSV) were frequently reported across all doses of abrocitinib (21%, 2%), baricitinib (8%, 6%) and upadacitinib (15%, 6%), but patients treated with 100 mg abrocitinib and 30 mg upadacitinib reported the highest prevalence of acne and HSV, respectively. Few studies reported serious AEs across all treatments and doses.</p><h3>Conclusions</h3><p>Data from real-world studies of JAKis in AD show effectiveness and safety similar to clinical trials using the highest treatment doses. It is important to be aware of HSV and acne risk as these AEs are the most common reasons for discontinuation. Interpretation of results was complicated by the lack of studies reporting dosage information.</p></div>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"27 1","pages":"49 - 66"},"PeriodicalIF":8.8,"publicationDate":"2025-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145601666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Perioperative Systemic Therapy for High-Risk Cutaneous Squamous Cell Carcinoma 高危皮肤鳞状细胞癌围手术期的全身治疗。
IF 8.8 1区 医学 Q1 DERMATOLOGY Pub Date : 2025-11-18 DOI: 10.1007/s40257-025-00995-z
Kelly M. Kimball, Rachel E. Politi, Kathryn T. Shahwan

The incidence of cutaneous squamous cell carcinoma (CSCC) is on the rise. While the majority of cases are curable with surgery alone, the burden of high-risk tumors that require additional therapies is increasing. While systemic therapy has long been used to treat locally advanced and metastatic CSCC, immunotherapy is a more recent advancement, and use of neoadjuvant and adjuvant systemic therapy in the perioperative setting is an area of ongoing study. While chemotherapy, epidermal growth factor inhibitors, and chemoradiation have all been studied in the perioperative setting, the response is highly variable, and side effects are common. Immunotherapy, in particular programmed cell death protein/ligand-1 inhibitors, have revolutionized treatment of advanced CSCC. Cemiplimab and pembrolizumab have been studied for neoadjuvant and adjuvant use, and atezolizumab for neoadjuvant use. Cemiplimab has shown the most promise, with a 64–75% major or complete pathologic response rate in the neoadjuvant setting, and significantly improved recurrence, metastasis, and disease-free survival rates over placebo in the adjuvant setting. While neoadjuvant and adjuvant immunotherapy has evolved as a promising treatment option for high-risk CSCC, several questions remain unanswered and are subject to ongoing research. This includes investigating optimal treatment regimens, duration, and timing; developing methods to better predict and identify responders; establishing long-term outcomes and safety data; and carrying out further studies in special populations such as organ transplant recipients.

皮肤鳞状细胞癌(CSCC)的发病率呈上升趋势。虽然大多数病例仅通过手术就可以治愈,但需要额外治疗的高风险肿瘤的负担正在增加。虽然全身治疗长期用于局部晚期和转移性CSCC,但免疫治疗是最近的进展,在围手术期使用新辅助和辅助全身治疗是一个正在进行的研究领域。虽然化疗、表皮生长因子抑制剂和放化疗都在围手术期进行了研究,但反应是高度可变的,副作用是常见的。免疫疗法,特别是程序性细胞死亡蛋白/配体-1抑制剂,已经彻底改变了晚期CSCC的治疗。已经研究了Cemiplimab和pembrolizumab用于新辅助和辅助使用,以及atezolizumab用于新辅助使用。Cemiplimab表现出了最大的希望,在新辅助治疗中,其主要或完全病理反应率为64-75%,并且在辅助治疗中,与安慰剂相比,其复发、转移和无病生存率显著提高。虽然新辅助和辅助免疫治疗已经发展成为高风险CSCC的一种有希望的治疗选择,但仍有几个问题尚未得到解答,需要进行进一步的研究。这包括调查最佳治疗方案、持续时间和时机;制定更好地预测和识别响应者的方法;建立长期结果和安全数据;并在特殊人群中进行进一步的研究,比如器官移植接受者。
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引用次数: 0
Efficacy and Safety of Dupilumab in Adults with Prurigo Nodularis with or Without Atopic Comorbidities: A Subgroup Analysis from Two Randomized Phase III Clinical Trials Dupilumab治疗伴有或不伴有特应性合并症的成人结节性痒疹的疗效和安全性:来自两项随机III期临床试验的亚组分析
IF 8.8 1区 医学 Q1 DERMATOLOGY Pub Date : 2025-11-11 DOI: 10.1007/s40257-025-00993-1
Brian S. Kim, Margarida Gonçalo, Tsukasa Ugajin, Xing-Hua Gao, Amy H. Praestgaard, Melanie Makhija, Joseph Zahn, Ashish Bansal, Simmi Wiggins

Background

Prurigo nodularis (PN) is a chronic inflammatory skin condition characterized by intensely pruritic papulonodular lesions. Patients with PN frequently experience comorbid atopic conditions. Dupilumab is the first approved therapy for PN, but the efficacy of dupilumab in patients with PN with or without atopic comorbidities has not been investigated.

Objective

We aimed to assess the efficacy and safety of dupilumab in patients with PN with or without a history of atopic comorbidities.

Methods

Randomized, double-blind, parallel-group, placebo-controlled, 24-week, phase III trials LIBERTY-PN PRIME and PRIME2 were conducted independently in 16 countries in North and South America, Europe, and Asia. Patients were randomized 1:1 to dupilumab 300 mg every 2 weeks or matched placebo. In this pre-specified subgroup analysis of pooled data, adults with moderate-to-severe PN, inadequately controlled by topical prescription therapies, were stratified according to the presence or absence of atopic comorbidity history. Investigators assessed itch (Worst Itch Numeric Rating Scale), skin lesions (Investigator’s Global Assessment for PN Stage), and patient-reported quality of life (evaluated using the Dermatology Life Quality Index, Skin Pain Numeric Rating Scale, Hospital Anxiety and Depression Scale, and a Sleep Numeric Rating Scale).

Results

Three hundred and eleven patients were randomized to dupilumab (N = 153; atopic/non-atopic n = 67/86) or placebo (N = 158; atopic/non-atopic n = 68/90). At week 24 in both the atopic and non-atopic subgroups, significantly more patients achieved clinically meaningful improvements with dupilumab treatment compared with placebo in itch (atopic: 58.2% vs 20.6%; P < 0.0001; non-atopic: 59.3% vs 17.8%; P < 0.0001), clear/almost clear skin (atopic: 52.2% vs 16.2%; P < 0.0001; non-atopic: 41.9% vs 17.8%; P = 0.0005), and concomitant itch and skin lesion improvements (atopic: 37.3% vs 7.4%; P = 0.0057; non-atopic 33.7% vs 10.0%; P = 0.007). Patients showed significant improvements in skin pain, Dermatology Life Quality Index, Hospital Anxiety and Depression Scale, and sleep, with dupilumab treatment compared with placebo, regardless of atopic history. Safety was generally consistent with the known dupilumab safety profile.

Conclusions

Dupilumab significantly improved disease signs, symptoms, and health-related quality of life with similar onset time and response magnitude compared with placebo in adult patients with PN, irrespective of the presence or absence of atopic comorbidities.

Clinical Trial Registration

ClinicalTrials.gov Identifiers: NCT04183335 and NCT04202679.

背景:结节性痒疹(PN)是一种慢性炎症性皮肤病,以强烈瘙痒性丘疹性病变为特征。PN患者经常出现共病性特应性疾病。Dupilumab是首个被批准用于治疗PN的药物,但Dupilumab在伴有或不伴有特应性合并症的PN患者中的疗效尚未被研究。目的:我们旨在评估dupilumab在有或没有特应性合并症史的PN患者中的疗效和安全性。方法:随机、双盲、平行组、安慰剂对照、24周、III期试验LIBERTY-PN PRIME和PRIME2在北美、南美、欧洲和亚洲的16个国家独立进行。患者以1:1的比例随机分配至dupilumab 300 mg,每2周或匹配安慰剂。在这个预先指定的汇总数据的亚组分析中,根据是否存在特应性合并症史,对局部处方治疗控制不足的中度至重度PN患者进行分层。研究人员评估了瘙痒(最严重瘙痒数值评定量表)、皮肤病变(研究者对PN阶段的整体评估)和患者报告的生活质量(使用皮肤病学生活质量指数、皮肤疼痛数值评定量表、医院焦虑和抑郁量表以及睡眠数值评定量表进行评估)。结果:311例患者被随机分配到dupilumab组(N = 153;特应性/非特应性N = 67/86)或安慰剂组(N = 158;特应性/非特应性N = 68/90)。在第24周,在特应性和非特应性亚组中,与安慰剂相比,接受dupilumab治疗的患者在瘙痒(特应性:58.2% vs 20.6%; P < 0.0001;非特应性:59.3% vs 17.8%; P < 0.0001)、皮肤清洁/几乎清洁(特应性:52.2% vs 16.2%; P < 0.0001;非特应性:41.9% vs 17.8%; P = 0.0005)以及瘙痒和皮肤病变改善(特应性:37.3% vs 7.4%; P = 0.0057;非特应性:33.7% vs 10.0%; P = 0.007)方面取得了具有临床意义的改善。与安慰剂相比,接受dupilumab治疗的患者在皮肤疼痛、皮肤病生活质量指数、医院焦虑和抑郁量表以及睡眠方面均有显著改善,无论是否有特应性病史。安全性与已知的dupilumab安全性基本一致。结论:与安慰剂相比,Dupilumab显著改善了成年PN患者的疾病体征、症状和与健康相关的生活质量,其发病时间和反应程度相似,无论是否存在特应性合并症。临床试验注册:ClinicalTrials.gov标识符:NCT04183335和NCT04202679。
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引用次数: 0
Long-Term Safety and Efficacy of Roflumilast Foam 0.3% in Patients with Seborrheic Dermatitis: A Phase II, Open-Label Trial of up to 52 Weeks 罗氟司特泡沫0.3%治疗脂溢性皮炎的长期安全性和有效性:长达52周的II期开放标签试验
IF 8.8 1区 医学 Q1 DERMATOLOGY Pub Date : 2025-11-01 DOI: 10.1007/s40257-025-00984-2
Andrew F. Alexis, Michael Bukhalo, Fran E. Cook-Bolden, James Q. Del Rosso, Zoe D. Draelos, Janet C. DuBois, Laura K. Ferris, Seth B. Forman, Steven E. Kempers, Leon H. Kircik, Edward Lain, Angela Y. Moore, David M. Pariser, Joseph Raoof, Matthew J. Zirwas, Melissa S. Seal, Saori Kato, David H. Chu, David Krupa, Scott Snyder, Patrick Burnett, David R. Berk

Background

The efficacy and safety of once-daily roflumilast foam 0.3%, a potent phosphodiesterase 4 inhibitor, has been demonstrated in patients with seborrheic dermatitis (SD).

Objectives

To evaluate long-term effects of roflumilast foam 0.3% in patients with SD.

Methods

A phase II, open-label trial (no. NCT04445987) was conducted in patients (aged ≥ 12 years) with SD who completed a prior roflumilast foam trial or were naïve to roflumilast and vehicle. Patients applied roflumilast foam 0.3% once daily to all affected areas, including the scalp, face, trunk, and intertriginous areas, for 24 or 52 weeks (during the course of the trial, the protocol was amended to extend the duration of treatment from 24 weeks to 52 weeks). The primary endpoints were occurrence of treatment-emergent adverse events (AEs); local tolerability and efficacy (via Investigator Global Assessment [IGA]) were also assessed.

Results

Overall, 400 patients participated, among whom 62 were enrolled for 52 weeks. AE rates were low, and ≤ 1.1% reported stinging sensation at the application site at each visit. Durable improvement in signs and symptoms of SD was observed at weeks 24 and 52, with 76.0% and 80.4% of patients, respectively, achieving an IGA of clear or almost clear.

Conclusions

Roflumilast foam 0.3% was well tolerated and improved and/or maintained improvements in signs and symptoms of SD for up to 52 weeks.

ClinicalTrials.gov Listing

NCT04445987.

背景:每日一次的罗氟司特泡沫0.3%(一种有效的磷酸二酯酶4抑制剂)在脂溢性皮炎(SD)患者中的有效性和安全性已被证明。目的:评价0.3%罗氟司特泡沫剂治疗SD患者的远期疗效。方法:一项II期开放标签试验(no。NCT04445987)在完成先前罗氟司特泡沫试验或naïve罗氟司特和载体的SD患者(年龄≥12岁)中进行。患者将罗氟司特泡沫0.3%每日一次涂抹于所有受影响的区域,包括头皮、面部、躯干和三节间区,持续24或52周(在试验过程中,修改方案,将治疗时间从24周延长至52周)。主要终点是治疗后出现的不良事件(ae)的发生;局部耐受性和有效性(通过研究者全球评估[IGA])也进行了评估。结果:总共有400名患者参与,其中62名患者入组52周。AE发生率低,每次就诊时在应用部位报告刺痛感≤1.1%。在第24周和第52周观察到SD的体征和症状的持续改善,分别有76.0%和80.4%的患者达到了清晰或几乎清晰的IGA。结论:0.3%的罗氟司特泡沫耐受性良好,可改善和/或维持SD症状和体征的改善长达52周。临床试验:政府上市:NCT04445987。
{"title":"Long-Term Safety and Efficacy of Roflumilast Foam 0.3% in Patients with Seborrheic Dermatitis: A Phase II, Open-Label Trial of up to 52 Weeks","authors":"Andrew F. Alexis,&nbsp;Michael Bukhalo,&nbsp;Fran E. Cook-Bolden,&nbsp;James Q. Del Rosso,&nbsp;Zoe D. Draelos,&nbsp;Janet C. DuBois,&nbsp;Laura K. Ferris,&nbsp;Seth B. Forman,&nbsp;Steven E. Kempers,&nbsp;Leon H. Kircik,&nbsp;Edward Lain,&nbsp;Angela Y. Moore,&nbsp;David M. Pariser,&nbsp;Joseph Raoof,&nbsp;Matthew J. Zirwas,&nbsp;Melissa S. Seal,&nbsp;Saori Kato,&nbsp;David H. Chu,&nbsp;David Krupa,&nbsp;Scott Snyder,&nbsp;Patrick Burnett,&nbsp;David R. Berk","doi":"10.1007/s40257-025-00984-2","DOIUrl":"10.1007/s40257-025-00984-2","url":null,"abstract":"<div><h3>Background</h3><p>The efficacy and safety of once-daily roflumilast foam 0.3%, a potent phosphodiesterase 4 inhibitor, has been demonstrated in patients with seborrheic dermatitis (SD).</p><h3>Objectives</h3><p>To evaluate long-term effects of roflumilast foam 0.3% in patients with SD.</p><h3>Methods</h3><p>A phase II, open-label trial (no. NCT04445987) was conducted in patients (aged ≥ 12 years) with SD who completed a prior roflumilast foam trial or were naïve to roflumilast and vehicle. Patients applied roflumilast foam 0.3% once daily to all affected areas, including the scalp, face, trunk, and intertriginous areas, for 24 or 52 weeks (during the course of the trial, the protocol was amended to extend the duration of treatment from 24 weeks to 52 weeks). The primary endpoints were occurrence of treatment-emergent adverse events (AEs); local tolerability and efficacy (via Investigator Global Assessment [IGA]) were also assessed.</p><h3>Results</h3><p>Overall, 400 patients participated, among whom 62 were enrolled for 52 weeks. AE rates were low, and ≤ 1.1% reported stinging sensation at the application site at each visit. Durable improvement in signs and symptoms of SD was observed at weeks 24 and 52, with 76.0% and 80.4% of patients, respectively, achieving an IGA of clear or almost clear.</p><h3>Conclusions</h3><p>Roflumilast foam 0.3% was well tolerated and improved and/or maintained improvements in signs and symptoms of SD for up to 52 weeks.</p><h3>ClinicalTrials.gov Listing</h3><p>NCT04445987.</p></div>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":"27 1","pages":"189 - 198"},"PeriodicalIF":8.8,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40257-025-00984-2.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145426493","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Correction to: Summary of Research: Efficacy and Safety of Delgocitinib Cream in Adults with Moderate to Severe Chronic Hand Eczema (DELTA 1 and DELTA 2): Results from Multicentre, Randomised, Controlled, Double‑Blind, Phase 3 Trials 更正:研究摘要:Delgocitinib乳膏治疗成人中重度慢性手部湿疹(DELTA 1和DELTA 2)的疗效和安全性:来自多中心、随机、对照、双盲、3期试验的结果。
IF 8.8 1区 医学 Q1 DERMATOLOGY Pub Date : 2025-11-01 DOI: 10.1007/s40257-025-00989-x
Robert Bissonnette, Fatima Albreiki, Benjamin D. Ehst, Anwar Al Hammadi, Sibylle Schliemann, Bin Yang, Jianzhong Zhang, Christopher G. Bunick
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引用次数: 0
The Burden of Acne Vulgaris on Health-Related Quality of Life and Psychosocial Well-Being Domains: A Systematic Review 寻常痤疮对健康相关生活质量和心理健康领域的负担:一项系统综述。
IF 8.8 1区 医学 Q1 DERMATOLOGY Pub Date : 2025-10-24 DOI: 10.1007/s40257-025-00983-3
Alison M. Layton, Vincenzo Bettoli, Valentine Delore, Esteban Puentes, Jerry K. L. Tan

Background

Acne vulgaris (acne) is a common dermatological condition that can profoundly affect psychosocial well-being. Health-related quality of life (HRQoL) is an important outcome measure to assess the burden of acne in research and clinical practice.

Objective

This systematic review aimed to identify, critically appraise, and synthesize current evidence on the effects of acne on HRQoL and other psychosocial outcomes.

Methods

Structured searches of PubMed and Web of Science were conducted to identify studies measuring any HRQoL or psychosocial outcome in patients with acne vulgaris (all ages). Eligible studies were those that included ≥ 50 patients with acne, measured HRQoL or psychosocial outcomes as primary endpoints, were conducted in Europe and North America, and were published in English from 1 January 2014 to 30 April 2024. Risk of bias was assessed using the Joanna Briggs Institute (JBI) critical appraisal tools.

Results

In total, 101 studies were deemed eligible for inclusion. They varied widely in terms of study design, population, outcomes, and quality, but overall demonstrated the adverse impacts of acne on HRQoL, mental health outcomes, and the lived experiences of people with acne. Despite their heterogeneity, studies frequently found that acne predominantly affected the emotional and psychological domains of HRQoL, and was particularly burdensome to adults, females, and those with more severe acne.

Conclusions

This review collated the spectrum of impacts that acne vulgaris can impose on psychosocial well-being, and highlighted the need for consensus outcome measures to streamline future research and improve clinical practice.

PROSPERO Registration

CRD42024539174.

背景:寻常痤疮(痤疮)是一种常见的皮肤病,可深刻影响社会心理健康。健康相关生活质量(HRQoL)是研究和临床实践中评估痤疮负担的重要指标。目的:本系统综述旨在识别、批判性评价和综合痤疮对HRQoL和其他社会心理结局影响的现有证据。方法:对PubMed和Web of Science进行结构化搜索,以确定测量寻常痤疮患者(所有年龄段)HRQoL或心理社会结局的研究。符合条件的研究是在欧洲和北美进行的,包括≥50例痤疮患者,以测量的HRQoL或社会心理结局为主要终点,并于2014年1月1日至2024年4月30日以英文发表。使用乔安娜布里格斯研究所(JBI)关键评估工具评估偏倚风险。结果:总共101项研究被认为符合纳入条件。他们在研究设计、人群、结果和质量方面差异很大,但总体上证明了痤疮对HRQoL、心理健康结果和痤疮患者的生活经历的不利影响。尽管存在异质性,但研究经常发现,痤疮主要影响HRQoL的情感和心理领域,对成年人、女性和痤疮更严重的人来说尤其沉重。结论:本综述整理了寻常痤疮对心理社会健康的一系列影响,并强调了共识性结果措施的必要性,以简化未来的研究和改善临床实践。普洛斯彼罗注册:CRD42024539174。
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引用次数: 0
期刊
American Journal of Clinical Dermatology
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