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Geriatric Psychodermatology: Current Concepts and Therapeutic Strategies. 老年精神皮肤病:当前的概念和治疗策略。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2026-01-16 DOI: 10.1007/s13555-025-01638-1
Alaya Kiser, Tamara Korkomaz, Brianna Ong, Anagha Bangalore Kumar, Katlein França

Introduction: Psychodermatology studies the connection between skin and mental health and is especially relevant in older adults, where visible skin changes and aging often reflect psychological well-being. This is an understudied area in dermatology.

Methods: This narrative review examined literature on the current concepts and management strategies of geriatric psychodermatology. Research databases such as MEDLINE, PubMed, Springer, Google Scholar, and others were investigated, with a total of 131 papers identified. No publication date limits were included.

Results: There is a complex and fascinating relationship between the skin and the brain often referred to as the "skin-brain axis." Common psychodermatologic disorders in the elderly include obsessive-compulsive and related disorders, delusional infestation, and psychogenic pruritus, and these are often difficult to diagnose and manage in the elderly. We also summarize secondary dermatoses from anxiety, depression, stress, and dementia in the elderly. Comprehensive geriatric assessment extends beyond physical health and includes dermatologic, psychiatric, cognitive, and psychosocial domains. Comprehensive care requires collaboration among dermatology, psychiatry, and geriatrics, often incorporating both pharmacologic and non-pharmacologic approaches. We also describe dermatologic signs of elder abuse, dementia complicating psychodermatoses, and review treatment strategies of these conditions.

Conclusion: Psychocutaneous dermatology is a relevant and understudied area that dermatologists should familiarize themselves with. Multidisciplinary care including pharmacologic and non-pharmacologic strategies are often required for the management of these patients.

心理皮肤病学研究皮肤与心理健康之间的联系,尤其与老年人相关,老年人可见的皮肤变化和衰老通常反映心理健康。这是皮肤病学研究不足的领域。方法:本文回顾了有关老年皮肤精神病学的当前概念和管理策略的文献。调查了MEDLINE、PubMed、施普林格、谷歌Scholar等研究数据库,共确定了131篇论文。未包括出版日期限制。结果:在皮肤和大脑之间有一种复杂而迷人的关系,通常被称为“皮肤-大脑轴”。老年人常见的精神皮肤病包括强迫症及相关疾病、妄想感染和心因性瘙痒,这些在老年人中通常难以诊断和治疗。我们也总结了继发性皮肤病从焦虑,抑郁,压力,和老年痴呆。全面的老年评估超越了身体健康,包括皮肤病学、精神病学、认知和社会心理领域。综合护理需要皮肤科、精神病学和老年病学之间的合作,通常结合药物和非药物方法。我们也描述了老年人虐待的皮肤症状,痴呆合并精神皮肤病,并审查这些条件的治疗策略。结论:心理皮肤病学是皮肤科医生应熟悉的一个相关且研究不足的领域。多学科护理包括药物和非药物策略往往需要管理这些患者。
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引用次数: 0
Psychometric Evaluation of Worst Pruritus Numeric Rating Scale in Adults With Moderate-to-Severe Atopic Dermatitis. 中度至重度特应性皮炎成人最严重瘙痒数值评定量表的心理测量评估。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2026-01-16 DOI: 10.1007/s13555-025-01635-4
Andrew Blauvelt, Angela Williams, Kimberly M Deininger, Shanshan Qin, Lauren Nelson, Lori McLeod

Introduction: Atopic dermatitis (AD) is a chronic, inflammatory skin disease with a hallmark symptom of pruritus. We developed Worst Pruritus Numeric Rating Scale (NRS)-a single-item, patient-reported outcome measure-to assess itch severity in clinical trial populations of adults with moderate-to-severe AD. The objective of this study was to evaluate the psychometric properties of Worst Pruritus NRS and determine its appropriateness for use in clinical trials assessing the efficacy of treatments among adults with moderate-to-severe AD.

Methods: We used data from a subset of 267 participants in a phase 2 clinical trial of rocatinlimab (NCT03703102; N = 274) to confirm reliability, validity, and ability to detect change in Worst Pruritus NRS. We estimated and confirmed a meaningful within-patient change (MWPC) threshold using anchor- and distribution-based methods.

Results: All intraclass correlation coefficients (ICCs) were ≥ 0.86, providing robust evidence for test-retest reliability. Evidence supported construct validity, including known-groups validity (all P < 0.0001). There were moderate, positive correlations between scores on Worst Pruritus NRS and supportive measures at week 16, including Dermatology Life Quality Index (DLQI) question 1 (itch item) (r = 0.78), DLQI (r = 0.66), Eczema Area and Severity Index (EASI) (r = 0.50), Investigator's Global Assessment (IGA) (r = 0.46), Body Surface Area of Involvement (BSA) (r = 0.40), and SCORing Atopic Dermatitis (SCORAD) itch item (r = 0.97). On average, patients with better DLQI question 1 scores, EASI, and IGA classifications achieved better (i.e., lower) scores on Worst Pruritus NRS at week 16 (P < 0.0001). Ability to detect change was supported with moderate-to-strong and positive correlations between Worst Pruritus NRS change scores and changes in supporting measures. MWPC estimates confirmed the commonly applied 4-point threshold value and a range of 3 to 4 points as indicative of meaningful within-patient change.

Conclusions: Worst Pruritus NRS is a reliable and valid patient-reported outcome measure to assess itch severity in clinical trial settings among adults with moderate-to-severe AD.

简介:特应性皮炎(AD)是一种慢性炎症性皮肤病,其标志性症状为瘙痒。我们开发了最严重瘙痒数值评定量表(NRS),这是一种单项的、患者报告的结果测量方法,用于评估中度至重度AD成人临床试验人群的瘙痒严重程度。本研究的目的是评估最严重瘙痒NRS的心理测量特性,并确定其是否适合用于评估成人中重度AD治疗效果的临床试验。方法:我们使用来自267名受试者的2期临床试验数据(NCT03703102; N = 274)来确认可靠性、有效性和检测最严重瘙痒症NRS变化的能力。我们使用基于锚点和分布的方法估计并确认了有意义的患者内变化(MWPC)阈值。结果:所有类内相关系数(ICCs)均≥0.86,为重测信度提供了有力证据。证据支持结构效度,包括已知组效度(所有P)结论:最严重瘙痒NRS是一种可靠和有效的患者报告的结果测量,用于评估临床试验中中度至重度AD成人患者的瘙痒严重程度。
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引用次数: 0
Egyptian National Consensus on Dermocosmetic Ingredient Selection Across Common Dermatology Scenarios: A RAND/UCLA Appropriateness Study. 埃及全国共识的皮肤化妆品成分选择跨越常见皮肤病的情况:兰德/加州大学洛杉矶分校的适当性研究。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2026-01-15 DOI: 10.1007/s13555-025-01650-5
Mahmoud A Rageh, Wael M Seoudy, Mohamed F Abozeid, Abeer Mohamed Elkholy, Alaa E A Moubasher, Amany Mohammad Abdel-Latif, Dalia Abdel Aziz Attallah, Essamelden M Mohamed, Hanan Abdelrady Assaf, Hanan Sabry, Mohamed Mahmoud Nasr, Mohamed Saad Hegazy, Nahla Hunter, Nehal Zuelfakkar, Nermeen Ibrahim Bedair, Noha Ezzat Mohammed, Sameh F Abdelkodous, Yasser Mostafa Gohary, Sara M Mohy

Introduction: Dermocosmetics are widely used to complement dermatologic care, yet context-specific guidance remains limited for populations with Fitzpatrick skin types III-V. We convened a national expert panel to generate transparent, reproducible recommendations across ten common clinical scenarios.

Methods: Egyptian dermatologists participated in round 1 (national survey, n = 601) and round 2 (expert panel, n = 16), both with anonymous ratings and inter-round feedback, using the RAND/UCLA appropriateness method (median bands 1-3/4-6/7-9; disagreement index (DI) = interpercentile range (IPR)/IPR adjusted for symmetry (IPRAS); DI > 1.0 = disagreement). Per-item outputs included median, P30, P70, IPR (30-70), asymmetry Index (AI), IPRAS, DI, and final category (appropriate/uncertain/inappropriate). We additionally benchmarked classifications against prior consensus, guidelines, and key evidence frameworks.

Results: Across ten vignettes and 30 ingredients (30 ingredients × 10 scenarios = 300 items; multiple raters per item in round 1), 158 (52.7%) items were appropriate (median ≥ 7; DI ≤ 1.0), 135 (45.0%) were uncertain, and 7 (2.3%) were inappropriate. Photoprotection had the highest appropriateness across scenarios (broad-spectrum/tinted SPF), with a small number of DI-flagged uncertain exceptions. Hydration/barrier agents (e.g., hyaluronic acid, peptides, ceramides) were appropriate in stress-aging, post-laser, and post-procedure care. Pigment modulators (tranexamic acid, arbutin, niacinamide, vitamin C, glabridin) were appropriate in melasma/post-inflammatory hyperpigmentation and chronic sun-induced pigmentation. Classical retinoids were inappropriate for postpartum/breastfeeding and immediate post-procedure; lower-irritancy retinoid esters were context-dependent. Botanicals showed inconsistent support. Panel disagreement (DI > 1.0) declined from 38.3% in round 1 to 15.7% (47/300) in round 2. Patterns largely aligned with prior consensus; visible-light-mitigating photoprotection and timing-specific retinoid use were emphasized for darker phototypes.

Conclusion: We provide a transparent, regionally relevant framework for dermocosmetic ingredient selection. Sun protection and barrier support are foundational; pigment modulators are scenario-specific; retinoids require selective use; botanicals remain adjunctive.

皮肤化妆品被广泛用于补充皮肤护理,但针对Fitzpatrick皮肤III-V型人群的具体指导仍然有限。我们召集了一个国家专家小组,针对10种常见的临床情况提出透明、可重复的建议。方法:埃及皮肤科医生参加第1轮(全国调查,n = 601)和第2轮(专家小组,n = 16),采用RAND/UCLA适当性方法(中位数范围1-3/4-6/7-9;分歧指数(DI) =百分位数范围(IPR)/经对称调整的IPR (IPRAS))进行匿名评分和轮间反馈;DI > 1.0 =不同意)。每项输出包括中位数、P30、P70、IPR(30-70)、不对称指数(AI)、IPRAS、DI和最终类别(适当/不确定/不适当)。我们还根据先前的共识、指南和关键证据框架对分类进行基准测试。结果:在10个小章节和30个成分(30个成分× 10个场景= 300个项目;第1轮每个项目有多个评分者)中,158个(52.7%)个项目是合适的(中位数≥7;DI≤1.0),135个(45.0%)不确定,7个(2.3%)是不合适的。光防护在各种情况下(广谱/着色SPF)的适宜性最高,只有少数di标记的不确定例外。水合/屏障剂(如透明质酸、多肽、神经酰胺)适用于应力老化、激光后和手术后护理。色素调节剂(氨甲环酸、熊果苷、烟酰胺、维生素C、光甘草定)适用于黄褐斑/炎症后色素沉着和慢性日晒引起的色素沉着。经典类维生素a不适合产后/母乳喂养和术后立即使用;低刺激性类维甲酸酯与环境相关。植物学的支持并不一致。小组分歧(DI bbb1.0)从第一轮的38.3%下降到第二轮的15.7%(47/300)。模式基本上与先前的共识一致;对于较暗的照相类型,强调了可见光减弱光保护和定时特异性类维生素a的使用。结论:我们为皮肤化妆品成分选择提供了一个透明的、区域相关的框架。防晒和屏障支持是基础;色素调节剂是特定场景的;类维生素a需要选择性使用;植物药仍然是辅助性的。
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引用次数: 0
Outcomes in Patients with Psoriasis Following Apremilast Treatment: Results from the German Psoriasis Registry PsoBest. 阿普米司特治疗后银屑病患者的预后:来自德国银屑病登记处PsoBest的结果。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2026-01-15 DOI: 10.1007/s13555-025-01631-8
Matthias Augustin, Stephan J Rustenbach, Ralph von Kiedrowski, Hamid Amouzadeh, Kathy Tran, Myriam Cordey, Ulrich Mrowietz

Introduction: The German national psoriasis registry PsoBest collects long-term data on the effectiveness, safety, and tolerability of systemic treatments for psoriatic disease. Here, we describe patient characteristics and the safety and effectiveness of apremilast for the treatment of psoriatic disease in Germany based on data from PsoBest.

Methods: This was a descriptive analysis of observational data collected from PsoBest using cross-sectional (baseline characteristics) and longitudinal (outcomes, safety) designs. PsoBest recruits patients with moderate to severe plaque psoriasis or psoriatic arthritis who initiate a new systemic psoriasis treatment. Adverse events (AEs) and sociodemographic descriptors were reported for patients exposed to apremilast during the study period (safety cohort). Clinical and patient-reported outcomes were collected 3, 6, and 12 months after the initiation of apremilast monotherapy (outcomes cohort).

Results: From January 15, 2015 to June 30, 2020, 595 registry patients were exposed to apremilast; 417 were treated with apremilast monotherapy. Patients taking apremilast had a higher mean age and higher proportions of comorbidities such as cardiovascular or metabolic disease compared with those taking other nonbiologic systemic or biologic drugs. The most common nonserious AEs were drug ineffectiveness (14.1%), diarrhea (9.4%), nausea (7.1%), and headache (6.1%). The highest incidence rates of nonserious and serious AEs of special interest were for infections and infestations per system organ class (8.03/100 patient-years) and malignant or unspecified tumors (2.50/100 patient-years), respectively. Improvements in Dermatology Life Quality Index, patient-defined treatment benefits (Patient Benefit Index), body surface area, and Psoriasis Area and Severity Index were observed after 3, 6, and 12 months of apremilast treatment.

Conclusions: Patients in routine care treated with apremilast in the German PsoBest registry experienced treatment benefits and improved skin, psoriasis severity, and quality of life. Safety was consistent with the established safety profile. Apremilast is safe and effective for treating moderate to severe psoriatic disease.

简介:德国国家银屑病登记处PsoBest收集银屑病全身治疗的有效性、安全性和耐受性的长期数据。在这里,我们根据PsoBest的数据描述了德国患者的特征以及阿普雷米司特治疗银屑病的安全性和有效性。方法:采用横断面(基线特征)和纵向(结局、安全性)设计对PsoBest收集的观察数据进行描述性分析。PsoBest招募患有中度至重度斑块型银屑病或银屑病关节炎的患者,他们开始了一种新的系统性银屑病治疗。在研究期间(安全队列),报告了暴露于阿普雷米司特的患者的不良事件(ae)和社会人口学描述。在阿普米司特单药治疗开始后3、6和12个月收集临床和患者报告的结果(结果队列)。结果:2015年1月15日至2020年6月30日,595例登记患者暴露于阿普拉米司特;417例接受阿普米司特单药治疗。与服用其他非生物系统或生物药物的患者相比,服用阿普米司特的患者平均年龄更高,心血管或代谢性疾病等合并症的比例更高。最常见的非严重ae是药物无效(14.1%)、腹泻(9.4%)、恶心(7.1%)和头痛(6.1%)。非严重和特别关注的严重ae的最高发生率分别是系统器官类别的感染和侵染(8.03/100患者-年)和恶性或未明确肿瘤(2.50/100患者-年)。在阿普米司特治疗3、6和12个月后,观察皮肤病学生活质量指数、患者定义的治疗获益(患者获益指数)、体表面积、牛皮癣面积和严重程度指数的改善。结论:在德国PsoBest注册中心,接受阿普米司特常规治疗的患者获得了治疗益处,改善了皮肤、银屑病的严重程度和生活质量。安全性与既定的安全概况一致。阿普拉米司特治疗中重度银屑病安全有效。
{"title":"Outcomes in Patients with Psoriasis Following Apremilast Treatment: Results from the German Psoriasis Registry PsoBest.","authors":"Matthias Augustin, Stephan J Rustenbach, Ralph von Kiedrowski, Hamid Amouzadeh, Kathy Tran, Myriam Cordey, Ulrich Mrowietz","doi":"10.1007/s13555-025-01631-8","DOIUrl":"https://doi.org/10.1007/s13555-025-01631-8","url":null,"abstract":"<p><strong>Introduction: </strong>The German national psoriasis registry PsoBest collects long-term data on the effectiveness, safety, and tolerability of systemic treatments for psoriatic disease. Here, we describe patient characteristics and the safety and effectiveness of apremilast for the treatment of psoriatic disease in Germany based on data from PsoBest.</p><p><strong>Methods: </strong>This was a descriptive analysis of observational data collected from PsoBest using cross-sectional (baseline characteristics) and longitudinal (outcomes, safety) designs. PsoBest recruits patients with moderate to severe plaque psoriasis or psoriatic arthritis who initiate a new systemic psoriasis treatment. Adverse events (AEs) and sociodemographic descriptors were reported for patients exposed to apremilast during the study period (safety cohort). Clinical and patient-reported outcomes were collected 3, 6, and 12 months after the initiation of apremilast monotherapy (outcomes cohort).</p><p><strong>Results: </strong>From January 15, 2015 to June 30, 2020, 595 registry patients were exposed to apremilast; 417 were treated with apremilast monotherapy. Patients taking apremilast had a higher mean age and higher proportions of comorbidities such as cardiovascular or metabolic disease compared with those taking other nonbiologic systemic or biologic drugs. The most common nonserious AEs were drug ineffectiveness (14.1%), diarrhea (9.4%), nausea (7.1%), and headache (6.1%). The highest incidence rates of nonserious and serious AEs of special interest were for infections and infestations per system organ class (8.03/100 patient-years) and malignant or unspecified tumors (2.50/100 patient-years), respectively. Improvements in Dermatology Life Quality Index, patient-defined treatment benefits (Patient Benefit Index), body surface area, and Psoriasis Area and Severity Index were observed after 3, 6, and 12 months of apremilast treatment.</p><p><strong>Conclusions: </strong>Patients in routine care treated with apremilast in the German PsoBest registry experienced treatment benefits and improved skin, psoriasis severity, and quality of life. Safety was consistent with the established safety profile. Apremilast is safe and effective for treating moderate to severe psoriatic disease.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145984599","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Improvement of Chronic Spontaneous Urticaria After Glucagon-Like Peptide 1 Receptor Agonist Therapy: Report of Two Cases. 胰高血糖素样肽1受体激动剂治疗后慢性自发性荨麻疹的改善:附2例报告。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2026-01-14 DOI: 10.1007/s13555-025-01640-7
Bartłomiej Kwiek, Julia Sieczych, Katarzyna Łukowska, Marcin Ambroziak

Chronic spontaneous urticaria (CSU) is a mast cell-driven disease that affects approximately 1% of the population. Second-generation non-sedating H1-antihistamines (H1AH) are considered the first-line treatment; however, a substantial proportion of patients remain refractory and require alternative therapeutic approaches, including anti-IgE antibodies or other agents that inhibit mast cell activation and degranulation. Glucagon-like peptide 1 receptor agonists (GLP-1RAs) are widely used for the treatment of type 2 diabetes mellitus and obesity and are known to reduce cardiovascular risk as well as comorbidities such as kidney disease and depression. In addition, GLP-1RAs have been reported to improve several autoimmune and autoinflammatory disorders, including dermatoses such as psoriasis, hidradenitis suppurativa, and atopic dermatitis. Several mechanisms have been proposed to explain the immunomodulatory effects of GLP-1RAs, including their influence on cytokine networks and immune cells, particularly mast cells. We report two female patients, aged 44 and 45 years, with long-standing CSU inadequately controlled on high-dose H1AH, who were initially prescreened for participation in a clinical trial with barzolvolimab. Before trial enrollment, both initiated GLP-1RA therapy (semaglutide or tirzepatide) for metabolic indications. Remarkably, both patients achieved complete resolution of CSU within 3 weeks of GLP-1RA initiation, with remission persisting for over 6 months. These observations suggest a potential immunometabolic mechanism linking GLP-1 signaling and mast cell activation, highlighting a novel therapeutic avenue for antihistamine-resistant CSU.

慢性自发性荨麻疹(CSU)是一种肥大细胞驱动的疾病,影响大约1%的人口。第二代非镇静性h1 -抗组胺药(H1AH)被认为是一线治疗;然而,相当大比例的患者仍然难治性,需要替代治疗方法,包括抗ige抗体或其他抑制肥大细胞活化和脱颗粒的药物。胰高血糖素样肽1受体激动剂(GLP-1RAs)广泛用于治疗2型糖尿病和肥胖症,已知可降低心血管风险以及肾脏疾病和抑郁症等合并症。此外,据报道,GLP-1RAs可改善多种自身免疫性和自身炎症性疾病,包括牛皮癣、化脓性汗腺炎和特应性皮炎等皮肤病。已经提出了几种机制来解释GLP-1RAs的免疫调节作用,包括它们对细胞因子网络和免疫细胞,特别是肥大细胞的影响。我们报告了两名女性患者,年龄分别为44岁和45岁,患有长期CSU,高剂量H1AH控制不足,他们最初被筛选参加barzolvolimab的临床试验。在试验入组前,两人都开始GLP-1RA治疗代谢适应症(西马鲁肽或替西帕肽)。值得注意的是,两名患者在GLP-1RA启动的3周内实现了CSU的完全缓解,缓解持续了6个多月。这些观察结果表明,GLP-1信号传导和肥大细胞活化之间存在潜在的免疫代谢机制,为抗组胺耐药性CSU提供了新的治疗途径。
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引用次数: 0
The Intersection of Sleep and Hair Loss: A Systematic Review. 睡眠和脱发的交叉:一个系统的回顾。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2026-01-14 DOI: 10.1007/s13555-025-01641-6
Tanya Boghosian, Hannah Mendez, Mira Sayegh, Alejandro Rabionet, Jacob Beer, Antonella Tosti

Introduction: Sleep disturbance is increasingly recognized as a modifier of dermatologic disease, yet its role in hair loss remains underexplored. Hair loss disorders, including alopecia areata (AA), androgenetic alopecia (AGA), telogen effluvium (TE), and scarring alopecias, carry substantial psychosocial burden and involve neuroendocrine and immune pathways sensitive to sleep quality.

Objective: To systematically evaluate associations between sleep disturbances and hair loss across major hair loss subtypes, define shared and subtype-specific mechanisms, and highlight insights relevant to counseling, symptom monitoring, and dermatologic management.

Methods: A Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA)-guided systematic review of PubMed and Scopus identified 291 studies examining sleep disturbances in hair loss. After duplicate removal and screening by two independent reviewers, 29 studies were included. Extracted data included study design, level of evidence, hair loss subtype, sleep measures, mechanisms, and psychosocial correlates.

Results: Overall evidence quality was low to moderate (1 level II, 11 level III, 14 level IV, and 3 level V), with cross-sectional studies predominating (n = 15). AA was most represented (n = 14), followed by AGA (n = 11), TE (n = 3), lichen planopilaris (LPP) (n = 1), and traction alopecia (n = 1). Sleep disturbance was consistently elevated across AA, AGA, TE, and LPP populations, commonly assessed by the PSQI. Mechanistic themes varied by subtype: cytokine activation, hypothalamic-pituitary-adrenal axis dysregulation, and altered clock-genes in AA; circadian misalignment, obstructive sleep apnea-related hypoxia, and hormonal imbalance in AGA; neurogenic inflammation and substance-P pathways in TE; and chronic pruritus and pain in LPP. Psychosocial distress amplified sleep disruption in most subtypes.

Conclusions: Across hair loss disorders, sleep disturbance emerges as a biologically plausible and clinically relevant contributor to disease burden. Although most evidence is observational, converging mechanistic and psychosocial data support a bidirectional relationship between sleep quality and hair loss. Incorporating brief sleep assessments into hair loss care and considering sleep-targeted interventions may improve disease stability and patient well-being. Longitudinal and mechanistic studies are needed to clarify causality and identify therapeutic targets.

引言:睡眠障碍被越来越多地认为是皮肤病的一种修饰剂,但其在脱发中的作用仍未得到充分探讨。脱发疾病,包括斑秃(AA)、雄激素源性脱发(AGA)、休眠期脱发(TE)和瘢痕性脱发,会带来沉重的社会心理负担,并涉及对睡眠质量敏感的神经内分泌和免疫途径。目的:系统地评估主要脱发亚型中睡眠障碍与脱发之间的关联,定义共享和特定亚型的机制,并强调与咨询、症状监测和皮肤病学管理相关的见解。方法:系统评价和荟萃分析(PRISMA)的首选报告项目- PubMed和Scopus引导的系统评价确定了291项研究,研究了脱发中的睡眠障碍。经过两位独立评论者的重复删除和筛选,纳入了29项研究。提取的数据包括研究设计、证据水平、脱发亚型、睡眠测量、机制和社会心理相关因素。结果:总体证据质量为中低水平(1个二级水平,11个三级水平,14个四级水平,3个V级水平),以横断面研究为主(n = 15)。AA最多(n = 14),其次是AGA (n = 11)、TE (n = 3)、扁平苔藓(LPP) (n = 1)和牵引性脱发(n = 1)。睡眠障碍在AA、AGA、TE和LPP人群中持续升高,通常由PSQI评估。机制主题因亚型而异:AA中的细胞因子激活、下丘脑-垂体-肾上腺轴失调和时钟基因改变;AGA患者的昼夜节律失调、阻塞性睡眠呼吸暂停相关的缺氧和激素失衡;TE的神经源性炎症和物质- p通路;LPP的慢性瘙痒和疼痛。在大多数亚型中,社会心理困扰加剧了睡眠中断。结论:在脱发障碍中,睡眠障碍是一种生物学上合理且临床相关的疾病负担因素。虽然大多数证据是观察性的,但趋同的机制和社会心理数据支持睡眠质量和脱发之间的双向关系。将短暂的睡眠评估纳入脱发护理,并考虑针对睡眠的干预措施,可能会改善疾病的稳定性和患者的健康状况。需要纵向和机制研究来澄清因果关系和确定治疗靶点。
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引用次数: 0
Retrospective Analysis of Lebrikizumab in the Management of Atopic Dermatitis: Insights from Real-World Practice. Lebrikizumab治疗特应性皮炎的回顾性分析:来自现实世界实践的见解。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2026-01-12 DOI: 10.1007/s13555-025-01630-9
Nikolaos Stavropoulos, Daniel Myszkowski, Dennis Braß, Vasileios Dervenis, Effimia Poungoura, Eggert Stockfleth

Introduction:  Atopic dermatitis (AD) is a chronic, relapsing inflammatory disease, significantly impacting a patient's quality of life. To date, a substantial proportion of patients present an insufficient response to available treatment options. Lebrikizumab, a monoclonal antibody targeting interleukin 13, has shown a promising clinical benefit in phase 3 trials, however, real-world data on the effectiveness and safety of lebrikizumab for atopic dermatitis (AD) are limited and mostly restricted to Asian populations. Aim of this study was to evaluate the real-world effectiveness and safety of lebrikizumab in patients with AD.

Methods:  This retrospective study included 35 patients from a largely homogenous Central European population with moderate to severe Atopic Dermatitis treated with lebrikizumab at the Dermatology Department of the St. Josef-Hospital in Bochum between December 2023 and April 2025. Eczema area and severity index (EASI), SCORing Atopic Dermatitis (SCORAD), peak-pruritus (PP)-numerical rating scale (NRS) and dermatology life quality index (DLQI) were assessed during the treatment.

Results: Lebrikizumab reduced all clinical indices by week 4, with improvements maintained through week 16. At week 24, the achievement rates for EASI-50 (50% reduction in EASI), EASI-75 (75% reduction in EASI) and EASI-90 (90% reduction in EASI) were 100%, 75% and 75%, respectively, and the SCORAD-50 (50% reduction in SCORAD) response rate was 64.2%. The proportions of patients achieving a ≥ 4-point reduction in the PP-NRS and in the DLQI at week 24 were 55.8% and 91.6%, respectively. No new safety signals were observed.

Conclusion:  Lebrikizumab demonstrated favorable real-world effectiveness and safety over 24 weeks in patients with moderate-to-severe AD, supporting its use in routine clinical practice.

特应性皮炎(AD)是一种慢性、复发性炎症性疾病,严重影响患者的生活质量。迄今为止,相当大比例的患者对现有的治疗方案反应不足。Lebrikizumab是一种靶向白细胞介素13的单克隆抗体,在3期试验中显示出有希望的临床益处,然而,关于Lebrikizumab治疗特应性皮炎(AD)的有效性和安全性的实际数据有限,而且主要局限于亚洲人群。本研究的目的是评估lebrikizumab在AD患者中的实际有效性和安全性。方法:这项回顾性研究包括35例来自中欧大部分同质人群的中度至重度特应性皮炎患者,这些患者于2023年12月至2025年4月在波hum St. josef医院皮肤科接受lebrikizumab治疗。评估治疗期间湿疹面积及严重程度指数(EASI)、特应性皮炎评分(SCORAD)、瘙痒峰(PP)-数值评定量表(NRS)和皮肤病生活质量指数(DLQI)。结果:Lebrikizumab在第4周降低了所有临床指标,并在第16周保持改善。在第24周,EASI-50 (EASI降低50%)、EASI-75 (EASI降低75%)和EASI-90 (EASI降低90%)的完成率分别为100%、75%和75%,SCORAD-50 (SCORAD降低50%)的有效率为64.2%。在第24周,PP-NRS和DLQI降低≥4点的患者比例分别为55.8%和91.6%。没有观察到新的安全信号。结论:Lebrikizumab在中重度AD患者24周内显示出良好的实际有效性和安全性,支持其在常规临床实践中的使用。
{"title":"Retrospective Analysis of Lebrikizumab in the Management of Atopic Dermatitis: Insights from Real-World Practice.","authors":"Nikolaos Stavropoulos, Daniel Myszkowski, Dennis Braß, Vasileios Dervenis, Effimia Poungoura, Eggert Stockfleth","doi":"10.1007/s13555-025-01630-9","DOIUrl":"https://doi.org/10.1007/s13555-025-01630-9","url":null,"abstract":"<p><strong>Introduction: </strong> Atopic dermatitis (AD) is a chronic, relapsing inflammatory disease, significantly impacting a patient's quality of life. To date, a substantial proportion of patients present an insufficient response to available treatment options. Lebrikizumab, a monoclonal antibody targeting interleukin 13, has shown a promising clinical benefit in phase 3 trials, however, real-world data on the effectiveness and safety of lebrikizumab for atopic dermatitis (AD) are limited and mostly restricted to Asian populations. Aim of this study was to evaluate the real-world effectiveness and safety of lebrikizumab in patients with AD.</p><p><strong>Methods: </strong> This retrospective study included 35 patients from a largely homogenous Central European population with moderate to severe Atopic Dermatitis treated with lebrikizumab at the Dermatology Department of the St. Josef-Hospital in Bochum between December 2023 and April 2025. Eczema area and severity index (EASI), SCORing Atopic Dermatitis (SCORAD), peak-pruritus (PP)-numerical rating scale (NRS) and dermatology life quality index (DLQI) were assessed during the treatment.</p><p><strong>Results: </strong>Lebrikizumab reduced all clinical indices by week 4, with improvements maintained through week 16. At week 24, the achievement rates for EASI-50 (50% reduction in EASI), EASI-75 (75% reduction in EASI) and EASI-90 (90% reduction in EASI) were 100%, 75% and 75%, respectively, and the SCORAD-50 (50% reduction in SCORAD) response rate was 64.2%. The proportions of patients achieving a ≥ 4-point reduction in the PP-NRS and in the DLQI at week 24 were 55.8% and 91.6%, respectively. No new safety signals were observed.</p><p><strong>Conclusion: </strong> Lebrikizumab demonstrated favorable real-world effectiveness and safety over 24 weeks in patients with moderate-to-severe AD, supporting its use in routine clinical practice.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145959046","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Efficacy and Safety of Platelet-Rich Plasma and Hyaluronic Acid Combination Treatment for Neck Rejuvenation in Thailand: A Prospective Study. 富血小板血浆和透明质酸联合治疗泰国颈部年轻化的疗效和安全性:一项前瞻性研究。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2026-01-11 DOI: 10.1007/s13555-025-01645-2
Stephanie T de Leon, Diandra A Zabala, Noldtawat Viriyaskultorn, Panyapat Buranaporn, Woramate Bhorntarakcharoen, Thrit Hutachoke, Thanyaporn Leesanguankul, Teerapat Wannawittayapa, Wetch Tantrapongsathorn, Sariya Sittiwanaruk, Rungsima Wanitphakdeedecha

Introduction: Combined platelet-rich plasma and hyaluronic acid (PRP-HA) offers a promising nonsurgical technique for tissue regeneration through synergistic efficacy and longevity effects. This study aims to investigate PRP-HA's efficacy and safety for neck rejuvenation.

Methods: This 32-week prospective trial enrolled 30 Thai participants with mild-to-moderate neck aging. Treatment consisted of three monthly intradermal PRP-HA injections to the anterior neck surface, with follow-ups at 2 weeks, and 1, 2, 3, and 6 months posttreatment completion. Assessment included skin firmness, elasticity, biometric parameters, pain scores, and adverse effects.

Results: Of 29 completing participants, neck skin firmness improved 54% from baseline at 3-month posttreatment completion, increasing to 65% at 6 months (p < 0.0001). While gross elasticity initially improved at 1 month posttreatment (p = 0.0217); it subsequently declined. The 6-month follow-up showed substantial reductions in melanin and erythema (p < 0.01). Sustained improvements were observed in hydration through study completion (p < 0.01). Sebum levels decreased significantly after the first two treatments and at 3 months posttreatment (p < 0.05). No significant changes appeared in skin texture, wrinkles, and brightness. Most participants reported 51-75% improvement after the third treatment, maintaining through 6 months. No severe adverse effects were reported.

Conclusions: PRP-HA demonstrates safe and effective improvements in neck skin firmness, hydration, and pigment and sebum regulation, with benefits lasting 6 months after three treatment sessions. However, variable effects on elasticity and modest results on wrinkles, texture, and brightness warrant further controlled trials to further elucidate and confirm its rejuvenative properties on the neck.

Trial registration: This trial is registered under the Thai Clinical Trials Registry (TCTR20230212003).

富血小板血浆和透明质酸联合应用(PRP-HA)具有协同效应和长寿效应,是一种很有前途的非手术组织再生技术。本研究旨在探讨PRP-HA在颈部年轻化中的有效性和安全性。方法:这项为期32周的前瞻性试验招募了30名轻度至中度颈部衰老的泰国参与者。治疗包括三个月皮内PRP-HA注射到颈部前表面,并在治疗完成后2周,1、2、3和6个月随访。评估包括皮肤紧致度、弹性、生物特征参数、疼痛评分和不良反应。结果:在29名完成治疗的参与者中,在治疗结束后3个月,颈部皮肤紧致度较基线改善了54%,在6个月时增加到65% (p结论:PRP-HA在颈部皮肤紧致度、水合作用、色素和皮脂调节方面表现出安全有效的改善,在三次治疗后持续6个月的益处。然而,对弹性的不同影响和对皱纹,质地和亮度的适度效果需要进一步的对照试验来进一步阐明和确认其对颈部的恢复活力的特性。试验注册:该试验在泰国临床试验注册中心(TCTR20230212003)注册。
{"title":"Efficacy and Safety of Platelet-Rich Plasma and Hyaluronic Acid Combination Treatment for Neck Rejuvenation in Thailand: A Prospective Study.","authors":"Stephanie T de Leon, Diandra A Zabala, Noldtawat Viriyaskultorn, Panyapat Buranaporn, Woramate Bhorntarakcharoen, Thrit Hutachoke, Thanyaporn Leesanguankul, Teerapat Wannawittayapa, Wetch Tantrapongsathorn, Sariya Sittiwanaruk, Rungsima Wanitphakdeedecha","doi":"10.1007/s13555-025-01645-2","DOIUrl":"https://doi.org/10.1007/s13555-025-01645-2","url":null,"abstract":"<p><strong>Introduction: </strong>Combined platelet-rich plasma and hyaluronic acid (PRP-HA) offers a promising nonsurgical technique for tissue regeneration through synergistic efficacy and longevity effects. This study aims to investigate PRP-HA's efficacy and safety for neck rejuvenation.</p><p><strong>Methods: </strong>This 32-week prospective trial enrolled 30 Thai participants with mild-to-moderate neck aging. Treatment consisted of three monthly intradermal PRP-HA injections to the anterior neck surface, with follow-ups at 2 weeks, and 1, 2, 3, and 6 months posttreatment completion. Assessment included skin firmness, elasticity, biometric parameters, pain scores, and adverse effects.</p><p><strong>Results: </strong>Of 29 completing participants, neck skin firmness improved 54% from baseline at 3-month posttreatment completion, increasing to 65% at 6 months (p < 0.0001). While gross elasticity initially improved at 1 month posttreatment (p = 0.0217); it subsequently declined. The 6-month follow-up showed substantial reductions in melanin and erythema (p < 0.01). Sustained improvements were observed in hydration through study completion (p < 0.01). Sebum levels decreased significantly after the first two treatments and at 3 months posttreatment (p < 0.05). No significant changes appeared in skin texture, wrinkles, and brightness. Most participants reported 51-75% improvement after the third treatment, maintaining through 6 months. No severe adverse effects were reported.</p><p><strong>Conclusions: </strong>PRP-HA demonstrates safe and effective improvements in neck skin firmness, hydration, and pigment and sebum regulation, with benefits lasting 6 months after three treatment sessions. However, variable effects on elasticity and modest results on wrinkles, texture, and brightness warrant further controlled trials to further elucidate and confirm its rejuvenative properties on the neck.</p><p><strong>Trial registration: </strong>This trial is registered under the Thai Clinical Trials Registry (TCTR20230212003).</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145951616","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Guselkumab Treatment ADHEREnce in BulGaria of Patients with Psoriasis-ADHERE-BG Study. 保加利亚银屑病患者的Guselkumab治疗依从性-依从性- bg研究
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2026-01-10 DOI: 10.1007/s13555-025-01643-4
Grisha S Mateev, Zdravka V Demerdjieva, Rumyana K Yankova, Klimentina D Gospodinova, Boryana E Ilieva, Razvigor B Darlenski

Introduction: Treatment adherence is crucial for managing chronic diseases, including plaque psoriasis. In Bulgaria, patients with plaque psoriasis can receive treatment with reimbursed biologics, such as guselkumab, if they meet National Health Insurance Fund (NHIF) requirements. These requirements include stringent disease criteria and a complex administrative process. The objective of this analysis is to assess the proportion of patients adhering to the guselkumab administration schedule, as specified in the summary of product characteristics (SmPC), after the first continuation of the NHIF treatment approval period (approximately 48 weeks).

Methods: This was a prospective, multicenter, single-country, noninterventional study. The primary endpoint was the proportion of patients adhering to the guselkumab administration schedule as outlined in the SmPC after the first continuation of the NHIF treatment approval period. Secondary endpoints included evaluating guselkumab's safety and efficacy, as well as patient profile.

Results: This study included 39 female and 61 male patients with plaque psoriasis, with a mean age of 51.5 years. Overall, 95% of enrolled patients adhered to the guselkumab dosing regimen (i.e., received all seven doses) at 50 weeks after study initiation. Treatment with guselkumab led to a rapid and sustained reduction in Psoriasis Area and Severity Index (PASI) scores, with 84.4% of patients achieving PASI 90 and 42.7% reaching PASI 100 by the final visit. Significant improvements were also observed in absolute PASI, body surface area (BSA), and Dermatology Life Quality Index (DLQI) scores, indicating marked disease control and enhanced quality of life across the study period. There were ten adverse events during the study, and no new safety signals for guselkumab were identified.

Conclusions: Bulgarian patients treated with guselkumab adhered well to treatment in this study, with an adherence rate comparable to that observed in randomized clinical trials and higher than the drug survival rates reported in real-world studies. This may be owing, in part, to the existing patient support programs specific to Bulgaria. Treatment with guselkumab in real-life clinical practice in Bulgaria was well tolerated and effective in reducing signs and symptoms of plaque psoriasis, consistent with the overall efficacy and safety profile demonstrated in randomized controlled trials.

治疗依从性是至关重要的管理慢性疾病,包括斑块牛皮癣。在保加利亚,斑块型银屑病患者如果符合国家健康保险基金(NHIF)的要求,可以接受报销的生物制剂治疗,如guselkumab。这些要求包括严格的疾病标准和复杂的行政程序。本分析的目的是评估在NHIF治疗批准期(约48周)首次延续后,按照产品特性摘要(SmPC)中规定的,坚持使用guselkumab给药计划的患者比例。方法:这是一项前瞻性、多中心、单一国家、非干预性研究。主要终点是在NHIF治疗批准期第一次延续后,SmPC中概述的坚持使用guselkumab给药计划的患者比例。次要终点包括评估guselkumab的安全性和有效性,以及患者概况。结果:本研究纳入斑块型银屑病患者39例,男性61例,平均年龄51.5岁。总体而言,95%的入组患者在研究开始后50周坚持使用guselkumab给药方案(即接受所有7个剂量)。guselkumab治疗导致银屑病面积和严重程度指数(PASI)评分快速持续下降,到最后一次就诊时,84.4%的患者达到PASI 90, 42.7%的患者达到PASI 100。绝对PASI、体表面积(BSA)和皮肤病生活质量指数(DLQI)评分也有显著改善,表明在整个研究期间,疾病得到了明显的控制,生活质量得到了提高。在研究期间有10个不良事件,没有发现新的guselkumab安全信号。结论:在本研究中,接受guselkumab治疗的保加利亚患者对治疗的依从性良好,其依从率与随机临床试验中观察到的依从率相当,高于现实世界研究中报道的药物生存率。这可能部分归因于保加利亚现有的患者支持方案。在保加利亚的实际临床实践中,使用guselkumab治疗在减轻斑块型银屑病的体征和症状方面具有良好的耐受性和有效性,与随机对照试验中显示的总体疗效和安全性一致。
{"title":"Guselkumab Treatment ADHEREnce in BulGaria of Patients with Psoriasis-ADHERE-BG Study.","authors":"Grisha S Mateev, Zdravka V Demerdjieva, Rumyana K Yankova, Klimentina D Gospodinova, Boryana E Ilieva, Razvigor B Darlenski","doi":"10.1007/s13555-025-01643-4","DOIUrl":"https://doi.org/10.1007/s13555-025-01643-4","url":null,"abstract":"<p><strong>Introduction: </strong>Treatment adherence is crucial for managing chronic diseases, including plaque psoriasis. In Bulgaria, patients with plaque psoriasis can receive treatment with reimbursed biologics, such as guselkumab, if they meet National Health Insurance Fund (NHIF) requirements. These requirements include stringent disease criteria and a complex administrative process. The objective of this analysis is to assess the proportion of patients adhering to the guselkumab administration schedule, as specified in the summary of product characteristics (SmPC), after the first continuation of the NHIF treatment approval period (approximately 48 weeks).</p><p><strong>Methods: </strong>This was a prospective, multicenter, single-country, noninterventional study. The primary endpoint was the proportion of patients adhering to the guselkumab administration schedule as outlined in the SmPC after the first continuation of the NHIF treatment approval period. Secondary endpoints included evaluating guselkumab's safety and efficacy, as well as patient profile.</p><p><strong>Results: </strong>This study included 39 female and 61 male patients with plaque psoriasis, with a mean age of 51.5 years. Overall, 95% of enrolled patients adhered to the guselkumab dosing regimen (i.e., received all seven doses) at 50 weeks after study initiation. Treatment with guselkumab led to a rapid and sustained reduction in Psoriasis Area and Severity Index (PASI) scores, with 84.4% of patients achieving PASI 90 and 42.7% reaching PASI 100 by the final visit. Significant improvements were also observed in absolute PASI, body surface area (BSA), and Dermatology Life Quality Index (DLQI) scores, indicating marked disease control and enhanced quality of life across the study period. There were ten adverse events during the study, and no new safety signals for guselkumab were identified.</p><p><strong>Conclusions: </strong>Bulgarian patients treated with guselkumab adhered well to treatment in this study, with an adherence rate comparable to that observed in randomized clinical trials and higher than the drug survival rates reported in real-world studies. This may be owing, in part, to the existing patient support programs specific to Bulgaria. Treatment with guselkumab in real-life clinical practice in Bulgaria was well tolerated and effective in reducing signs and symptoms of plaque psoriasis, consistent with the overall efficacy and safety profile demonstrated in randomized controlled trials.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145948516","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Psychometric Evaluation of Skin Pain and Sleep Disturbance Numeric Rating Scales in Moderate-to-Severe Atopic Dermatitis. 中重度特应性皮炎患者皮肤疼痛和睡眠障碍数值评定量表的心理测量评估。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2026-01-09 DOI: 10.1007/s13555-025-01634-5
Andrew Blauvelt, Kimberly M Deininger, Joshua Porter, Alexis Sohn, Shanshan Qin, Lori McLeod, Angela J Rylands, Lauren Nelson

Introduction: Atopic dermatitis (AD) is a chronic inflammatory skin condition often associated with skin pain and sleep disturbance. The AD Skin Pain Numeric Rating Scale (SP-NRS) and Sleep Disturbance NRS (SD-NRS) are single-item patient-reported outcome measures developed to assess AD-related skin pain and sleep disturbance severity, respectively, in AD clinical trials.

Methods: We used data from three randomized, double-blinded, placebo-controlled clinical trials of rocatinlimab in adults (aged ≥ 18 years) (ROCKET-IGNITE and ROCKET-SHUTTLE) and adolescents (aged ≥ 12 to < 18 years) (ROCKET-ASTRO) with moderate-to-severe AD to assess the reliability, validity, and responsiveness of the AD SP-NRS and SD-NRS. Clinical outcome assessments (COAs) supported the psychometric evaluation, and we estimated meaningful change thresholds for the AD SP-NRS and SD-NRS using anchor-based methods, which we confirmed with distribution-based methods. We included data from both the treatment arm and placebo in our analyses, and we analyzed results from adult and adolescent populations separately.

Results: This psychometric analysis sample used 262 adults (ROCKET-IGNITE, n = 145; ROCKET-SHUTTLE, n = 117) and 109 adolescents (ROCKET-ASTRO, n = 109), subsets from the initial data cuts of the respective clinical trials, in the psychometric analysis sample. Both AD SP-NRS and SD-NRS scores demonstrated high test-retest reliability for both adults and adolescents (intraclass correlation coefficients ≥ 0.80) and moderate-to-strong (|r| ≥ 0.30) positive correlations with most supporting COAs. Anchor-based meaningful within-patient change threshold ranges derived for AD SP-NRS and SD-NRS scores supported both 3-point and 4-point improvement thresholds for characterizing clinically meaningful changes.

Conclusions: The AD SP-NRS and SD-NRS are reliable, valid, and responsive measures for assessing moderate-to-severe AD in adults and adolescents in clinical trials. The meaningful change thresholds identified in this study can be used in future clinical trials to interpret treatment effects.

特应性皮炎(AD)是一种慢性炎症性皮肤病,常伴有皮肤疼痛和睡眠障碍。AD皮肤疼痛数值评定量表(SP-NRS)和睡眠障碍数值评定量表(SD-NRS)是在AD临床试验中分别用于评估AD相关皮肤疼痛和睡眠障碍严重程度的单项患者报告结果测量。方法:我们使用rocatinlimab在成人(≥18岁)(ROCKET-IGNITE和ROCKET-SHUTTLE)和青少年(≥12岁)中进行的三个随机、双盲、安慰剂对照临床试验的数据。结果:该心理测量分析样本使用262名成人(ROCKET-IGNITE, n = 145; ROCKET-SHUTTLE, n = 117)和109名青少年(ROCKET-ASTRO, n = 109),这些亚群来自各自临床试验的初始数据cut,在心理测量分析样本中。AD SP-NRS和SD-NRS评分在成人和青少年中均表现出较高的重测信度(类内相关系数≥0.80),并且与大多数支持coa呈中至强(|或|≥0.30)正相关。基于锚定的AD SP-NRS和SD-NRS评分的患者内有意义的变化阈值范围支持3分和4分改善阈值来表征临床有意义的变化。结论:在临床试验中,AD SP-NRS和SD-NRS是评估成人和青少年中重度AD的可靠、有效和反应灵敏的方法。本研究确定的有意义的变化阈值可用于未来的临床试验来解释治疗效果。
{"title":"Psychometric Evaluation of Skin Pain and Sleep Disturbance Numeric Rating Scales in Moderate-to-Severe Atopic Dermatitis.","authors":"Andrew Blauvelt, Kimberly M Deininger, Joshua Porter, Alexis Sohn, Shanshan Qin, Lori McLeod, Angela J Rylands, Lauren Nelson","doi":"10.1007/s13555-025-01634-5","DOIUrl":"https://doi.org/10.1007/s13555-025-01634-5","url":null,"abstract":"<p><strong>Introduction: </strong>Atopic dermatitis (AD) is a chronic inflammatory skin condition often associated with skin pain and sleep disturbance. The AD Skin Pain Numeric Rating Scale (SP-NRS) and Sleep Disturbance NRS (SD-NRS) are single-item patient-reported outcome measures developed to assess AD-related skin pain and sleep disturbance severity, respectively, in AD clinical trials.</p><p><strong>Methods: </strong>We used data from three randomized, double-blinded, placebo-controlled clinical trials of rocatinlimab in adults (aged ≥ 18 years) (ROCKET-IGNITE and ROCKET-SHUTTLE) and adolescents (aged ≥ 12 to < 18 years) (ROCKET-ASTRO) with moderate-to-severe AD to assess the reliability, validity, and responsiveness of the AD SP-NRS and SD-NRS. Clinical outcome assessments (COAs) supported the psychometric evaluation, and we estimated meaningful change thresholds for the AD SP-NRS and SD-NRS using anchor-based methods, which we confirmed with distribution-based methods. We included data from both the treatment arm and placebo in our analyses, and we analyzed results from adult and adolescent populations separately.</p><p><strong>Results: </strong>This psychometric analysis sample used 262 adults (ROCKET-IGNITE, n = 145; ROCKET-SHUTTLE, n = 117) and 109 adolescents (ROCKET-ASTRO, n = 109), subsets from the initial data cuts of the respective clinical trials, in the psychometric analysis sample. Both AD SP-NRS and SD-NRS scores demonstrated high test-retest reliability for both adults and adolescents (intraclass correlation coefficients ≥ 0.80) and moderate-to-strong (|r| ≥ 0.30) positive correlations with most supporting COAs. Anchor-based meaningful within-patient change threshold ranges derived for AD SP-NRS and SD-NRS scores supported both 3-point and 4-point improvement thresholds for characterizing clinically meaningful changes.</p><p><strong>Conclusions: </strong>The AD SP-NRS and SD-NRS are reliable, valid, and responsive measures for assessing moderate-to-severe AD in adults and adolescents in clinical trials. The meaningful change thresholds identified in this study can be used in future clinical trials to interpret treatment effects.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145942798","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
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Dermatology and Therapy
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