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Efficacy and Safety of a Drinkable Nutraceutical in Premenopausal Women with Telogen Effluvium: A 6-Month, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study. 一种可饮用营养品对绝经前妇女休止期排尿的疗效和安全性:一项为期6个月、随机、多中心、双盲、安慰剂对照研究
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2026-01-01 Epub Date: 2025-11-25 DOI: 10.1007/s13555-025-01585-x
Claudia Bernárdez, Sebastian Podlipnik, Gillian E Westgate, Ralf Paus, Laura Zamfir, Daniela Grohmann, Manuel Sáez Moya

Introduction: Hair loss is a multifactorial and complex condition influenced by hormonal changes, nutritional deficiencies, genetic predisposition, oxidative stress, aging, inflammation, and psychological stress. This 6-month study evaluated the hair growth-promoting efficacy and safety of a drinkable nutraceutical (Olistic© Women) formulated with standardized ingredients to support hair health through multiple biological pathways.

Methods: A total of 106 premenopausal female subjects (18-40 years) clinically diagnosed with telogen effluvium were randomized in a double-blind manner into the active (n = 53) or placebo (n = 53) arm, taking 1 vial (25 mL) per day for 6 months. The primary endpoint was the increase in hair density from baseline versus placebo assessed by phototrichoscopy using TrichoScan®; the secondary endpoints were the change in anagen-to-catagen/telogen (A:C/T) ratio assessed by phototrichogram using TrichoScan®, as well as safety and tolerability. This study was reviewed and approved (approval number 20230918-EC48.23) by the Comité de Ética de la Investigación con medicamentos (CEIm) Regional de la Comunidad de Madrid in Madrid, Spain.

Results: Daily oral supplementation with the active product was well tolerated and resulted in a statistically significant increase in hair density versus placebo at day 90 (17.53 ± 2.46 vs 9.56 ± 2.43 hairs/cm2; P = 0.02) and day 180 (27.31 ± 2.61 vs 18.23 ± 2.98 hairs/cm2; P < 0.01). The A:C/T ratio showed a statistically significant increase from day 0 to day 180 in the active arm (from 8.20:1 to 14.19:1) versus placebo (from 7.43:1 to 8.76:1) (P < 0.001).

Conclusion: The tested nutraceutical showed a statistically significant increase in hair density and A:C/T ratio compared to placebo over 6 months in premenopausal women with telogen effluvium. These results not only support efficacy and safety of the tested nutraceutical but also that a multifactorial nutraceutical approach can effectively manage telogen effluvium in premenopausal women.

Trial registration: ClinicalTrials.gov identifier, NCT07111312 (retrospectively registered 07/2025).

简介:脱发是一种多因素的复杂疾病,受激素变化、营养缺乏、遗传易感性、氧化应激、衰老、炎症和心理压力的影响。这项为期6个月的研究评估了一种可饮用营养品(Olistic©Women)的促进头发生长的功效和安全性,该营养品由标准化成分配制,通过多种生物途径支持头发健康。方法:106例经临床诊断为休止期排尿的绝经前女性(18-40岁)以双盲方式随机分为主动组(n = 53)和安慰剂组(n = 53),每天服用1小瓶(25 mL),持续6个月。主要终点是毛发密度较基线相比安慰剂的增加,使用TrichoScan®进行光毛发镜检查评估;次要终点是使用TrichoScan®进行的毛发摄影评估的生长期-衰退期/休止期(A:C/T)比率的变化,以及安全性和耐受性。本研究由西班牙马德里Ética de la Investigación医疗保健委员会(CEIm)区域委员会审查并批准(批准号20230918-EC48.23)。结果:每日口服补充活性产品耐受良好,与安慰剂相比,在第90天(17.53±2.46 vs 9.56±2.43毛发/cm2; P = 0.02)和第180天(27.31±2.61 vs 18.23±2.98毛发/cm2)时头发密度增加具有统计学意义;P结论:经测试的营养保健产品与安慰剂相比,在6个月内绝经前休止期排出的妇女的头发密度和a:C/T比值增加具有统计学意义。这些结果不仅支持所测试的营养品的有效性和安全性,而且还支持多因素营养品方法可以有效地控制绝经前妇女的休止期排尿。试验注册:ClinicalTrials.gov标识符,NCT07111312(回顾性注册于07/2025)。
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引用次数: 0
Burden, Treatment Patterns and Real-World Barriers to Prescribing Advanced Treatments in Adults with Atopic Dermatitis in Brazil and Colombia. 巴西和哥伦比亚成人特应性皮炎的负担、治疗模式和现实世界障碍
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2026-01-01 Epub Date: 2025-11-19 DOI: 10.1007/s13555-025-01589-7
Emmanuel Papadimitropoulos, Peter Anderson, Guilherme Muzy, Jenny Austin, Anne Roehrig, Camila De Lima Tostes, Silvia Sabatino

Introduction: This study aimed to explore the relationship between atopic dermatitis (AD) disease severity and impact on patients and to describe AD treatment patterns and barriers to treatment in Brazil and Colombia.

Methods: Data were drawn from the Adelphi AD Disease Specific Programme™, a cross-sectional survey of physicians and their patients with AD, conducted in Brazil and Colombia between May 2022 and July 2023. Physicians provided data on demographics, clinical characteristics, treatments, and reasons for not prescribing targeted therapy (TT). Patients completed various patient-reported outcome (PRO) questionnaires: Patient-Oriented Eczema Measure, Dermatology Life Quality Index, EuroQol five-dimensional, and Work Productivity and Activity Impairment. Data were analysed descriptively. Comparisons between current severity were made using analysis of variance (ANOVA) or Kruskal-Wallis tests.

Results: Overall, 100 physicians provided data for 624 adult patients with AD from Brazil (n = 328) and Colombia (n = 296): 47% currently mild, 43% moderate, and 10% severe. For all the PRO measures analysed in Colombia and for the majority in Brazil, the impact on patients increased with increasing disease severity (p < 0.05). In total, 85% of patients with AD in Brazil and 73% in Colombia were treated with topical therapies, with 51% in Brazil and 77% in Colombia receiving systemic therapies, which included biologics (Brazil 12%; Colombia 33%) and oral Janus kinase inhibitors (Brazil 5% and Colombia 10%). The main barriers to TT in Brazil were patients being unable to pay for treatment and treatment not being covered by health insurance. In Colombia, the main barriers were formulary restrictions and patients being very recently diagnosed.

Conclusions: Increased AD disease severity was associated with a greater patient impact and reduced quality of life, with healthcare costs and formulary restrictions hindering optimal treatment across Brazil and Colombia.

本研究旨在探讨特应性皮炎(AD)疾病严重程度与患者影响之间的关系,并描述巴西和哥伦比亚的AD治疗模式和治疗障碍。方法:数据来自Adelphi AD疾病特定计划™,这是一项对巴西和哥伦比亚的AD医生及其患者的横断面调查,于2022年5月至2023年7月期间进行。医生提供了人口统计学、临床特征、治疗和不开靶向治疗(TT)的原因的数据。患者完成了各种患者报告结果(PRO)问卷调查:以患者为导向的湿疹测量、皮肤病生活质量指数、EuroQol五维度以及工作效率和活动障碍。对数据进行描述性分析。采用方差分析(ANOVA)或Kruskal-Wallis检验对当前严重程度进行比较。结果:总体而言,来自巴西(n = 328)和哥伦比亚(n = 296)的100名医生提供了624名成年AD患者的数据:47%目前为轻度,43%为中度,10%为重度。对于在哥伦比亚分析的所有PRO措施和在巴西分析的大多数措施,对患者的影响随着疾病严重程度的增加而增加(p结论:阿尔茨海默病严重程度的增加与更大的患者影响和生活质量的降低相关,医疗成本和处方限制阻碍了巴西和哥伦比亚的最佳治疗。
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引用次数: 0
Atopic Dermatitis Successfully Treated with Lebrikizumab in Real-World Clinical Practice in Czech Republic: A Case Series. 在捷克共和国的临床实践中,Lebrikizumab成功治疗特应性皮炎:一个病例系列。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2026-01-01 Epub Date: 2025-12-05 DOI: 10.1007/s13555-025-01608-7
Marie Jandová, Radek Litvik, Martin Tichý, Spyridon Gkalpakiotis

Atopic dermatitis (AD) is a chronic inflammatory skin disease associated with impaired quality of life and a substantial burden of disease. Lebrikizumab is a monoclonal antibody that selectively binds with high affinity to interleukin-13, thereby inhibiting its cascade signaling and reducing inflammation. Lebrikizumab has demonstrated efficacy and safety in adults and adolescents ≥ 12 years with moderate-to-severe AD in randomized, placebo-controlled, phase 3 clinical trials. Here, we report a case series of four patients with moderate-to-severe AD who transitioned to lebrikizumab treatment in the Czech Republic. All four patients had failed previous targeted therapies (biologics or Janus kinase inhibitors) and/or cyclosporine treatments and presented with associated comorbidities. After 12 to 16 weeks of treatment with lebrikizumab, clinically significant improvements in signs and symptoms (assessed by Eczema Area and Severity Index [EASI], pruritus Numerical Rate Scale, quality of life assessed by the Dermatology Life Quality Index [DLQI], and/or Patient Oriented Eczema Measure [POEM]) were reported. The results of these four clinical cases support the effectiveness observed in randomized clinical trials and suggest that lebrikizumab may be an effective treatment for moderate-severe AD in real-world clinical practice, even in patients with comorbidities who have failed previous advanced treatments.

特应性皮炎(AD)是一种慢性炎症性皮肤病,与生活质量受损和疾病负担相关。Lebrikizumab是一种单克隆抗体,选择性地与白细胞介素-13高亲和力结合,从而抑制其级联信号传导并减轻炎症。在随机、安慰剂对照的3期临床试验中,Lebrikizumab已经证明了对患有中重度AD的成人和青少年≥12岁的有效性和安全性。在这里,我们报告了捷克共和国4例中度至重度AD患者过渡到lebrikizumab治疗的病例系列。所有4例患者先前的靶向治疗(生物制剂或Janus激酶抑制剂)和/或环孢素治疗均失败,并出现相关合并症。经lebrikizumab治疗12至16周后,临床显著改善体征和症状(通过湿疹面积和严重程度指数[EASI],瘙痒数值率量表,皮肤病生活质量指数[DLQI]评估的生活质量,和/或患者定向湿疹测量[POEM])。这四个临床病例的结果支持随机临床试验中观察到的有效性,并提示lebrikizumab可能是现实世界临床实践中中重度AD的有效治疗方法,即使是在先前高级治疗失败的合并症患者中也是如此。
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引用次数: 0
A 6-Month, Prospective, Multi-arm Study for the Efficacy of Standardized Nutraceuticals to Improve Hair Fiber Thickness and Strength. 标准化营养品改善头发纤维厚度和强度的6个月前瞻性多组研究
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2026-01-01 Epub Date: 2025-10-31 DOI: 10.1007/s13555-025-01582-0
Zoe Draelos, Patricia K Farris, Adina Hazan, Isabelle Raymond

Introduction: Hair thinning is a prevalent concern influenced by multiple factors including stress, hormonal changes, diet, and lifestyle, with varying impacts across demographic groups. Oral supplements addressing these key root causes through a multi-targeting, patented, botanical-based Synergen Complex have been developed to combat hair thinning across different populations. This study sought to build on existing evidence from previous clinical studies evaluating hair growth and quality by evaluating the effectiveness of these nutraceuticals in enhancing hair fiber diameter, and thus hair strength and length, in adults with thinning hair.

Methods: This 6-month, prospective, open-label study included women, plant-based women, menopausal women, parous women, and men consuming commercially available hair growth nutraceuticals (HGNs) targeted to different demographics (Nutrafol® Women, Vegan, Balance, Postpartum, and Men). All subjects had hair thinning, self-reported and confirmed by the study dermatologist. Assessments occurred at baseline, day 90, and day 180. Measurements included hair shaft diameter via light microscopy, hair breakage/shedding via a four-region hair pull test, investigator global assessment (IGA) of hair parameters, and subject self-perception questionnaire.

Results: A total of 252 participants enrolled, with 244 completing the study per protocol. Ingestion of the HGNs was associated with a significant increase in hair shaft diameter across all groups by day 180. Hair pull tests showed significant reductions in intact, broken, and total hair shedding overall. In-person IGA was correlated with significant improvements in hair attributes-strength, length, thickness, and overall hair health-across all groups. Self-perception data revealed strong agreement across groups with statements regarding hair improvements by day 180.

Conclusions: This study demonstrates that ingestion of these bio-specific HGNs are associated with significantly enhanced hair shaft diameter and decreased breakage, resulting in longer, stronger hair across their intended populations. These findings support the use of these HGNs for hair thinning, offering alternative options for various populations for improving hair growth and thickness.

Clinicaltrials: gov identifier, NCT06362941.

头发稀疏是一个普遍关注的问题,受多种因素的影响,包括压力、荷尔蒙变化、饮食和生活方式,在不同的人口群体中有不同的影响。口服补充剂解决这些关键的根本原因,通过多目标,专利,植物为基础的增效复合物已开发对抗脱发在不同的人群。这项研究试图建立在先前临床研究的现有证据的基础上,通过评估这些营养保健品在增加头发纤维直径方面的有效性,从而提高头发的强度和长度,从而评估头发的生长和质量。方法:这项为期6个月的前瞻性、开放标签研究包括女性、植物性女性、绝经期女性、产后女性和男性,他们使用市售的头发生长营养保健品(hgn),针对不同的人群(Nutrafol®女性、素食者、平衡者、产后和男性)。所有受试者都有头发稀疏的情况,这是他们自己报告的,并得到了皮肤科医生的证实。评估分别在基线、第90天和第180天进行。测量方法包括通过光学显微镜测量毛干直径,通过四区拔毛测试测量头发破损/脱落,研究者对头发参数的整体评估(IGA),以及受试者自我感知问卷。结果:共有252名参与者入组,其中244人完成了每个方案的研究。到第180天,摄入HGNs与所有组的毛干直径显著增加有关。毛发拉扯测试显示完整、断裂和全部毛发脱落明显减少。在所有人群中,面对面的IGA与头发属性的显著改善——强度、长度、厚度和整体头发健康——相关。自我认知数据显示,在180天内,两组人对头发改善的看法非常一致。结论:本研究表明,摄入这些生物特异性hgn与显著增加毛干直径和减少断裂有关,从而使目标人群的头发更长、更结实。这些发现支持使用这些hgn来治疗头发稀疏,为不同人群提供了改善头发生长和厚度的替代选择。临床试验:政府识别码,NCT06362941。
{"title":"A 6-Month, Prospective, Multi-arm Study for the Efficacy of Standardized Nutraceuticals to Improve Hair Fiber Thickness and Strength.","authors":"Zoe Draelos, Patricia K Farris, Adina Hazan, Isabelle Raymond","doi":"10.1007/s13555-025-01582-0","DOIUrl":"10.1007/s13555-025-01582-0","url":null,"abstract":"<p><strong>Introduction: </strong>Hair thinning is a prevalent concern influenced by multiple factors including stress, hormonal changes, diet, and lifestyle, with varying impacts across demographic groups. Oral supplements addressing these key root causes through a multi-targeting, patented, botanical-based Synergen Complex have been developed to combat hair thinning across different populations. This study sought to build on existing evidence from previous clinical studies evaluating hair growth and quality by evaluating the effectiveness of these nutraceuticals in enhancing hair fiber diameter, and thus hair strength and length, in adults with thinning hair.</p><p><strong>Methods: </strong>This 6-month, prospective, open-label study included women, plant-based women, menopausal women, parous women, and men consuming commercially available hair growth nutraceuticals (HGNs) targeted to different demographics (Nutrafol<sup>®</sup> Women, Vegan, Balance, Postpartum, and Men). All subjects had hair thinning, self-reported and confirmed by the study dermatologist. Assessments occurred at baseline, day 90, and day 180. Measurements included hair shaft diameter via light microscopy, hair breakage/shedding via a four-region hair pull test, investigator global assessment (IGA) of hair parameters, and subject self-perception questionnaire.</p><p><strong>Results: </strong>A total of 252 participants enrolled, with 244 completing the study per protocol. Ingestion of the HGNs was associated with a significant increase in hair shaft diameter across all groups by day 180. Hair pull tests showed significant reductions in intact, broken, and total hair shedding overall. In-person IGA was correlated with significant improvements in hair attributes-strength, length, thickness, and overall hair health-across all groups. Self-perception data revealed strong agreement across groups with statements regarding hair improvements by day 180.</p><p><strong>Conclusions: </strong>This study demonstrates that ingestion of these bio-specific HGNs are associated with significantly enhanced hair shaft diameter and decreased breakage, resulting in longer, stronger hair across their intended populations. These findings support the use of these HGNs for hair thinning, offering alternative options for various populations for improving hair growth and thickness.</p><p><strong>Clinicaltrials: </strong>gov identifier, NCT06362941.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"353-363"},"PeriodicalIF":4.2,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12873040/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145421351","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Is Cumulative Life Course Impairment Considered in Psoriasis Management? A Multinational Survey of People with Psoriasis and Healthcare Professionals. 银屑病治疗中是否考虑累积生命过程损害?对牛皮癣患者和医疗保健专业人员的跨国调查。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2026-01-01 Epub Date: 2025-11-22 DOI: 10.1007/s13555-025-01573-1
Raymond Matthews, April W Armstrong, Matthias Augustin, Christopher Baker, José Manuel Carrascosa, Brian Kirby, Richard Langley, Sandy McBride, Adam Reich, Ricardo Romiti, Francesca Sampogna, Richard B Warren

Introduction: Delays remain in patients receiving effective treatment strategies that have potential to clear their skin of psoriasis, improve their quality of life (QoL) and change the psoriatic disease course, which, if uncontrolled, can irreversibly alter an individual's life course (i.e. cumulative life course impairment [CLCI]). This study explored current international awareness and consideration of the potential impact of psoriasis over the life course within clinical assessments and decisions about its management.

Methods: Cross-sectional surveys collated insights from people with psoriasis and healthcare professionals (HCPs) treating psoriasis (dermatologists and primary care physicians [PCPs]) across 29 countries.

Results: Data were collected from 487 people with psoriasis, 574 dermatologists and 618 PCPs. Despite people with psoriasis highlighting a range of daily activities that are 'very frequently' or 'always' affected by their psoriasis, 37% were never or rarely asked by their HCPs how the disease affects their life. Fewer than half of people with psoriasis had a high understanding of the potential future impact of psoriasis (or CLCI-contributing factors), and 44% were unaware that clear/almost clear skin is now a realistic treatment target. Almost half of HCPs considered psoriasis to be of early onset when it presented at ≤ 15 years of age. Despite HCP awareness of the impact of psoriasis on QoL, many of the contributing factors to CLCI were not addressed routinely in clinical practice nor considered when deciding on treatment; 40% of dermatologists set treatment goals (such as clear skin/almost clear skin/target Dermatology Life Quality Index [DLQI]) sometimes, less frequently, or not at all.

Conclusions: Misalignment exists in the experience of people living with psoriasis versus its assessment in clinical practice. Support is needed for assessment and monitoring of elements that may contribute to CLCI in clinical practice worldwide, to guide early psoriasis treatment decision-making to mitigate the risk for CLCI. Infographic available for this article. INFOGRAPHIC.

患者接受有效治疗策略的延迟仍然存在,这些治疗策略有可能清除银屑病的皮肤,改善他们的生活质量(QoL)并改变银屑病病程,如果不加以控制,可能不可逆转地改变个体的生命历程(即累积生命历程损害[CLCI])。本研究探讨了目前国际上对牛皮癣在生命过程中潜在影响的认识和考虑,并对其临床评估和管理决策进行了探讨。方法:横断面调查收集了来自29个国家的牛皮癣患者和治疗牛皮癣的医疗保健专业人员(皮肤科医生和初级保健医生[pcp])的见解。结果:收集了487名牛皮癣患者、574名皮肤科医生和618名pcp的数据。尽管牛皮癣患者强调一系列日常活动“非常频繁”或“总是”受到牛皮癣的影响,但37%的人从未或很少被他们的医护人员问及这种疾病如何影响他们的生活。不到一半的牛皮癣患者对牛皮癣潜在的未来影响(或导致银屑病的因素)有高度的了解,44%的人不知道清洁/几乎清洁的皮肤现在是一个现实的治疗目标。几乎一半的医护人员认为牛皮癣在≤15岁时出现是早发性的。尽管HCP意识到牛皮癣对生活质量的影响,但许多导致CLCI的因素在临床实践中没有得到常规处理,在决定治疗时也没有考虑到;40%的皮肤科医生有时、很少或根本不设定治疗目标(如皮肤清洁/几乎清洁/目标皮肤生活质量指数[DLQI])。结论:银屑病患者的经验与临床评估存在偏差。在全球临床实践中,需要支持对可能导致CLCI的因素进行评估和监测,以指导银屑病早期治疗决策,以减轻CLCI的风险。本文提供的信息图。信息图表。
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引用次数: 0
Lebrikizumab for the Treatment of Moderate to Severe Atopic Eczema: Real-World Experience from a Tertiary Centre. Lebrikizumab治疗中度至重度特应性湿疹:来自三级中心的真实世界经验。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2026-01-01 Epub Date: 2025-12-06 DOI: 10.1007/s13555-025-01614-9
Azmeralda Abraheem, Neenu Sebastian, Firas C Kreeshan, Tim H Clayton, Hamish J A Hunter, Richard B Warren

Introduction: Lebrikizumab, a human monoclonal antibody that targets interleukin-13, is approved for treating moderate to severe atopic dermatitis in many regions. However, real-world data are lacking and are needed to inform its efficacy and safety in broader populations.

Methods: This retrospective study reviewed the Eczema Area and Severity Index (EASI) and Dermatology Life Quality Index (DLQI) at baseline and 16-20 weeks of 84 consecutive patients who received lebrikizumab subcutaneously at the label dose in a tertiary centre.

Results: EASI scores were available at 16-20 weeks for 72 patients. At this timepoint, 80.6% (58/72) achieved EASI 50, 56.9% (41/72) reached EASI 75, and 27.8% (20/72) attained EASI 90. DLQI was reduced by an average of - 1.5 points at 16-20 weeks. No serious adverse events were reported. Ocular adverse events occurred in 21.4% of the cohort (18/84). Eleven out of 14 patients that previously experienced conjunctivitis with dupilumab or tralokinumab had no recurrence with lebrikizumab.

Conclusion: In this real-world cohort of patients with atopic dermatitis, lebrikizumab demonstrated efficacy comparable to that observed in clinical trials. It may provide an alternative treatment option for individuals who have discontinued other biologics as a result of conjunctivitis.

Lebrikizumab是一种靶向白介素-13的人单克隆抗体,在许多地区被批准用于治疗中度至重度特应性皮炎。然而,缺乏真实世界的数据,需要了解其在更广泛人群中的有效性和安全性。方法:本回顾性研究回顾了基线和16-20周84例连续在第三级中心接受标签剂量来布单抗皮下注射的患者的湿疹面积和严重程度指数(EASI)和皮肤病生活质量指数(DLQI)。结果:72例患者在16-20周时获得EASI评分。在此时间点,80.6%(58/72)达到EASI 50, 56.9%(41/72)达到EASI 75, 27.8%(20/72)达到EASI 90。16-20周时DLQI平均下降- 1.5点。无严重不良事件报告。眼部不良事件发生率为21.4%(18/84)。14例既往使用杜匹单抗或曲洛单抗经历结膜炎的患者中有11例使用莱布单抗后没有复发。结论:在这个现实世界的特应性皮炎患者队列中,lebrikizumab显示出与临床试验中观察到的疗效相当的疗效。它可能为因结膜炎而停用其他生物制剂的个体提供另一种治疗选择。
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引用次数: 0
Comparison of All-Cause Mortality in Generalized Pustular Psoriasis and Plaque Psoriasis: A Systematic Review and Meta-Analysis. 广泛性脓疱性银屑病和斑块性银屑病全因死亡率的比较:系统回顾和荟萃分析。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2026-01-01 Epub Date: 2025-11-08 DOI: 10.1007/s13555-025-01584-y
Bruce Strober, Lluís Puig, Mark G Lebwohl, Bhargav Lakshminarasimhan, Shah Alam Khan, Nichiren Pillai, Bregt Kappelhoff, Amy R Weatherill, Richard B Warren

Introduction: Generalized pustular psoriasis (GPP) is a chronic, systemic neutrophilic inflammatory disease, associated with acute flares and life-threatening complications. Plaque psoriasis, which is clinically and pathologically distinct from GPP, is also associated with mortality. While this has improved with the advent of effective biological therapies, progress in GPP is limited. The objective of this study was to compare all-cause mortality in GPP patients with that of plaque psoriasis patients and the general population.

Methods: Studies reporting mortality in GPP and ≥ 1 comparator group were selected for inclusion in meta-analyses through a systematic literature review and review of unpublished data. Two independent reviewers performed study screening and data extraction. Pooled hazard ratios (HRs) were calculated using random effects models.

Results: Primary meta-analyses included studies in Sweden and the USA, representing 3652, 8308 and 10,102 people with GPP, with plaque psoriasis and in the general population, respectively. All-cause mortality was 1.78 times higher (95% confidence interval [CI]: 1.52-2.09; P < 0.0001) for GPP than for plaque psoriasis and 2.92 times higher (95% CI: 1.12-7.60; P = 0.03) than for the general population. Sensitivity analyses, including studies in Germany and France, confirmed the primary results for GPP versus plaque psoriasis; pooled HRs were 1.79-2.31 (P < 0.01 for all analyses). Effect sizes across all four studies were considerably heterogeneous (I2 = 93.58%; Q = 54.93; P < 0.0001). A study in Germany, with significant heterogeneity, possibly due to miscoding issues, was included in a sensitivity analysis for GPP patients versus the general population; the pooled HR reduced to 1.63 (95% CI: 0.45-5.97; P = 0.46), with considerable heterogeneity in effect sizes (I2 = 98.35%; Q = 61.42; P < 0.0001).

Conclusion: GPP patients' all-cause mortality is 2-3 times higher than those for plaque psoriasis patients and the general population, highlighting the need for improved management of GPP. This analysis provides a reference point to evaluate changes in mortality following the introduction of targeted treatments.

简介:全身性脓疱性牛皮癣(GPP)是一种慢性全身性中性粒细胞炎症性疾病,伴有急性发作和危及生命的并发症。斑块型银屑病在临床和病理上与GPP不同,也与死亡率相关。虽然随着有效生物疗法的出现,这种情况有所改善,但GPP的进展有限。本研究的目的是比较GPP患者与斑块型银屑病患者和一般人群的全因死亡率。方法:通过系统的文献回顾和未发表的资料回顾,选择报告GPP死亡率和≥1个比较组的研究纳入meta分析。两名独立审稿人进行研究筛选和数据提取。采用随机效应模型计算合并风险比(hr)。结果:主要荟萃分析包括瑞典和美国的研究,分别代表3652、8308和10102名GPP患者、斑块型牛皮癣患者和普通人群。全因死亡率高1.78倍(95%可信区间[CI]: 1.52-2.09; P = 93.58%; Q = 54.93; P = 98.35%; Q = 61.42; P)结论:GPP患者的全因死亡率比斑块型银屑病患者和一般人群高2-3倍,突出了GPP管理的必要性。该分析为评估引入靶向治疗后死亡率的变化提供了参考点。
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引用次数: 0
Healthcare Resource Utilization and Economic Burden Across Clinical Phenotypes of Moderate-to-Severe Atopic Dermatitis in United States Dermatology Facilities. 美国皮肤科机构中重度特应性皮炎临床表型的医疗资源利用和经济负担
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2026-01-01 Epub Date: 2025-11-17 DOI: 10.1007/s13555-025-01590-0
Matthew Zirwas, Peter Lio, Lawrence Rasouliyan, Amanda G Althoff, Danae A Black, Lorenzo Sabatelli, Gil Yosipovitch

Introduction: Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by intense itch and recurrent lesions that impose clinical and economic burden. The individual and combined contributions of itch intensity and lesion severity to healthcare resource utilization (HCRU) and costs are not well defined. This study characterized real-world clinical phenotypes of moderate-to-severe AD based on itch and lesion severity and quantified their associations with HCRU and healthcare charges.

Methods: A retrospective cohort study was conducted using linked electronic health records and claims data from the OMNY Health Dermatology Platform (January 2022-June 2024). Patients aged ≥ 12 years with moderate-to-severe AD, defined by prescription treatment, were included. Patients were stratified into four clinical phenotypes based on their scores on the Itch Numerical Rating Scale (NRS) and Investigator Global Assessment (IGA): moderate itch and moderate lesions (MI-ML), severe itch and moderate lesions (SI-ML), moderate itch and severe lesions (MI-SL), and severe itch and severe lesions (SI-SL). Annualized all-cause HCRU and total healthcare charges were assessed using multinomial propensity score weighting. Logistic regression identified predictors of high total charges (≥ 90th percentile).

Results: Among 4433 patients with moderate-to-severe AD, phenotype distribution was MI-ML (33%), SI-ML (43%), MI-SL (4%), and SI-SL (21%). While HCRU event rates (hospitalizations, emergency visits) were similar across phenotypes, mean annual total charges differed notably. Compared with MI-ML ($23,697), charges increased with severe itch (SI-ML: + $2197), severe lesions (MI-SL: + $3705), and both severe itch and lesions (SI-SL: + $10,448), driven mainly by pharmacy and outpatient costs. Mean annual charges were highest in SI-SL ($34,145), followed by MI-SL ($27,402), SI-ML ($25,894), and MI-ML ($23,697). Severe itch alone was associated with elevated pharmacy expenditures, whereas severe lesions primarily increased outpatient costs. In multivariable models, biologic use, systemic therapy, and comorbidities were predictors of high total charges.

Conclusion: Both itch intensity and lesion severity independently and additively contributed to HCRU and economic burden of moderate-to-severe AD. Severe itch primarily increased pharmacy spending, while severe lesions drove outpatient costs. The combined phenotype of severe itch and lesions incurred the highest overall charges, underscoring the need for phenotype-informed, comprehensive AD management strategies.

特应性皮炎(AD)是一种慢性炎症性皮肤病,其特征是强烈瘙痒和复发性病变,给临床和经济带来负担。瘙痒强度和病变严重程度对医疗资源利用(HCRU)和成本的个体和综合贡献尚未得到很好的定义。本研究基于瘙痒和病变严重程度表征了中重度AD的真实临床表型,并量化了它们与HCRU和医疗费用的关系。方法:采用OMNY健康皮肤病平台(2022年1月- 2024年6月)的相关电子健康记录和索赔数据进行回顾性队列研究。年龄≥12岁的中度至重度AD患者,由处方治疗定义。根据患者在瘙痒数值评定量表(NRS)和研究者整体评估(IGA)上的得分,将患者分为四种临床表型:中度瘙痒和中度病变(MI-ML)、重度瘙痒和中度病变(SI-ML)、中度瘙痒和重度病变(MI-SL)和重度瘙痒和重度病变(SI-SL)。采用多项倾向评分加权法评估年化全因HCRU和总医疗费用。Logistic回归确定了高总收费的预测因子(≥90百分位)。结果:4433例中重度AD患者中,表型分布为MI-ML(33%)、SI-ML(43%)、MI-SL(4%)、SI-SL(21%)。虽然不同表型的HCRU事件发生率(住院、急诊)相似,但平均年总费用差异显著。与MI-ML(23,697美元)相比,严重瘙痒(SI-ML: + 2197美元),严重病变(MI-SL: + 3705美元)和严重瘙痒和病变(SI-SL: + 10,448美元)的费用增加,主要是由药房和门诊费用驱动的。SI-SL的平均年费用最高(34145美元),其次是MI-SL(27402美元)、SI-ML(25894美元)和MI-ML(23697美元)。严重瘙痒本身与药房费用增加有关,而严重病变主要增加门诊费用。在多变量模型中,生物制剂使用、全身治疗和合并症是高总费用的预测因子。结论:瘙痒强度和病变严重程度对中重度AD患者的HCRU和经济负担有独立和共同的影响。严重的瘙痒主要增加了药房支出,而严重的病变则增加了门诊费用。严重瘙痒和病变的组合表型导致最高的总体费用,强调需要表型信息,全面的AD管理策略。
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引用次数: 0
Matching-Adjusted Indirect Comparison of the Efficacy of Delgocitinib Cream and Dupilumab in the Treatment of Moderate to Severe Atopic Hand Eczema. 德尔古替尼乳膏与杜匹单抗治疗中重度特应性手部湿疹疗效的匹配校正间接比较。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2026-01-01 Epub Date: 2025-11-15 DOI: 10.1007/s13555-025-01592-y
David Cohen, Anthony Bewley, Andreas Wollenberg, H Chih-Ho Hong, April Armstrong, Emilie Jonsen, Douglas Maslin, Henrik Thoning, Rie von Eyben, Raj Chovatiya

Introduction: A matching-adjusted indirect comparison (MAIC) was performed comparing the efficacy of delgocitinib and dupilumab in patients with atopic hand eczema (AHE), one aetiological subtype of chronic hand eczema (CHE).

Methods: DELTA 1/2 were phase 3 trials in which adults with moderate to severe CHE received delgocitinib cream 20 mg/g or cream vehicle twice daily for 16 weeks. LIBERTY-AD-HAFT was a phase 3 trial in which patients with moderate to severe AD with hand or foot involvement received subcutaneous dupilumab or placebo every 2 weeks for 16 weeks. An anchored MAIC was conducted using individual patient data (IPD) from DELTA 1/2 and aggregate published data from LIBERTY-AD-HAFT, with vehicle and placebo as the common anchor. IPD from patients with AHE as the primary subtype in DELTA 1/2 were weighted to match age, race, sex and baseline Hand Eczema Severity Index (HECSI) score in LIBERTY-AD-HAFT.

Results: LIBERTY-AD-HAFT included 133 patients (dupilumab, n = 67, placebo, n = 66) while DELTA 1/2 included 345 patients with AHE; the effective sample size after weighted matching was 201 (delgocitinib, n = 128, cream vehicle, n = 73). Anchor-adjusted odds ratios comparing delgocitinib versus dupilumab at week 16 were 1.1 (95% CI: 0.3, 3.4; p = 0.890) for Investigator's Global Assessment for Chronic Hand Eczema / Hand and Foot Investigator's Global Assessment score 0/1, 1.2 (95% CI: 0.4, 3.2; p = 0.773) for HECSI 75 and 1.3 (95% CI: 0.4, 4.9; p = 0.661) for HECSI 90 while response difference for HECSI percent improvement was 11.7% (95% CI: -9.2%, 32.7%; p = 0.273).

Conclusions: Topical delgocitinib and dupilumab in patients with AHE had comparable efficacy, with all results being numerically in favour of delgocitinib, although not statistically significant.

Clinical trial registration: NCT04871711, NCT04872101, NCT04417894.

摘要:采用匹配调整间接比较(MAIC)方法,比较delgocitinib和dupilumab治疗慢性手湿疹(CHE)一种病因亚型特应性手湿疹(AHE)患者的疗效。方法:DELTA 1/2是3期试验,其中中度至重度CHE成人患者接受delgocitinib乳膏20mg /g或乳膏载体,每天两次,持续16周。LIBERTY-AD-HAFT是一项3期试验,在该试验中,患有中度至重度AD并累及手足的患者每2周接受皮下注射杜匹单抗或安慰剂,持续16周。锚定的MAIC使用来自DELTA 1/2的个体患者数据(IPD)和来自LIBERTY-AD-HAFT的汇总已发表数据,以载体和安慰剂作为共同锚定。作为DELTA 1/2主要亚型的AHE患者的IPD进行加权,以匹配LIBERTY-AD-HAFT中的年龄、种族、性别和基线手部湿疹严重程度指数(HECSI)评分。结果:LIBERTY-AD-HAFT纳入133例患者(dupilumab, n = 67,安慰剂,n = 66), DELTA 1/2纳入345例AHE患者;加权匹配后的有效样本量为201例(delgocitinib, n = 128, cream vehicle, n = 73)。第16周时,delgocitinib与dupilumab在慢性手湿疹/手脚研究者总体评估评分0/1的比值比为1.1 (95% CI: 0.3, 3.4; p = 0.890), HECSI 75的比值比为1.2 (95% CI: 0.4, 3.2; p = 0.773), HECSI 90的比值比为1.3 (95% CI: 0.4, 4.9; p = 0.661),而HECSI百分比改善的反应差异为11.7% (95% CI: -9.2%, 32.7%; p = 0.273)。结论:局部delgocitinib和dupilumab在AHE患者中具有相当的疗效,所有结果在数值上都有利于delgocitinib,尽管没有统计学意义。临床试验注册:NCT04871711、NCT04872101、NCT04417894。
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引用次数: 0
A Phase 3, Long-Term, Open-Label Study of Difamilast Ointment to Evaluate Efficacy and Safety in Japanese Infants with Atopic Dermatitis. Difamilast软膏对日本婴儿特应性皮炎的疗效和安全性的一项长期、开放标签的3期研究。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2026-01-01 Epub Date: 2025-10-31 DOI: 10.1007/s13555-025-01581-1
Hidehisa Saeki, Yukihiro Ohya, Naoko Baba, Tomomi Imamura, Daisuke Yokota, Hidetsugu Tsubouchi

Introduction: Difamilast is the first selective phosphodiesterase 4 inhibitor approved for atopic dermatitis (AD) in Japan. A phase 3, 52-week, open-label study was conducted to evaluate efficacy and safety of difamilast ointments in Japanese infants with AD aged 3 to < 24 months, because the clinical study in this population has not been conducted.

Methods: Infants (n = 41) received difamilast 0.3% ointment twice daily in a 4-week primary evaluation period, and subsequently received difamilast 0.3% or 1% ointment on the basis of the existing clinical symptoms in a 48-week, long-term extension period.

Results: The response rate in Investigator's Global Assessment score was 56.1% at week 4, and it increased to 75.6% at week 52. The response rate in Eczema Area and Severity Index 75 was 82.9% at week 4, and the approximately same response rate was maintained at 80.5% at week 52. Adverse events (AEs) were reported in 41 (100.0%) infants, most of which were mild or moderate in severity. The most frequently observed AE was nasopharyngitis (82.9%), followed by gastroenteritis (46.3%). The investigational medicinal product-related AE, folliculitis, was reported in one infant (2.4%). No clinically relevant abnormalities were reported in clinical laboratory tests, physical examinations, and vital signs.

Conclusion: Difamilast ointments applied twice daily to Japanese infants with AD aged 3 to < 24 months for up to 52 weeks are effective and well tolerated, indicating a new useful treatment option for this population.

Clinical trial registration: ClinicalTrials.gov identifier NCT05372653.

Difamilast是日本首个被批准用于治疗特应性皮炎(AD)的选择性磷酸二酯酶4抑制剂。方法:在为期4周的初步评估期内,41名婴儿(n = 41)每天2次接受0.3%的difamilast软膏治疗,随后在48周的长期延长期内,根据现有临床症状接受0.3%或1%的difamilast软膏治疗。结果:第4周时研究者全球评估评分的有效率为56.1%,第52周时提高到75.6%。第4周时,湿疹面积和严重指数75的有效率为82.9%,第52周时大致相同的有效率维持在80.5%。41例(100.0%)婴儿报告了不良事件(ae),其中大多数为轻度或中度严重程度。最常见的AE是鼻咽炎(82.9%),其次是胃肠炎(46.3%)。研究药品相关AE(毛囊炎)报告1例(2.4%)。临床实验室检查、体格检查和生命体征未见临床相关异常。结论:Difamilast软膏应用于日本3岁AD婴儿,每日两次,临床试验注册:ClinicalTrials.gov标识符NCT05372653。
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引用次数: 0
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