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Tailoring Abrocitinib Treatment for Moderate-to-Severe Atopic Dermatitis to Patient Disease Course: A Narrative Review. 根据患者病程调整阿布替尼治疗中重度特应性皮炎:叙述性回顾。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-19 DOI: 10.1007/s13555-025-01618-5
Jonathan I Silverberg, Eric Simpson, Melinda Gooderham, Stephan Weidinger, Melissa Watkins, Justine Alderfer

Atopic dermatitis (AD) is a chronic inflammatory skin condition characterized by intense itching, redness, and eczema. It significantly impacts the quality of life of affected individuals, often requiring long-term management strategies. Abrocitinib, an oral Janus kinase 1 (JAK1) inhibitor, is approved for the treatment of moderate-to-severe AD. Phase 2 and phase 3 abrocitinib randomized clinical trials in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) clinical development program have demonstrated the efficacy and safety of abrocitinib in both adults and adolescents with moderate-to-severe AD. This review article explores the benefit-risk profile of a flexible abrocitinib dosing approach, tailoring dose based on individualized treatment of patients and highlighting the available supportive data from the JADE randomized clinical trials for healthcare professionals as part of joint provider-patient decision making. Dosing flexibility and maintenance with the lowest effective dose is necessary to treat patients according to their individual disease course while minimizing safety risks. Safety data indicate that incidence of treatment-emergent adverse events is reflective of the current dosage, with no carry-over risk from a previous higher dosage. Overall, abrocitinib represents a valuable AD therapy that can be administered according to individual patient needs.Graphical abstract available for this article.

特应性皮炎(AD)是一种慢性炎症性皮肤病,其特征是强烈的瘙痒、发红和湿疹。它严重影响患者的生活质量,通常需要长期的管理策略。Abrocitinib是一种口服Janus激酶1 (JAK1)抑制剂,被批准用于治疗中重度AD。JAK1特应性皮炎疗效和安全性(JADE)临床开发项目中的2期和3期阿布替尼随机临床试验证明了阿布替尼对成人和青少年中重度AD患者的有效性和安全性。这篇综述文章探讨了灵活的阿布替尼给药方法的收益-风险概况,根据患者的个体化治疗定制剂量,并强调了来自JADE随机临床试验的可用支持数据,这些数据是医疗保健专业人员作为提供者-患者联合决策的一部分。剂量的灵活性和最低有效剂量的维持是必要的,以治疗患者根据他们的个别病程,同时尽量减少安全风险。安全性数据表明,治疗中出现的不良事件的发生率反映了当前的剂量,没有先前较高剂量的遗留风险。总的来说,阿布替尼代表了一种有价值的阿尔茨海默病治疗方法,可以根据患者的个人需要进行管理。本文提供图形摘要。
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引用次数: 0
Clinical Implications of the Skin Microbiota in the Therapy of Cutaneous T Cell Lymphoma: A Scoping Review. 皮肤微生物群在皮肤T细胞淋巴瘤治疗中的临床意义:范围综述。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-19 DOI: 10.1007/s13555-025-01619-4
Sonia Czyz, Joshua Quan, Kerry Yang, Raed Alhusayen, Jori Hardin

Cutaneous T cell lymphomas (CTCL) are non-Hodgkin T cell malignancies defined by malignant T cell transformation and accumulation in the skin. Limited understanding of CTCL pathogenesis, including the role of the tumor microenvironment, hinders effective treatment. Emerging evidence implicates the skin microbiota as a key modulator of disease, with microbial dysbiosis contributing to progression and representing a novel therapeutic target. This review synthesizes findings from 37 rigorously selected studies, outlining current knowledge of the CTCL-associated microbiome, mycobiome, and virome. It evaluates therapeutic strategies aimed at microbial colonization, emphasizing the potential of modulating host-microbe interactions. Additionally, we provide comprehensive clinical insight into the indications for microbial-modulating strategies of the microbiota in CTCL.

皮肤T细胞淋巴瘤(CTCL)是非霍奇金T细胞恶性肿瘤,定义为恶性T细胞在皮肤中的转化和积聚。对CTCL发病机制的了解有限,包括肿瘤微环境的作用,阻碍了有效的治疗。新出现的证据表明,皮肤微生物群是疾病的关键调节剂,微生物生态失调有助于疾病进展,并代表了一种新的治疗靶点。本综述综合了37项严格选择的研究结果,概述了目前对ctcl相关微生物组、真菌组和病毒组的了解。它评估了针对微生物定植的治疗策略,强调了调节宿主-微生物相互作用的潜力。此外,我们还提供了全面的临床见解,了解CTCL中微生物群调节策略的适应症。
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引用次数: 0
Comparison of Efficacy of Intradermal Stromal Vascular Fraction Injection Versus Saline Injection in the Treatment of Atrophic Acne Scar: A 10-Week, Prospective, Randomized, Split-Face, Single-Blind Controlled Trial. 皮内基质血管组分注射与生理盐水注射治疗萎缩性痤疮疤痕的疗效比较:一项为期10周的前瞻性、随机、裂面、单盲对照试验。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-18 DOI: 10.1007/s13555-025-01617-6
Joong Heon Suh, Ji-Young Kim, Ji Young Yoon, Jun Hyo Lee, Dong Hyo Kim, Ungsik Jin, Dae Hun Suh

Introduction: Management of atrophic acne scars remains challenging, and conventional treatments often yield suboptimal or inconsistent outcomes. Stromal vascular fraction (SVF), a cell-rich fraction derived from adipose tissue, has recently gained attention as a promising regenerative therapy. Several previous studies have reported benefits of SVF when combined with other treatment modalities; however, its stand-alone efficacy for atrophic acne scars has not been clearly investigated. In addition, molecular evidence supporting the regenerative effects of SVF in acne scar treatment remains limited.

Methods: This randomized, evaluator-blinded, split-face clinical trial was conducted in 14 patients with bilateral facial atrophic acne scars. One side was treated with intradermal SVF injection, while the contralateral side received normal saline (NS). Clinical outcomes were assessed using scar counts, Évaluation Clinique des Cicatrices d'Acne (ECCA) scores, Scar Global Assessment (SGA) scores, and standardized photography at baseline, 5 weeks, and 10 weeks. Skin biopsies were analyzed via immunohistochemistry for markers of epidermal regeneration (cytokeratin 14, cytokeratin 15, p63, integrin β1) and dermal remodeling (collagen I, elastin, vimentin).

Results: At 10 weeks after initial treatment, the SVF-treated side showed a significantly greater reduction in total scar count compared to the NS-treated side (56.4% vs. 13.2%, p < 0.001). Scar subtype analysis revealed that all scar types (ice pick, boxcar, and rolling) responded more favorably to SVF treatment, with large effect sizes (Cohen's d > 0.99). ECCA and SGA scores were also significantly decreased on the SVF-treated side. Immunohistochemical analysis revealed marked upregulation of epidermal progenitor markers and increased deposition of collagen I, elastin, and vimentin in the SVF-treated tissue.

Conclusion: We clinically demonstrated that SVF injection improves atrophic acne scars and simultaneously revealed its regenerative mechanisms involving epidermal and dermal remodeling. This supports the use of SVF as an evidence-based treatment modality for atrophic acne scars.

Trial registration: ClinicalTrials.gov Identifier, NCT07094958.

简介:萎缩性痤疮疤痕的管理仍然具有挑战性,传统的治疗方法往往产生次优或不一致的结果。基质血管组分(SVF)是一种来源于脂肪组织的富含细胞的组分,近年来作为一种有前景的再生疗法而受到关注。先前的几项研究报告了SVF与其他治疗方式联合使用的益处;然而,其对萎缩性痤疮疤痕的独立疗效尚未得到明确的研究。此外,支持SVF在痤疮疤痕治疗中的再生作用的分子证据仍然有限。方法:对14例双侧面部萎缩性痤疮疤痕患者进行随机、评价者双盲、裂面临床试验。一侧皮下注射SVF,对侧皮下注射生理盐水。临床结果通过疤痕计数、Évaluation疤痕痤疮临床(ECCA)评分、疤痕总体评估(SGA)评分和基线、5周和10周的标准化摄影进行评估。通过免疫组化分析皮肤活检组织中表皮再生标志物(细胞角蛋白14、细胞角蛋白15、p63、整合素β1)和真皮重塑标志物(I型胶原、弹性蛋白、波形蛋白)。结果:在初始治疗后10周,svf治疗侧的疤痕总数明显比ns治疗侧减少(56.4% vs. 13.2%, p 0.99)。svf治疗侧的ECCA和SGA评分也显著降低。免疫组织化学分析显示,在svf处理的组织中,表皮祖细胞标志物明显上调,胶原I、弹性蛋白和波形蛋白的沉积增加。结论:我们临床证明SVF注射改善萎缩性痤疮疤痕,同时揭示了其涉及表皮和真皮重塑的再生机制。这支持使用SVF作为萎缩性痤疮疤痕的循证治疗方式。试验注册:ClinicalTrials.gov标识符,NCT07094958。
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引用次数: 0
Advances in Pathophysiology and Therapeutic Paradigm Shifts in Chronic Spontaneous Urticaria: A Narrative Review. 慢性自发性荨麻疹病理生理学和治疗模式转变的进展:叙述性综述。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-18 DOI: 10.1007/s13555-025-01600-1
Han B Kim, Ji Y Um, Bo Y Chung, Chun W Park, Hye O Kim

Chronic spontaneous urticaria (CSU) is a debilitating inflammatory skin disorder characterized by recurrent wheals and/or angioedema lasting beyond 6 weeks without identifiable triggers. Recent advances have shifted the understanding of CSU from a historically idiopathic condition to one increasingly recognized as an immune-mediated disease with distinct endotypes, including type I (autoallergic) and type IIb (autoimmune). This narrative review synthesizes contemporary insights into CSU pathophysiology, endotype classification, and systemic manifestations, while highlighting the substantial impact on quality of life, sleep, and psychological health. Advances in biomarker research, including total serum immunoglobulin E (IgE) levels, basophil activation tests (BAT), and eosinophil counts, support progress toward personalized treatment approaches. Therapeutically, management of CSU has evolved from empirical symptom control with H1 antihistamines toward mechanism-based precision medicine. Omalizumab remains the established second-line therapy, and dupilumab received US Food and Drug Administration (FDA) approval in 2025 for antihistamine-refractory disease. In parallel, several targeted therapies are under investigation, including Bruton's tyrosine kinase (BTK) inhibitors, anti-KIT antibodies, and Janus kinase (JAK) inhibitors. These therapeutic mechanisms may offer sustained benefit, though long-term outcomes require validation through controlled trials. Integration of psychological interventions, such as cognitive behavioral therapy combined with pharmacotherapy, underscores the need for holistic patient care. Despite these advances, challenges remain in biomarker validation, sequencing of new therapies, and bridging clinical trial evidence with real-world practice. Future directions include refining endotype-driven personalized care, conducting long-term real-world studies, and developing cost-effective, globally accessible treatment strategies to optimize patient outcomes.

慢性自发性荨麻疹(CSU)是一种衰弱性炎症性皮肤病,其特征是反复发作的皮疹和/或血管性水肿持续6周以上,无可识别的诱因。最近的进展已经将对CSU的理解从历史上的特发性疾病转变为越来越多地被认为是一种具有不同内型的免疫介导疾病,包括I型(自身过敏性)和IIb型(自身免疫性)。这篇叙述性综述综合了当代对CSU病理生理学、内源性分类和系统表现的见解,同时强调了对生活质量、睡眠和心理健康的实质性影响。生物标志物研究的进展,包括总血清免疫球蛋白E (IgE)水平、嗜碱性粒细胞激活试验(BAT)和嗜酸性粒细胞计数,支持个性化治疗方法的进展。在治疗上,CSU的管理已经从H1抗组胺药的经验症状控制发展到基于机制的精准医学。Omalizumab仍然是既定的二线治疗,dupilumab于2025年获得美国食品和药物管理局(FDA)批准用于抗组胺难治性疾病。与此同时,一些靶向治疗正在研究中,包括布鲁顿酪氨酸激酶(BTK)抑制剂、抗kit抗体和Janus激酶(JAK)抑制剂。这些治疗机制可能提供持续的益处,尽管长期结果需要通过对照试验验证。心理干预的整合,如认知行为治疗与药物治疗相结合,强调了对患者整体护理的必要性。尽管取得了这些进步,但在生物标志物验证、新疗法测序以及将临床试验证据与现实世界的实践相结合方面仍存在挑战。未来的方向包括完善内源性驱动的个性化护理,进行长期的现实世界研究,以及开发具有成本效益的、全球可及的治疗策略,以优化患者的结果。
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引用次数: 0
Survey on the Actual Use of Topical Anti-Inflammatory Drugs Among Patients with Atopic Dermatitis. 特应性皮炎患者局部抗炎药物实际使用情况调查。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-18 DOI: 10.1007/s13555-025-01580-2
Hiroyuki Murota, Shinichi Noto, Miyuki Matsukawa, Yasuhito Konishi, Daisaku Michikami, Rikiya Toda, Takeshi Nakahara

Introduction: Atopic dermatitis (AD) is a chronic inflammatory skin condition requiring long-term management to maintain remission and prevent relapse. Appropriate use of topical anti-inflammatory medications is an important factor in improving symptoms in patients with AD. This study aimed to investigate the treatment methods for maintaining remission and application of anti-inflammatory topical therapy.

Methods: This observational study was conducted in October 2022, using medical claims data from DeSC Healthcare Inc., linked with survey data collected from users of kencom®, a health promotion application. Eligible patients were adults aged ≥ 19 years with a confirmed AD diagnosis and prescription history. The survey evaluated (1) the actual treatment situation during the remission maintenance phase; and (2) instructions, actual status and adherence for application of anti-inflammatory topical therapy.

Results: A total of 626 patients who answered the kencom® survey and met eligibility criteria were included. Of these, 42.3% were instructed to stop medication once eczema improved, while 34.2% were instructed to continue during remission. Regarding instructions for the amount applied, the most common response was "No specific instructions" (44.2%), followed by "Fingertip-unit (FTU)" (27.2%). In actual practice, "FTU" was the most common amount (42.2%). Regarding application area, the most frequent instruction and actual practice were "Apply only to areas with eczema with remaining inflammation" at 52.6% and 62.5%, respectively, followed by "Apply not only to the eczema or remaining inflamed areas but also the surrounding areas" at 24.0% and 37.2%. Regarding the application method, "Apply thinly" was the most common instruction and actual practice at 32.7% and 48.4%, respectively. Treatment adherence rates were generally high, at over 60%.

Conclusion: Guidance from healthcare professionals has a crucial role in the proper use of topical therapies for AD. It is essential to ensure that topical medications are used properly to help patients achieve their treatment goals.

特应性皮炎(AD)是一种慢性炎症性皮肤病,需要长期治疗以维持缓解并防止复发。适当使用局部抗炎药物是改善AD患者症状的重要因素。本研究旨在探讨维持缓解的治疗方法及抗炎局部治疗的应用。方法:这项观察性研究于2022年10月进行,使用DeSC Healthcare Inc.的医疗索赔数据,并将从健康促进应用程序kencom®用户收集的调查数据联系起来。符合条件的患者为年龄≥19岁、确诊AD且有处方史的成年人。调查评估(1)缓解维持期的实际治疗情况;(2)局部抗炎治疗的使用说明、现状及依从性。结果:共有626名患者回答了kencom®调查并符合资格标准。其中,42.3%的人在湿疹改善后被指示停止用药,而34.2%的人在缓解期间被指示继续用药。至于用量的说明,最常见的回答是“没有具体说明”(44.2%),其次是“指尖单位”(27.2%)。在实际操作中,“FTU”是最常见的金额(42.2%)。在使用区域方面,最常见的使用说明和实际操作是“仅适用于湿疹及残余炎症部位”,分别占52.6%和62.5%,其次是“不仅适用于湿疹或残余炎症部位,还适用于周围区域”,分别占24.0%和37.2%。在使用方法上,“薄敷”是最常见的指导,实际操作最多,分别占32.7%和48.4%。治疗依从率普遍较高,超过60%。结论:卫生保健专业人员的指导对正确使用局部治疗AD起着至关重要的作用。确保适当使用局部药物以帮助患者实现治疗目标是至关重要的。
{"title":"Survey on the Actual Use of Topical Anti-Inflammatory Drugs Among Patients with Atopic Dermatitis.","authors":"Hiroyuki Murota, Shinichi Noto, Miyuki Matsukawa, Yasuhito Konishi, Daisaku Michikami, Rikiya Toda, Takeshi Nakahara","doi":"10.1007/s13555-025-01580-2","DOIUrl":"https://doi.org/10.1007/s13555-025-01580-2","url":null,"abstract":"<p><strong>Introduction: </strong>Atopic dermatitis (AD) is a chronic inflammatory skin condition requiring long-term management to maintain remission and prevent relapse. Appropriate use of topical anti-inflammatory medications is an important factor in improving symptoms in patients with AD. This study aimed to investigate the treatment methods for maintaining remission and application of anti-inflammatory topical therapy.</p><p><strong>Methods: </strong>This observational study was conducted in October 2022, using medical claims data from DeSC Healthcare Inc., linked with survey data collected from users of kencom®, a health promotion application. Eligible patients were adults aged ≥ 19 years with a confirmed AD diagnosis and prescription history. The survey evaluated (1) the actual treatment situation during the remission maintenance phase; and (2) instructions, actual status and adherence for application of anti-inflammatory topical therapy.</p><p><strong>Results: </strong>A total of 626 patients who answered the kencom® survey and met eligibility criteria were included. Of these, 42.3% were instructed to stop medication once eczema improved, while 34.2% were instructed to continue during remission. Regarding instructions for the amount applied, the most common response was \"No specific instructions\" (44.2%), followed by \"Fingertip-unit (FTU)\" (27.2%). In actual practice, \"FTU\" was the most common amount (42.2%). Regarding application area, the most frequent instruction and actual practice were \"Apply only to areas with eczema with remaining inflammation\" at 52.6% and 62.5%, respectively, followed by \"Apply not only to the eczema or remaining inflamed areas but also the surrounding areas\" at 24.0% and 37.2%. Regarding the application method, \"Apply thinly\" was the most common instruction and actual practice at 32.7% and 48.4%, respectively. Treatment adherence rates were generally high, at over 60%.</p><p><strong>Conclusion: </strong>Guidance from healthcare professionals has a crucial role in the proper use of topical therapies for AD. It is essential to ensure that topical medications are used properly to help patients achieve their treatment goals.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145773867","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
Treatment Preferences Among Systemic Therapy-Naïve Patients with Atopic Dermatitis or Psoriasis in Germany: A Multicentre Study. 德国系统性Therapy-Naïve特应性皮炎或银屑病患者的治疗偏好:一项多中心研究
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-13 DOI: 10.1007/s13555-025-01615-8
Svenja Royeck, Anna Daphne Bamidis, Conrad Weckbecker, Silke C Hofmann, Sonja Ständer, Natalija Novak, Galina Balakirski, Dagmar Wilsmann-Theis

Introduction: Despite the expanding range of approved systemic therapies for atopic dermatitis (AD) and psoriasis (PSO), data on patient preferences remain limited. It is largely unknown whether patients wish to initiate systemic treatment, which route of administration (oral versus subcutaneous) they prefer, or what factors drive their treatment preferences. This study evaluated the desire for systemic therapy among systemic treatment-naïve patients with AD or PSO, including disease-specific influencing factors and preferences for administration routes (subcutaneous injections vs. tablets).

Methods: Eligible patients with AD or PSO were recruited at two German university hospitals. Questionnaires collected demographic and clinical data, including disease severity, pruritus and pain intensity, quality of life (QoL) impairment, and desire for systemic therapy. Data analysis comprised Mann-Whitney U tests (between-group comparisons), and Spearman correlations (factors influencing therapy desire).

Results: From 253 recruited patients, systemic treatment-naïve patients with moderate-to-severe disease severity exclusively using topical therapies were selected (56 with AD, 63 with PSO); 77.8% of patients with PSO and 67.9% of patients with AD desired systemic therapy, mainly for superior efficacy, QoL improvement, and pruritus reduction. Administration preferences differed significantly (PSO 57.1% injections; AD 73.7% tablets; p < 0.005). The desire for systemic therapy moderately correlated with pain intensity (ρ = 0.422, p < 0.001) and QoL impairment (ρ = 0.379, p < 0.005) in AD and with male sex in PSO (ρ = 0.347, p < 0.005).

Conclusions: Most topically treated patients with moderate-to-severe AD or PSO desire systemic therapy, with distinct disease-specific administration preferences.

导语:尽管特应性皮炎(AD)和牛皮癣(PSO)的全身疗法范围不断扩大,但关于患者偏好的数据仍然有限。患者是否希望开始全身治疗,他们更喜欢哪种给药途径(口服还是皮下注射),或者是什么因素驱动了他们的治疗偏好,这些在很大程度上是未知的。本研究评估了全身性treatment-naïve AD或PSO患者对全身治疗的渴望,包括疾病特异性影响因素和给药途径的偏好(皮下注射与片剂)。方法:在德国两所大学医院招募符合条件的AD或PSO患者。问卷收集了人口统计学和临床数据,包括疾病严重程度、瘙痒和疼痛强度、生活质量(QoL)损害以及对全身治疗的渴望。数据分析包括Mann-Whitney U检验(组间比较)和Spearman相关性(影响治疗意愿的因素)。结果:从253名招募的患者中,选择了仅使用局部治疗的中重度疾病严重程度的全身性treatment-naïve患者(56名AD患者,63名PSO患者);77.8%的PSO患者和67.9%的AD患者希望全身治疗,主要是为了更好的疗效、改善生活质量和减少瘙痒。给药偏好差异显著(PSO注射57.1%;AD片剂73.7%;p结论:大多数局部治疗的中重度AD或PSO患者希望全身治疗,具有明显的疾病特异性给药偏好。
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引用次数: 0
Summary of Research: Apremilast in Japanese Patients with Palmoplantar Pustulosis: A Randomized, Phase 3 Trial. 研究总结:阿普米司特治疗日本掌跖脓疱病:一项随机3期试验。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-13 DOI: 10.1007/s13555-025-01583-z
Tadashi Terui, Yukari Okubo, Satomi Kobayashi, Akimichi Morita, Shinichi Imafuku, Yayoi Tada, Masatoshi Abe, Bruce Strober, Melinda Gooderham, Yasuhito Hara, Wendy Zhang, Junichiro Shimauchi, Masafumi Yaguchi, Takeshi Kimura, Ryuichi Ogawa, Hamid Amouzadeh, Masamoto Murakami

This Summary of Research provides an overview of the results of a phase 3 study that assessed the efficacy and safety of apremilast in Japanese patients with moderate to severe palmoplantar pustulosis (PPP) who had not responded to topical treatment (NCT05174065). Patients were randomized to apremilast or placebo for 16 weeks, after which patients randomized to placebo transitioned to apremilast through 52 weeks. This study showed that apremilast significantly improved PPP clinical severity, symptoms, and patient-reported quality of life compared with placebo after 16 weeks of treatment. The benefits of apremilast were maintained or further improved over 52 weeks of treatment. The most common side effects (experienced by > 10% of patients) included diarrhea, nasopharyngitis, nausea, soft stool, and headache, and were consistent with previous studies of apremilast. Side effects were mainly mild to moderate. The results from this phase 3 study support apremilast as a systemic oral treatment option for patients with PPP with inadequate response to topical treatment, for whom treatment options are limited.

本研究摘要概述了一项3期研究的结果,该研究评估了阿普雷米司特对局部治疗无反应的日本中度至重度掌跖脓疱病(PPP)患者的疗效和安全性(NCT05174065)。患者被随机分配到阿普米司特或安慰剂组16周,之后随机分配到安慰剂组的患者在52周内过渡到阿普米司特组。该研究表明,与安慰剂相比,阿普雷米司特治疗16周后可显著改善PPP临床严重程度、症状和患者报告的生活质量。在52周的治疗中,阿普米司特的疗效得以维持或进一步改善。最常见的副作用(约占患者的10%)包括腹泻、鼻咽炎、恶心、便软和头痛,这与先前对阿普米司特的研究一致。副作用以轻中度为主。这项3期研究的结果支持阿普雷米司特作为局部治疗反应不足的PPP患者的全身口服治疗选择,这些患者的治疗选择有限。
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引用次数: 0
Exploring New Dimensions in Longitudinal Rosacea Management. 探索纵向酒渣鼻管理的新维度。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-12 DOI: 10.1007/s13555-025-01612-x
Martin Schaller, Belinda Welsh, Giuseppe Micali, Jerry Tan, James Del Rosso, Julie Harper, Thomas Dirschka, Soyun Cho, Luiz M C Almeida, Khen Kon, Wioletta Barańska-Rybak, Johannes Dayrit, Linda Stein Gold

Rosacea is a common, chronic, inflammatory disease of the skin, which predominantly (but not exclusively) affects the centrofacial region. Clinical features may include transient or persistent facial erythema, recurrent flushing, telangiectasia, papules, pustules, phymatous changes, and ocular disturbances. These can lead to significant physical and psychological burden and discomfort, which adversely affects a patient's quality of life (QoL). While current guidelines provide recommendations on treatment initiation and modification, there is a lack of information for long-term management and maintenance. The Rosacea-Expert Advice on Combined and Holistic approaches (REACH) group is an international group of experienced dermatologists, brought together to address these shortcomings. This paper summarizes discussions from three REACH Global Scientific Committee (GSC) meetings, with the objective to simplify the rosacea management pathway and ensure that healthcare professionals are aware of rosacea triggers, pathogenesis, risk factors, comorbidities, chronicity, patient satisfaction, monitoring, and treatment options. The REACH GSC developed a rosacea management pathway as a backbone for this publication-to advise on each step, including pitfalls to avoid, patient discussions to conduct, tools and guidelines to employ, and clinical factors to consider. Being able to discern all the clinical features of rosacea specific to each patient is imperative, from recognizing overriding signs and symptoms to understanding potential comorbidities and assessing impact on QoL. Clear and sensitive communication regarding these elements, and what outcomes are achievable, will help to optimize therapeutic management and foster a sense of patient empowerment and disease control. For patients, being able to engage in their own long-term care of symptoms, signs, and flares is critical. Deepening the understanding of the condition as a chronic, yet eminently manageable one, will help empower patients with rosacea and their dermatologists alike. The REACH GSC project was initiated and funded by Galderma.

酒渣鼻是一种常见的慢性皮肤炎症性疾病,主要(但不是唯一)影响中央面部区域。临床特征可能包括短暂或持续的面部红斑、反复潮红、毛细血管扩张、丘疹、脓疱、肿性改变和视力障碍。这些会导致严重的身体和心理负担和不适,从而对患者的生活质量(QoL)产生不利影响。虽然目前的指南提供了关于治疗开始和修改的建议,但缺乏长期管理和维持的信息。酒渣鼻-综合和整体方法专家建议(REACH)小组是一个由经验丰富的皮肤科医生组成的国际小组,聚集在一起解决这些缺点。本文总结了三次REACH全球科学委员会(GSC)会议的讨论,目的是简化酒渣鼻的管理途径,并确保医疗保健专业人员了解酒渣鼻的诱因、发病机制、危险因素、合并症、慢性、患者满意度、监测和治疗方案。REACH GSC制定了酒渣鼻管理途径作为本出版物的支柱,对每个步骤提出建议,包括避免的陷阱,进行的患者讨论,使用的工具和指南,以及考虑的临床因素。从识别最重要的体征和症状到了解潜在的合并症和评估对生活质量的影响,能够识别每位患者特有的酒渣鼻的所有临床特征是必要的。就这些因素以及可实现的结果进行清晰而敏感的沟通,将有助于优化治疗管理,培养患者赋权和疾病控制的意识。对于患者来说,能够参与自己的症状,体征和耀斑的长期护理是至关重要的。加深对这种慢性疾病的理解,将有助于红斑痤疮患者和他们的皮肤科医生。REACH GSC项目由高德美发起并资助。
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引用次数: 0
Bimekizumab Efficacy and Safety in Patients with Psoriatic Arthritis with Substantial Skin and Nail Psoriasis to 1 Year. 比美珠单抗治疗银屑病关节炎伴皮肤和指甲银屑病1年疗效和安全性
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-12 DOI: 10.1007/s13555-025-01599-5
Diamant Thaçi, Akihiko Asahina, Wolf-Henning Boehncke, Alice B Gottlieb, Mark Lebwohl, Richard B Warren, Heather Edens, Barbara Ink, Rajan Bajracharya, Jason Coarse, Joseph F Merola
<p><strong>Introduction: </strong>Individuals with psoriatic arthritis (PsA) and plaque-type psoriasis and nail involvement have more severe disease and worse quality of life than those without. Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. Here, we assess 52-week efficacy and safety of bimekizumab in individuals with PsA who had baseline plaque-type psoriasis (≥ 3% body surface area) and nail involvement (modified Nail Psoriasis Severity Index [mNAPSI] > 0).</p><p><strong>Methods: </strong>We conducted a post hoc analysis of BE OPTIMAL (NCT03895203; biologic disease-modifying antirheumatic drug [biologic]-naïve patients) and BE COMPLETE/BE VITAL open-label extension (NCT03896581/NCT04009499; patients with prior inadequate response/intolerance to tumour necrosis factor inhibitors [TNFi-IR]). Participants were randomised to subcutaneously administered bimekizumab 160 mg every 4 weeks (Q4W), placebo or reference arm (adalimumab 40 mg Q2W; BE OPTIMAL only). At week 16, placebo-randomised participants switched to bimekizumab (PBO/BKZ). Participants who completed BE COMPLETE week 16 could enter BE VITAL. Efficacy and safety data are reported by study to week 52. Efficacy outcomes included American College of Rheumatology ≥ 50% improvement (ACR50), Psoriasis Area and Severity Index 100% improvement (PASI100) and nail psoriasis resolution (mNAPSI = 0).</p><p><strong>Results: </strong>Overall, 263 (placebo n = 88; bimekizumab n = 133; reference [adalimumab] n = 42) biologic-naïve and 159 (placebo n = 54; bimekizumab n = 105) TNFi-IR participants had baseline plaque-type psoriasis and nail involvement. In bimekizumab-randomised participants with baseline plaque-type psoriasis and nail involvement, improvements in the proportion of participants achieving efficacy responses across disease domains were sustained from week 16 to week 52, including ACR50 (65.4% biologic-naïve; 61.0% TNFi-IR), PASI100 (60.9%; 63.8%), and mNAPSI = 0 (68.4%; 70.5%). PBO/BKZ switchers demonstrated improvements from week 16 to week 52 after receiving 36 weeks of bimekizumab treatment, for ACR50 (63.6% biologic-naïve; 51.9% TNFi-IR), PASI100 (64.8%; 57.4%), and mNAPSI = 0 (73.9%; 63.0%). To week 52, exposure-adjusted incidence rates/100 patient years for ≥ 1 treatment-emergent adverse event in all bimekizumab-treated (≥ 1 dose) participants with baseline plaque-type psoriasis and nail involvement were 181.1 (biologic-naïve) and 99.2 (TNFi-IR).</p><p><strong>Conclusions: </strong>Bimekizumab treatment resulted in consistent, sustained efficacy to 52 weeks in biologic-naïve and TNFi-IR individuals with PsA and baseline plaque-type psoriasis and nail involvement. Bimekizumab was well tolerated, with a safety profile consistent with previous reports. Graphical abstract available for this article.</p><p><strong>Trial registration: </strong>BE OPTIMAL: NCT03895203; BE COMPLETE: NCT03896581; BE VITAL: NCT04009499 (ClinicalTr
简介:银屑病关节炎(PsA)和斑块型银屑病和指甲累及的个体有更严重的疾病和更差的生活质量比那些没有。Bimekizumab是一种单克隆IgG1抗体,选择性抑制白细胞介素(IL)-17F和IL- 17a。在这里,我们评估了比美珠单抗在基线斑块型银屑病(≥3%体表面积)和指甲受损伤(改良的指甲银屑病严重指数[mNAPSI] >)的PsA患者的52周疗效和安全性。方法:我们对BE OPTIMAL (NCT03895203;生物疾病改善抗风湿药物[biologic]-naïve患者)和BE COMPLETE/BE VITAL开放标签扩展(NCT03896581/NCT04009499;先前对肿瘤坏死因子抑制剂[TNFi-IR]反应不足/不耐受的患者)进行了事后分析。参与者被随机分配到皮下注射比美珠单抗160毫克每4周(Q4W),安慰剂或参考组(阿达木单抗40毫克Q2W;仅BE OPTIMAL)。在第16周,安慰剂随机分组的参与者切换到比美珠单抗(PBO/BKZ)。完成BE COMPLETE第16周的参与者可以进入BE VITAL。疗效和安全性数据由研究报告至第52周。疗效结果包括美国风湿病学会改善≥50% (ACR50),牛皮癣面积和严重程度指数改善100% (PASI100)和指甲牛皮癣消退(mNAPSI = 0)。结果:总的来说,263名(安慰剂n = 88;比美珠单抗n = 133;参考[阿达木单抗]n = 42) biologic-naïve和159名(安慰剂n = 54;比美珠单抗n = 105) TNFi-IR参与者有基线斑块型银屑病和指甲受累。在基线斑块型银屑病和指甲受损伤的比美单抗随机分组参与者中,从第16周到第52周,在疾病领域获得疗效反应的参与者比例持续改善,包括ACR50 (65.4% biologic-naïve; 61.0% TNFi-IR), PASI100(60.9%; 63.8%)和mNAPSI = 0(68.4%; 70.5%)。PBO/BKZ转换者在接受36周比美珠单抗治疗后的第16周至第52周表现出改善,ACR50 (63.6% biologic-naïve; 51.9% TNFi-IR), PASI100(64.8%; 57.4%)和mNAPSI = 0(73.9%; 63.0%)。到第52周,基线斑块型银屑病和指甲受损伤的所有接受比美珠单抗治疗(≥1剂量)的参与者中,≥1次治疗出现的不良事件的暴露调整发生率/100患者年为181.1 (biologic-naïve)和99.2 (TNFi-IR)。结论:在PsA和基线斑块型银屑病和指甲受损伤的biologic-naïve和TNFi-IR个体中,比美珠单抗治疗可获得持续52周的持续疗效。比美珠单抗耐受性良好,安全性与先前的报告一致。本文提供图形摘要。试验注册:BE OPTIMAL: NCT03895203;完成:nct03896581;至关重要:NCT04009499 (ClinicalTrials.gov)。
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引用次数: 0
Drug Stratification Based on Real-World Evidence in Psoriasis: A Narrative Review. 基于真实世界证据的银屑病药物分层:叙述性综述。
IF 4.2 3区 医学 Q1 DERMATOLOGY Pub Date : 2025-12-10 DOI: 10.1007/s13555-025-01610-z
William Göte Sindrup, Alex Birk Nielsen, Amanda Kvist-Hansen, Lone Skov

Over the past two decades, numerous highly effective biological treatments have been developed for patients with moderate-to-severe psoriasis. As a result of more effective therapies, treatment goals have shifted from a 50% to a 90% reduction in psoriasis area and severity index. Although randomized controlled trials provide some insight, they often include only a subset of patients, have short durations, and do not compare different treatments. Many patients respond well to these new treatments; however, some do not respond at all, whereas others experience a loss of effectiveness after an initial response. No definitive guidelines on the best time to start treatment or on how to choose the most suitable treatment for an individual patient have yet been established. Furthermore, it remains uncertain whether optimal treatment or specific therapy reduces the risk of developing comorbidities. Real-world data have revealed adverse effects, such as tuberculosis reactivation with tumor necrosis factor inhibitors, worsening of inflammatory bowel disease with interleukin-17 inhibitors, and potential cardiovascular events associated with particularly interleukin-12/23 inhibition. Studies from both clinical trials and real-world settings have also shown that patients with high body mass index, smokers, older individuals, and those with prior biological treatments tend to have poorer treatment outcomes. Recently, studies have indicated that genetic markers such as HLA-C*06:02, initial treatment response, and post-initiation drug concentration levels can predict treatment response. The integration of genetic markers, clinical data, and advanced technologies may aid in developing more personalized treatment plans for patients in the future.

在过去的二十年里,针对中重度牛皮癣患者已经开发出了许多高效的生物治疗方法。由于更有效的治疗方法,治疗目标已从50%的牛皮癣面积和严重程度指数减少到90%。虽然随机对照试验提供了一些见解,但它们通常只包括一小部分患者,持续时间短,并且不能比较不同的治疗方法。许多患者对这些新疗法反应良好;然而,有些人根本没有反应,而另一些人在最初的反应后就失去了效果。关于开始治疗的最佳时间或如何为个别患者选择最合适的治疗方法,目前还没有确定的指导方针。此外,尚不确定最佳治疗或特定治疗是否能降低发生合并症的风险。现实世界的数据已经揭示了不良反应,如肿瘤坏死因子抑制剂的结核再活化,白细胞介素-17抑制剂的炎症性肠病恶化,特别是白细胞介素-12/23抑制剂相关的潜在心血管事件。来自临床试验和现实环境的研究也表明,高体重指数患者、吸烟者、老年人和先前接受过生物治疗的患者往往治疗效果较差。最近的研究表明,遗传标记如HLA-C*06:02、初始治疗反应和起始后药物浓度水平可以预测治疗反应。遗传标记、临床数据和先进技术的整合可能有助于未来为患者制定更个性化的治疗计划。
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引用次数: 0
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Dermatology and Therapy
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