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What's New After NICE Acne Guidelines. NICE 痤疮指南之后的新动向。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-10-01 Epub Date: 2024-09-21 DOI: 10.1007/s13555-024-01275-0
Alison M Layton, Girish Gupta, Daron Seukeran, Thivi Maruthappu, Stephanie Gaillard, Heather Whitehouse, Faisal R Ali, Angelika Razzaque, Firas Al-Niaimi, Sarah Copperwheat

Introduction: Acne remains one of the most common inflammatory dermatoses seen worldwide. There are significant challenges when managing acne relating to a variety of factors, including (1) lack of consensus on the use of the numerous available grading systems and outcome measures, (2) appreciation of the numerous areas that relate to severity, (3) the chronic nature of acne which requires a longitudinal approach to management (including both facial and truncal disease), and (4) the need to target acne early to avoid physical and psychosocial scarring. Consideration of these aspects when managing acne should result in improved outcomes. Acne guidelines review the available evidence based on robust clinical trials and are usually supplemented with some expert opinion when evidence is not available.

Methods: In this paper, the UK Acne Working Group reflects on the latest National Institute for Health and Care Excellence (NICE) acne guidelines with a goal of providing additional practical insights.

Conclusion: The group have identified areas where new evidence has now become available since the formulation of the NICE acne guidelines. This publication considers newly approved acne medications in the UK, guidance on assessing acne severity, approaches to managing truncal acne, acne sequelae, and adult female acne with hormonal therapies.

导言:痤疮是全球最常见的炎症性皮肤病之一。痤疮的治疗面临诸多挑战,其中包括:(1) 在使用众多可用的分级系统和疗效衡量标准方面缺乏共识;(2) 对与严重程度相关的众多领域缺乏了解;(3) 由于痤疮具有慢性性质,因此需要采取纵向治疗方法(包括面部和躯干疾病);(4) 需要及早针对痤疮进行治疗,以避免在身体和心理上留下疤痕。在治疗痤疮时考虑到这些方面,应能改善治疗效果。痤疮指南以可靠的临床试验为基础,对现有证据进行审查,在没有证据的情况下,通常会辅以一些专家意见:在本文中,英国痤疮工作组对最新的美国国家健康与护理优化研究所(NICE)痤疮指南进行了反思,旨在提供更多实用的见解:工作组确定了自 NICE 制定痤疮指南以来出现新证据的领域。本出版物考虑了英国新批准的痤疮药物、评估痤疮严重程度的指南、管理截肢痤疮的方法、痤疮后遗症以及使用激素疗法的成年女性痤疮。
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引用次数: 0
Vorasidenib-Induced Trichomegaly and Hypertrichosis: a New Side Effect in a Patient with Diffuse Astrocytoma. 沃拉西地尼诱发的毛细血管扩张和多毛症:弥漫性星形细胞瘤患者的一种新副作用
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-10-01 Epub Date: 2024-08-31 DOI: 10.1007/s13555-024-01263-4
Michela Starace, Stephano Cedirian, Luca Rapparini, Francesca Bruni, Bianca Maria Piraccini

Vorasidenib, an oral dual inhibitor targeting mutant enzymes isocitrate dehydrogenase 1 and 2, is utilized in the management of diffuse low-grade gliomas. Despite limited documentation of its adverse events, we present the case of a 44-year-old male who exhibited trichomegaly and hypertrichosis of body hair, eyebrows, and eyelashes following one month of vorasidenib treatment. Notably, the patient experienced diffuse hair regrowth on the scalp, including in areas affected by severe androgenetic alopecia. This report holds significance as it highlights a previously unreported side effect, thereby enhancing our understanding of emerging therapies for brain tumors and their associated adverse reactions.

Vorasidenib是一种针对异柠檬酸脱氢酶1和2突变酶的口服双重抑制剂,用于治疗弥漫性低级别胶质瘤。尽管有关该药不良反应的文献有限,但我们仍发现一名 44 岁的男性患者在接受沃拉西地尼治疗一个月后,体毛、眉毛和睫毛出现了毛囊扩张和多毛症。值得注意的是,患者的头皮出现了弥漫性毛发再生,包括受严重雄激素性脱发影响的部位。这份报告的意义在于,它强调了一种以前未报道过的副作用,从而加深了我们对脑肿瘤新兴疗法及其相关不良反应的了解。
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引用次数: 0
A New TGF-β Mimetic, XEP™-716 Miniprotein™, Exhibiting Regenerative Properties Objectivized by Instrumental Evaluation 一种新型 TGF-β 拟态物质 XEP™-716 Miniprotein™,通过仪器评估显示出客观的再生特性
IF 3.4 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-09-19 DOI: 10.1007/s13555-024-01273-2
Hanane Chajra, Thibaut Saguet, Corinne Granger, Lionel Breton, Pedro Contreiras Pinto, Mickael Machicoane, Jean Marc Le Doussal
<h3 data-test="abstract-sub-heading">Introduction</h3><p>Skin aging, which results from intrinsic and extrinsic factors, is characterized by a rough, uneven and wrinkled appearance of the skin at the macroscopic level. At the microscopic level, aging shows lowered keratinocyte turnover, flattened dermal-epidermal junction and reduced collagen fiber density; however, use of skin biopsies to evaluate characteristic properties of these microscopic changes is too limiting for panelists and rarely used. The development of non-invasive techniques is an opportunity to be considered for such evaluations. Our objective was to demonstrate the rejuvenating effects of XEP™-716 Miniprotein™ on skin, a miniprotein having TGF-β beta-like properties, in vitro on normal human fibroblasts and at the clinical level.</p><h3 data-test="abstract-sub-heading">Methods</h3><p>In vitro, the skin rejuvenation properties of XEP™-716 Miniprotein™ were studied by quantification of well-known dermal components such as collagen type I, hyaluronic acid and elastin. At the clinical level, we used a non-invasive technique, the confocal laser scanning microscopy (CLSM) system, which enabled non-invasive morphological characterization of skin structures (stratum corneum thickness, viable epidermis, full epidermis, dermal-epidermal junction, papillae, dermal collagen density) and high-frequency ultrasonography to quantify the dermal density and thickness, which are useful parameters for quantifying rejuvenating effects on skin. Lastly, a cutometer was used to assess the skin's biomechanical properties, mainly firmness and elasticity. This monocentric double-blind, split-face, randomized, placebo-controlled clinical trial compared the active ingredient XEP™-716 Miniprotein™ in a vehicle on one hemiface versus vehicle alone on the other (placebo) and enrolled panelists aged 40 to 60 years old. All measurements were carried out on the malar area before and after 28 and 56 days of twice daily application of a cosmetic cream formulation containing either 2.5% or 5% XEP™-716 Miniprotein™. The skin rejuvenating properties were demonstrated by studying dermo-epidermal junction (DEJ) flattening reduction using the measure of two parameters by CLSM: the DEJ length and number of edged papillae. Dermis rejuvenation was assessed by measuring the collagen fiber perimeters (CLSM), dermal density and dermal thickness (ultrasonography).</p><h3 data-test="abstract-sub-heading">Results</h3><p>The in vitro results confirmed the ability of XEP™-716 Miniprotein™ to stimulate the key extracellular macromolecules, namely collagen type I, hyaluronic acid and elastin, at a level comparable to that induced by TGF beta growth factor. The clinical data showed that after 28 and 56 days of topical XEP™-716 Miniprotein™ application, there was a statistically significant increase of DEJ length, number of edged papillae and collagen fiber perimeters. At the same time point, the B-scan images of facial skin showed a s
导言:皮肤老化是内在和外在因素共同作用的结果,在宏观层面上表现为皮肤粗糙、不平整和起皱。在微观层面上,衰老表现为角质细胞更替减少、真皮-表皮交界处变平以及胶原纤维密度降低;然而,使用皮肤活检来评估这些微观变化的特征特性对专家小组成员来说限制太多,很少使用。非侵入性技术的发展为此类评估提供了机会。我们的目标是在体外正常人成纤维细胞和临床层面上证明 XEP™-716 Miniprotein™ 对皮肤的嫩肤效果,它是一种具有 TGF-β 类似特性的微型蛋白。方法在体外,我们通过量化 I 型胶原蛋白、透明质酸和弹性蛋白等众所周知的真皮成分来研究 XEP™-716 Miniprotein™ 的嫩肤特性。在临床层面,我们使用了一种非侵入性技术--共焦激光扫描显微镜(CLSM)系统,该系统可对皮肤结构(角质层厚度、存活表皮、完整表皮、真皮-表皮交界处、乳头、真皮胶原蛋白密度)进行非侵入性形态学表征,并使用高频超声波成像技术对真皮密度和厚度进行量化,这些都是量化皮肤年轻化效果的有用参数。最后,使用切口计评估皮肤的生物力学特性,主要是紧致度和弹性。这项单中心、双盲、分面、随机、安慰剂对照临床试验比较了一侧半面的活性成分XEP™-716 Miniprotein™与另一侧半面的活性成分XEP™-716 Miniprotein™。在每天两次使用含有 2.5% 或 5% XEP™-716 Miniprotein™ 的化妆品乳霜配方 28 天和 56 天之前和之后,所有测量均在颧骨部位进行。通过 CLSM 测量两个参数:DEJ 长度和边缘乳头数量,研究真皮-表皮交界处(DEJ)扁平减少的情况,从而证明其嫩肤特性。通过测量胶原纤维周长(CLSM)、真皮密度和真皮厚度(超声波)来评估真皮年轻化情况。结果体外实验结果证实,XEP™-716 Miniprotein™ 能够刺激关键的细胞外大分子,即 I 型胶原蛋白、透明质酸和弹性蛋白,其刺激水平与 TGF beta 生长因子诱导的水平相当。临床数据显示,局部使用 XEP™-716 Miniprotein™ 28 天和 56 天后,DEJ 长度、边缘乳头数量和胶原纤维周长均有显著的统计学增长。在同一时间点,面部皮肤的 B 扫描图像显示,真皮密度和厚度在统计学上有显著增加。这些结果表明,DEJ变得更加起伏,与真皮的连接更加紧密,而乳头状真皮则更加致密,这两种特征都是年轻皮肤的典型特征。本文中介绍的体外和临床结果表明,XEP™-716 Miniprotein™ 是一种有效的成分,可使成熟皮肤的 DEJ 和真皮层恢复活力。
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引用次数: 0
Complete Skin Clearance is Associated with the Greatest Benefits to Health-Related Quality of Life and Perceived Symptoms for Patients with Psoriasis 彻底清除皮肤可为银屑病患者带来与健康相关的生活质量和自觉症状方面的最大益处
IF 3.4 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-09-17 DOI: 10.1007/s13555-024-01261-6
Matthias Augustin, Alice B. Gottlieb, Mark Lebwohl, Andreas Pinter, Richard B. Warren, Luis Puig, Rhys Warham, Jérémy Lambert, Susanne Wiegratz, Balint Szilagyi, Andrew Blauvelt

Introduction

With newer biologics, the achievement of complete skin clearance has become an attainable treatment goal for patients with plaque psoriasis. We evaluate how improvements in Psoriasis Area and Severity Index (PASI) responses, particularly at incremental improvements approaching complete skin clearance (PASI 100), translate into improvements in health-related quality of life (HRQoL) and patient-perceived symptoms.

Methods

Data from the BE RADIANT phase 3b trial (NCT03536884) and its open-label extension (OLE), pooled across all study visits and treatments over 16 weeks (randomised patients) and 2 years (patients entering the OLE), were analysed using mixed-effects logistic regression models. Proportions of patients achieving a Dermatology Life Quality Index (DLQI) of 0/1, DLQI item scores of 0, and Psoriasis Symptoms and Impacts Measure (P-SIM) item scores of 0 for itching, scaling, and skin pain at specific PASI improvement levels were estimated.

Results

Seven hundred and forty-three patients were randomised to treatment; 654 entered the OLE. Using 16-week pooled data, there were incremental improvements in the proportions of patients estimated by our model to achieve DLQI 0/1 with PASI 100 compared with 95% (PASI = 95%) and 90% (PASI = 90%) improvements in PASI (93.0%, 89.3%, and 83.8% achieving DLQI 0/1, respectively). Estimated proportions achieving DLQI item scores of 0 had the greatest increases at higher PASI improvement levels for Items 1 (itchy, sore, painful, or stinging skin), 2 (embarrassment), and 4 (choice of clothing). Estimated proportions of patients achieving P-SIM = 0 were also higher for PASI 100 (itching: 61.7%; scaling: 82.2%; skin pain: 96.9%) than for PASI = 95% (50.8%; 72.3%; 95.7%) and PASI = 90% (39.8%; 59.5%; 94.0%). Similar benefits of incremental PASI improvements were estimated using 2-year data.

Conclusions

Complete skin clearance translated into the greatest benefits to HRQoL and patient-perceived symptoms, over and above skin clearance between 90% and 100%, highlighting the importance of targeting PASI 100 as a treatment outcome for patients with psoriasis.

Trial Registration Number

NCT03536884.

导言随着生物制剂的更新换代,实现皮肤完全清除已成为斑块状银屑病患者可以达到的治疗目标。我们评估了银屑病面积和严重程度指数(PASI)反应的改善,尤其是在接近皮肤完全清除(PASI 100)时的递增改善,如何转化为健康相关生活质量(HRQoL)和患者感知症状的改善。方法 使用混合效应逻辑回归模型分析了 BE RADIANT 3b 期试验(NCT03536884)及其开放标签扩展试验(OLE)的数据,这些数据汇集了 16 周(随机患者)和 2 年(进入 OLE 的患者)的所有研究访问和治疗。估算了在特定 PASI 改善水平下,皮肤科生活质量指数 (DLQI) 达到 0/1、DLQI 项目得分达到 0,以及瘙痒、脱屑和皮肤疼痛方面的银屑病症状和影响测量 (P-SIM) 项目得分达到 0 的患者比例。使用 16 周的汇总数据,与 PASI 改善程度达到 95% (PASI = 95%) 和 90% (PASI = 90%) 的患者相比,我们的模型估计 PASI 100 达到 DLQI 0/1 的患者比例有所提高(分别为 93.0%、89.3% 和 83.8% 达到 DLQI 0/1)。达到 DLQI 项目 0 分的估计比例在项目 1(皮肤瘙痒、疼痛或刺痛)、项目 2(尴尬)和项目 4(衣服的选择)的 PASI 改善水平较高时增幅最大。PASI = 100(瘙痒:61.7%;脱屑:82.2%;皮肤疼痛:96.9%)患者达到 P-SIM = 0 的估计比例也高于 PASI = 95% (50.8%;72.3%;95.7%)和 PASI = 90% (39.8%;59.5%;94.0%)。结论皮肤完全清除可为患者的 HRQoL 和患者感知的症状带来最大益处,超过 90% 至 100% 之间的皮肤清除率,突出了将 PASI 100 作为银屑病患者治疗结果目标的重要性。
{"title":"Complete Skin Clearance is Associated with the Greatest Benefits to Health-Related Quality of Life and Perceived Symptoms for Patients with Psoriasis","authors":"Matthias Augustin, Alice B. Gottlieb, Mark Lebwohl, Andreas Pinter, Richard B. Warren, Luis Puig, Rhys Warham, Jérémy Lambert, Susanne Wiegratz, Balint Szilagyi, Andrew Blauvelt","doi":"10.1007/s13555-024-01261-6","DOIUrl":"https://doi.org/10.1007/s13555-024-01261-6","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>With newer biologics, the achievement of complete skin clearance has become an attainable treatment goal for patients with plaque psoriasis. We evaluate how improvements in Psoriasis Area and Severity Index (PASI) responses, particularly at incremental improvements approaching complete skin clearance (PASI 100), translate into improvements in health-related quality of life (HRQoL) and patient-perceived symptoms.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>Data from the BE RADIANT phase 3b trial (NCT03536884) and its open-label extension (OLE), pooled across all study visits and treatments over 16 weeks (randomised patients) and 2 years (patients entering the OLE), were analysed using mixed-effects logistic regression models. Proportions of patients achieving a Dermatology Life Quality Index (DLQI) of 0/1, DLQI item scores of 0, and Psoriasis Symptoms and Impacts Measure (P-SIM) item scores of 0 for itching, scaling, and skin pain at specific PASI improvement levels were estimated.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Seven hundred and forty-three patients were randomised to treatment; 654 entered the OLE. Using 16-week pooled data, there were incremental improvements in the proportions of patients estimated by our model to achieve DLQI 0/1 with PASI 100 compared with 95% (PASI = 95%) and 90% (PASI = 90%) improvements in PASI (93.0%, 89.3%, and 83.8% achieving DLQI 0/1, respectively). Estimated proportions achieving DLQI item scores of 0 had the greatest increases at higher PASI improvement levels for Items 1 (itchy, sore, painful, or stinging skin), 2 (embarrassment), and 4 (choice of clothing). Estimated proportions of patients achieving P-SIM = 0 were also higher for PASI 100 (itching: 61.7%; scaling: 82.2%; skin pain: 96.9%) than for PASI = 95% (50.8%; 72.3%; 95.7%) and PASI = 90% (39.8%; 59.5%; 94.0%). Similar benefits of incremental PASI improvements were estimated using 2-year data.</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>Complete skin clearance translated into the greatest benefits to HRQoL and patient-perceived symptoms, over and above skin clearance between 90% and 100%, highlighting the importance of targeting PASI 100 as a treatment outcome for patients with psoriasis.</p><h3 data-test=\"abstract-sub-heading\">Trial Registration Number</h3><p>NCT03536884.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142249587","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
Impact of Disease Factors of Patients with Psoriasis and Psoriatic Arthritis on Biologic Therapy Switching: Real-World Evidence from the CorEvitas Psoriasis Registry 银屑病和银屑病关节炎患者的疾病因素对生物疗法转换的影响:来自 CorEvitas 银屑病登记处的真实世界证据
IF 3.4 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-09-16 DOI: 10.1007/s13555-024-01258-1
Philip J. Mease, Andrew Blauvelt, Adam P. Sima, Silky W. Beaty, Robert Low, Braulio Gomez, Marie Gurrola, Mark G. Lebwohl

Introduction

Patients with psoriasis (PSO) and psoriatic arthritis (PsA) may frequently switch biologic therapies over the course of treatment because of symptom variability and individual responses. Real-world studies analyzing patient characteristics and clinical factors associated with biologic switching are limited.

Methods

This longitudinal cohort study used real-world data from the CorEvitas Psoriasis Registry to evaluate the relationship between associated disease factors and biologic switching among patients with PSO and PsA in the United States (US) and Canada following initiation of a biologic. Patients were evaluated between April 2015–August 2022. Combinations of disease severity (as measured by Psoriasis Area Severity Index [PASI]) and Dermatology Life Quality Index (DLQI) as a measure of health-related quality of life (HRQoL) were assessed, and the association with time to switching was calculated using Cox proportional hazards regression modeling.

Results

Among 2580 patient-initiations (instances of patients initiating a biologic), 504 (19.5%) switched biologics within 30 months of initiation. Switching was more frequent when either PASI > 10 or DLQI > 5 compared with PASI ≤ 10 or DLQI ≤ 5 at follow-up. Patients with higher skin involvement (PASI > 10) and impact on HRQoL (DLQI > 5) were 14 times more likely to switch (hazard ratio = 14.2, 95% confidence interval: 10.7, 18.9) than those with lower skin involvement (PASI ≤ 10) and HRQoL (DLQI ≤ 5).

Conclusions

Patients with PSO and PsA treated in a real-world dermatology setting with substantial disease factors following biologic initiation were more likely to switch therapies. Those with PASI > 10 and DLQI > 5 switched more frequently than those with PASI ≤ 10 and DLQI ≤ 5.

导言银屑病(PSO)和银屑病关节炎(PsA)患者在治疗过程中可能会因症状变化和个体反应而频繁更换生物制剂疗法。这项纵向队列研究利用 CorEvitas 银屑病登记处的真实数据,评估了美国和加拿大 PSO 和 PsA 患者在开始使用生物制剂后相关疾病因素与生物制剂转换之间的关系。患者的评估时间为 2015 年 4 月至 2022 年 8 月。评估了疾病严重程度(以银屑病面积严重程度指数[PASI]衡量)和皮肤病生活质量指数(DLQI)的组合,作为健康相关生活质量(HRQoL)的衡量标准,并使用Cox比例危险回归模型计算了与转换时间的关系。结果在2580例患者中(开始使用生物制剂的患者实例),有504例(19.5%)在开始使用后30个月内转换了生物制剂。与随访时PASI≤10或DLQI≤5相比,PASI > 10或DLQI > 5的患者更换生物制剂的频率更高。皮肤受累程度较高(PASI > 10)且对 HRQoL 有影响(DLQI > 5)的患者转换疗法的可能性是皮肤受累程度较低(PASI ≤ 10)且 HRQoL 较低(DLQI ≤ 5)的患者的 14 倍(危险比 = 14.2,95% 置信区间:10.7, 18.9)。与PASI≤10和DLQI≤5的患者相比,PASI > 10和DLQI > 5的患者更换疗法的频率更高。
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引用次数: 0
Impact of Disease Burden of Patients with Psoriasis on Biologic Therapy Switching: Real-World Evidence from the CorEvitas Psoriasis Registry 银屑病患者的疾病负担对生物疗法转换的影响:来自 CorEvitas 银屑病登记处的真实证据
IF 3.4 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-09-16 DOI: 10.1007/s13555-024-01257-2
Andrew Blauvelt, Robert R. McLean, Silky W. Beaty, Adam P. Sima, Robert Low, Jeffrey L. Stark, Laura McClung, Jerry Bagel

Introduction

Due to variable psoriasis symptoms, disease progression, and individual responses to therapy, patients may start, stop, or switch biologic therapies. Real-world data on the associated disease burden of patients with psoriasis who do and do not switch biologics are incomplete.

Methods

This study compared disease burden among patients from the CorEvitas Psoriasis Registry (July 2017–December 2021) who switched biologics and those who did not within 4–12 months following initiation. Disease-related patient-reported outcomes (PROs) were recorded, including skin pain, itching, activity impairment, and effects on health-related quality of life (HRQoL). Disease severity was measured by body surface area (BSA) and Psoriasis Area and Severity Index (PASI). Unadjusted and adjusted regression models were used to compare study outcome measures between the two groups.

Results

This study included 2145 patients, with 159 classified as switchers and 1986 as non-switchers. The most common reason for switching therapy was failure to maintain initial response (51.7%; n = 78). Moderate-to-severe disease (BSA ≥ 3) was found among 83.0% (n = 132) of switchers versus 26.1% (n = 516) of non-switchers. PASI > 5 was reported among 49.7% (n = 79) of switchers versus 8.6% (n = 171) of non-switchers. Differences in skin pain, itching, and effects on HRQoL between switchers and non-switchers were larger in magnitude for bio-experienced patients.

Conclusions

Patients who switched biologic therapy experienced a greater disease burden of psoriasis across PROs than non-switchers. Patient-centered factors may be important drivers of biologic switching. Our findings suggest the association between switching and disease burden may be stronger among patients with prior biologic therapy experience.

导言由于银屑病症状、疾病进展和个体对治疗的反应各不相同,患者可能会开始、停止或更换生物制剂疗法。本研究比较了 CorEvitas 银屑病登记处(2017 年 7 月至 2021 年 12 月)中在开始治疗后 4-12 个月内更换生物制剂和未更换生物制剂的患者的疾病负担。记录了与疾病相关的患者报告结果(PROs),包括皮肤疼痛、瘙痒、活动障碍以及对健康相关生活质量(HRQoL)的影响。疾病严重程度通过体表面积(BSA)和银屑病面积与严重程度指数(PASI)进行测量。研究采用未调整和调整回归模型来比较两组患者的研究结果。转换疗法的最常见原因是未能维持初始反应(51.7%;n = 78)。83.0%的转换者(n = 132)和26.1%的非转换者(n = 516)患有中重度疾病(BSA ≥ 3)。49.7%(n = 79)的转换者与 8.6%(n = 171)的非转换者相比,PASI 为 5。有生物治疗经验的患者在皮肤疼痛、瘙痒以及对 HRQoL 的影响方面,转换者与非转换者之间的差异更大。以患者为中心的因素可能是生物制剂转换的重要驱动因素。我们的研究结果表明,对于有过生物制剂治疗经验的患者来说,转换疗法与疾病负担之间的关系可能会更密切。
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引用次数: 0
Pharmacodynamic Response to Deucravacitinib, an Oral, Selective, Allosteric TYK2 Inhibitor, in a Global, Phase 2, Randomized, Double-Blind, Placebo-Controlled Psoriasis Trial 在一项全球性、第 2 期、随机、双盲、安慰剂对照银屑病试验中,对口服、选择性、异位 TYK2 抑制剂 Deucravacitinib 的药效学反应
IF 3.4 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-09-16 DOI: 10.1007/s13555-024-01262-5
Ian M. Catlett, Lu Gao, Yanhua Hu, Subhashis Banerjee, James G. Krueger

Background

Psoriasis, a chronic, immune-mediated, inflammatory disease, affects 2‒3% of the population. Tyrosine kinase 2 (TYK2) mediates cytokine signaling involved in adaptive [interleukin (IL)-12, IL-23] and innate (type-I interferons) immune responses; IL-23–driven T-helper (Th)17 pathways play a key role in chronic inflammation in psoriasis. In a phase 2 trial, deucravacitinib, an oral, selective, allosteric TYK2 inhibitor, reduced IL-23/Th17 and type-I interferon pathway expression in the skin of patients with moderate to severe plaque psoriasis, reductions that were accompanied by clinical improvement of psoriatic lesions.

Objectives

The aim of this study was to identify biomarkers of psoriatic disease in serum from patients enrolled in the phase 2 trial and to assess the effects of deucravacitinib on those biomarkers.

Methods

Serum biomarkers from Olink proteomics and other quantitative assays were evaluated for a pharmacodynamic response to deucravacitinib treatment and correlation with psoriasis disease activity measures.

Results

Serum biomarkers associated with the IL-23/Th17 pathway [IL-17A, IL-17C, IL-19, IL-20, beta-defensin, and peptidase inhibitor 3 (PI3)] were upregulated in patients with psoriasis versus healthy controls. Deucravacitinib treatment reduced IL-17A (adjusted mean change from baseline at Day 85; 12 mg once daily versus placebo; −0.240 versus −0.067), IL-17C (−14.850 versus −1.664), IL-19 (−96.445 versus −8.119), IL-20 (−0.265 versus −0.064), beta-defensin (−65,025.443 versus −7553.961), and PI3 (−14.005 versus −1.360) expression. Reductions in serum biomarker expression occurred in a dose- and time-dependent manner, with significant reductions from baseline seen with deucravacitinib doses ≥ 3 mg twice daily (P ≤ 0.05). Biomarker expression correlated with disease activity measures such as Psoriasis Area and Severity Index (PASI) at baseline. Biomarker expression also correlated with PASI scores at Week 12.

Conclusion

IL-23/Th17 pathway expression in the serum of patients with psoriasis is an indicator of disease activity and response to deucravacitinib treatment.

Trial registration number

NCT02931838.

背景牛皮癣是一种免疫介导的慢性炎症性疾病,发病率占总人口的 2-3%。酪氨酸激酶2(TYK2)介导细胞因子信号转导,参与适应性[白细胞介素(IL)-12、IL-23]和先天性(I型干扰素)免疫反应;IL-23驱动的T-helper(Th)17通路在银屑病的慢性炎症中起着关键作用。在一项2期试验中,口服选择性异位TYK2抑制剂deucravacitinib降低了中度至重度斑块状银屑病患者皮肤中IL-23/Th17和I型干扰素通路的表达,同时银屑病皮损的临床症状也得到了改善。结果与健康对照组相比,银屑病患者与IL-23/Th17通路相关的血清生物标记物[IL-17A、IL-17C、IL-19、IL-20、β-防御素和肽酶抑制剂3 (PI3)]上调。Deucravacitinib治疗可降低IL-17A(第85天时与基线相比的调整后平均变化;12毫克,每日一次与安慰剂相比;-0.240与-0.067)、IL-17C(-14.850与-1.664)、IL-19(-96.445与-8.119)、IL-20(-0.265与-0.064)、β-防御素(-65,025.443与-7553.961)和PI3(-14.005与-1.360)的表达。血清生物标志物表达的降低呈剂量和时间依赖性,在deucravacitinib剂量≥3毫克、每天两次时,生物标志物表达较基线显著降低(P≤0.05)。生物标志物的表达与基线时的银屑病面积和严重程度指数(PASI)等疾病活动指标相关。结论银屑病患者血清中IL-23/Th17通路的表达是疾病活动性和对deucravacitinib治疗反应的指标。
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引用次数: 0
Exploring the Intersection of Body Dysmorphic Disorder (BDD) and Dermatological Conditions: A Narrative Review 探索身体畸形障碍 (BDD) 与皮肤病的交集:叙述性综述
IF 3.4 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-09-12 DOI: 10.1007/s13555-024-01256-3
Vivian Li, Kelly Frasier, Emily Woolhiser, Kathleen Daly, Sara Christoforides, Courtnee Harpine, Karina Stech, Stefany Acosta, Edwin D. Lephart

This narrative literature review examined the intricate relationship between body dysmorphic disorder (BDD) and dermatological conditions, with a brief focus on those characterized by conspicuous skin irregularities such as acne vulgaris, psoriasis, and vitiligo. Highlighting the significant prevalence of BDD among individuals afflicted with dermatological issues, our analysis illuminated the profound psychological repercussions stemming from an exaggerated preoccupation with perceived skin imperfections. Through an exploration of the underlying BDD symptoms, we analyzed the complex dynamics between skin health and mental well-being, emphasizing the disorder’s impact on patients’ psychological and social functioning. This narrative review further investigated the consequential effects of BDD on essential aspects of dermatological treatment, including patient adherence to therapeutic regimens, overall quality of life (QOL), and the effectiveness of available treatments. In addition to presenting current therapeutic approaches, we advocate for the integration of psycho-dermatological interventions tailored to mitigate the dual burden of skin conditions and psychological distress. Future research directions proposed include longitudinal studies to assess the long-term effects of BDD on skin disease prognosis and psychosocial well-being, which aim to refine and optimize treatment modalities to contribute to a more holistic understanding of BDD within dermatological practice.

这篇叙事性文献综述研究了身体畸形障碍(BDD)与皮肤病之间错综复杂的关系,并简要聚焦于那些以明显皮肤不规则为特征的疾病,如寻常痤疮、银屑病和白癜风。我们的分析强调了 BDD 在皮肤病患者中的显著流行率,揭示了对皮肤瑕疵的夸大关注所产生的深刻心理影响。通过对 BDD 潜在症状的探讨,我们分析了皮肤健康与心理健康之间复杂的动态关系,强调了该疾病对患者心理和社会功能的影响。这篇叙述性综述进一步研究了 BDD 对皮肤病治疗重要方面的影响,包括患者对治疗方案的依从性、整体生活质量 (QOL) 以及现有治疗方法的有效性。除了介绍当前的治疗方法外,我们还主张整合皮肤心理干预措施,以减轻皮肤病和心理困扰的双重负担。我们提出的未来研究方向包括纵向研究,以评估 BDD 对皮肤病预后和社会心理健康的长期影响,旨在完善和优化治疗方法,从而在皮肤科实践中对 BDD 有更全面的了解。
{"title":"Exploring the Intersection of Body Dysmorphic Disorder (BDD) and Dermatological Conditions: A Narrative Review","authors":"Vivian Li, Kelly Frasier, Emily Woolhiser, Kathleen Daly, Sara Christoforides, Courtnee Harpine, Karina Stech, Stefany Acosta, Edwin D. Lephart","doi":"10.1007/s13555-024-01256-3","DOIUrl":"https://doi.org/10.1007/s13555-024-01256-3","url":null,"abstract":"<p>This narrative literature review examined the intricate relationship between body dysmorphic disorder (BDD) and dermatological conditions, with a brief focus on those characterized by conspicuous skin irregularities such as acne vulgaris, psoriasis, and vitiligo. Highlighting the significant prevalence of BDD among individuals afflicted with dermatological issues, our analysis illuminated the profound psychological repercussions stemming from an exaggerated preoccupation with perceived skin imperfections. Through an exploration of the underlying BDD symptoms, we analyzed the complex dynamics between skin health and mental well-being, emphasizing the disorder’s impact on patients’ psychological and social functioning. This narrative review further investigated the consequential effects of BDD on essential aspects of dermatological treatment, including patient adherence to therapeutic regimens, overall quality of life (QOL), and the effectiveness of available treatments. In addition to presenting current therapeutic approaches, we advocate for the integration of psycho-dermatological interventions tailored to mitigate the dual burden of skin conditions and psychological distress. Future research directions proposed include longitudinal studies to assess the long-term effects of BDD on skin disease prognosis and psychosocial well-being, which aim to refine and optimize treatment modalities to contribute to a more holistic understanding of BDD within dermatological practice.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142181574","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 of Brodalumab in Patients with Psoriasis and Risk Factors for Treatment Failure: A Review of Post Hoc Analyses 银屑病患者使用布达鲁单抗的疗效及治疗失败的风险因素:事后分析综述
IF 3.4 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-09-12 DOI: 10.1007/s13555-024-01264-3
Mark G. Lebwohl, April W. Armstrong, Andrew F. Alexis, Edward L. Lain, Abby A. Jacobson

Factors such as obesity, alcohol consumption, and tobacco use are associated with both increased psoriasis severity and inadequate response to systemic and biologic therapies. Obesity is linked to chronic inflammation, which can contribute to psoriasis pathogenesis. Fixed-dose therapies may have reduced efficacy in patients with a higher body mass index, while weight-based dosing can increase the burden of drug-specific side effects. Alcohol and nicotine from tobacco have also been shown to stimulate keratinocyte and immune cell proliferation and production of proinflammatory cytokines. While these risk factors are prevalent among patients with moderate-to-severe psoriasis, their influence on treatment outcomes may be overlooked when evaluating therapeutic options. Brodalumab is a fully human interleukin-17 receptor A antagonist approved for the treatment of moderate-to-severe psoriasis. In this review, we describe the lifestyle-related risk factors associated with decreased response to treatment. We further summarize the post hoc analyses of brodalumab in participant subgroups with moderate-to-severe psoriasis and a history of prior biologic failure, obesity, and alcohol or tobacco use from two phase 3 clinical trials (AMAGINE-2 and AMAGINE-3; ClinicalTrials.gov identifiers: NCT01708603 and NCT01708629, respectively). Our review of clinical trial and real-world data suggests that brodalumab is an efficacious and safe treatment option for patients with lifestyle factors that increase the likelihood of treatment failure, allowing them to achieve skin clearance and improve quality of life.

肥胖、饮酒和吸烟等因素与银屑病严重程度的增加以及对全身疗法和生物疗法的反应不足有关。肥胖与慢性炎症有关,而慢性炎症可导致银屑病发病。固定剂量疗法可能会降低体重指数较高患者的疗效,而基于体重的剂量会增加药物特异性副作用的负担。烟草中的酒精和尼古丁也被证明会刺激角质细胞和免疫细胞增殖并产生促炎细胞因子。虽然这些风险因素在中重度银屑病患者中普遍存在,但在评估治疗方案时可能会忽略它们对治疗效果的影响。Brodalumab 是一种全人白细胞介素-17 受体 A 拮抗剂,已被批准用于治疗中重度银屑病。在这篇综述中,我们描述了与生活方式相关的导致治疗反应减弱的风险因素。我们进一步总结了两项三期临床试验(AMAGINE-2 和 AMAGINE-3;ClinicalTrials.gov identifiers:分别为 NCT01708603 和 NCT01708629)。我们对临床试验和真实世界数据的审查表明,对于存在增加治疗失败可能性的生活方式因素的患者来说,布达鲁单抗是一种有效而安全的治疗选择,它能让患者实现皮肤清除并改善生活质量。
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引用次数: 0
Cutaneous Manifestations in Patients with Dermatomyositis, Are They Only Skin Deep? 皮肌炎患者的皮肤表现,只是皮毛吗?
IF 3.4 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-09-12 DOI: 10.1007/s13555-024-01266-1
Stephanie McKee, Jason Xenakis, Harriet Makin, Chris Marshall, Randall Winnette, Rohit Aggarwal, Sarah Knight

Background

Dermatomyositis (DM) is a rare and severely debilitating autoimmune disease that can affect children and adults; however, there is little understanding of the patient-reported experience and uncertainty around validated clinical outcomes assessments (COAs) that could measure changes in the condition during clinical trials of new treatments.

Objectives

The aim of this study was to understand the patient experience of DM, with a focus on its cutaneous manifestations, to describe the patient experience and determine the suitability of existing COA measures.

Methods

Adult (≥ 18 years) patients (N = 28) with severe active cutaneous manifestations of DM were interviewed. In the 90-min interviews, open-ended questions and probes were used to elicit descriptions of key clinical manifestations and patients’ experiences of DM, including the symptoms and impacts on their daily lives and wellbeing.

Results

Patients reported 13 different skin manifestations of DM. The most common were rash (n = 28, 100%), itch (n = 28, 100%), dry skin (n = 23, 82%), and swelling of the skin (n = 17, 61%). The head and face, followed by hands, were perceived as the most bothersome body areas affected by skin manifestations, because they are exposed and visible to themselves and other people. All patients (n = 28, 100%) reported at least one impact of DM, which varied greatly between patients, but included emotional, psychological, cognitive, and physical impacts, and those affecting daily life, such as work and sleep. Over half of the patients (n = 19, 67%) reported that their daily activities were impacted by DM.

Conclusions

The qualitative interviews with patients revealed that the presentation of DM manifestations is highly variable but affects patients’ emotional wellbeing, physical activities, and daily life significantly.

背景皮肌炎(Dermatomyositis,DM)是一种罕见的严重致残性自身免疫性疾病,可影响儿童和成人;然而,人们对患者报告的经历知之甚少,而且在新疗法临床试验期间,可用于衡量病情变化的有效临床结果评估(COA)也存在不确定性。本研究旨在了解 DM 患者的经历,重点是其皮肤表现,以描述患者的经历并确定现有 COA 测量方法的适用性。方法对患有严重活动性皮肤表现的 DM 成人患者(≥ 18 岁)(N = 28)进行访谈。在 90 分钟的访谈中,采用了开放式问题和探究式问题,以了解主要临床表现的描述和患者对 DM 的体验,包括症状及其对日常生活和健康的影响。最常见的是皮疹(28 例,100%)、瘙痒(28 例,100%)、皮肤干燥(23 例,82%)和皮肤肿胀(17 例,61%)。头部和脸部,其次是手部,被认为是最受皮肤表现困扰的身体部位,因为它们暴露在外,自己和他人都能看到。所有患者(n = 28,100%)都报告了至少一种 DM 影响,这些影响因患者而异,但包括情绪、心理、认知和身体影响,以及影响日常生活(如工作和睡眠)的影响。结论 对患者进行的定性访谈显示,DM 的表现形式千差万别,但对患者的情绪健康、身体活动和日常生活影响很大。
{"title":"Cutaneous Manifestations in Patients with Dermatomyositis, Are They Only Skin Deep?","authors":"Stephanie McKee, Jason Xenakis, Harriet Makin, Chris Marshall, Randall Winnette, Rohit Aggarwal, Sarah Knight","doi":"10.1007/s13555-024-01266-1","DOIUrl":"https://doi.org/10.1007/s13555-024-01266-1","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Background</h3><p>Dermatomyositis (DM) is a rare and severely debilitating autoimmune disease that can affect children and adults; however, there is little understanding of the patient-reported experience and uncertainty around validated clinical outcomes assessments (COAs) that could measure changes in the condition during clinical trials of new treatments.</p><h3 data-test=\"abstract-sub-heading\">Objectives</h3><p>The aim of this study was to understand the patient experience of DM, with a focus on its cutaneous manifestations, to describe the patient experience and determine the suitability of existing COA measures.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>Adult (≥ 18 years) patients (<i>N</i> = 28) with severe active cutaneous manifestations of DM were interviewed. In the 90-min interviews, open-ended questions and probes were used to elicit descriptions of key clinical manifestations and patients’ experiences of DM, including the symptoms and impacts on their daily lives and wellbeing.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Patients reported 13 different skin manifestations of DM. The most common were rash (<i>n</i> = 28, 100%), itch (<i>n</i> = 28, 100%), dry skin (<i>n</i> = 23, 82%), and swelling of the skin (<i>n</i> = 17, 61%). The head and face, followed by hands, were perceived as the most bothersome body areas affected by skin manifestations, because they are exposed and visible to themselves and other people. All patients (<i>n</i> = 28, 100%) reported at least one impact of DM, which varied greatly between patients, but included emotional, psychological, cognitive, and physical impacts, and those affecting daily life, such as work and sleep. Over half of the patients (<i>n</i> = 19, 67%) reported that their daily activities were impacted by DM.</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>The qualitative interviews with patients revealed that the presentation of DM manifestations is highly variable but affects patients’ emotional wellbeing, physical activities, and daily life significantly.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142181576","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
期刊
Dermatology and Therapy
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