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Cumulative Benefit Over 52 Weeks With Deucravacitinib Versus Apremilast in Moderate to Severe Plaque Psoriasis: POETYK PSO-1 Post Hoc Analysis. 中度至重度斑块状银屑病患者52周内服用Deucravacitinib与Apremilast的累积疗效:POETYK PSO-1 后期分析。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-07-01 Epub Date: 2024-06-22 DOI: 10.1007/s13555-024-01201-4
April W Armstrong, Sang Hee Park, Vardhaman Patel, Pierre Nicolas, Wei-Jhih Wang, Matthew J Colombo, Viktor Chirikov

Introduction: Deucravacitinib demonstrated superior efficacy to apremilast in patients with moderate to severe plaque psoriasis in the POETYK PSO-1 and PSO-2 clinical trials. In the study reported here, we aimed to determine the overall 52-week cumulative clinical benefit of treatment initiated with deucravacitinib versus apremilast and to compare the 52-week cumulative benefit of initiating and staying on deucravacitinib versus initiating apremilast and continuing or switching to deucravacitinib at week 24 of treatment.

Methods: This post hoc analysis of POETYK PSO-1 data (ClinicalTrials.gov identifier: NCT03624127) determined the cumulative clinical benefit of deucravacitinib 6 mg once daily and apremilast 30 mg twice daily in adults with moderate to severe plaque psoriasis. Patients treated with apremilast who did not achieve a 50% reduction in the Psoriasis Area and Severity Index (PASI 50) at week 24 were switched to deucravacitinib. The cumulative clinical benefit of deucravacitinib versus apremilast over 52 weeks was based on cumulative measures of ≥ 75% improvement from baseline in PASI score (PASI 75) and the proportion of patients with a static Physician Global Assessment score of 0 or 1 (sPGA 0/1). Ratios of area under the curve estimates between treatments were calculated and compared based on analysis of covariance regression models.

Results: Patients initiating deucravacitinib (N = 332) had a greater cumulative benefit as measured by the PASI 75 and sPGA 0/1 than those initiating apremilast (N = 168). Over 52 weeks, those initiating deucravacitinib experienced 50% more benefit as measured by PASI 75 and 58% more benefit as measured by sPGA 0/1 than those initiating apremilast. Results were consistent with the primary analysis when patients were classified by prior systemic and prior biologic therapy exposure.

Conclusion: Results from this analysis corroborate the primary efficacy analysis supporting the use of deucravacitinib compared with apremilast for moderate to severe plaque psoriasis, regardless of prior systemic or biologic use.

简介在 POETYK PSO-1 和 PSO-2 临床试验中,德拉瓦替尼对中重度斑块状银屑病患者的疗效优于阿普司特。在本文报告的研究中,我们旨在确定开始使用去氯法替尼与阿普司特治疗52周的总体累积临床获益,并比较开始使用并坚持使用去氯法替尼与开始使用阿普司特并在治疗第24周时继续使用或改用去氯法替尼的52周累积获益:这项对POETYK PSO-1数据(ClinicalTrials.gov标识符:NCT03624127)的事后分析确定了中重度斑块状银屑病成人患者每天一次、每次6毫克的deucravacitinib和每天两次、每次30毫克的apremilast的累积临床疗效。接受阿普司特治疗的患者如果在第24周时银屑病面积和严重程度指数(PASI 50)没有达到50%的下降,则改用deucravacitinib治疗。52周内,德拉瓦替尼与阿普瑞司特的累积临床获益基于PASI评分(PASI 75)较基线改善≥75%的累积测量值,以及静态医生总体评估评分为0或1分(sPGA 0/1)的患者比例。根据协方差回归分析模型计算并比较了不同治疗方法的曲线下面积估计值之比:结果:根据PASI 75和sPGA 0/1来衡量,开始接受德拉瓦替尼治疗的患者(332人)比开始接受阿普司特治疗的患者(168人)有更大的累积获益。在52周的时间里,与阿普司特相比,根据PASI 75和sPGA 0/1来衡量,开始使用deucravacitinib的患者获益多50%,而开始使用阿普司特的患者获益多58%。根据既往接受过系统治疗和生物治疗的患者进行分类后,结果与主要分析一致:该分析结果证实了主要疗效分析结果,支持在中重度斑块状银屑病治疗中,与阿普司特相比使用去氯伐他替尼,而与既往接受过系统治疗或生物制剂治疗的患者无关。
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引用次数: 0
Evaluating Access to Prescription Medications in the Atopic Dermatitis Patient Population in the USA. 评估美国特应性皮炎患者获得处方药的情况。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-07-01 Epub Date: 2024-06-16 DOI: 10.1007/s13555-024-01205-0
Allison R Loiselle, Raj Chovatiya, Isabelle J Thibau, Jessica K Johnson, Michele Guadalupe, Wendy Smith Begolka

Introduction: Despite advances in atopic dermatitis (AD) treatments, many patients face challenges obtaining medications. This study aimed to determine the frequency and causes of insurance coverage delays and denials for AD prescriptions and characterize the associated wait times and extent to which patients understand what to do when faced with a coverage issue.

Methods: This was a cross-sectional, observational study in which adult U.S. residents (aged 18+ years) with AD or caregivers of pediatric U.S. patients with AD (aged 0-17 years) completed an online survey (3 June-16 July 2021).

Results: Respondents (N = 978) were primarily adults with AD (81.8%), female (67.7%), and white (70.2%). There were 645 insurance delays or denials for AD prescriptions, with 48.1% (470/978) of respondents experiencing at least one delay/denial in the past year. Most delays/denials were for topical steroids (39.2%, 253/645), the most highly used prescription treatment class (83.9%, 821/978). However, the highest rate of delay/denials was for biologics, of which 43.6% (109/250) of all prescriptions faced a delay or denial. Denials were caused primarily by step therapy (27.6%) and delays by prior authorization (55.1%). Only 56.0% of respondents said they would know what to do if they faced an issue with AD prescription coverage.

Conclusions: Patients with AD frequently experience insurance-related barriers to obtaining recommended therapies, and many do not know how to respond when these barriers arise. Strategies to improve timely therapeutic access are needed.

简介:尽管特应性皮炎(AD)治疗取得了进展,但许多患者在获得药物治疗方面仍面临挑战。本研究旨在确定特应性皮炎处方药保险拖延和拒绝承保的频率和原因,并描述相关的等待时间以及患者在遇到承保问题时了解该如何处理的程度:这是一项横断面观察性研究,由患有注意力缺失症的美国成年居民(18 岁以上)或患有注意力缺失症的美国儿科患者(0-17 岁)的照顾者完成在线调查(2021 年 6 月 3 日至 7 月 16 日):受访者(N = 978)主要为成人注意力缺失症患者(81.8%)、女性(67.7%)和白人(70.2%)。过去一年中,有 645 例 AD 处方被保险延迟或拒绝,其中 48.1%(470/978)的受访者至少经历过一次延迟/拒绝。大多数延误/拒绝是针对局部类固醇(39.2%,253/645),这是使用率最高的处方治疗类别(83.9%,821/978)。然而,生物制剂的延误/拒绝率最高,在所有处方中,43.6%(109/250)的处方面临延误或拒绝。拒绝处方的主要原因是分步治疗(27.6%)和预先授权(55.1%)。只有 56.0% 的受访者表示,如果他们遇到有关注意力缺失症处方保险的问题,他们知道该怎么办:结论:AD 患者在获得推荐疗法时经常会遇到与保险相关的障碍,许多患者在遇到这些障碍时不知道如何应对。我们需要制定一些策略来改善治疗的及时性。
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引用次数: 0
Late-Onset Reactions after Hyaluronic Acid Dermal Fillers: A Consensus Recommendation on Etiology, Prevention and Management. 透明质酸皮肤填充剂后的晚发反应:关于病因、预防和管理的共识建议。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-07-01 Epub Date: 2024-06-22 DOI: 10.1007/s13555-024-01202-3
Wioletta Baranska-Rybak, José V Lajo-Plaza, Lee Walker, Navid Alizadeh

Hyaluronic acid (HA) dermal fillers, generally considered low-risk, can lead to rare late-onset reactions (LORs) manifesting between 3 and 4 months postinjection, occasionally even as early as 24 h postinjection. The Complication Assessment and Risk Evaluation (CARE) board was established to review these reactions. In this publication, the authors aims to explore the etiological hypotheses underlying LORs, associated risk factors, prevention, and management approaches suggested by the CARE board. The CARE board identified three etiological hypotheses contributing to LORs. Firstly, the physicochemical structure of the filler, particularly low molecular weight HA, which may trigger an immune response. Secondly, infection, potentially introduced during injection or by dormant biofilm activation. Lastly, an imbalance in the host immune system, caused by factors like autoimmune diseases or viral infections, may lead to extended foreign body reactions, delayed type IV hypersensitivity, or adjuvant-based reactions. Based on these hypotheses, the board categorized various risk factors as patient-related (e.g., recent dental treatment, current medical status, active autoimmune disease), product-related (e.g., molecular weight), and procedure-related (e.g., aseptic technique and trauma). To reduce the risk of LORs, the CARE board recommends diligent patient selection, including comprehensive medical history assessment and informed consent. Practitioners should maintain an effective aseptic technique, and choose an appropriate product and injection depth for the anatomical location. Post-procedure, patients should receive education on proper filler care. Management of LORs depends on the suspected etiology, and the CARE board has proposed an algorithm to determine the most appropriate treatment. Hyaluronidase is recommended for noninflammatory reactions in the absence of active infection, while watchful waiting and/or steroid treatment may be preferred for inflammatory reactions. Hyaluronidase is not recommended as a first-line treatment for infections, which require drainage, bacterial culture, and antibiotic treatment. However, the board emphasizes the need for individualized evaluation and treatment in all cases.

透明质酸(HA)皮肤填充剂通常被认为是低风险的,但也可能导致罕见的迟发反应(LORs),表现为注射后 3 到 4 个月,有时甚至早在注射后 24 小时就会出现。并发症评估和风险评价(CARE)委员会的成立就是为了审查这些反应。在本刊物中,作者旨在探讨 LORs 的病因假设、相关风险因素、预防措施以及 CARE 委员会建议的处理方法。CARE 委员会确定了导致 LORs 的三个病因假设。首先,填充物的理化结构,尤其是低分子量 HA,可能会引发免疫反应。其次是感染,可能是在注射过程中或通过休眠生物膜的激活引起的。最后,由自身免疫性疾病或病毒感染等因素引起的宿主免疫系统失衡,可能会导致扩展的异物反应、迟发性 IV 型超敏反应或基于佐剂的反应。根据这些假设,委员会将各种风险因素分为与患者相关的因素(如近期牙科治疗、当前医疗状况、活动性自身免疫性疾病)、与产品相关的因素(如分子量)和与手术相关的因素(如无菌技术和创伤)。为降低 LOR 的风险,CARE 委员会建议谨慎选择患者,包括全面的病史评估和知情同意。医生应保持有效的无菌技术,并根据解剖位置选择合适的产品和注射深度。术后,患者应接受有关正确填充护理的教育。对 LOR 的处理取决于疑似病因,CARE 委员会提出了一种算法来确定最合适的治疗方法。对于无活动性感染的非炎症性反应,建议使用透明质酸酶,而对于炎症性反应,则可选择观察等待和/或类固醇治疗。不建议将透明质酸酶作为感染的一线治疗方法,因为感染需要引流、细菌培养和抗生素治疗。不过,委员会强调所有病例都需要进行个体化评估和治疗。
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引用次数: 0
Disease Course, Treatment Patterns and Goals Among Patients with Non-segmental Vitiligo Across Europe and the United States. 欧洲和美国非节段型白癜风患者的病程、治疗模式和目标。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-07-01 Epub Date: 2024-06-26 DOI: 10.1007/s13555-024-01212-1
David Rosmarin, Ahmed M Soliman, Simran Marwaha, James Piercy, Heidi S Camp, Peter Anderson, Khaled Ezzedine

Introduction: There is currently a lack of research regarding disease course and burden as well as treatment patterns and goals in patients with non-segmental vitiligo (NSV). The aim of this analysis was to evaluate disease course, treatment patterns and goals in patients with NSV.

Methods: This analysis used secondary data from the Adelphi Real World Vitiligo Disease Specific Programme 2021, specifically, a survey of physicians and their adult and adolescent patients with NSV. Physicians categorized patients by the extent of NSV at time of survey completion as mild, moderate or severe/very severe. Physician-reported patient information included demographics, current/previously prescribed NSV therapies, treatment satisfaction and the Vitiligo Noticeability Scale (VNS). Patients completed a survey on treatment satisfaction and the VNS. Treatment pattern data were stratified by disease extent and Fitzpatrick skin type.

Results: At survey completion, physicians reported that 38, 50 and 12% of patients (N = 1865) had improving, stable and deteriorating/progressing disease, respectively. Most patients (96%) with mild disease at treatment initiation still had mild disease at the time of survey completion. More than half of patients with moderate disease (62%) or severe/very severe disease (57%) at treatment initiation still had moderate or severe/very severe disease at survey completion. Topical calcineurin inhibitors (TCIs) were the most common treatment in 40% of patients followed by phototherapy in 30%. Patients hoped for re-pigmentation (mild 56%, moderate 62%, severe/very severe 66%), reduction (mild 50%, moderate 56%, severe/very severe 49%) or cessation of affected areas with vitiligo (mild 48%, moderate 54%, severe/very severe 43%).

Conclusion: The study findings indicate that a significant proportion of patients with NSV are not improving on current treatments, most commonly TCIs and phototherapy. The results highlight the unmet need for novel and effective therapies to substantially improve re-pigmentation, an important treatment goal for patients with NSV.

导言:目前,有关非节段性白癜风(NSV)患者的病程、负担以及治疗模式和目标的研究还很缺乏。本分析旨在评估非节段性白癜风患者的病程、治疗模式和目标:这项分析使用了 2021 年阿德尔菲真实世界白癜风疾病专项计划(Adelphi Real World Vitiligo Disease Specific Programme™ 2021)的二手数据,特别是对医生及其成年和青少年 NSV 患者的调查。在完成调查时,医生根据患者的 NSV 程度将其分为轻度、中度或重度/极重度。医生报告的患者信息包括人口统计学特征、当前/之前开具的 NSV 治疗处方、治疗满意度和白癜风可察觉性量表 (VNS)。患者填写了一份关于治疗满意度和 VNS 的调查表。治疗模式数据按疾病程度和菲茨帕特里克皮肤类型进行分层:调查结束时,医生报告说分别有38%、50%和12%的患者(1865人)病情好转、稳定和恶化/进展。大多数在开始治疗时病情较轻的患者(96%)在完成调查时病情仍然较轻。在开始治疗时病情为中度(62%)或重度/极重度(57%)的患者中,一半以上在调查结束时病情仍为中度或重度/极重度。局部降钙素抑制剂(TCIs)是最常见的治疗方法,占 40% 的患者,其次是光疗,占 30%。患者希望重新获得色素沉着(轻度56%,中度62%,重度/极重度66%)、减轻(轻度50%,中度56%,重度/极重度49%)或停止患处的白癜风(轻度48%,中度54%,重度/极重度43%):研究结果表明,相当一部分 NSV 患者在接受现有治疗(最常见的是 TCIs 和光疗)后病情未见好转。研究结果凸显了对新型有效疗法的需求尚未得到满足,而新型有效疗法可大幅改善色素再沉着,这是 NSV 患者的一个重要治疗目标。
{"title":"Disease Course, Treatment Patterns and Goals Among Patients with Non-segmental Vitiligo Across Europe and the United States.","authors":"David Rosmarin, Ahmed M Soliman, Simran Marwaha, James Piercy, Heidi S Camp, Peter Anderson, Khaled Ezzedine","doi":"10.1007/s13555-024-01212-1","DOIUrl":"10.1007/s13555-024-01212-1","url":null,"abstract":"<p><strong>Introduction: </strong>There is currently a lack of research regarding disease course and burden as well as treatment patterns and goals in patients with non-segmental vitiligo (NSV). The aim of this analysis was to evaluate disease course, treatment patterns and goals in patients with NSV.</p><p><strong>Methods: </strong>This analysis used secondary data from the Adelphi Real World Vitiligo Disease Specific Programme<sup>™</sup> 2021, specifically, a survey of physicians and their adult and adolescent patients with NSV. Physicians categorized patients by the extent of NSV at time of survey completion as mild, moderate or severe/very severe. Physician-reported patient information included demographics, current/previously prescribed NSV therapies, treatment satisfaction and the Vitiligo Noticeability Scale (VNS). Patients completed a survey on treatment satisfaction and the VNS. Treatment pattern data were stratified by disease extent and Fitzpatrick skin type.</p><p><strong>Results: </strong>At survey completion, physicians reported that 38, 50 and 12% of patients (N = 1865) had improving, stable and deteriorating/progressing disease, respectively. Most patients (96%) with mild disease at treatment initiation still had mild disease at the time of survey completion. More than half of patients with moderate disease (62%) or severe/very severe disease (57%) at treatment initiation still had moderate or severe/very severe disease at survey completion. Topical calcineurin inhibitors (TCIs) were the most common treatment in 40% of patients followed by phototherapy in 30%. Patients hoped for re-pigmentation (mild 56%, moderate 62%, severe/very severe 66%), reduction (mild 50%, moderate 56%, severe/very severe 49%) or cessation of affected areas with vitiligo (mild 48%, moderate 54%, severe/very severe 43%).</p><p><strong>Conclusion: </strong>The study findings indicate that a significant proportion of patients with NSV are not improving on current treatments, most commonly TCIs and phototherapy. The results highlight the unmet need for novel and effective therapies to substantially improve re-pigmentation, an important treatment goal for patients with NSV.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":null,"pages":null},"PeriodicalIF":3.5,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11265022/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141455831","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
Canadian Expert Consensus on the Use of Halobetasol Propionate/Tazarotene Lotion for Plaque Psoriasis. 关于使用卤贝他索丙酸盐/他扎罗汀乳液治疗斑块状银屑病的加拿大专家共识。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-07-01 Epub Date: 2024-06-25 DOI: 10.1007/s13555-024-01204-1
Lyn Guenther, Irina Turchin, Ron Vender, Lorne E Albrecht, Catherine Maari, Howard Yanofsky, Vimal H Prajapati

Introduction: An expert panel of Canadian dermatologists was assembled to develop consensus statements regarding the current landscape of topical therapies for plaque psoriasis and the place in therapy of the recently approved fixed-dose combination halobetasol propionate (HP)/tazarotene (TAZ) lotion (HP/TAZ) in the treatment algorithm for plaque psoriasis.

Method: A modified nominal group technique, which combined both independent and group input from the expert panel, was used to develop the consensus statements. The expert panel completed surveys to elicit their independent views on the current landscape of topical therapies for plaque psoriasis in Canada. The first expert panel session was held to discuss the existing body of literature and develop draft consensus statements about topical therapies and the place in therapy of HP/TAZ. Independent feedback on the draft consensus statements was solicited from expert panel members prior to another expert panel session where the amended consensus statements were further discussed, edited and, finally, voted on.

Results: The expert panel reached consensus on 20 statements.

Conclusion: Expert panel members agreed, based on the existing body of literature, that there is a place in therapy for HP/TAZ to address several current unmet treatment needs of patients with plaque psoriasis. Studies have shown that HP/TAZ is an effective and safe first-line treatment for moderate-to-severe plaque psoriasis. Due to its cosmetically pleasing vehicle and once-daily administration, HP/TAZ may improve patient acceptance and treatment adherence.

简介:我们组建了一个由加拿大皮肤科医生组成的专家小组,就目前治疗斑块状银屑病的外用疗法以及最近获批的固定剂量复方丙酸卤贝他索(HP)/他扎罗汀(TAZ)洗剂(HP/TAZ)在斑块状银屑病治疗方案中的地位达成共识:采用改良的名义小组技术,结合专家组的独立意见和小组意见,制定共识声明。专家小组完成了调查问卷,以了解他们对目前加拿大斑块状银屑病外用疗法现状的独立看法。第一次专家小组会议讨论了现有文献,并就局部疗法和 HP/TAZ 在治疗中的地位制定了共识声明草案。在召开另一次专家小组会议之前,征求了专家小组成员对共识声明草案的独立反馈意见,并在会上对修订后的共识声明进行了进一步的讨论、编辑,最后进行了投票表决:结果:专家小组就 20 项声明达成了共识:专家组成员根据现有文献一致认为,HP/TAZ 可用于治疗斑块状银屑病患者目前尚未满足的治疗需求。研究表明,HP/TAZ 是治疗中度至重度斑块状银屑病有效、安全的一线疗法。HP/TAZ的载体美观大方,而且每天用药一次,因此可以提高患者的接受度和治疗依从性。
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引用次数: 0
Profound Sexual Dysfunction Among Patients with Hidradenitis Suppurativa: A Cross-sectional Study. 化脓性扁桃体炎患者的严重性功能障碍:横断面研究
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-07-01 Epub Date: 2024-06-13 DOI: 10.1007/s13555-024-01196-y
Piotr K Krajewski, Alexandra Strobel, Michael Schultheis, Petra Staubach, Stephan Grabbe, Katharina Hennig, Lukasz Matusiak, Esther von Stebut, Simone Garcovich, Hans Bayer, Marcus Heise, Uwe Kirschner, Georgios Nikolakis, Jacek C Szepietowski

Introduction: Sexual health, a critical aspect of overall well-being, is often compromised in individuals with chronic disorders. Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition that mainly affects intertriginous areas, potentially impacting sexual health as a result of its specific symptoms and psychosocial burden.

Methods: This cross-sectional study utilized data from the EpiCAi project, focusing on 199 patients with HS. Participants completed digital questionnaires assessing sexual health via sex-specific instruments: the Female Sexual Function Index (FSFI) for women and the International Index of Erectile Function (IIEF) for men, alongside different psychosocial scales. The disease severity was assessed using the Hurley stage and the Lesion Identification Scheme for Acne Inversa (LISAI).

Results: The majority of the participants reported impaired sexual health, with significant clinical sexual dysfunctions noted in 71.8% of women (FSFI score < 26) and erectile dysfunction in 63.8% of men. Sexual dysfunction was associated with several factors, including age, and marital status. Psychosocial factors, notably depression and quality of life, showed strong correlations with sexual health outcomes. Notably, women over 40 and those treated with biologics reported more severe dysfunction, while among men, employment status significantly influenced sexual health.

Conclusions: HS profoundly affects the sexual health of both male and female patients, with significant impacts on their quality of life and psychological well-being. The findings underscore the necessity for healthcare providers to address sexual health proactively in the management of HS, considering both physical symptoms and psychosocial impacts. This holistic approach is essential for improving patient outcomes and overall quality of life.

Trial registration: German Register for Clinical Trials, identifier DRKS00025315.

导言:性健康是整体健康的一个重要方面,而慢性疾病患者的性健康往往会受到影响。化脓性扁平湿疹(HS)是一种慢性炎症性皮肤病,主要影响三叉神经间区域,其特殊症状和社会心理负担可能会影响性健康:这项横断面研究利用了 EpiCAi 项目的数据,重点研究了 199 名 HS 患者。参与者填写了通过特定性别工具评估性健康的数字问卷:女性的女性性功能指数(FSFI)和男性的国际勃起功能指数(IIEF),以及不同的心理社会量表。疾病严重程度采用赫利分期和痤疮皮损识别系统(LISAI)进行评估:结果:大多数参与者都表示性健康受到了损害,71.8%的女性出现了严重的临床性功能障碍(FSFI 评分结论):性病严重影响了男性和女性患者的性健康,并对他们的生活质量和心理健康产生了重大影响。研究结果突出表明,医疗服务提供者在治疗性病时必须积极主动地解决性健康问题,同时考虑到身体症状和心理影响。这种综合方法对于改善患者的治疗效果和整体生活质量至关重要:试验注册:德国临床试验注册中心,标识符 DRKS00025315。
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引用次数: 0
Improvement in Measures of Quality of Life and Symptoms of Anxiety and Depression in Patients with Severe Alopecia Areata Achieving Sustained Scalp Hair Regrowth with Baricitinib. 重度脱发患者使用巴利替尼后头皮毛发持续再生,生活质量以及焦虑和抑郁症状得到改善。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-07-01 Epub Date: 2024-06-21 DOI: 10.1007/s13555-024-01208-x
Brittany Craiglow, Yang Won Lee, Sergio Vañó-Galván, Alexander Egeberg, Yves Dutronc, Frederick Durand, Evangeline Pierce, Guanglei Yu, Yun-Fei Chen, Arash Mostaghimi

Introduction: Alopecia areata (AA) is an autoimmune disease associated with high rates of emotional and psychosocial distress. The analysis reported here describes the evolution of measures assessing health-related quality of life (HRQoL) and symptoms of anxiety and depression up to week 104 in patients who achieved sustained scalp hair regrowth during treatment with baricitinib in the BRAVE-AA phase III trials.

Methods: This post-hoc analysis included data from the double-blind, parallel-group, randomized, placebo-controlled phase III trials BRAVE-AA1 (ClinicalTrials.gov number: NCT03570749) and BRAVE-AA2 (ClinicalTrials.gov number: NCT03899259). Adults with severe AA (defined as a Severity of Alopecia Tool [SALT] score ≥ 50) randomized to baricitinib 4 mg or baricitinib 2 mg at baseline who achieved SALT score ≤ 20 by week 36 and maintained SALT score ≤ 20 through week 104 on the same dose of baricitinib were included in this analysis of integrated data. Scalp hair regrowth (SALT score) and improvements in Skindex-16 AA Scale and Hospital Anxiety and Depression Scale (HADS) domain scores were analyzed over the 104-week period using descriptive statistics.

Results: In total, 131 patients (88 on baricitinib 4 mg and 43 on baricitinib 2 mg) were included in this analysis. Across the two groups, the mean age (standard deviation) was 37.2 years (12.7), and 84 (64.1%) patients were female. The interquartile range) for time to achieve a SALT score ≤ 20 for patients treated with baricitinib 4 mg and baricitinib 2 mg was 13.1 and 19.6 weeks, respectively. By week 104, 91% (baricitinib 2 mg) and 96% (baricitinib 4 mg) of patients had achieved a SALT score ≤ 10 on baricitinib treatment. In both groups, progressive improvements in the Skindex-16 AA and HADS domain scores were observed up to week 104.

Conclusion: This analysis of adults with severe AA treated with baricitinib revealed that achievement of sustained clinically meaningful scalp hair regrowth (SALT score ≤ 20) was associated with improvements in both measures of HRQoL and symptoms of anxiety and depression up to week 104.

简介斑秃(AA)是一种自身免疫性疾病,与高发的情绪和社会心理困扰有关。本文报告的分析描述了BRAVE-AA III期试验中使用巴利昔尼治疗期间头皮毛发持续再生的患者截至第104周的健康相关生活质量(HRQoL)评估指标以及焦虑和抑郁症状的变化情况:这项事后分析包括来自双盲、平行组、随机、安慰剂对照III期试验BRAVE-AA1(ClinicalTrials.gov编号:NCT03570749)和BRAVE-AA2(ClinicalTrials.gov编号:NCT03899259)的数据。在基线随机接受巴利昔尼 4 毫克或巴利昔尼 2 毫克治疗的重度 AA 患者(定义为脱发严重程度工具 [SALT] 评分≥ 50 分),如果在第 36 周之前达到 SALT 评分≤ 20 分,并且在第 104 周之前服用相同剂量的巴利昔尼仍保持 SALT 评分≤ 20 分,则纳入本次综合数据分析。使用描述性统计方法分析了104周内头皮毛发再生情况(SALT评分)以及Skindex-16 AA量表和医院焦虑抑郁量表(HADS)领域评分的改善情况:共有131名患者(88名服用巴利昔尼4毫克,43名服用巴利昔尼2毫克)参与了此次分析。两组患者的平均年龄(标准差)为 37.2 岁(12.7),84 名(64.1%)患者为女性。接受巴利替尼4毫克和巴利替尼2毫克治疗的患者达到SALT评分≤20分的时间(四分位数间距)分别为13.1周和19.6周。到第104周时,91%(巴利替尼2毫克)和96%(巴利替尼4毫克)的患者在接受巴利替尼治疗后SALT评分≤10分。在这两组患者中,Skindex-16 AA和HADS领域评分均有逐步改善,直至第104周:对接受巴利昔尼治疗的成人重度AA患者进行的分析表明,在第104周之前,实现有临床意义的持续头皮毛发再生(SALT评分≤20分)与HRQoL以及焦虑和抑郁症状的改善有关。
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引用次数: 0
A Systematic Review and Meta-analysis of Mobile Health Applications and Telemonitoring in Atopic Dermatitis Self-Management. 移动健康应用和远程监控在特应性皮炎自我管理中的应用的系统回顾和元分析。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-07-01 Epub Date: 2024-06-22 DOI: 10.1007/s13555-024-01213-0
Ivan Cherrez-Ojeda, Karla Robles-Velasco, María F Osorio, Ana Ormaza Vera, Zouina Sarfraz, Azza Sarfraz, Annia Cherrez, Sofia Cherrez, Jorge Mario Sanchez Caraballo

Introduction: Up to 25% of children and 5.6% of adults in the USA have atopic dermatitis (AD), with substantial impacts on quality of life. Effective control can be challenging despite therapy efforts. The emergence of information and communication technologies (ICT) in AD management prompted this study to assess its impact on self-management. We conducted a meta-analysis to assess outcomes from peer-reviewed clinical trials evaluating the effectiveness of teledermatology, mobile health (mHealth) apps, and electronic devices for managing AD.

Methods: We searched PubMed, Web of Science, Scopus, and Embase for articles written in English and published until May 2023.

Results: Twelve trials with 2424 participants were selected from 811 studies. A meta-analysis of 1038 individuals reported a mean difference (MD) of -1.57 [95% confidence interval (CI): -2.24, -0.91] for the Patient Oriented Eczema Measure (POEM). A meta-analysis of 495 individuals reported a Dermatology Life Quality Index (DLQI) MD of -0.59 [95% CI: -0.95, -0.23]. Despite heterogeneity (I2 = 47% and I2 = 74%), the impact was significant (P ≤ 0.001). SCORing Atopic Dermatitis (SCORAD) showed an insignificant MD of -0.12 (P = 0.91).

Conclusion: mHealth applications and telemonitoring show significant improvement in patients' quality of life (DLQI) and self-management (POEM) but no significant impact on AD severity (SCORAD).

简介:在美国,多达 25% 的儿童和 5.6% 的成年人患有特应性皮炎(AD),这对他们的生活质量造成了严重影响。尽管治疗努力,但有效的控制仍具有挑战性。信息和通信技术(ICT)在特应性皮炎管理中的出现促使本研究评估其对自我管理的影响。我们进行了一项荟萃分析,评估了同行评议的临床试验结果,这些试验评估了远程皮肤病学、移动健康(mHealth)应用程序和电子设备对AD管理的有效性:我们检索了PubMed、Web of Science、Scopus和Embase上截至2023年5月发表的英文文章:结果:从 811 项研究中筛选出了 12 项试验,共有 2424 名参与者。对1038人进行的荟萃分析表明,患者湿疹测量(POEM)的平均差异(MD)为-1.57 [95%置信区间(CI):-2.24, -0.91]。对 495 人进行的荟萃分析表明,皮肤科生活质量指数 (DLQI) 的 MD 为-0.59 [95% CI:-0.95, -0.23]。尽管存在异质性(I2 = 47% 和 I2 = 74%),但影响显著(P ≤ 0.001)。结论:移动医疗应用和远程监控对患者的生活质量(DLQI)和自我管理(POEM)有显著改善,但对AD严重程度(SCORAD)无显著影响。
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引用次数: 0
Ustekinumab in Hidradenitis Suppurativa: A Systematic Review and Meta-analysis. Ustekinumab 治疗化脓性扁桃体炎:系统综述与 Meta 分析。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-07-01 Epub Date: 2024-06-22 DOI: 10.1007/s13555-024-01207-y
Rahul Masson, Justine Seivright, Tristan Grogan, Swetha Atluri, Iltefat Hamzavi, Marcia Hogeling, Vivian Y Shi, Jennifer L Hsiao

Introduction: Hidradenitis suppurativa (HS) is a frequently debilitating, inflammatory skin condition. Patients may have a limited response to adalimumab, currently the only Food and Drug Administration (FDA)-approved biologic treatment for HS. Ustekinumab is an interleukin-12/23 inhibitor that has been utilized in HS, but there is a lack of an updated systematic review on its efficacy and safety. The aim of this study is to perform a systematic review and meta-analysis of the literature on the efficacy and safety of ustekinumab for HS.

Methods: In October 2022, MEDLINE and Embase databases were searched for articles on ustekinumab in HS. Data extraction was performed on relevant articles by two reviewers. The primary study outcome was the pooled response rate of HS to ustekinumab. A fixed-effects meta-analysis was performed, and Cochran's Q statistic and I squared index were used to assess heterogeneity. Statistical significance was determined at p < 0.05. This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors.

Results: From 2012 to 2022, ten articles (nine case series and one prospective trial) with 88 patients met the inclusion criteria. Patients with reported disease severity had Hurley stage II (17.6%, 12/68) or III (82.4%, 56/68) disease. The majority (80.7%, 71/88) had previously failed at least one biologic treatment. A meta-analysis of all ten studies showed a pooled response rate of 67% (95% CI 0.57-0.76). Study limitations include a small number of patients and randomized controlled trials (RCTs).

Conclusions: Ustekinumab may be a helpful treatment option to consider for HS that is recalcitrant to first-line biologic therapies, but RCTs are needed to determine optimal dosing regimens and the specific patient populations that would benefit the most from this agent.

导言化脓性扁平湿疹(HS)是一种常使人衰弱的炎症性皮肤病。阿达木单抗是目前唯一获得美国食品药品管理局(FDA)批准的治疗HS的生物制剂,但患者对阿达木单抗的反应有限。乌司替库单抗是一种白细胞介素-12/23抑制剂,已被用于治疗HS,但目前缺乏关于其疗效和安全性的最新系统性综述。本研究旨在对乌斯特库单抗治疗HS的疗效和安全性的文献进行系统回顾和荟萃分析:2022年10月,在MEDLINE和Embase数据库中检索了有关乌司替尼治疗HS的文章。由两名审稿人对相关文章进行数据提取。主要研究结果是HS对乌司替尼的总反应率。进行固定效应荟萃分析,并使用 Cochran's Q 统计量和 I 平方指数评估异质性。统计显著性以 p 为标准:从2012年到2022年,共有10篇文章(9篇病例系列和1篇前瞻性试验)的88名患者符合纳入标准。报告病情严重程度的患者为赫利II期(17.6%,12/68)或III期(82.4%,56/68)。大多数患者(80.7%,71/88)曾至少失败过一次生物治疗。对所有十项研究进行的荟萃分析显示,总反应率为 67%(95% CI 0.57-0.76)。研究的局限性包括患者人数较少和随机对照试验(RCT):结论:对于一线生物疗法无效的HS患者,乌司替库单抗可能是一种有益的治疗选择,但还需要进行RCT研究,以确定最佳给药方案以及从该药物中获益最多的特定患者群体。
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引用次数: 0
Patient Perspectives on the Prevalence and Burden of Intertriginous Psoriasis: Results from a National Survey of Adults with Psoriasis in the United States. 患者对带状银屑病发病率和负担的看法:美国成人银屑病患者全国调查结果》。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-07-01 Epub Date: 2024-06-14 DOI: 10.1007/s13555-024-01190-4
Teri Greiling, Melodie Young, Melissa S Seal, Robert C Higham, April Armstrong

Introduction: A survey was conducted by The Harris Poll on behalf of Arcutis Biotherapeutics in the USA to understand perspectives and burden of patients with psoriasis using prescription topical treatments for their disease. This manuscript presents results from the subset of patients with intertriginous psoriasis.

Methods: The survey was conducted online October 21-November 24, 2021, among 507 US adults aged 18+ years with psoriasis diagnosed by a healthcare provider and currently using prescription topical treatment. Participants with intertriginous psoriasis were patients with plaque psoriasis reporting symptoms in the armpit, groin, under breast, stomach fold, or between the buttocks.

Results: Of the 507 respondents, 320 (64%) reported symptoms in intertriginous areas at some point, typically between the buttocks (31%). Most patients with intertriginous psoriasis reported it made them feel embarrassed (80%), anxious (79%), or depressed (69%). In addition, 45% of these patients reported intertriginous psoriasis caused a negative impact on sexual anxiety or distress. Quality of life impact was reported as "very strong negative impact" in 16% of patients with groin involvement vs. 6% in patients with no groin involvement and 15% in women vs. 6% in men. Patients with intertriginous psoriasis reported that itch (61%), scaling (53%), redness (49%), and skin cracking (46%) related to intertriginous psoriasis had the greatest negative impact on quality of life. Most (86%) of these patients said they would be more adherent if a single treatment option could be used to treat all affected areas of their body.

Conclusion: Psoriasis involvement in intertriginous areas over the course of disease is common and has a negative impact on these patients' quality of life, particularly emotional well-being and sexual health.

简介:Harris Poll 代表 Arcutis Biotherapeutics 在美国进行了一项调查,以了解使用处方外用疗法治疗银屑病的患者的观点和负担。本手稿介绍了三叉神经间银屑病患者子集的调查结果:调查于 2021 年 10 月 21 日至 11 月 24 日在线进行,对象是 507 名年龄在 18 岁以上、经医疗机构诊断为银屑病且目前正在使用处方外用药治疗的美国成年人。三叉神经间银屑病患者是指症状出现在腋窝、腹股沟、乳房下、腹部皱褶或臀部之间的斑块状银屑病患者:在 507 名受访者中,有 320 人(64%)曾报告在三叉神经间部位出现过症状,其中以臀部之间为典型(31%)。大多数三叉神经间银屑病患者表示,这让他们感到尴尬(80%)、焦虑(79%)或抑郁(69%)。此外,这些患者中有 45% 的人表示三叉神经间银屑病对性焦虑或性困难造成了负面影响。腹股沟受累的患者中有 16% 的人称生活质量受到了 "非常严重的负面影响",而腹股沟未受累的患者中只有 6%;女性患者中有 15% 的人称生活质量受到了 "非常严重的负面影响",而男性患者中只有 6%。三叉神经间银屑病患者表示,与三叉神经间银屑病相关的瘙痒(61%)、脱屑(53%)、发红(49%)和皮肤皲裂(46%)对生活质量的负面影响最大。这些患者中的大多数(86%)表示,如果能采用单一治疗方案治疗身体的所有患病部位,他们会更加坚持治疗:结论:银屑病在病程中累及三叉神经间区域的情况很常见,会对这些患者的生活质量,尤其是情感健康和性健康造成负面影响。
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引用次数: 0
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