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A Descriptive, Post Hoc Analysis of Efficacy and Safety of Risankizumab in Diverse Racial and Ethnic Patient Populations With Moderate-to-Severe Psoriasis. 中度至重度银屑病患者中不同种族和人种利赞单抗疗效和安全性的描述性事后分析。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-10-01 Epub Date: 2024-10-02 DOI: 10.1007/s13555-024-01268-z
Andrew F Alexis, Melinda Gooderham, Shawn G Kwatra, Ahmad Amin, Susan Taylor, Ramon Espaillat, Trisha Rettig, Tianshuang Wu, Linyu Shi, Mark I Kaldas, Deanne M Dilley, Ranjeeta Sinvhal, Chudy Nduaka, Benjamin Lockshin

Introduction: Historically, patients with skin of color are underdiagnosed with psoriasis and underrepresented in clinical trials. In this study, we assess the efficacy and safety of risankizumab in patients with moderate-to-severe plaque psoriasis by race and ethnicity in the open label extension LIMMitless (NCT03047395).

Methods: Patients received continuous treatment with 150 mg risankizumab through their initial trial and the open label extension. Patients self-identified their race and ethnicity. Efficacy was assessed using Psoriasis Area Severity Index (PASI) and Dermatology Life Quality Index (DLQI). Safety is reported by events/100 patient-years.

Results: A total of 897 patients (race: 662 White, 196 Asian, 25 Black or African American, 14 Other; ethnicity: 98 Hispanic or Latino, 799 non-Hispanic or Latino) were included in this analysis. Compared to baseline, patients had a mean percent reduction in PASI between 94.6% (Asian) and 99.3% (Black or African American) and reported mean percent improvements in DLQI ranging from 87.1% (Asian and Black or African American) to 93.7% (Hispanic or Latino) at week 100.

Conclusion: While the data presented here comprise a small retrospective descriptive analysis and cannot detect statistical differences, efficacy of risankizumab for the treatment of moderate-to-severe plaque psoriasis appears similar across the racial and ethnic groups studied and no new safety signals were detected.

简介:一直以来,有色人种银屑病患者的诊断率较低,在临床试验中的代表性也不足。在这项研究中,我们将在开放标签扩展项目 LIMMitless(NCT03047395)中,按种族和民族评估利妥珠单抗对中重度斑块状银屑病患者的疗效和安全性:患者在初始试验和开放标签扩展试验中持续接受 150 毫克利抗珠单抗治疗。患者自报种族和民族。疗效采用银屑病面积严重程度指数(PASI)和皮肤病生活质量指数(DLQI)进行评估。安全性按每 100 患者年发生的事件进行报告:本分析共纳入 897 名患者(种族:662 名白人、196 名亚裔、25 名黑人或非裔美国人、14 名其他;族裔:98 名西班牙裔或拉丁裔、799 名非西班牙裔或拉丁裔)。与基线相比,患者的 PASI 平均下降率介于 94.6%(亚裔)和 99.3%(黑人或非裔美国人)之间,第 100 周的 DLQI 平均改善率介于 87.1%(亚裔和黑人或非裔美国人)和 93.7%(西班牙裔或拉丁裔美国人)之间:虽然本文提供的数据只是一个小型的回顾性描述分析,无法检测出统计学差异,但利桑珠单抗治疗中重度斑块状银屑病的疗效在所研究的种族和民族群体中似乎相似,而且没有发现新的安全信号。
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引用次数: 0
Correction: Consensus Recommendations for the Management of Atopic Dermatitis in the United Arab Emirates. 更正:阿拉伯联合酋长国特应性皮炎管理共识建议》。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-10-01 DOI: 10.1007/s13555-024-01276-z
Ahmed Ameen, Ahmed Al Dhaheri, Ashraf M Reda, Ayman Alnaeem, Fatima Al Marzooqi, Fatima Albreiki, Huda Rajab Ali, Hussein Abdel Dayem, Jawaher Alnaqbi, Mariam Al Zaabi, Mohammed Ahmed, Georg Stingl, Muna Al Murrawi
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引用次数: 0
Advanced Systemic Treatments in Patients with Moderate-to-Severe Atopic Dermatitis: Key Learnings from Physicians Practicing in Nine Asian Countries and Territories. 中重度特应性皮炎患者的先进系统治疗:九个亚洲国家和地区执业医师的主要经验。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-10-01 Epub Date: 2024-09-28 DOI: 10.1007/s13555-024-01278-x
Chia-Yu Chu, Ramesh Bhat Marne, Christina Man-Tung Cheung, Le Ngoc Diep, Nopadon Noppakun, Endi Novianto, Maria Lourdes H Palmero, Yong-Kwang Tay, Azizan Noor Zalmy

Introduction: Rapid progress made in the management of atopic dermatitis (AD) in recent years and the differences in patient journey between Asian and non-Asian populations call for a review of current atopic dermatitis landscape in Asia.

Methods: A roundtable meeting with nine regional dermatological experts was held in June 2023 to discuss the optimal management approaches for moderate-to-severe AD, focusing on the use of advanced therapies.

Results: Disease burden on patients' quality of life, treatment adherence, and financial constraints were identified as major concerns when managing patients with moderate-to-severe AD in parts of Asia. It was agreed that the Hanifin and Rajka's criteria or the UK Working Party's Diagnostic Criteria for Atopic Dermatitis can be used to guide the clinical diagnosis of AD. Meanwhile, patient-reported outcome scales including the Dermatology Life Quality Index and Atopic Dermatitis Control Tool can be used alongside depression monitoring scales to monitor treatment outcomes in patients with AD, allowing a better understanding for individualized treatment. When managing moderate-to-severe AD, phototherapy should be attempted after failure with topical treatments, followed by conventional disease-modifying antirheumatic drugs and, subsequently, biologics or Janus kinase inhibitors. Systemic corticosteroids can be used as short-term therapy for acute flares. Although these advanced treatments are known to be effective, physicians have to take into consideration safety concerns and limitations when prescribing these treatments.

Conclusions: Treatments in AD have evolved and its management varies country by country. Unique challenges across Asian countries necessitate a different management approach in Asian patients with AD.

简介:近年来,特应性皮炎(AD)的治疗取得了突飞猛进的进展,而亚洲与非亚洲人群在患者治疗过程中存在差异,因此有必要对亚洲特应性皮炎的现状进行回顾:方法:2023年6月,九位地区皮肤科专家召开了一次圆桌会议,讨论中重度特应性皮炎的最佳治疗方法,重点是先进疗法的使用:结果:在亚洲部分地区,疾病对患者生活质量造成的负担、治疗依从性和经济限制被认为是管理中重度 AD 患者的主要问题。与会者一致认为,哈尼芬和拉杰卡的标准或英国特应性皮炎工作组的诊断标准可用于指导 AD 的临床诊断。同时,包括皮肤科生活质量指数和特应性皮炎控制工具在内的患者报告结果量表可与抑郁监测量表一起用于监测AD患者的治疗结果,以便更好地了解个体化治疗。在治疗中重度 AD 时,应在局部治疗失败后尝试光疗,然后使用传统的改变病情抗风湿药物,最后使用生物制剂或 Janus 激酶抑制剂。全身性皮质类固醇激素可作为急性发作的短期疗法。虽然这些先进的治疗方法已知有效,但医生在开具处方时必须考虑到安全问题和局限性:AD 的治疗方法在不断发展,各国的治疗方法也不尽相同。亚洲各国面临的独特挑战要求对亚洲的 AD 患者采取不同的管理方法。
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引用次数: 0
Comprehensive Codified Algorithms to Identify the Underestimated Burden of Hidradenitis Suppurativa in the United States. 综合编纂算法,确定美国被低估的化脓性扁桃体炎负担。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-10-01 Epub Date: 2024-09-24 DOI: 10.1007/s13555-024-01259-0
John R Ingram, Yvonne Geissbühler, John Darcy, Stephen Foley, Alex Gaffney, Aine McConnon, Craig Richardson, Amit Garg

Introduction: Hidradenitis suppurativa (HS) is a painful, inflammatory skin disease associated with a high disease burden and long diagnostic delay. Prevalence estimates of HS vary widely in the literature owing to differing estimation methodologies. This study aimed to apply stepwise algorithms to estimate the prevalence of possible/diagnosed cases of HS in the US.

Methods: This was a retrospective cohort study in adult and pediatric patients with HS which utilized data from four US databases (MarketScan [Medicare and Medicaid] and Optum [electronic health record (EHR) and Clinformatics Data Mart (CDM)]). Patients with possible/diagnosed HS were identified using two algorithms (termed Algorithm 1 and Algorithm 2), which assessed symptoms such as multiple skin boils in site-specific areas based on international classification of disease (ICD) codes. Patients with diagnosed HS were defined as having ≥ 2 outpatient or ≥ 1 inpatient diagnosis codes of HS. In each database, patients with continuous medical and pharmacy benefits in the 365 days pre-index and 0-365 days post-index periods were eligible for inclusion.

Results: Across all databases, Algorithm 2 (MarketScan Medicare [N = 309,916]; MarketScan Medicaid [N = 188,783]; Optum EHR [N = 366,158]; Optum CDM [N = 173,812]) identified more patients with possible/diagnosed HS than Algorithm 1 (MarketScan Medicare [N = 194,353]; MarketScan Medicaid [N = 99,276]; Optum EHR [N = 177,957]; Optum CDM [N = 112,244]). Based on ICD-9/10 codes, the 5-year period prevalence of HS ranged from 0.06% to 0.12% across all databases, while for Algorithm 1 and Algorithm 2, this ranged from 0.27% to 0.41% and 0.49% to 0.78%, respectively. Adults and females generally had a higher 5-year period prevalence versus pediatric patients and males, respectively.

Conclusion: This real-world study highlights that HS diagnosis codes alone may be insufficient to estimate the prevalence of HS, demonstrating the value of employing algorithms in practice which assess for parameters such as multiple skin boils in site-specific areas. Integrating robust methods to identify the prevalence of HS may improve the diagnostic delay observed in HS and improve treatment outcomes.

简介化脓性扁平湿疹(HS)是一种疼痛的炎症性皮肤病,疾病负担重,诊断时间长。由于估算方法不同,文献中对化脓性扁平湿疹患病率的估算也大相径庭。本研究旨在应用逐步算法估算美国 HS 可能/确诊病例的患病率:这是一项针对成人和儿童 HS 患者的回顾性队列研究,利用了美国四个数据库(MarketScan [医疗保险和医疗补助] 和 Optum [电子健康记录 (EHR) 和 Clinformatics Data Mart (CDM)])中的数据。使用两种算法(称为算法 1 和算法 2)确定可能/确诊为 HS 的患者,这两种算法根据国际疾病分类 (ICD) 代码评估特定部位的多发性皮肤疖等症状。确诊为 HS 的患者定义为门诊患者中 HS 诊断代码≥2 个或住院患者中 HS 诊断代码≥1 个。在每个数据库中,在指数发布前的 365 天和指数发布后的 0-365 天内连续享受医疗和药房福利的患者均符合纳入条件:在所有数据库中,算法 2(MarketScan Medicare [N = 309,916]; MarketScan Medicaid [N = 188,783]; Optum EHR [N = 366,158];Optum CDM [N = 173,812]) 相比算法 1(MarketScan Medicare [N = 194,353]; MarketScan Medicaid [N = 99,276]; Optum EHR [N = 177,957]; Optum CDM [N = 112,244])识别出更多可能/确诊为 HS 的患者。根据 ICD-9/10 编码,所有数据库的 5 年期 HS 患病率介于 0.06% 到 0.12% 之间,而算法 1 和算法 2 的患病率分别介于 0.27% 到 0.41% 和 0.49% 到 0.78% 之间。与儿科患者和男性相比,成人和女性的 5 年患病率普遍较高:这项真实世界的研究强调,仅凭HS诊断代码可能不足以估算HS的患病率,这表明在实践中采用算法评估特定部位多发皮肤疖等参数的价值。整合可靠的方法来确定HS的患病率,可以改善HS的诊断延迟并提高治疗效果。
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引用次数: 0
Demographics, Disease Characteristics, and Time to Effective Treatment of Patients with Psoriasis in the Ghent PsoPlus Cohort of 2021. 2021 年根特 PsoPlus 队列中银屑病患者的人口统计、疾病特征和有效治疗时间。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-10-01 Epub Date: 2024-10-04 DOI: 10.1007/s13555-024-01277-y
Evelyn Meulewaeter, Anke Eylenbosch, Evelien Verhaeghe, Rani Soenen, Jo Lambert

Introduction: Psoriasis is a chronic immune-mediated skin disease with several comorbidities and a considerable influence on quality of life. Many patients with moderate-to-severe psoriasis are undertreated and have a substantial disease duration before effective treatment is started. This study analyzed patient and disease characteristics and time to effective treatment of patients with psoriasis who consulted PsoPlus. It also examined whether a treat-to-target (T2T) approach, which is implemented in PsoPlus, has an impact on treatment choice and disease progression.

Methods: Through a single center, retrospective study, 170 patients in the PsoPlus dedicated clinic were compared at moment of enrollment in PsoPlus and at the last recorded consultation in 2021.

Results: Median disease duration at the first PsoPlus consultation was 16.0 (interquartile range (IQR) 19.0) years. There was a significant difference in Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) between the first and the last recorded PsoPlus consultation (PASI 6.0 (IQR 6.4) vs. 0.6 (IQR 2.6); DLQI 11 (IQR 11) vs. 2 (IQR 6); p < 0.001). A weak positive Spearman correlation (rs) was found between disease duration and PASI at the first PsoPlus consultation (rs = 0.175; p = 0.034), while a weak negative correlation (rs = - 0.2; p = 0.013) was found at the last registered PsoPlus consultation. Patients with a disease duration of more than 20 years had significantly more switches of treatment than those with a shorter disease duration (p < 0.001). Median time from psoriasis onset until PASI ≤ 2 was 16.0 years. Median time from the first PsoPlus consultation until PASI ≤ 2 was 7.0 months.

Conclusion: The PsoPlus program with its T2T approach effectively improves clinical outcomes and quality of life for patients with psoriasis in a relatively short period, emphasizing the value of a structured, personalized treatment plan for long-term management.

简介银屑病是一种免疫介导的慢性皮肤病,有多种并发症,对生活质量有很大影响。许多中重度银屑病患者治疗不足,在开始有效治疗前病程较长。本研究分析了就诊于 PsoPlus 的银屑病患者的病情特征和有效治疗时间。研究还探讨了 PsoPlus 采用的 "靶向治疗"(T2T)方法是否会对治疗选择和疾病进展产生影响:通过单中心回顾性研究,对PsoPlus专科门诊的170名患者在加入PsoPlus时和2021年最后一次就诊记录进行了比较:首次接受 PsoPlus 诊疗时的中位病程为 16.0 年(四分位距(IQR)为 19.0 年)。牛皮癣面积和严重程度指数(PASI)和皮肤科生活质量指数(DLQI)在首次和最后一次 PsoPlus 咨询记录之间存在明显差异(PASI 6.0 (IQR 6.4) vs. 0.6 (IQR 2.6);DLQI 11 (IQR 11) vs. 2 (IQR 6);PASI 6.0 (IQR 6.4) vs. 0.6 (IQR 2.6);DLQI 11 (IQR 11) vs. 0.6 (IQR 2.6))。在第一次 PsoPlus 会诊时,病程与 PASI 之间发现了微弱的负相关(rs = 0.175;p = 0.034),而在最后一次登记的 PsoPlus 会诊时则发现了微弱的负相关(rs = - 0.2;p = 0.013)。与病程较短的患者相比,病程超过 20 年的患者接受治疗的次数明显较多(p 结论:PsoPlus 计划是一种有效的治疗方法,它能帮助患者在最短的时间内获得最佳治疗效果:采用 T2T 方法的 PsoPlus 计划能在较短时间内有效改善银屑病患者的临床疗效和生活质量,强调了结构化、个性化治疗计划在长期管理中的价值。
{"title":"Demographics, Disease Characteristics, and Time to Effective Treatment of Patients with Psoriasis in the Ghent PsoPlus Cohort of 2021.","authors":"Evelyn Meulewaeter, Anke Eylenbosch, Evelien Verhaeghe, Rani Soenen, Jo Lambert","doi":"10.1007/s13555-024-01277-y","DOIUrl":"10.1007/s13555-024-01277-y","url":null,"abstract":"<p><strong>Introduction: </strong>Psoriasis is a chronic immune-mediated skin disease with several comorbidities and a considerable influence on quality of life. Many patients with moderate-to-severe psoriasis are undertreated and have a substantial disease duration before effective treatment is started. This study analyzed patient and disease characteristics and time to effective treatment of patients with psoriasis who consulted PsoPlus. It also examined whether a treat-to-target (T2T) approach, which is implemented in PsoPlus, has an impact on treatment choice and disease progression.</p><p><strong>Methods: </strong>Through a single center, retrospective study, 170 patients in the PsoPlus dedicated clinic were compared at moment of enrollment in PsoPlus and at the last recorded consultation in 2021.</p><p><strong>Results: </strong>Median disease duration at the first PsoPlus consultation was 16.0 (interquartile range (IQR) 19.0) years. There was a significant difference in Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) between the first and the last recorded PsoPlus consultation (PASI 6.0 (IQR 6.4) vs. 0.6 (IQR 2.6); DLQI 11 (IQR 11) vs. 2 (IQR 6); p < 0.001). A weak positive Spearman correlation (r<sub>s</sub>) was found between disease duration and PASI at the first PsoPlus consultation (r<sub>s</sub> = 0.175; p = 0.034), while a weak negative correlation (r<sub>s</sub> = - 0.2; p = 0.013) was found at the last registered PsoPlus consultation. Patients with a disease duration of more than 20 years had significantly more switches of treatment than those with a shorter disease duration (p < 0.001). Median time from psoriasis onset until PASI ≤ 2 was 16.0 years. Median time from the first PsoPlus consultation until PASI ≤ 2 was 7.0 months.</p><p><strong>Conclusion: </strong>The PsoPlus program with its T2T approach effectively improves clinical outcomes and quality of life for patients with psoriasis in a relatively short period, emphasizing the value of a structured, personalized treatment plan for long-term management.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2889-2903"},"PeriodicalIF":3.5,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11480273/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142371246","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
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。
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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
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Dermatology and Therapy
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