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Efficacy and safety of sofpironium in treatment of primary hyperhidrosis: a systematic review.
Pub Date : 2025-12-01 Epub Date: 2024-12-13 DOI: 10.1080/09546634.2024.2441258
Ramez M Odat, Abdullah Yousef Aldalati, Bara M Hammadeh, Ayham Mohammad Hussein, Muhammad Idrees, Hamza Marzouk, Sakhr Alshwayyat, Hamdah Hanifa

Background: Primary axillary hyperhidrosis has limited noninvasive and effective treatment, and we present the use of sofpironium bromide as a promising treatment option. We aimed to assess the efficacy and safety of sofpironium in patients with primary hyperhidrosis.

Methods: We systematically searched the databases for Studies that assessed sofpironium bromide in patients with primary axillary hyperhidrosis. Methodological quality was determined using the Cochrane Risk of Bias Assessment tool and Newcastle-Ottowa scale.

Results: Five studies were included (752 patients). They used 5% sofpironium, except for one study that used 5%, 10%, and 15% sofpironium. Studies have shown a significant difference in the incidence of patients with an HDSS score of 1 or 2 ranging from 53.9% to 86.7% and reported a greater reduction in the mean change in the DLQI score in the sofpironium group. They also noted a more significant reduction in the total gravimetric weight of sweat in the sofpironium group. A 1.5 point or greater improvement in HDSM-Ax score ranged from 48.2% to 69.1%. Serious adverse events were not observed in the intervention group.

Conclusion: Sofpironium gel provides notable improvements in symptom severity, sweat reduction, and quality of life, with mostly mild localized adverse events.Hyperhidrosis is relatively common, affecting 4.8% of the US population and negatively affects physical, social, and psychological well-being.Sofpironium bromide is recently approved by the FDA for the treatment of primary axillary hyperhidrosisSofpironium bromide showed promising results in terms of safety and efficacy for treating hyperhidrosisWe systematically assessed the use of sofpironium gel reported in five studies (752 patients)Sofpironium gel provides notable improvements in symptom severity, sweat reduction and quality of life, with mostly mild localized adverse events.

背景:原发性腋窝多汗症的非侵入性有效治疗方法有限,我们提出使用索菲溴铵作为一种有前景的治疗方案。我们旨在评估索非戎对原发性多汗症患者的疗效和安全性:我们在数据库中系统检索了对原发性腋下多汗症患者使用索非戎溴化物进行评估的研究。采用 Cochrane 偏倚风险评估工具和纽卡斯尔-奥托瓦量表确定方法学质量:结果:共纳入五项研究(752 名患者)。除一项研究使用了5%、10%和15%的索非戎外,其他研究均使用了5%的索非戎。研究显示,HDSS 评分为 1 分或 2 分的患者发生率存在明显差异,从 53.9% 到 86.7% 不等,并报告称索菲戎组的 DLQI 评分平均变化减少幅度更大。他们还注意到,在索非ironium 组中,汗液总重量的减少更为明显。HDSM-Ax 评分提高 1.5 分或更多的比例为 48.2% 至 69.1%。干预组未发现严重不良事件:多汗症比较常见,占美国人口的 4.8%,对身体、社会和心理健康造成负面影响。我们系统地评估了五项研究(752 名患者)报告的索非戎凝胶的使用情况。索非戎凝胶可显著改善症状的严重程度、减少出汗和提高生活质量,局部不良反应大多较轻。
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引用次数: 0
Bibliometric analysis and description of research trends in the treatment of psoriasis with biologic agents in the past two decades (2004-2023). 对过去二十年(2004-2023 年)使用生物制剂治疗银屑病的研究趋势进行文献计量分析和描述。
Pub Date : 2024-12-01 Epub Date: 2024-06-16 DOI: 10.1080/09546634.2024.2346282
Yingdong Wang, Junchen Li, Chenqi Guo, Guojing Yang, Haiyue Lin, Yu Zhang

Background: Biologics are essential in treating psoriasis. In recent years, the pathogenesis exploration and development of new target drugs have provided a more complete evidence-based foundation for the biological treatment of psoriasis. This study aims to use bibliometrics to analyze the research status and development trends of biologics in psoriasis.

Methods: The bibliometric analysis of publications related to biologics in psoriasis from 2004 to 2023 was conducted using the Web of Science Core Collection (WoSCC) database as the search data source. To perform the bibliometric analysis and create visual knowledge graphs, CiteSpace, the Bibliometrix R package, and VOSviewers were utilized.

Results: The study included a total of 3800 articles. The United States had the highest number of publications. The leading authors and institutions were Steven R. Feldman and the University of Manchester, respectively, in the global partnership. The cluster plot divided all keywords into 11 categories. Currently, Secukinumab and Guselkumab are representative biological agents being studied due to their considerable efficacy and long-term safety.

Conclusions: Targeted therapy has emerged as a significant trend in the current treatment of psoriasis. Early and active use of biologics can effectively control disease progression, prevent or delay the occurrence of comorbidities, and may even alter the natural course of psoriasis. However, further investigation is required to fully understand the specific mechanisms of psoriasis and the use of biological agents.

背景:生物制剂是治疗银屑病的关键。近年来,发病机制的探索和新靶向药物的开发为银屑病的生物治疗提供了更完整的循证基础。本研究旨在利用文献计量学分析银屑病生物制剂的研究现状和发展趋势:以科学网核心数据库(WoSCC)为检索数据源,对2004年至2023年银屑病生物制剂相关论文进行文献计量分析。为了进行文献计量分析和创建可视化知识图谱,使用了CiteSpace、Bibliometrix R软件包和VOSviewers:研究共收录了 3800 篇文章。美国的论文数量最多。在全球合作中,主要作者和机构分别是 Steven R. Feldman 和曼彻斯特大学。聚类图将所有关键词分为 11 类。目前,塞库单抗(Secukinumab)和古谢库单抗(Guselkumab)因其显著疗效和长期安全性成为正在研究的代表性生物制剂:靶向治疗已成为当前银屑病治疗的重要趋势。结论:靶向治疗已成为当前银屑病治疗的重要趋势,早期积极使用生物制剂可有效控制疾病进展,预防或延缓合并症的发生,甚至可能改变银屑病的自然病程。然而,要充分了解银屑病和生物制剂使用的具体机制,还需要进一步的研究。
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引用次数: 0
A systematic review of recent randomized controlled trials for palmoplantar pustulosis. 近期针对掌跖脓疱病随机对照试验的系统回顾。
Pub Date : 2024-12-01 Epub Date: 2024-10-10 DOI: 10.1080/09546634.2024.2414048
Miranda K Branyiczky, Shahnawaz Towheed, Tiago Torres, Ronald Vender

Background: Palmoplantar pustulosis (PPP) is a chronic inflammatory condition, that leads to significant functional impairment and reduced quality of life. Despite its low incidence, treatment options are diverse and often ineffective, necessitating a review of recent therapeutic advances.

Objective: This review aims to evaluate the efficacy and safety of recent therapeutic options for the treatment of PPP, focusing on phototherapy, systemic therapies, and biologics.

Materials and methods: A systematic literature search identified 13 studies evaluating phototherapy and systemic therapies, including biologics. Inclusion criteria focused on randomized controlled trials with participants diagnosed with PPP.

Results: Phototherapy showed success: excimer laser demonstrated high efficacy for severe disease [PPP Area and Severity Index (PPPASI)-75 of 95.0%], while psoralen plus ultraviolet A therapy with retinoids or fumaric acid esters worked well in milder disease (PPPASI-90 of 90.0 and 81.8%, respectively). Evidence supports the efficacy and safety of guselkumab, brodalumab, and apremilast over a range of disease severity (PPPASI-50 ranged from 57.4 to 78.3% at week 16). Agents including anakinra, secukinumab, spesolimab, and RIST4721 (primary outcomes not achieved) may not be first-line treatments. By targeting multiple inflammatory pathways in PPP, JAK inhibitors may be more effective than biologics in treating PPP; however, more research is needed to confirm their safety and appropriate use.

Conclusions: Multiple new treatments exist for PPP with promising results, however longer-term studies with standardized outcome reporting are needed to determine optimal treatment strategies and their comparative efficacy.

背景:掌跖脓疱病(PPP)是一种慢性炎症,会导致严重的功能障碍和生活质量下降。尽管其发病率较低,但治疗方案多种多样,而且往往效果不佳,因此有必要对近期的治疗进展进行综述:本综述旨在评估治疗 PPP 的最新治疗方案的有效性和安全性,重点关注光疗、系统疗法和生物制剂:通过系统性文献检索确定了 13 项评估光疗和全身疗法(包括生物制剂)的研究。纳入标准主要集中在以确诊为 PPP 患者为对象的随机对照试验:结果:光疗取得了成功:准分子激光对重症患者疗效显著[PPP面积和严重程度指数(PPPASI)-75为95.0%],而补骨脂素加紫外线A疗法配合维甲酸或富马酸酯对轻症患者疗效显著(PPPASI-90分别为90.0%和81.8%)。有证据支持古舍库单抗、布罗达鲁单抗和阿普瑞米拉特在不同病情严重程度下的疗效和安全性(第16周时的PPPASI-50从57.4%到78.3%不等)。anakinra、secukinumab、spesolimab和RIST4721(主要结果未达到)等药物可能不是一线治疗药物。通过靶向PPP中的多种炎症通路,JAK抑制剂在治疗PPP方面可能比生物制剂更有效;然而,还需要更多的研究来确认其安全性和适当的使用:结论:目前已有多种治疗 PPP 的新疗法,并取得了可喜的成果,但要确定最佳治疗策略及其疗效比较,还需要进行更长期的研究,并提供标准化的结果报告。
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引用次数: 0
Comparative efficacy of targeted systemic therapies for pruritus in moderate-to-severe atopic dermatitis without topical treatment: a network meta-analysis. 中重度特应性皮炎瘙痒症患者无需局部治疗的系统性靶向疗法疗效比较:网络荟萃分析。
Pub Date : 2024-12-01 Epub Date: 2024-11-26 DOI: 10.1080/09546634.2024.2432930
Mei Xiong, Qiaoli Gao, Hu Ren, Tingting Zhong

Background: Chronic pruritus is the most prevalent and severe symptom of atopic dermatitis (AD).

Objective: This network meta-analysis aims to assess the comparative efficacy of systemic targeted monotherapies in alleviating pruritus among adults and adolescents with moderate-to-severe AD.

Methods: Data were collected from phase 3/4 randomized controlled trials (RCTs) published until 24 August 2024, focusing on targeted therapies for moderate-to-severe AD. The outcome measure was the proportion of patients achieving a ≥ 4-point improvement from baseline on the Pruritus Numerical Rating Scale (NRS). This analysis included both primary endpoints (week 12 or week 16) and secondary endpoints (weeks 2, 4, and 8).

Results: Eleven reports comprising 16 studies with 8,462 participants were included. At all time points examined, targeted therapies demonstrated statistically significant efficacy over placebo, with upadacitinib 30 mg showing the highest response rate. The next most effective treatments at the primary endpoint were abrocitinib 200 mg, upadacitinib 15 mg, dupilumab 300 mg, and lebrikizumab 250 mg. Cumulative ranking probabilities at secondary endpoints varied based on time points.

Conclusion: Targeted therapies, particularly upadacitinib 30 mg, showed significant advantages in managing moderate-to-severe AD pruritus. Further direct comparative trials are needed for conclusive evidence.

背景:慢性瘙痒症是特应性皮炎(AD)最普遍、最严重的症状:慢性瘙痒是特应性皮炎(AD)最普遍、最严重的症状:本网络荟萃分析旨在评估系统性靶向单一疗法在缓解中重度特应性皮炎成人和青少年瘙痒症方面的疗效比较:数据收集自2024年8月24日前发表的3/4期随机对照试验(RCT),重点是治疗中重度AD的靶向疗法。结果测量指标为瘙痒数字评定量表(NRS)较基线改善≥4分的患者比例。该分析包括主要终点(第12周或第16周)和次要终点(第2周、第4周和第8周):结果:共纳入了 11 份报告,16 项研究,8462 名参与者。在所有考察的时间点上,靶向疗法的疗效在统计学上均显著优于安慰剂,其中乌达帕替尼 30 毫克的应答率最高。在主要终点上,疗效次之的疗法是阿罗西替尼 200 毫克、达帕替尼 15 毫克、达比鲁单抗 300 毫克和来布利珠单抗 250 毫克。次要终点的累积排名概率因时间点而异:结论:靶向疗法,尤其是高达替尼30毫克,在治疗中重度AD瘙痒症方面具有显著优势。要获得确凿证据,还需要进一步的直接比较试验。
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引用次数: 0
UCOMB-real life data: treatment strategies for chronic urticaria patients with comorbidities. UCOMB 真实生活数据:合并症慢性荨麻疹患者的治疗策略。
Pub Date : 2024-12-01 Epub Date: 2024-03-20 DOI: 10.1080/09546634.2024.2329784
Petra Staubach, Benedikt Bilo, Joachim W Fluhr, Karoline Krause, Kanokvalai Kulthanan, Andac Salman, Connie Katelaris, Jonathan A Bernstein, Marcus Maurer, Caroline Mann

Background: There is a lack of real-life safety data on treatment options for chronic urticaria in the presence of comedication and comorbidities.

Methods: We present a single-center UCARE pilot study of 212 outpatients with chronic urticaria. Patients were divided into three groups according to different CU therapies according to international guidelines.

Results: Of 212 patients, 108 (mean age 48.9 years, 71.3% female) had 59 comorbidities, including cardiovascular, autoimmune and malignant diseases. Patients were followed for a mean of 24.6 months (SD ± 21.3). Urticaria therapies were divided into three groups: A: 105 (97.2%) with omalizumab and 2nd generation antihistamines), B: 16 patients (14.8%): dual therapy with antihistamines and cyclosporine in 10 (9.3%), montelukast in five (4. 6%), dapsone in four (3.7%), hydroxychloroquine in one patient (0.9%), C: 12 (11.1%) patients received a third drug for 4.9 months (SD ± 3.2) and one quadruple therapy (2.1 months). 10 out of 12 (83.3%) patients received montelukast, two (16.7%) cyclosporine, two (16.7%) dapsone and one (8.3%) hydroxychloroquine as a third drug for chronic urticaria.

Conclusions: Combining treatment modalities for chronic urticaria and comorbidities are available and feasible with a good safety profile.

背景:慢性荨麻疹的治疗方案缺乏真实的安全性数据:目前还缺乏关于慢性荨麻疹治疗方案在合并用药和并发症情况下的实际安全性数据:我们对 212 名慢性荨麻疹门诊患者进行了一项单中心 UCARE 试验研究。结果:212 名患者中,108 人(平均年龄为 40 岁)患有慢性荨麻疹:212名患者中有108人(平均年龄48.9岁,71.3%为女性)患有59种并发症,包括心血管疾病、自身免疫性疾病和恶性疾病。患者的平均随访时间为 24.6 个月(SD ± 21.3)。荨麻疹疗法分为三组:A组:105人(97.2%)使用奥马珠单抗和第二代抗组胺药);B组:16人(14.8%):10人(9.3%)使用抗组胺药和环孢素双重疗法,5人(4.6%),4 名患者(3.7%)使用达哌酮,1 名患者(0.9%)使用羟氯喹,C:12 名患者(11.1%)接受第三种药物治疗 4.9 个月(SD ± 3.2),1 名患者接受四联疗法(2.1 个月)。12名患者中有10名(83.3%)接受了孟鲁司特、2名(16.7%)环孢素、2名(16.7%)达帕松和1名(8.3%)羟氯喹作为治疗慢性荨麻疹的第三种药物:结论:慢性荨麻疹和合并症的联合治疗方法是可行的,并且具有良好的安全性。
{"title":"UCOMB-real life data: treatment strategies for chronic urticaria patients with comorbidities.","authors":"Petra Staubach, Benedikt Bilo, Joachim W Fluhr, Karoline Krause, Kanokvalai Kulthanan, Andac Salman, Connie Katelaris, Jonathan A Bernstein, Marcus Maurer, Caroline Mann","doi":"10.1080/09546634.2024.2329784","DOIUrl":"10.1080/09546634.2024.2329784","url":null,"abstract":"<p><strong>Background: </strong>There is a lack of real-life safety data on treatment options for chronic urticaria in the presence of comedication and comorbidities.</p><p><strong>Methods: </strong>We present a single-center UCARE pilot study of 212 outpatients with chronic urticaria. Patients were divided into three groups according to different CU therapies according to international guidelines.</p><p><strong>Results: </strong>Of 212 patients, 108 (mean age 48.9 years, 71.3% female) had 59 comorbidities, including cardiovascular, autoimmune and malignant diseases. Patients were followed for a mean of 24.6 months (SD ± 21.3). Urticaria therapies were divided into three groups: A: 105 (97.2%) with omalizumab and 2nd generation antihistamines), B: 16 patients (14.8%): dual therapy with antihistamines and cyclosporine in 10 (9.3%), montelukast in five (4. 6%), dapsone in four (3.7%), hydroxychloroquine in one patient (0.9%), C: 12 (11.1%) patients received a third drug for 4.9 months (SD ± 3.2) and one quadruple therapy (2.1 months). 10 out of 12 (83.3%) patients received montelukast, two (16.7%) cyclosporine, two (16.7%) dapsone and one (8.3%) hydroxychloroquine as a third drug for chronic urticaria.</p><p><strong>Conclusions: </strong>Combining treatment modalities for chronic urticaria and comorbidities are available and feasible with a good safety profile.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2329784"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140178556","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comparison between super-responders and non-super-responders in psoriasis under adalimumab treatment: a real-life cohort study on the effectiveness and drug survival over one-year. 阿达木单抗治疗银屑病超级应答者和非超级应答者的比较:关于一年疗效和药物存活率的真实队列研究。
Pub Date : 2024-12-01 Epub Date: 2024-03-21 DOI: 10.1080/09546634.2024.2331782
Yizhang Liu, Kun Hu, Lu Jian, Yongfang Duan, Mi Zhang, Yehong Kuang

Background: Data on the characteristics and treatment outcomes of super-responders and non-super-responders in psoriasis under adalimumab treatment are limited.

Methods: A retrospective analysis from psoriatic patients treated with adalimumab was compared to characterize super-responders vs non-super-responders' groups, identify factors associated with super response, and assess treatment outcomes after switching.

Results: 15 out of 70 (21.4%) patients were categorized as super-responder. The proportion of patients achieving a PASI 100 response was significantly higher in super-responders than non-super-responders at weeks 12, 24, and 52. Female sex and Charlson Co-morbidity Index were significantly associated with super-responders. A high level of high-density lipoprotein was independently associated with PASI 90 response at weeks 24 and 52. Additionally, nearly 35%-43% of non-super-responders switching to interleukin-17A (IL-17A) inhibitors may achieve a PASI 100 response at week 12. In contrast, all super-responders switching to IL-17A inhibitors achieved a PASI 100 response at week 4.

Conclusions: Super-responders treated with adalimumab have a higher rate of being female and fewer comorbidities. And super-responders have better PASI responses than non-super-responders, whether the patients were treated with adalimumab or switched to IL-17A inhibitors.

背景:有关阿达木单抗治疗银屑病超级应答者和非超级应答者的特征和治疗结果的数据有限:有关阿达木单抗治疗银屑病超级应答者和非超级应答者的特征和治疗结果的数据有限:方法:对接受阿达木单抗治疗的银屑病患者进行回顾性分析,比较超级应答者与非超级应答者群体的特征,确定与超级应答相关的因素,并评估转换治疗方案后的治疗效果:70名患者中有15名(21.4%)被归类为超级应答者。在第 12、24 和 52 周,超级应答者达到 PASI 100 应答的比例明显高于非超级应答者。女性性别和 Charlson 共病指数与超级应答者有显著相关性。高密度脂蛋白水平与第 24 周和第 52 周的 PASI 90 反应独立相关。此外,在转用白细胞介素-17A(IL-17A)抑制剂的非超级应答者中,近35%-43%可能在第12周达到PASI 100应答。相比之下,所有改用IL-17A抑制剂的超级应答者都能在第4周达到PASI 100应答:接受阿达木单抗治疗的超级应答者中女性比例更高,合并症更少。结论:接受阿达木单抗治疗的超级应答者中女性比例较高,合并症较少,而且超级应答者的PASI应答优于非超级应答者,无论患者是接受阿达木单抗治疗还是改用IL-17A抑制剂治疗。
{"title":"Comparison between super-responders and non-super-responders in psoriasis under adalimumab treatment: a real-life cohort study on the effectiveness and drug survival over one-year.","authors":"Yizhang Liu, Kun Hu, Lu Jian, Yongfang Duan, Mi Zhang, Yehong Kuang","doi":"10.1080/09546634.2024.2331782","DOIUrl":"10.1080/09546634.2024.2331782","url":null,"abstract":"<p><strong>Background: </strong>Data on the characteristics and treatment outcomes of super-responders and non-super-responders in psoriasis under adalimumab treatment are limited.</p><p><strong>Methods: </strong>A retrospective analysis from psoriatic patients treated with adalimumab was compared to characterize super-responders vs non-super-responders' groups, identify factors associated with super response, and assess treatment outcomes after switching.</p><p><strong>Results: </strong>15 out of 70 (21.4%) patients were categorized as super-responder. The proportion of patients achieving a PASI 100 response was significantly higher in super-responders than non-super-responders at weeks 12, 24, and 52. Female sex and Charlson Co-morbidity Index were significantly associated with super-responders. A high level of high-density lipoprotein was independently associated with PASI 90 response at weeks 24 and 52. Additionally, nearly 35%-43% of non-super-responders switching to interleukin-17A (IL-17A) inhibitors may achieve a PASI 100 response at week 12. In contrast, all super-responders switching to IL-17A inhibitors achieved a PASI 100 response at week 4.</p><p><strong>Conclusions: </strong>Super-responders treated with adalimumab have a higher rate of being female and fewer comorbidities. And super-responders have better PASI responses than non-super-responders, whether the patients were treated with adalimumab or switched to IL-17A inhibitors.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2331782"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140186793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Dupliumab therapy for alopecia areata: a case series and review of the literature. 杜普单抗治疗斑秃:病例系列和文献综述。
Pub Date : 2024-12-01 Epub Date: 2024-02-11 DOI: 10.1080/09546634.2024.2312245
Jundong Huang, Jia Jian, Tingting Li, Min Li, Kaifu Luo, Sihan Deng, Yan Tang, Fangfen Liu, Zhixiang Zhao, Wei Shi, Ji Li

Background: A growing body of research supports the important role of the TH2 axis in alopecia areata (AA). Dupilumab is a humanized monoclonal antibody against IL-4Rα that downregulates TH2 response. Although efficacy has been shown in clinical trials, real-world data on the use of dupilumab in AA patients is limited.

Objectives: To report on a case series of 10 patients with AA who were treated with dupilumab and provide real-world evidence regarding its efficacy in treating severe AA.

Methods: In this retrospective single-center study, all AA patients treated with dupilumab treatment were included between May 2022 and October 2023. Clinical outcome measures (Severity of Alopecia Tool, SALT) and adverse events (AEs) were analyzed. In addition, a literature review was conducted to summarize the efficacy of AA with dupilumab and the characteristics of patients previously reported in the literature.

Results: We identified 10 patients with AA who were or are being treated with dupilumab, with a median (range) treatment duration of 8 (3-15) months. Of these, four patients have high serum immunoglobulin E (IgE) levels (≥200IU/ml). The mean (IQR) pretreatment SALT score was 79% (52-100). Seven of 10 patients achieved at least 50% re-growth. Of those who improved, the mean (IQR) percentage change in SALT score at 3 months and the end of follow-up was 57% (29%-89%) and 95% (68-100), respectively. Notably, seven patients (70%) had white hair regrowth, with the white hair slowly decreasing over time and the proportion of pigmented black hair increasing. Dupilumab was well tolerated by all patients. No adverse events were reported.

Conclusions: Overall, our research supports dupilumab as another candidate that possesses potential benefits for AA. High levels of IgE may be not prerequisites for dupilumab's successful treatment response.

背景:越来越多的研究支持 TH2 轴在斑秃(AA)中的重要作用。杜匹鲁单抗是一种针对 IL-4Rα 的人源化单克隆抗体,可下调 TH2 反应。虽然在临床试验中显示出了疗效,但在 AA 患者中使用杜匹单抗的实际数据却很有限:报告 10 例接受杜比单抗治疗的 AA 患者的系列病例,并提供有关杜比单抗治疗重症 AA 疗效的实际证据:在这项回顾性单中心研究中,纳入了2022年5月至2023年10月期间接受过杜比鲁单抗治疗的所有AA患者。对临床结果指标(脱发严重程度工具,SALT)和不良事件(AEs)进行了分析。此外,我们还进行了文献综述,总结了使用杜必鲁单抗治疗AA的疗效以及之前文献报道的患者特征:结果:我们发现有10名AA患者曾经或正在接受杜比单抗治疗,中位(范围)治疗时间为8(3-15)个月。其中,4 名患者的血清免疫球蛋白 E (IgE) 水平较高(≥200IU/ml)。治疗前 SALT 评分的平均值(IQR)为 79% (52-100)。10 位患者中有 7 位至少实现了 50%的再生长。在病情好转的患者中,3 个月和随访结束时 SALT 评分的平均(IQR)百分比变化分别为 57% (29%-89%) 和 95% (68-100)。值得注意的是,7 名患者(70%)的白发重新生长,随着时间的推移,白发慢慢减少,色素沉着的黑发比例增加。所有患者对杜比鲁单抗的耐受性良好。无不良反应报告:总之,我们的研究支持将杜比鲁单抗作为另一种对 AA 有潜在益处的候选药物。高水平的 IgE 可能不是杜利单抗成功治疗的先决条件。
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引用次数: 0
Practical considerations relevant to treatment with the gene therapy beremagene geperpavec-svdt for dystrophic epidermolysis bullosa. 使用基因疗法 beremagene geperpavec-svdt 治疗营养不良性表皮松解症的实际考虑因素。
Pub Date : 2024-12-01 Epub Date: 2024-05-09 DOI: 10.1080/09546634.2024.2350232
Amy S Paller, Shireen V Guide, Diego Ayala, Mercedes E Gonzalez, Anne W Lucky, Isin Sinem Bagci, M Peter Marinkovich

Background/purpose: Dystrophic epidermolysis bullosa (DEB), a rare genetic skin disease caused by loss-of-function mutations in COL7A1, the gene encoding type VII collagen (COL7), is characterized by skin blistering, scarring, and extracutaneous manifestations that markedly reduce patient quality-of-life. Beremagene geperpavec-svdt ('B-VEC') is a gene therapy employing a non-integrating, replication-defective herpes simplex virus type 1 (HSV-1)-based vector encoding two copies of full-length human COL7A1 to restore COL7 protein after topical administration to DEB wounds. B-VEC was approved in the United States in 2023 as the first topical gene therapy and the first approved treatment for DEB. However, few providers have experience with use of this gene therapy.

Methods: Data was obtained through literature review and the experience of providers who participated in the B-VEC clinical study or initiated treatment after B-VEC approval.

Results: This review discusses the burden of disease, describes the clinical trial outcomes of B-VEC, and provides physician and patient/caregiver recommendations as a practical guide for the real-world use of B-VEC, which can be administered in-office or at the patient's home.

Conclusions: By continuing to optimize the practical aspects of B-VEC administration, the focus will continue to shift to patient-centric considerations and improved patient outcomes.

背景/目的:萎缩性表皮松解症(DEB)是一种罕见的遗传性皮肤病,由编码 VII 型胶原蛋白(COL7)的 COL7A1 基因功能缺失突变引起,其特征是皮肤起疱、结疤和皮外表现,明显降低了患者的生活质量。Beremagene geperpavec-svdt("B-VEC")是一种基因疗法,它采用非整合、复制缺陷型单纯疱疹病毒 1 型(HSV-1)为基础的载体,编码两个拷贝的全长人类 COL7A1,在 DEB 伤口局部给药后可恢复 COL7 蛋白。B-VEC 于 2023 年在美国获得批准,是第一种局部基因疗法,也是第一种获得批准的 DEB 治疗方法。然而,很少有医疗机构有使用这种基因疗法的经验:方法:通过文献综述和参与 B-VEC 临床研究或在 B-VEC 获批后开始治疗的医疗服务提供者的经验获取数据:本综述讨论了疾病的负担,描述了B-VEC的临床试验结果,并提供了医生和患者/护理人员的建议,作为B-VEC实际应用的实用指南:结论:通过继续优化 B-VEC 施用的实用性,重点将继续转向以患者为中心的考虑因素和改善患者的治疗效果。
{"title":"Practical considerations relevant to treatment with the gene therapy beremagene geperpavec-svdt for dystrophic epidermolysis bullosa.","authors":"Amy S Paller, Shireen V Guide, Diego Ayala, Mercedes E Gonzalez, Anne W Lucky, Isin Sinem Bagci, M Peter Marinkovich","doi":"10.1080/09546634.2024.2350232","DOIUrl":"10.1080/09546634.2024.2350232","url":null,"abstract":"<p><strong>Background/purpose: </strong>Dystrophic epidermolysis bullosa (DEB), a rare genetic skin disease caused by loss-of-function mutations in <i>COL7A1</i>, the gene encoding type VII collagen (COL7), is characterized by skin blistering, scarring, and extracutaneous manifestations that markedly reduce patient quality-of-life. Beremagene geperpavec-svdt ('B-VEC') is a gene therapy employing a non-integrating, replication-defective herpes simplex virus type 1 (HSV-1)-based vector encoding two copies of full-length human <i>COL7A1</i> to restore COL7 protein after topical administration to DEB wounds. B-VEC was approved in the United States in 2023 as the first topical gene therapy and the first approved treatment for DEB. However, few providers have experience with use of this gene therapy.</p><p><strong>Methods: </strong>Data was obtained through literature review and the experience of providers who participated in the B-VEC clinical study or initiated treatment after B-VEC approval.</p><p><strong>Results: </strong>This review discusses the burden of disease, describes the clinical trial outcomes of B-VEC, and provides physician and patient/caregiver recommendations as a practical guide for the real-world use of B-VEC, which can be administered in-office or at the patient's home.</p><p><strong>Conclusions: </strong>By continuing to optimize the practical aspects of B-VEC administration, the focus will continue to shift to patient-centric considerations and improved patient outcomes.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2350232"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140900052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Characterization of psoriasis patients in special body areas: real-world evidence from the Chinese Psoriasis Standardized Diagnosis and Treatment Center. 特殊身体部位银屑病患者的特征:来自中国银屑病规范化诊疗中心的真实证据。
Pub Date : 2024-12-01 Epub Date: 2024-07-11 DOI: 10.1080/09546634.2024.2337264
Yuge Gao, Chao Li, Meng Tong, Yizhou Hu, Yuzhen Li

Background: While extensive research has provided a wealth of information on psoriasis in general, there remains a critical gap in understanding the unique characteristics of psoriasis in special body areas, such as the scalp, nails, palms, and genitals.

Objective: To investigate the characterization and treatment of psoriasis patients in special body areas.

Methods: The study was a retrospective analysis of patients with psoriasis enrolled in the Psoriasis Standardized Diagnosis and Treatment Center Project between January 2020 and September 2021.

Results: The study encompassed 346 patients, 81% of them had psoriasis in at least two special body areas, with the nails as the most common area. Patients with genital psoriasis reported higher Dermatology Life Quality Index (DLQI) scores. A higher propensity for scalp and palmoplantar psoriasis was noted in patients with genital psoriasis. The proportion of patients treated with biologics rose, as the number of specific areas involved increased.

Conclusions: Patients with genital psoriasis are more likely to have scalp and palmoplantar psoriasis. This study highlights the significant escalation in the proportion of biologics when the involvement of special body areas was ≥2.

背景:尽管大量研究提供了有关银屑病的大量信息,但在了解特殊身体部位(如头皮、指甲、手掌和生殖器)银屑病的独特特征方面仍存在重大差距:调查特殊身体部位银屑病患者的特征和治疗方法:该研究对2020年1月至2021年9月期间加入银屑病规范化诊疗中心项目的银屑病患者进行回顾性分析:研究涵盖346名患者,其中81%的患者至少在两个特殊身体部位患有银屑病,指甲是最常见的部位。生殖器银屑病患者的皮肤科生活质量指数(DLQI)得分较高。生殖器银屑病患者患头皮银屑病和掌跖银屑病的几率更高。随着受累部位的增加,接受生物制剂治疗的患者比例也在上升:结论:生殖器银屑病患者更有可能患有头皮银屑病和掌跖银屑病。本研究强调,当涉及的特殊身体部位≥2 个时,使用生物制剂的比例会显著上升。
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引用次数: 0
Efficacy of lebrikizumab in adolescent patients with moderate-to-severe atopic dermatitis: 16-week results from three randomized phase 3 clinical trials. 来曲珠单抗对中重度特应性皮炎青少年患者的疗效:三项随机三期临床试验的 16 周结果。
Pub Date : 2024-12-01 Epub Date: 2024-05-12 DOI: 10.1080/09546634.2024.2324833
Adelaide A Hebert, Carsten Flohr, H Chih-Ho Hong, Alan D Irvine, Evangeline Pierce, Hany Elmaraghy, Sreekumar Pillai, Zach Dawson, Sherry Chen, Clara Armengol, Elaine Siegfried, Stephan Weidinger

Background: Lebrikizumab, a high-affinity monoclonal antibody targeting IL-13, previously demonstrated clinical efficacy in three randomized, double-blind, placebo-controlled Phase 3 trials that included adults and adolescents with moderate-to-severe atopic dermatitis (AD): ADvocate1, ADvocate2, and ADhere.

Aim: This subset analysis evaluated 16-week physician- and patient-reported outcomes of lebrikizumab in the adolescent patients enrolled in these three trials.

Methods: Eligible adolescents (≥12 to <18 years weighing ≥40kg) were randomized 2:1 to subcutaneous lebrikizumab (500 mg loading doses at baseline and Week 2 followed by 250 mg every 2 weeks) or placebo as monotherapy in ADvocate1&2, and in combination with topical corticosteroids (TCS) in the ADhere study. Week 16 analyses included clinical efficacy outcomes (IGA (0,1) with ≥2-point improvement, EASI 75, EASI 90), patient-reported Pruritus NRS ≥4-point improvement and Sleep-Loss Scale ≥2-point improvement.

Results: Pooled ADvocate1&2 16-week results in lebrikizumab (N = 67) vs placebo (N = 35) were: IGA (0,1) 46.6% vs 14.3% (p < 0.01), EASI 75 62.0% vs 17.3% (p < 0.001), EASI 90 40.7% vs 11.5% (p < 0.01), Pruritus NRS 48.9% vs 13.1% (p < 0.01), and Sleep-Loss Scale 26.9% vs 6.9% (p = 0.137). Corresponding results for ADhere, (lebrikizumab + TCS, N = 32; placebo + TCS, N = 14), were consistent.

Conclusions: Lebrikizumab treatment demonstrated efficacy in improving the signs and symptoms of AD in adolescent patients, consistent with the ADvocate and ADhere overall population results.

研究背景Lebrikizumab是一种靶向IL-13的高亲和力单克隆抗体,曾在三项随机、双盲、安慰剂对照的3期试验中显示出临床疗效,这些试验包括成人和中重度特应性皮炎(AD)青少年患者:ADvocate1、ADvocate2和ADhere.Aim:本子集分析评估了这三项试验中加入的青少年患者使用来曲珠单抗16周后医生和患者报告的疗效:方法:符合条件的青少年(≥12 岁至结果:在ADvocate1和2试验中,来布瑞珠单抗(67例)与安慰剂(35例)的16周汇总结果如下:IGA (0,1) 46.6% vs 14.3% (p p p p = 0.137)。ADhere的相应结果(来布利珠单抗+TCS,N = 32;安慰剂+TCS,N = 14)一致:结论:利布利珠单抗治疗对改善青少年患者的AD体征和症状具有疗效,这与ADvocate和ADhere的总体结果一致。
{"title":"Efficacy of lebrikizumab in adolescent patients with moderate-to-severe atopic dermatitis: 16-week results from three randomized phase 3 clinical trials.","authors":"Adelaide A Hebert, Carsten Flohr, H Chih-Ho Hong, Alan D Irvine, Evangeline Pierce, Hany Elmaraghy, Sreekumar Pillai, Zach Dawson, Sherry Chen, Clara Armengol, Elaine Siegfried, Stephan Weidinger","doi":"10.1080/09546634.2024.2324833","DOIUrl":"10.1080/09546634.2024.2324833","url":null,"abstract":"<p><strong>Background: </strong>Lebrikizumab, a high-affinity monoclonal antibody targeting IL-13, previously demonstrated clinical efficacy in three randomized, double-blind, placebo-controlled Phase 3 trials that included adults and adolescents with moderate-to-severe atopic dermatitis (AD): ADvocate1, ADvocate2, and ADhere.</p><p><strong>Aim: </strong>This subset analysis evaluated 16-week physician- and patient-reported outcomes of lebrikizumab in the adolescent patients enrolled in these three trials.</p><p><strong>Methods: </strong>Eligible adolescents (≥12 to <18 years weighing ≥40kg) were randomized 2:1 to subcutaneous lebrikizumab (500 mg loading doses at baseline and Week 2 followed by 250 mg every 2 weeks) or placebo as monotherapy in ADvocate1&2, and in combination with topical corticosteroids (TCS) in the ADhere study. Week 16 analyses included clinical efficacy outcomes (IGA (0,1) with ≥2-point improvement, EASI 75, EASI 90), patient-reported Pruritus NRS ≥4-point improvement and Sleep-Loss Scale ≥2-point improvement.</p><p><strong>Results: </strong>Pooled ADvocate1&2 16-week results in lebrikizumab (<i>N</i> = 67) vs placebo (<i>N</i> = 35) were: IGA (0,1) 46.6% vs 14.3% (<i>p</i> < 0.01), EASI 75 62.0% vs 17.3% (<i>p</i> < 0.001), EASI 90 40.7% vs 11.5% (<i>p</i> < 0.01), Pruritus NRS 48.9% vs 13.1% (<i>p</i> < 0.01), and Sleep-Loss Scale 26.9% vs 6.9% (<i>p</i> = 0.137). Corresponding results for ADhere, (lebrikizumab + TCS, <i>N</i> = 32; placebo + TCS, <i>N</i> = 14), were consistent.</p><p><strong>Conclusions: </strong>Lebrikizumab treatment demonstrated efficacy in improving the signs and symptoms of AD in adolescent patients, consistent with the ADvocate and ADhere overall population results.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"35 1","pages":"2324833"},"PeriodicalIF":0.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140913615","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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The Journal of dermatological treatment
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