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Bridging the Gap: Comparing Patient-Clinician Views on Treatment Goals and Communication in the Management of Atopic Dermatitis Within the Asia-Pacific Region. 缩小差距:比较亚太地区特应性皮炎患者与医生在治疗目标和沟通方面的观点。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-08-01 Epub Date: 2024-07-15 DOI: 10.1007/s13555-024-01232-x
Chia-Yu Chu, Yung Chan, Siriwan Wananukul, Hao Cheng, Nisha Suyien Chandran, Ramesh Bhat, Sang Wook Son, Han-Fang Liao, Sean Gardiner, See-Hwee Yeo, Sophie Bozhi Chen, Qi Qing Ng, Yoko Kataoka

Introduction: It remains unclear how patients with atopic dermatitis (AD) and clinicians perceive the level of patient-clinician communication and if there could be potential lapses. This cross-sectional study aims to compare perspectives between patients with AD and dermatologists regarding communication and treatment expectations in Asia.

Methods: Moderate-to-severe patients with AD and practicing dermatologists were recruited from eight Asia-Pacific territories, including Mainland China, Hong Kong, India, Japan, Singapore, South Korea, Taiwan, and Thailand. Patients and dermatologists completed separate surveys designed to elicit their expectations regarding AD management, and their perceived level of patient-clinician communication. Patients were also asked about their treatment satisfaction and whether they prefer additional treatment beyond what was prescribed. Demographic information and responses were analyzed using descriptive statistics. The study was reviewed by the institutional review board in each territory, and all participants provided informed consent.

Results: A total of 1103 patients and 271 dermatologists completed the surveys. Both patients and dermatologists were largely aligned in their top treatment goals in AD management. However, greater proportions of patients prioritized the prevention of exacerbation (78.0% versus 47.2%), minimization of treatment adverse effects (46.4% versus 9.1%), and improvement in mental health (16.0% versus 4.9%), compared with dermatologists. Although patient-clinician communication was observed to be generally good, 10.9% of patients reported dissatisfaction with communication in AD management. The majority of patients were either "very satisfied" or "satisfied" with their latest acute AD treatment, but 65.5% of patients still desired additional treatment.

Conclusions: This multinational study has provided insights on the perspectives of Asian patients and dermatologists in treatment goals, AD management, and communication. In general, both patients and dermatologists were aligned in treatment goals and there was satisfactory patient-clinician communication in most aspects. However, potential areas of improvement have been identified to further enhance patient-centered care.

导言:特应性皮炎(AD)患者和临床医生如何看待患者与医生之间的沟通水平,以及是否可能存在潜在的失误,目前仍不清楚。这项横断面研究旨在比较亚洲特应性皮炎患者和皮肤科医生对沟通和治疗期望的看法:方法:从亚太地区的八个国家(包括中国大陆、中国香港、印度、日本、新加坡、韩国、中国台湾和泰国)招募了中度至重度 AD 患者和执业皮肤科医生。患者和皮肤科医生分别填写了调查问卷,旨在了解他们对AD管理的期望,以及他们对患者与医生沟通水平的看法。此外,还询问了患者对治疗的满意度,以及他们是否愿意接受处方以外的额外治疗。采用描述性统计方法对人口统计学信息和回答进行了分析。该研究已通过各地区机构审查委员会的审查,所有参与者均已知情同意:共有 1103 名患者和 271 名皮肤科医生完成了调查。患者和皮肤科医生在AD治疗的首要目标上基本一致。然而,与皮肤科医生相比,更多的患者优先考虑预防病情恶化(78.0% 对 47.2%)、尽量减少治疗不良反应(46.4% 对 9.1%)和改善心理健康(16.0% 对 4.9%)。虽然患者与医生之间的沟通普遍良好,但仍有 10.9% 的患者对 AD 管理中的沟通表示不满意。大多数患者对最近的急性AD治疗表示 "非常满意 "或 "满意",但仍有65.5%的患者希望得到额外治疗:这项跨国研究深入了解了亚洲患者和皮肤科医生在治疗目标、AD 管理和沟通方面的观点。总体而言,患者和皮肤科医生的治疗目标是一致的,患者与医生在大多数方面的沟通也令人满意。然而,我们也发现了一些需要改进的地方,以进一步加强以患者为中心的护理。
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引用次数: 0
Dupilumab Reduces Urticaria Activity, Itch, and Hives in Patients with Chronic Spontaneous Urticaria Regardless of Baseline Serum Immunoglobulin E Levels 无论基线血清免疫球蛋白 E 水平如何,杜匹单抗都能减轻慢性自发性荨麻疹患者的荨麻疹活动、瘙痒和荨麻疹症状
IF 3.4 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-07-27 DOI: 10.1007/s13555-024-01231-y
Marcus Maurer, Thomas B. Casale, Sarbjit S. Saini, Moshe Ben-Shoshan, Elizabeth Laws, Jennifer Maloney, Deborah Bauer, Allen Radin, Melanie Makhija

Introduction

In chronic spontaneous urticaria (CSU), interleukin (IL)-4 and IL-13 may promote mast cell activation directly via IL-4 receptor expression, or indirectly via upregulated immunoglobulin E (IgE) production. Dupilumab significantly improved CSU signs and symptoms in the phase 3, randomized, placebo-controlled LIBERTY-CSU CUPID Study A. This analysis explores the impact of dupilumab on CSU signs and symptoms and serum IgE levels in patients from LIBERTY-CSU CUPID Study A with serum total IgE above and below 100 IU/mL at baseline.

Methods

Patients with H1-antihistamine-refractory CSU received dupilumab (n = 70) or placebo (n = 68) for 24 weeks. Efficacy endpoints were change from baseline to weeks 12 and 24 in serum total IgE levels, Itch Severity Score over 7 days (ISS7), Urticaria Activity Score over 7 days (UAS7), and Hives Severity Score over 7 days (HSS7) in dupilumab- or placebo-treated patients with serum total IgE above and below 100 IU/mL at baseline.

Results

Dupilumab treatment significantly reduced median (interquartile range) IgE levels at week 12 [dupilumab: −31.9% (−41.9; −22.6); placebo: −6.3% (−21.3; 14.9)] and week 24 [dupilumab: −48.2% (−56.8; − 39.5); placebo: − 6.3% (−34.5; 14.8)]. Similar IgE reductions relative to baseline were observed in dupilumab-treated patients regardless of baseline IgE level. Dupilumab treatment improved ISS7, UAS7, and HSS7 over 12 and 24 weeks, regardless of baseline serum IgE level (interaction p ≥ 0.59 for all treatment by subgroup comparisons), with weak correlations (r < 0.2) observed between IgE level changes and ISS7, UAS7, and HSS7 outcomes.

Conclusions

Dupilumab significantly improved CSU signs and symptoms and reduced serum IgE, regardless of baseline IgE levels. In the current analysis, baseline total IgE had no predictive value as a dupilumab treatment response biomarker in CSU. Downregulation of IgE, a key mediator of mast cell activation and histamine release, may at least partially explain the effectiveness of dupilumab in reducing CSU signs and symptoms.

Trial Registration

ClinicalTrials.gov Identifier: NCT04180488.

导言:在慢性自发性荨麻疹(CSU)中,白细胞介素(IL)-4和IL-13可能直接通过IL-4受体的表达或间接通过免疫球蛋白E(IgE)分泌的上调促进肥大细胞的活化。方法H1-抗组胺难治性CSU患者接受杜利单抗(n = 70)或安慰剂(n = 68)治疗24周。疗效终点为基线时血清总IgE高于或低于100 IU/mL的dupilumab或安慰剂治疗患者的血清总IgE水平、7天内瘙痒严重程度评分(ISS7)、7天内荨麻疹活动评分(UAS7)和7天内荨麻疹严重程度评分(HSS7)从基线到第12周和第24周的变化。结果 在第12周[dupilumab:-31.9% (-41.9; -22.6);安慰剂:-6.3% (-21.3; 14.9)]和第24周[dupilumab:-48.2% (-56.8; -39.5);安慰剂:-6.3% (-34.5; 14.8)]时,dupilumab治疗显著降低了IgE水平的中位数(四分位数间距)。无论基线 IgE 水平如何,在接受杜匹单抗治疗的患者中都观察到了与基线相似的 IgE 下降。无论基线血清 IgE 水平如何,杜比鲁单抗治疗 12 周和 24 周后均可改善 ISS7、UAS7 和 HSS7(所有亚组治疗比较的交互作用 p ≥ 0.59),IgE 水平变化与 ISS7、UAS7 和 HSS7 结果之间的相关性较弱(r < 0.2)。在目前的分析中,基线总 IgE 对 CSU 的治疗反应生物标志物没有预测价值。IgE是肥大细胞活化和组胺释放的关键介质,下调IgE至少可以部分解释dupilumab在减少CSU体征和症状方面的有效性:NCT04180488。
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引用次数: 0
Evaluation of the Safety and Effectiveness of Oral Minoxidil in Children: A Systematic Review. 儿童口服米诺地尔的安全性和有效性评估:系统回顾
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-07-01 Epub Date: 2024-06-11 DOI: 10.1007/s13555-024-01197-x
Kimberly N Williams, Chrislene T Y Olukoga, Antonella Tosti

The minimal adverse-effect profile and positive clinical response of low-dose oral minoxidil (LDOM) have recently caused the drug to gain popularity for the treatment of hair disorders in adults. However, in the pediatric population, hesitancy still surrounds the use of oral minoxidil given the wide profile of potential side effects the drug offers. This review aims to characterize the safety and use of oral minoxidil in children for the treatment of all disorders to equip physicians with ample knowledge when prescribing oral minoxidil in the pediatric population. A total of 41 studies (19 case reports, 10 cohort studies, 7 retrospective chart reviews, and 5 case series) that reported data on 442 pediatric patients for whom oral minoxidil was used for treatment were included. Conditions for which treatment with minoxidil was described were hair disorders (83.9%, 371/442) and hypertension (11.3%, 50/442); accidental usage (4.8%, 21/442) was also noted in the literature and included in this review. This review is broken down by dosage and describes the safety and efficacy of oral minoxidil in pediatric patients aged 0 to 18 years old for the treatment of hair disorders. This review found that LDOM may represent a safe option for the treatment of hair disorders in children. This study also suggests moderate and high doses of oral minoxidil may not be safe for use in children. Additional studies are needed to further understand this drug's efficacy and safety in children.

低剂量口服米诺地尔(LDOM)的不良反应极小,临床反应良好,因此最近在治疗成人毛发疾病方面大受欢迎。然而,在儿科人群中,由于口服米诺地尔的潜在副作用较多,人们对其使用仍然犹豫不决。本综述旨在描述儿童口服米诺地尔治疗各种疾病的安全性和使用情况,使医生在为儿科人群开具口服米诺地尔处方时掌握充足的知识。本研究共纳入了 41 项研究(19 项病例报告、10 项队列研究、7 项回顾性病历审查和 5 项病例系列),这些研究报告了 442 名使用米诺地尔口服液治疗的儿科患者的数据。使用米诺地尔治疗的病症包括毛发失调(83.9%,371/442 例)和高血压(11.3%,50/442 例);意外使用(4.8%,21/442 例)也在文献中有所提及,并纳入了本综述。本综述按剂量细分,介绍了 0 至 18 岁儿童患者口服米诺地尔治疗毛发疾病的安全性和有效性。本综述发现,LDOM 可能是治疗儿童毛发疾病的一种安全选择。这项研究还表明,适量和高剂量的米诺地尔口服液用于儿童可能并不安全。要进一步了解这种药物对儿童的疗效和安全性,还需要进行更多的研究。
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引用次数: 0
Exploratory Efficacy Evaluation of Apremilast for the Treatment of Japanese Patients with Palmoplantar Pustulosis: 32-Week Results from a Phase 2, Randomized, Placebo-Controlled Study. 阿普司特治疗日本掌跖脓疱病的探索性疗效评估:一项为期 32 周的 2 期随机安慰剂对照研究结果。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-07-01 Epub Date: 2024-06-19 DOI: 10.1007/s13555-024-01195-z
Yukari Okubo, Tadashi Terui, Satomi Kobayashi, Shigetoshi Sano, Akimichi Morita, Shinichi Imafuku, Yayoi Tada, Masatoshi Abe, Masafumi Yaguchi, Takeshi Kimura, Junichiro Shimauchi, Wendy Zhang, Hamid Amouzadeh, Masamoto Murakami

Introduction: Palmoplantar pustulosis (PPP) is a pruritic, painful, chronic dermatitis that greatly impacts functioning and quality of life and can be difficult to treat. Approved treatment options for PPP are limited, and many patients do not fully respond to current treatments.

Methods: This was a randomized, double-blind, placebo-controlled, phase 2 study in Japanese patients with moderate to severe PPP and inadequate response to topical treatment. Patients were randomized 1:1 to receive apremilast 30 mg twice daily or placebo for 16 weeks followed by an extension phase where all patients received apremilast through week 32. PPP Area and Severity Index (PPPASI), modified PPPASI (which evaluates pustules and vesicles separately), and Palmoplantar Severity Index (PPSI) total scores and subscores (erythema, pustules/vesicles, and desquamation/scales) were evaluated over 32 weeks of apremilast treatment. Achievement of ≥ 50% improvement in PPPASI (PPPASI-50) was evaluated at week 16 among baseline demographic and clinical characteristic subgroups.

Results: At week 16, improvements in total score and subscores for PPPASI, modified PPASI, and PPSI, as well as rates of PPPASI-50 were at least moderately greater with apremilast than placebo. Mean PPPASI total score decreased by - 68.3% from baseline to week 32 with continued apremilast treatment. At week 32, mean change from baseline in PPPASI/modified PPPASI subscores ranged from - 58.5% to - 77.0% with apremilast. At week 32, PPSI total score for physician and patient assessments decreased by - 51.3% and - 40.0%, respectively, with continued apremilast treatment. PPPASI-50 response at week 16 was greater with apremilast versus placebo in most demographic and baseline characteristic subgroups.

Conclusions: Improvements in all PPPASI and PPSI total scores and subscores observed with apremilast over 16 weeks were maintained through 32 weeks in patients with moderate to severe PPP and inadequate response to topical treatment. Rates of PPPASI-50 response at week 16 were mostly consistent across patient subgroups.

Clinicaltrials: GOV: NCT04057937.

简介:掌跖脓疱病(PPP)是一种瘙痒、疼痛的慢性皮炎,严重影响患者的功能和生活质量,而且难以治疗。已获批准的 PPP 治疗方案有限,许多患者对目前的治疗方法没有完全反应:这是一项随机、双盲、安慰剂对照的 2 期研究,研究对象是中度至重度 PPP 且对局部治疗反应不佳的日本患者。患者按1:1的比例随机接受阿普司特30毫克,每天两次或安慰剂治疗16周,然后进入延长阶段,所有患者接受阿普司特治疗至第32周。阿普司特治疗 32 周后,对 PPP 面积和严重程度指数 (PPPASI)、改良 PPPASI(分别评估脓疱和囊泡情况)和掌跖严重程度指数 (PPSI) 的总分和分值(红斑、脓疱/囊泡和脱屑/鳞屑)进行评估。在第16周评估基线人口统计学和临床特征亚组的PPPASI(PPPASI-50)改善≥50%的情况:结果:第16周时,阿普司特对PPPASI、改良PPASI和PPSI的总分和亚分以及PPPASI-50的改善率至少中等程度高于安慰剂。阿普司特持续治疗后,PPPASI总分的平均值从基线到第32周下降了-68.3%。第32周,阿普瑞司特治疗后,PPPASI/改良PPPASI子分数从基线到第32周的平均变化范围为-58.5%至-77.0%。在第32周,继续使用阿普瑞司特治疗后,医生和患者评估的PPSI总分分别下降了-51.3%和-40.0%。在大多数人口统计学和基线特征亚组中,阿普瑞司特治疗第16周时的PPPASI-50反应大于安慰剂:结论:在中度至重度PPP和局部治疗反应不充分的患者中,阿普瑞司特治疗16周后观察到的所有PPPASI和PPSI总分和亚分的改善可维持到32周。不同亚组患者在第16周时的PPPASI-50反应率基本一致:GOV:NCT04057937。
{"title":"Exploratory Efficacy Evaluation of Apremilast for the Treatment of Japanese Patients with Palmoplantar Pustulosis: 32-Week Results from a Phase 2, Randomized, Placebo-Controlled Study.","authors":"Yukari Okubo, Tadashi Terui, Satomi Kobayashi, Shigetoshi Sano, Akimichi Morita, Shinichi Imafuku, Yayoi Tada, Masatoshi Abe, Masafumi Yaguchi, Takeshi Kimura, Junichiro Shimauchi, Wendy Zhang, Hamid Amouzadeh, Masamoto Murakami","doi":"10.1007/s13555-024-01195-z","DOIUrl":"10.1007/s13555-024-01195-z","url":null,"abstract":"<p><strong>Introduction: </strong>Palmoplantar pustulosis (PPP) is a pruritic, painful, chronic dermatitis that greatly impacts functioning and quality of life and can be difficult to treat. Approved treatment options for PPP are limited, and many patients do not fully respond to current treatments.</p><p><strong>Methods: </strong>This was a randomized, double-blind, placebo-controlled, phase 2 study in Japanese patients with moderate to severe PPP and inadequate response to topical treatment. Patients were randomized 1:1 to receive apremilast 30 mg twice daily or placebo for 16 weeks followed by an extension phase where all patients received apremilast through week 32. PPP Area and Severity Index (PPPASI), modified PPPASI (which evaluates pustules and vesicles separately), and Palmoplantar Severity Index (PPSI) total scores and subscores (erythema, pustules/vesicles, and desquamation/scales) were evaluated over 32 weeks of apremilast treatment. Achievement of ≥ 50% improvement in PPPASI (PPPASI-50) was evaluated at week 16 among baseline demographic and clinical characteristic subgroups.</p><p><strong>Results: </strong>At week 16, improvements in total score and subscores for PPPASI, modified PPASI, and PPSI, as well as rates of PPPASI-50 were at least moderately greater with apremilast than placebo. Mean PPPASI total score decreased by - 68.3% from baseline to week 32 with continued apremilast treatment. At week 32, mean change from baseline in PPPASI/modified PPPASI subscores ranged from - 58.5% to - 77.0% with apremilast. At week 32, PPSI total score for physician and patient assessments decreased by - 51.3% and - 40.0%, respectively, with continued apremilast treatment. PPPASI-50 response at week 16 was greater with apremilast versus placebo in most demographic and baseline characteristic subgroups.</p><p><strong>Conclusions: </strong>Improvements in all PPPASI and PPSI total scores and subscores observed with apremilast over 16 weeks were maintained through 32 weeks in patients with moderate to severe PPP and inadequate response to topical treatment. Rates of PPPASI-50 response at week 16 were mostly consistent across patient subgroups.</p><p><strong>Clinicaltrials: </strong>GOV: NCT04057937.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"1863-1873"},"PeriodicalIF":3.5,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11264648/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141418301","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
Insights into the Window of Opportunity and Outcome Measures in Patients with Moderate to Severe Hidradenitis Suppurativa Treated with Secukinumab: A Real-World Study. 对使用塞库单抗治疗中度至重度化脓性扁桃体炎患者的机会之窗和疗效测量的见解:一项真实世界研究。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-07-01 Epub Date: 2024-06-19 DOI: 10.1007/s13555-024-01209-w
Sofía Haselgruber, Pablo Fernández-Crehuet-Serrano, María Dolores Fernández-Ballesteros, Alicia Padial-Gómez, Juan Carlos Hernández-Rodríguez, Juan Ortiz-Álvarez, Pedro Navarro-Guillamón, Cristina Membrive-Jiménez, Carlos Cuenca-Barrales, Alejandro Molina-Leyva

Introducion: The concept of a window of opportunity in hidradenitis suppurativa (HS) management suggests that early initiation of biological therapy leads to better outcomes, though its timing remains uncertain.

Methods: We conducted a retrospective observational multicenter study, including consecutive patients with moderate to severe HS who initiated secukinumab treatment following prior failure with systemic antibiotics or adalimumab. Therapeutic burden was defined as the sum of previous systemic treatment cycles and previous major surgical interventions for HS. Patients were followed up for 24 weeks. Main outcomes were safety and effectiveness, assessed through the proportion of patients achieving HS Clinical Response (HiSCR) and a 55% reduction in International HS Severity Score System (IHS4-55). Additionally, potential predictors of response to secukinumab were studied. Analysis was performed on an intention-to-treat basis.

Results: A total of 67 patients (33 men, 34 women) were included, with a mean age of 41.55 (11.94) years and a mean baseline IHS4 of 17.88 (11.13). The mean therapeutic burden was 6.06 (3.49). At week 24, 10.45% (7/67) of patients experienced adverse events, with three leading to treatment discontinuation. At week 24, 41.79% (28/67) of patients achieved HiSCR, and 44.78% (30/67) of patients achieved IHS4-55. HiSCR could not be calculated in 12 patients with a baseline AN count < 3. A lower therapeutic burden was significantly associated with a higher likelihood of achieving HiSCR and IHS4-55 at week 24.

Conclusions: Secukinumab showed safety and efficacy in real-world patients with HS, and the inverse correlation found between therapeutic burden and treatment response supports the concept of a window of opportunity, offering insights into its timing.

引言:化脓性扁桃体炎(HS)治疗中的 "机会之窗 "概念表明,尽早开始生物治疗可获得更好的疗效,但其时机仍不确定:我们进行了一项回顾性多中心观察研究,研究对象包括曾接受全身抗生素或阿达木单抗治疗失败后开始接受secukinumab治疗的中度至重度HS连续患者。治疗负担定义为既往系统治疗周期和既往HS重大手术干预的总和。对患者进行了为期24周的随访。主要结果是安全性和有效性,通过获得HS临床应答(HiSCR)和国际HS严重程度评分系统(IHS4-55)降低55%的患者比例进行评估。此外,还研究了预测对赛库单抗反应的潜在因素。分析以意向治疗为基础:共纳入67名患者(33名男性,34名女性),平均年龄为41.55(11.94)岁,平均基线IHS4为17.88(11.13)分。平均治疗负担为 6.06(3.49)。第 24 周时,10.45% 的患者(7/67)出现不良反应,其中 3 例导致治疗中止。第24周时,41.79%(28/67)的患者达到了HiSCR,44.78%(30/67)的患者达到了IHS4-55。12例基线AN计数患者的HiSCR无法计算:塞库单抗在现实世界的 HS 患者中显示出了安全性和有效性,治疗负担与治疗反应之间的反相关性支持了机会之窗的概念,为治疗时机的选择提供了启示。
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引用次数: 0
Predicting Abrocitinib Efficacy at Week 12 Based on Clinical Response at Week 4: A Post Hoc Analysis of Four Randomized Studies in Moderate-to-Severe Atopic Dermatitis. 根据第 4 周的临床反应预测阿罗西替尼第 12 周的疗效:对四项中重度特应性皮炎随机研究的事后分析。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-07-01 Epub Date: 2024-06-19 DOI: 10.1007/s13555-024-01183-3
April W Armstrong, Andrew F Alexis, Andrew Blauvelt, Jonathan I Silverberg, Claire Feeney, Mark Levenberg, Gary Chan, Fan Zhang, Luke Fostvedt

Introduction: Early prediction of abrocitinib efficacy in atopic dermatitis (AD) could help identify candidates for an early dose increase. A predictive model determined week 12 efficacy based on week 4 responses in patients receiving abrocitinib 100 mg/day and assessed the effect of an abrocitinib dose increase on platelet counts.

Methods: Analysis included the phase 3 trials JADE MONO-1 (NCT03349060), MONO-2 (NCT03575871), COMPARE (NCT03720470), and TEEN (NCT03796676). For platelet counts and simulations, a phase 2 psoriasis trial (NCT02201524) and phase 2b (NCT02780167) and phase 3 (MONO-1, MONO-2, and REGIMEN (NCT03627767)) abrocitinib trials were pooled. A training-and-validation framework assessed potential predictors of response at week 4: score and score change from baseline in the Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), and Peak Pruritus Numerical Rating Scale (PP-NRS), and percentage change from baseline in EASI. The dependent variables at week 12 were ≥ 75% improvement in EASI (EASI-75) and IGA score of 0 (clear) or 1 (almost clear) and ≥ 2-point improvement from baseline. The probability of each variable to predict week 12 EASI-75 and IGA responses was calculated.

Results: In the training cohort (n = 453), 72% of the ≥ 50% improvement in EASI (EASI-50) at week 4 responders and 16% of the nonresponders with abrocitinib 100 mg achieved EASI-75 at week 12; 48% and 6% of the week 4 EASI-50 responders and nonresponders, respectively, achieved week 12 IGA response. Similar results occurred with week 4 IGA = 2, ≥ 4-point improvement from baseline in PP-NRS, or EASI = 8 responders/nonresponders. Platelet counts after an abrocitinib dose increase from 100 to 200 mg were similar to those seen with continuous dosing with abrocitinib 100 mg or 200 mg.

Conclusion: Achieving week 4 clinical responses with abrocitinib 100 mg may be useful in predicting week 12 responses. Week 4 nonresponders may benefit from a dose increase to abrocitinib 200 mg, and those that receive this dose increase are likely to achieve treatment success at week 12, with no significant impact on platelet count recovery. Video abstract available for this article.

Clinical trial registration: NCT03349060, NCT03575871, NCT03720470, NCT03796676, NCT02201524, NCT02780167 and NCT03627767.

简介:早期预测阿罗西替尼对特应性皮炎(AD)的疗效有助于确定早期增加剂量的候选者。一个预测模型根据接受阿罗西替尼100毫克/天治疗的患者第4周的反应确定第12周的疗效,并评估阿罗西替尼剂量增加对血小板计数的影响:分析包括3期试验JADE MONO-1(NCT03349060)、MONO-2(NCT03575871)、COMPARE(NCT03720470)和TEEN(NCT03796676)。在血小板计数和模拟方面,汇总了银屑病 2 期试验(NCT02201524)和 2b 期(NCT02780167)及 3 期(MONO-1、MONO-2 和 REGIMEN(NCT03627767))阿昔替尼试验。一个训练-验证框架评估了第4周时的潜在预测因素:湿疹面积和严重程度指数(EASI)、研究者总体评估(IGA)和瘙痒峰值数字评定量表(PP-NRS)的得分和得分与基线相比的变化,以及EASI与基线相比的百分比变化。第 12 周的因变量为 EASI(EASI-75)改善≥ 75%,IGA 评分为 0(无瘙痒)或 1(基本无瘙痒),且与基线相比改善≥ 2 分。计算了每个变量预测第 12 周 EASI-75 和 IGA 反应的概率:在训练队列(n = 453)中,第4周EASI(EASI-50)改善≥50%的阿罗西替尼100 mg应答者中有72%在第12周达到EASI-75,无应答者中有16%在第12周达到EASI-75;第4周EASI-50应答者和无应答者中分别有48%和6%在第12周达到IGA应答。第4周IGA=2、PP-NRS较基线改善≥4分或EASI=8的应答者/无应答者也有类似结果。阿罗西替尼剂量从100毫克增加到200毫克后,血小板计数与连续服用阿罗西替尼100毫克或200毫克时相似:结论:使用阿罗西替尼100毫克治疗第4周后出现临床应答,可能有助于预测第12周的应答情况。第4周无应答者可从阿罗西替尼200毫克的剂量增加中获益,接受该剂量增加的患者很可能在第12周取得治疗成功,且对血小板计数恢复无显著影响。本文有视频摘要:NCT03349060、NCT03575871、NCT03720470、NCT03796676、NCT02201524、NCT02780167和NCT03627767。
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引用次数: 0
Psychodermatology of Chronic Pruritus: An Overview of the Link Between Itch and Distress. 慢性瘙痒的心理皮肤病学:瘙痒与痛苦之间的联系概述。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-07-01 Epub Date: 2024-06-24 DOI: 10.1007/s13555-024-01214-z
Bárbara R Ferreira, Olivia M Katamanin, Mohammad Jafferany, Laurent Misery

Chronic pruritus (CP) is defined as an unpleasant sensation causing a desire to scratch and lasting > 6 weeks. It has a multifactorial etiology but is more frequently associated with chronic inflammatory dermatoses and systemic disorders. Psychogenic pruritus and neurological disorders are other less common etiologies, while, in some patients, it is idiopathic. CP appears to be processed by non-histaminergic pathway, contributing to its complexity and therapeutic challenge. Moreover, regardless of the etiology, it is multidimensional, including cognitive, motivational and affective components. There is a close link between psychological distress and pruritus, with particular clinical expression in chronic inflammatory dermatoses, involving the activation of the hypothalamic-pituitary-adrenal axis (and its cutaneous equivalent), the sympathetic nervous system, the release of hormones and peptides, the role of immune cells (T and B cells, macrophages) and immune-related cells in the skin (mast cells, dendritic cells and keratinocytes). Moreover, there is strong evidence that psychological factors influence the experience of pruritus. CP can also cause psychiatric disorders, including but not limited to anxiety and depression, and also lead to significant quality of life (QoL) impairment. Thereby, although a psychodermatological assessment should ideally be carried out in the context of a specific psychodermatology consultation, a brief mental health assessment could be part of the general dermatological approach to these patients. Considering that mental health, QoL and pruritus are closely linked, psychotherapeutic interventions and/or psychotropic drugs should thus be considered in some patients as an adjunct to the pharmacological treatment of CP.

慢性瘙痒症(CP)的定义是一种引起搔抓欲望的不愉快感觉,持续时间超过 6 周。它的病因是多方面的,但更常见的是与慢性炎症性皮肤病和全身性疾病有关。精神性瘙痒症和神经系统疾病是其他不太常见的病因,而有些患者则是特发性的。CP 似乎是通过非组胺能途径处理的,这就增加了其复杂性和治疗难度。此外,无论病因如何,CP 都是多方面的,包括认知、动机和情感因素。心理困扰与皮肤瘙痒症之间存在密切联系,在慢性炎症性皮肤病中的临床表现尤为明显,涉及下丘脑-垂体-肾上腺轴(及其皮肤等同轴)的激活、交感神经系统、激素和肽的释放、免疫细胞(T 细胞和 B 细胞、巨噬细胞)的作用以及皮肤中的免疫相关细胞(肥大细胞、树突状细胞和角质形成细胞)。此外,有确凿证据表明,心理因素会影响瘙痒的体验。CP 还可引起精神障碍,包括但不限于焦虑和抑郁,并导致严重的生活质量(QoL)损害。因此,尽管理想的皮肤心理评估应在专门的皮肤心理咨询中进行,但简短的心理健康评估也可作为针对这些患者的一般皮肤病治疗方法的一部分。考虑到心理健康、生活质量和瘙痒症密切相关,因此应考虑对某些患者采取心理治疗干预措施和/或精神药物,作为 CP 药物治疗的辅助手段。
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引用次数: 0
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
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
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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Dermatology and Therapy
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