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Real-Life Data of Secukinumab in Patients with Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis, and Ankylosing Spondylitis: Patient Baseline Characteristics Data from the PROMPT Study. Secukinumab 用于中重度斑块状银屑病、银屑病关节炎和强直性脊柱炎患者的实际生活数据:来自 PROMPT 研究的患者基线特征数据。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-11-07 DOI: 10.1007/s13555-024-01299-6
Ploysyne Rattanakaemakorn, Parawee Chevaisrakul, Chanisada Wongpraparut, Praveena Chiowchanwisawakit, Napatra Tovanabutra, Pimchanok Tantiwong, Warayuwadee Amornpinyo, Panlop Chakkavittumrong, Punchong Hanvivadhanakul, Sumapa Chaiamnuay, Supapat Laodheerasiri, Bensachee Pattamadilok, Charoen Choonhakarn, Ajanee Mahakkanukrauh, Duangkamol Aiewruengsurat, Siripan Sangmala, Nisa Pretikul, Kittiwan Sumethkul, Panchalee Satpanich, Metavee Boonsiri, Naruemon Sangob, Pravit Asawanonda

Introduction: Secukinumab has proven to be effective and safe in psoriasis (PsO), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) in the phase 3 studies. However, data on real-world practice is limited.

Methods: This study is an ongoing, multicenter, 2-year observational study that focuses on patients with moderate to severe plaque PsO, active PsA, or AS receiving secukinumab. The aim of this study is to present baseline data for the entire study population.

Results: A total of 127 patients were enrolled, with 101 having PsO, 12 with PsA, and 14 with AS. Among the patients, approximately 54.0% were male. The mean body mass index ranged from 25.0 to 27.4 kg/m2 across all groups. Patients with PsO had the longest disease duration with an average of 11.0 years, followed by AS (3.0 years) and PsA (1.0 year). Previous biologic therapy was observed in 6.9-8.1% of patients. Baseline disease severity scores revealed moderate to severe disease. In the PsO group, the mean Psoriasis Area and Severity Index score was 16.1. For patients with PsA, the mean Tender Joint Count was 9.1, and the mean Swollen Joint Count was 6.7. In the AS group, the mean Bath Ankylosing Spondylitis Disease Activity Index score was 4.6, and the mean Ankylosing Spondylitis Disease Activity Score was 3.7.

Conclusion: The study demonstrates disease durations, disease activity, and treatment history in Thai patients that were generally consistent with previous randomized controlled studies. Long-term data on the efficacy and safety of the treatment will be presented in future publications.

简介在三期研究中,塞库单抗被证明对银屑病(PsO)、银屑病关节炎(PsA)和强直性脊柱炎(AS)有效且安全。然而,有关实际应用的数据却很有限:本研究是一项正在进行的多中心、为期两年的观察性研究,主要针对接受secukinumab治疗的中重度斑块型PsO、活动性PsA或AS患者。本研究旨在提供整个研究人群的基线数据:共有127名患者入组,其中101人患有PsO,12人患有PsA,14人患有AS。患者中约 54.0% 为男性。所有组别的平均体重指数在 25.0 至 27.4 kg/m2 之间。PsO患者的病程最长,平均为11.0年,其次是AS(3.0年)和PsA(1.0年)。6.9%-8.1%的患者曾接受过生物治疗。基线疾病严重程度评分显示患者患有中度至重度疾病。在 PsO 组中,牛皮癣面积和严重程度指数的平均值为 16.1 分。PsA患者的平均关节触痛数为9.1,平均关节肿胀数为6.7。在强直性脊柱炎组中,巴斯强直性脊柱炎疾病活动指数平均值为4.6分,强直性脊柱炎疾病活动评分平均值为3.7分:研究显示,泰国患者的病程、疾病活动度和治疗史与之前的随机对照研究基本一致。有关疗效和安全性的长期数据将在今后的出版物中介绍。
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引用次数: 0
A Pilot Study on the Comparative Efficacy and Tolerability of a Novel Dermo-cosmetic Cream with 15% Azelaic Acid for Mild to Moderate Acne: A New Approach to Acne Treatment. 一项关于含 15%杜鹃花酸的新型皮肤美容霜对轻度至中度痤疮的疗效和耐受性比较的试点研究:治疗痤疮的新方法。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-11-02 DOI: 10.1007/s13555-024-01294-x
Aura Vladuti, Afshin Hatami, Amélie Clément, Carine Mainzer

Introduction: Acne is a one of the most frequent skin conditions among teenagers and young adults. It is currently managed with topical retinoids and antibiotics, which can present numerous side effects, thus reducing treatment adherence and effectiveness. We evaluated the efficacy and tolerability of a novel dermo-cosmetic cream (α-AZ) in treating mild to moderate acne.

Methods: Subjects were randomized into three groups: group 1 received α-AZ cream, group 2 was treated with α-AZ combined with an oral acne treatment routine, and group 3 received a topical acne treatment, for 84 days. All treated patients underwent a 28-day maintenance period with α-AZ cream. Total acne and post-inflammatory hyperpigmentation (PIH) scoring, quality of life (QoL), and skin tolerance were all evaluated during the treatment and maintenance periods.

Results: Acne and PIH lesions significantly decreased in group 1 compared to group 3 (p < 0.001), with a reduction in acne of 66.52 ± 2.92% in group 1 versus 52.55 ± 3.90% in group 3. Patients in group 1 achieved nearly clear skin by the end of the treatment. α-AZ cream treatment was well tolerated and all participants experienced an enhanced QoL. Participants expressed high satisfaction. Additional enhancements in all groups were noted during the maintenance phase across all clinical parameters.

Conclusion: The novel dermo-cosmetic α-AZ cream could serve as a valuable new approach to current treatments for mild and moderate acne. It can be used alone, as a once-daily adjuvant to oral acne treatments, or as part of a maintenance regimen.

Trial registration: ISRCTN registry, ISRCTN70142596, registered retrospectively on 11/12/2023.

简介痤疮是青少年中最常见的皮肤病之一。目前,治疗痤疮的方法主要是外用维甲酸类药物和抗生素,但这些药物会产生许多副作用,从而降低了治疗的依从性和有效性。我们对一种新型皮肤美容霜(α-AZ)治疗轻度至中度痤疮的疗效和耐受性进行了评估:受试者被随机分为三组:第一组接受α-AZ药膏治疗,第二组接受α-AZ联合口服痤疮治疗,第三组接受痤疮局部治疗,共84天。所有接受治疗的患者都使用了为期 28 天的α-AZ 乳霜。在治疗和维持期间,对痤疮和炎症后色素沉着(PIH)总评分、生活质量(QoL)和皮肤耐受性进行了评估:结果:与第 3 组相比,第 1 组的痤疮和 PIH 病变明显减少(P新型皮肤化妆品 α-AZ 乳霜可作为目前治疗轻度和中度痤疮的一种有价值的新方法。它既可单独使用,也可作为口服痤疮治疗的辅助药物,或作为维持治疗方案的一部分:ISRCTN注册号:ISRCTN70142596,于2023年12月11日进行了回顾性注册。
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引用次数: 0
Equity and Outcome Events in Hidradenitis Suppurativa: Exploring Effect Modifiers Associated with Diagnostic Delay in the Real World. 化脓性扁桃体炎的公平与结果事件:探索现实世界中与诊断延迟相关的效应调节因素
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-11-02 DOI: 10.1007/s13555-024-01291-0
Nicole Murray, Isabel Truman, Gary Milligan, Himanshu Modi, Nicholas Adlard

Introduction: Patients with hidradenitis suppurativa (HS) experience significantly delayed diagnoses of 7-10 years from symptom onset on average, but the reasons for this remain largely unknown. This study investigated drivers of diagnostic delay from the perspective of healthcare system equity.

Methods: A literature review was performed to identify published factors associated with delayed HS diagnosis to inform data analysis. Clinical and demographic data from the Adelphi HS Disease Specific Programme (DSP)™, a real-world cross-sectional survey of dermatologists and their consulting patients in France, Germany, Italy, Spain, the UK and the USA in 2020/2021, were used to model factors influencing delay to diagnosis from onset of symptoms and first consultation.

Results: Factors influencing delay to HS diagnosis in the literature with the most available evidence were misdiagnosis, delay in specialist referral and patient embarrassment. Data analysis revealed that increasing age was associated with reduced diagnostic delay after symptom onset. Patients with HS who were White or in Germany were also more likely to receive a faster diagnosis. Smokers, patients with concomitant conditions, or a family history of HS were slower to be diagnosed. When time to diagnosis following first consultation was assessed, increasing age was associated with quicker diagnosis. Moreover, patients with a family history of HS were diagnosed quicker, whereas those with high body mass index, more concomitant conditions, in employment, managed by multiple physicians or European were more delayed.

Conclusion: On the basis of a thorough analysis of real-world data, multiple factors that potentially influenced the timely diagnosis of HS have been identified. For the first time, this study quantifies the relative impact of these modifiers, providing valuable insights into areas that require attention for faster diagnoses and improved disease outcomes.

导言:化脓性扁桃体炎(HS)患者的诊断严重滞后,从症状出现到确诊平均需要 7-10 年时间,但造成这种情况的原因在很大程度上仍不为人所知。本研究从医疗保健系统公平性的角度调查了诊断延迟的驱动因素:方法:我们进行了文献综述,以确定已发表的与房颤诊断延迟相关的因素,为数据分析提供依据。阿德尔菲HS疾病专项计划(DSP)™是2020/2021年对法国、德国、意大利、西班牙、英国和美国的皮肤科医生及其就诊患者进行的一项真实世界横断面调查,该计划提供的临床和人口统计学数据被用于模拟从症状出现到首次就诊的诊断延迟影响因素:在现有证据最多的文献中,影响 HS 诊断延误的因素包括误诊、专家转诊延误和患者尴尬。数据分析显示,年龄的增加与症状出现后诊断延迟的减少有关。白种人或德国人的 HS 患者也更有可能更快得到诊断。吸烟者、合并症患者或有HS家族史的患者确诊速度较慢。在评估首次就诊后的诊断时间时,年龄越大,诊断越快。此外,有 HS 家族史的患者确诊较快,而体重指数高、并发症多、在职、由多名医生管理或欧洲人的患者确诊较晚:在对真实世界数据进行全面分析的基础上,确定了可能影响 HS 及时诊断的多种因素。本研究首次量化了这些影响因素的相对影响,为更快诊断和改善疾病预后需要关注的领域提供了有价值的见解。
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引用次数: 0
Long-Term Efficacy and Safety of Bimekizumab and Other Biologics in Moderate to Severe Plaque Psoriasis: Updated Systematic Literature Review and Network Meta-analysis. 比美单抗和其他生物制剂对中度至重度斑块状银屑病的长期疗效和安全性:最新系统文献综述和网络 Meta 分析。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-11-01 DOI: 10.1007/s13555-024-01302-0
Richard B Warren, Kerry Donnelly, Sandeep Kiri, Vanessa Taieb, Mahmoud Slim, Kyle Fahrbach, Binod Neupane, Marissa Betts, April Armstrong

Introduction: Biologic treatments have made complete skin clearance in moderate to severe plaque psoriasis a real possibility. Although clinical trials demonstrated the superiority of bimekizumab over secukinumab, adalimumab, and ustekinumab, direct comparisons with other biologics are not available. This systematic literature review (SLR) and network meta-analysis (NMA) aimed to evaluate the 1-year efficacy and safety of bimekizumab versus other biologic systemic therapies for moderate to severe plaque psoriasis.

Methods: We conducted an SLR to retrieve published randomised controlled trials (RCTs) in patients with moderate to severe plaque psoriasis. We searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews and PsycINFO on 13 January 2022. Two NMA types were used to analyse the long-term achievement of 100% improvement from baseline in Psoriasis Area and Severity Index (PASI 100): (1) NMA of cumulative clinical benefits, based on the area under the curve, from week 0 to 52; (2) multinomial NMA at weeks 44‒60. Binomial NMA was used to evaluate long-term serious adverse events (SAEs).

Results: The SLR identified 38 RCTs, of which 19 were included in the NMA. Bimekizumab 320 mg administered every 4 weeks to week 16 then every 8 weeks (Q4W/Q8W) showed a greater cumulative average number of days of PASI 100 response compared with all other biologics. These differences were statistically significant versus all biologics, except risankizumab 150 mg. The multinomial NMA demonstrated that interleukin (IL)-17 and IL-23 inhibitors were the most efficacious treatments. No significant differences were found in long-term occurrence of SAEs.

Conclusion: Bimekizumab 320 mg Q4W/Q8W was superior to most other treatments in maintaining complete skin clearance during the first year of treatment. It demonstrated a greater cumulative average number of days with completely clear skin while displaying a comparable safety profile compared with all other biologics.

简介:生物制剂治疗已使中度至重度斑块状银屑病患者的皮肤完全清除成为可能。尽管临床试验证明了bimekizumab优于secukinumab、adalimumab和ustekinumab,但尚无与其他生物制剂的直接比较。本系统性文献综述(SLR)和网络荟萃分析(NMA)旨在评估bimekizumab与其他生物制剂系统疗法治疗中重度斑块状银屑病的1年疗效和安全性:我们进行了一次SLR检索,以检索已发表的针对中重度斑块状银屑病患者的随机对照试验(RCT)。我们检索了2022年1月13日的MEDLINE、Embase、Cochrane对照试验中央登记册、Cochrane系统综述数据库和PsycINFO。采用两种NMA类型分析牛皮癣面积和严重程度指数(PASI 100)从基线改善100%的长期成就:(1)基于曲线下面积的累积临床获益NMA,从第0周到第52周;(2)第44-60周的多项式NMA。二项式 NMA 用于评估长期严重不良事件 (SAE):SLR确定了38项RCT,其中19项纳入了NMA。与所有其他生物制剂相比,比美单抗 320 毫克每 4 周给药一次至第 16 周,然后每 8 周给药一次(Q4W/Q8W),PASI 100 反应的累积平均天数更多。除利桑珠单抗 150 毫克外,与所有生物制剂相比,这些差异均具有统计学意义。多项式 NMA 显示,白细胞介素 (IL)-17 和 IL-23 抑制剂是最有效的治疗方法。在SAEs的长期发生率方面没有发现明显差异:结论:Bimekizumab 320 mg Q4W/Q8W 在治疗第一年保持皮肤完全清除方面优于大多数其他治疗方法。结论:与所有其他生物制剂相比,比美单抗 320 毫克 Q4W/Q8W 在保持皮肤完全清除方面优于大多数其他治疗方法,其皮肤完全清除的累积平均天数更多,同时显示出相当的安全性。
{"title":"Long-Term Efficacy and Safety of Bimekizumab and Other Biologics in Moderate to Severe Plaque Psoriasis: Updated Systematic Literature Review and Network Meta-analysis.","authors":"Richard B Warren, Kerry Donnelly, Sandeep Kiri, Vanessa Taieb, Mahmoud Slim, Kyle Fahrbach, Binod Neupane, Marissa Betts, April Armstrong","doi":"10.1007/s13555-024-01302-0","DOIUrl":"https://doi.org/10.1007/s13555-024-01302-0","url":null,"abstract":"<p><strong>Introduction: </strong>Biologic treatments have made complete skin clearance in moderate to severe plaque psoriasis a real possibility. Although clinical trials demonstrated the superiority of bimekizumab over secukinumab, adalimumab, and ustekinumab, direct comparisons with other biologics are not available. This systematic literature review (SLR) and network meta-analysis (NMA) aimed to evaluate the 1-year efficacy and safety of bimekizumab versus other biologic systemic therapies for moderate to severe plaque psoriasis.</p><p><strong>Methods: </strong>We conducted an SLR to retrieve published randomised controlled trials (RCTs) in patients with moderate to severe plaque psoriasis. We searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews and PsycINFO on 13 January 2022. Two NMA types were used to analyse the long-term achievement of 100% improvement from baseline in Psoriasis Area and Severity Index (PASI 100): (1) NMA of cumulative clinical benefits, based on the area under the curve, from week 0 to 52; (2) multinomial NMA at weeks 44‒60. Binomial NMA was used to evaluate long-term serious adverse events (SAEs).</p><p><strong>Results: </strong>The SLR identified 38 RCTs, of which 19 were included in the NMA. Bimekizumab 320 mg administered every 4 weeks to week 16 then every 8 weeks (Q4W/Q8W) showed a greater cumulative average number of days of PASI 100 response compared with all other biologics. These differences were statistically significant versus all biologics, except risankizumab 150 mg. The multinomial NMA demonstrated that interleukin (IL)-17 and IL-23 inhibitors were the most efficacious treatments. No significant differences were found in long-term occurrence of SAEs.</p><p><strong>Conclusion: </strong>Bimekizumab 320 mg Q4W/Q8W was superior to most other treatments in maintaining complete skin clearance during the first year of treatment. It demonstrated a greater cumulative average number of days with completely clear skin while displaying a comparable safety profile compared with all other biologics.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":null,"pages":null},"PeriodicalIF":3.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142562757","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Melasma: A Clinical and Epidemiological Single-Group Observational Study in the Greek Population. 黄褐斑:希腊人群的临床和流行病学单组观察研究。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-11-01 DOI: 10.1007/s13555-024-01297-8
Eftychia Platsidaki, Vasiliki Markantoni, Electra Nicolaidou, Alexander Katoulis, Dimitrios Rigopoulos, Alexandros J Stratigos, Stamatios Gregoriou

Introduction: Melasma is a common acquired disorder of melanogenesis that predominately affects women and presents as hyperpigmented skin lesions mainly located on the face. The study aims to investigate the epidemiologic characteristics and hormonal profiles in melasma patients.

Methods: One hundred fifty patients were enrolled in this study in a tertiary care hospital. Clinical patterns, pigment depth, disease severity, underlying conditions, and heredity were recorded. Endocrinologic profile and vitamin D levels were assessed.

Results: On clinical examination, the condition indicated a centrofacial localization in 74% of the patients. Extra facial melasma was noticed in 10 patients who had centrofacial melasma to begin with. Wood's lamp examination showed the dermal type as the most common. A family history of melasma was noted in 38% of the patients. Melasma Area and Severity Index (MASI) score ranged from 0.3 to 10.8, with a mean score of 4.12 ± 2.06. Pregnancy-induced melasma was reported in 36.1% of the patients. In 17.4% of women, melasma was related to using oral contraceptives. In 22% of patients, mild vitamin D deficiency was detected, while 21% had thyroid disorders.

Conclusion: There is a strong correlation between family history and prevalence of melasma. Sun exposure is a major precipitating factor and should be carefully addressed in Mediterranean countries like Greece. However, other factors such as concomitant medication, multiple pregnancies, use of oral contraceptives, thyroid disorders and vitamin D deficiency might precipitate melasma.

导言:黄褐斑是一种常见的后天性黑色素生成障碍,主要影响女性,表现为色素沉着性皮肤损害,主要位于面部。本研究旨在调查黄褐斑患者的流行病学特征和荷尔蒙特征:方法:本研究在一家三甲医院招募了 150 名黄褐斑患者。记录了临床模式、色素深度、疾病严重程度、基础疾病和遗传情况。对内分泌情况和维生素 D 水平进行了评估:临床检查显示,74%的患者的病症位于面部中央。有 10 名患者的面部黄褐斑在一开始就位于面部中心位置。伍德灯检查显示,真皮型黄褐斑最为常见。38%的患者有黄褐斑家族史。黄褐斑面积和严重程度指数(MASI)从 0.3 到 10.8 不等,平均值为 4.12 ± 2.06。据报告,36.1%的患者有妊娠引起的黄褐斑。17.4%的妇女的黄褐斑与使用口服避孕药有关。22%的患者被检测出轻度缺乏维生素D,21%的患者患有甲状腺疾病:结论:家族病史与黄褐斑发病率之间存在密切联系。在希腊等地中海国家,日晒是一个主要诱发因素,应谨慎对待。然而,其他因素,如同时服用药物、多次怀孕、使用口服避孕药、甲状腺疾病和维生素D缺乏症也可能诱发黄褐斑。
{"title":"Melasma: A Clinical and Epidemiological Single-Group Observational Study in the Greek Population.","authors":"Eftychia Platsidaki, Vasiliki Markantoni, Electra Nicolaidou, Alexander Katoulis, Dimitrios Rigopoulos, Alexandros J Stratigos, Stamatios Gregoriou","doi":"10.1007/s13555-024-01297-8","DOIUrl":"https://doi.org/10.1007/s13555-024-01297-8","url":null,"abstract":"<p><strong>Introduction: </strong>Melasma is a common acquired disorder of melanogenesis that predominately affects women and presents as hyperpigmented skin lesions mainly located on the face. The study aims to investigate the epidemiologic characteristics and hormonal profiles in melasma patients.</p><p><strong>Methods: </strong>One hundred fifty patients were enrolled in this study in a tertiary care hospital. Clinical patterns, pigment depth, disease severity, underlying conditions, and heredity were recorded. Endocrinologic profile and vitamin D levels were assessed.</p><p><strong>Results: </strong>On clinical examination, the condition indicated a centrofacial localization in 74% of the patients. Extra facial melasma was noticed in 10 patients who had centrofacial melasma to begin with. Wood's lamp examination showed the dermal type as the most common. A family history of melasma was noted in 38% of the patients. Melasma Area and Severity Index (MASI) score ranged from 0.3 to 10.8, with a mean score of 4.12 ± 2.06. Pregnancy-induced melasma was reported in 36.1% of the patients. In 17.4% of women, melasma was related to using oral contraceptives. In 22% of patients, mild vitamin D deficiency was detected, while 21% had thyroid disorders.</p><p><strong>Conclusion: </strong>There is a strong correlation between family history and prevalence of melasma. Sun exposure is a major precipitating factor and should be carefully addressed in Mediterranean countries like Greece. However, other factors such as concomitant medication, multiple pregnancies, use of oral contraceptives, thyroid disorders and vitamin D deficiency might precipitate melasma.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":null,"pages":null},"PeriodicalIF":3.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142562758","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy and Safety of a Fixed-Dose Combination Gel with Adapalene 0.1% and Clindamycin 1% for the Treatment of Acne Vulgaris (CACTUS): A Randomized, Controlled, Assessor-Blind, Phase III Clinical Trial. 阿达帕林 0.1%和克林霉素 1%固定剂量复方凝胶治疗大疱性痤疮(CACTUS)的有效性和安全性:一项随机、对照、评估者盲法的 III 期临床试验。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-11-01 DOI: 10.1007/s13555-024-01286-x
Chao Luan, Wen Lin Yang, Jia Wen Yin, Lie Hua Deng, Bin Chen, Hong Wei Liu, Shou Min Zhang, Jian De Han, Zhi Jun Liu, Xiang Rong Dai, Qiu Ju Yin, Xiao Hui Yu, Kun Chen, Heng Gu, Benjamin Xiao Yi Li

Background: Combination therapy is required for the treatment of moderate acne vulgaris. However, patient compliance in applying multiple topical formulations is poor.

Objective: To assess the efficacy and safety of a fixed-dose combination gel with adapalene 0.1% and clindamycin 1% (adapalene-clindamycin) relative to adapalene 0.1% monotherapy and clindamycin 1% monotherapy in patients with moderate facial acne vulgaris.

Methods: This was a randomized, controlled, assessor-blind, phase III study conducted in patients with moderate facial acne vulgaris.

Results: A total of 1617 patients were enrolled. At week 12, patients in the adapalene-clindamycin gel treatment group showed a significant reduction in the percentage change from baseline in total lesion count (- 66.85%), compared with adapalene alone (- 50.82%) or clindamycin gel alone (- 57.61%). The difference in the least square means of the adapalene-clindamycin gel group and adapalene group, or clindamycin gel group was - 16.08% (95% CI - 19.95% to - 12.21%) and - 9.38% (95% CI - 13.25% to - 5.51%;), respectively. At week 12, 19.28% of participants who received adapalene-clindamycin gel achieved at least 2-grade improvement in IGA, versus 7.74% with adapalene gel (OR 3.05, 95% CI 1.93, 4.80) and 14.77% with clindamycin gel (OR 1.42, 95% CI 0.97, 2.07). The study also achieved all its secondary endpoints. Adverse event rates were mostly mild to moderate and comparable across the three treatment groups.

Conclusion: Adapalene 0.1%-clindamycin 1% combination gel is well tolerated and demonstrated superior efficacy over 0.1% adapalene gel monotherapy and 1% clindamycin gel monotherapy for the treatment of moderate acne vulgaris.

Trial registration: ClinicalTrials.gov identifier NCT03615768.

背景:治疗中度寻常型痤疮需要联合疗法。然而,患者对使用多种外用制剂的依从性很差:评估阿达帕林 0.1%和克林霉素 1%(阿达帕林-克林霉素)固定剂量联合凝胶相对于阿达帕林 0.1%单药治疗和克林霉素 1%单药治疗对中度面部寻常痤疮患者的疗效和安全性:这是一项在中度面部寻常型痤疮患者中开展的随机对照、评估者盲法III期研究:结果:共有 1617 名患者参加了研究。第12周时,阿达帕林-克林霉素凝胶治疗组患者的皮损总数与基线相比的百分比变化显著减少(-66.85%),而单独使用阿达帕林(-50.82%)或单独使用克林霉素凝胶(-57.61%)的患者的皮损总数与基线相比的百分比变化显著减少。阿达帕林-克林霉素凝胶组与阿达帕林组或克林霉素凝胶组的最小平方均值差异分别为-16.08%(95% CI - 19.95%至-12.21%)和-9.38%(95% CI - 13.25%至-5.51%)。第12周时,接受阿达帕林-克林霉素凝胶治疗的参与者中有19.28%的IGA至少改善了2个等级,而接受阿达帕林凝胶治疗的参与者中有7.74%的IGA至少改善了2个等级(OR值为3.05,95% CI为1.93,4.80),接受克林霉素凝胶治疗的参与者中有14.77%的IGA至少改善了2个等级(OR值为1.42,95% CI为0.97,2.07)。该研究还达到了所有次要终点。不良事件发生率大多为轻度至中度,三个治疗组的不良事件发生率相当:阿达帕林0.1%-克林霉素1%联合凝胶的耐受性良好,在治疗中度寻常型痤疮方面的疗效优于阿达帕林0.1%凝胶单药治疗和克林霉素1%凝胶单药治疗:试验注册:ClinicalTrials.gov identifier NCT03615768。
{"title":"Efficacy and Safety of a Fixed-Dose Combination Gel with Adapalene 0.1% and Clindamycin 1% for the Treatment of Acne Vulgaris (CACTUS): A Randomized, Controlled, Assessor-Blind, Phase III Clinical Trial.","authors":"Chao Luan, Wen Lin Yang, Jia Wen Yin, Lie Hua Deng, Bin Chen, Hong Wei Liu, Shou Min Zhang, Jian De Han, Zhi Jun Liu, Xiang Rong Dai, Qiu Ju Yin, Xiao Hui Yu, Kun Chen, Heng Gu, Benjamin Xiao Yi Li","doi":"10.1007/s13555-024-01286-x","DOIUrl":"https://doi.org/10.1007/s13555-024-01286-x","url":null,"abstract":"<p><strong>Background: </strong>Combination therapy is required for the treatment of moderate acne vulgaris. However, patient compliance in applying multiple topical formulations is poor.</p><p><strong>Objective: </strong>To assess the efficacy and safety of a fixed-dose combination gel with adapalene 0.1% and clindamycin 1% (adapalene-clindamycin) relative to adapalene 0.1% monotherapy and clindamycin 1% monotherapy in patients with moderate facial acne vulgaris.</p><p><strong>Methods: </strong>This was a randomized, controlled, assessor-blind, phase III study conducted in patients with moderate facial acne vulgaris.</p><p><strong>Results: </strong>A total of 1617 patients were enrolled. At week 12, patients in the adapalene-clindamycin gel treatment group showed a significant reduction in the percentage change from baseline in total lesion count (- 66.85%), compared with adapalene alone (- 50.82%) or clindamycin gel alone (- 57.61%). The difference in the least square means of the adapalene-clindamycin gel group and adapalene group, or clindamycin gel group was - 16.08% (95% CI - 19.95% to - 12.21%) and - 9.38% (95% CI - 13.25% to - 5.51%;), respectively. At week 12, 19.28% of participants who received adapalene-clindamycin gel achieved at least 2-grade improvement in IGA, versus 7.74% with adapalene gel (OR 3.05, 95% CI 1.93, 4.80) and 14.77% with clindamycin gel (OR 1.42, 95% CI 0.97, 2.07). The study also achieved all its secondary endpoints. Adverse event rates were mostly mild to moderate and comparable across the three treatment groups.</p><p><strong>Conclusion: </strong>Adapalene 0.1%-clindamycin 1% combination gel is well tolerated and demonstrated superior efficacy over 0.1% adapalene gel monotherapy and 1% clindamycin gel monotherapy for the treatment of moderate acne vulgaris.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier NCT03615768.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":null,"pages":null},"PeriodicalIF":3.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142564195","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Cost-Effectiveness Study of Difamilast 1% for the Treatment of Atopic Dermatitis in Adult Japanese Patients. 治疗日本成年特应性皮炎的 1%地拉米司特成本效益研究
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-11-01 DOI: 10.1007/s13555-024-01300-2
Takeshi Nakahara, Shinichi Noto, Miyuki Matsukawa, Hiroe Takeda, Yilong Zhang, Tomohiro Kondo

Introduction: Difamilast has proven to be an effective treatment for the treatment of atopic dermatitis (AD) in Japan, but its cost-effectiveness remains unknown. Therefore, the objective of the current study was to determine the cost-effectiveness of difamilast 1% compared with delgocitinib 0.5% in Japanese adult patients with moderate-to-severe AD and compared with placebo in Japanese adult patients with all-severity AD from a Japanese public health-care perspective.

Methods: The analysis was conducted using a cost-effectiveness model from the Japanese public health-care perspective. This model had four health states ("clear," "mild," "moderate," and "severe") defined according to the Eczema Area and Severity Index score. The time horizon of the analysis was 1 year. Because the analysis period was short, no discount rate was applied. The proportions of patients previously estimated by the anchored matching-adjusted indirect comparison were implemented in the model. The model was further populated with data from the literature. The main model outcomes were quality-adjusted life-years (QALY), costs, and outcomes, including the incremental cost-effectiveness ratio. All prices were stated in JPY at the price level from 2018 April to 2019 March. One-way sensitivity analysis and probabilistic sensitivity analysis (PSA) were performed to assess the robustness of the results.

Results: In the base case, the cost-effectiveness of difamilast 1% compared with delgocitinib 0.5% and placebo was JPY 827,054/QALY and JPY 1,518,657/QALY, respectively. The PSA showed that the cost-effectiveness of difamilast 1% compared with delgocitinib 0.5% and placebo had a 66.6% and 99.6% probability of being below the JPY 5 million/QALY threshold, respectively.

Conclusion: The results suggest that difamilast 1% is a more cost-effective treatment option compared with delgocitinib 0.5% in Japanese adult patients with moderate-to-severe AD and compared with placebo in adult patients with all-severity AD from a Japanese public health-care perspective.

简介:在日本,地拉米司特已被证明是治疗特应性皮炎(AD)的有效疗法,但其成本效益仍然未知。因此,本研究旨在从日本公共医疗保健的角度出发,确定地拉米司特 1%与德尔戈西替尼 0.5%在日本中重度特应性皮炎成年患者中的成本效益,以及地拉米司特 1%与安慰剂在日本所有严重程度特应性皮炎成年患者中的成本效益:分析采用了日本公共医疗保健角度的成本效益模型。该模型有四种健康状态("无"、"轻度"、"中度 "和 "重度"),根据湿疹面积和严重程度指数评分进行定义。分析的时间跨度为 1 年。由于分析时间较短,因此未采用贴现率。模型中采用了之前通过锚定匹配调整间接比较法估算出的患者比例。模型中还进一步加入了文献数据。模型的主要结果是质量调整生命年(QALY)、成本和结果,包括增量成本效益比。所有价格均以日元表示,价格水平为 2018 年 4 月至 2019 年 3 月。为评估结果的稳健性,进行了单向敏感性分析和概率敏感性分析(PSA):在基本病例中,1%地拉米司特与0.5%德尔戈西替尼和安慰剂相比,成本效益分别为827,054日元/QALY和1,518,657日元/QALY。PSA 显示,与德尔戈西替尼 0.5% 和安慰剂相比,地拉米司特 1%的成本效益分别有 66.6% 和 99.6% 的概率低于 500 万日元/QALY 临界值:结果表明,从日本公共医疗保健的角度来看,在日本中重度AD成年患者中,与德尔戈西替尼0.5%相比,地拉米司特1%是一种更具成本效益的治疗方案;在所有严重程度AD成年患者中,与安慰剂相比,地拉米司特1%是一种更具成本效益的治疗方案。
{"title":"Cost-Effectiveness Study of Difamilast 1% for the Treatment of Atopic Dermatitis in Adult Japanese Patients.","authors":"Takeshi Nakahara, Shinichi Noto, Miyuki Matsukawa, Hiroe Takeda, Yilong Zhang, Tomohiro Kondo","doi":"10.1007/s13555-024-01300-2","DOIUrl":"https://doi.org/10.1007/s13555-024-01300-2","url":null,"abstract":"<p><strong>Introduction: </strong>Difamilast has proven to be an effective treatment for the treatment of atopic dermatitis (AD) in Japan, but its cost-effectiveness remains unknown. Therefore, the objective of the current study was to determine the cost-effectiveness of difamilast 1% compared with delgocitinib 0.5% in Japanese adult patients with moderate-to-severe AD and compared with placebo in Japanese adult patients with all-severity AD from a Japanese public health-care perspective.</p><p><strong>Methods: </strong>The analysis was conducted using a cost-effectiveness model from the Japanese public health-care perspective. This model had four health states (\"clear,\" \"mild,\" \"moderate,\" and \"severe\") defined according to the Eczema Area and Severity Index score. The time horizon of the analysis was 1 year. Because the analysis period was short, no discount rate was applied. The proportions of patients previously estimated by the anchored matching-adjusted indirect comparison were implemented in the model. The model was further populated with data from the literature. The main model outcomes were quality-adjusted life-years (QALY), costs, and outcomes, including the incremental cost-effectiveness ratio. All prices were stated in JPY at the price level from 2018 April to 2019 March. One-way sensitivity analysis and probabilistic sensitivity analysis (PSA) were performed to assess the robustness of the results.</p><p><strong>Results: </strong>In the base case, the cost-effectiveness of difamilast 1% compared with delgocitinib 0.5% and placebo was JPY 827,054/QALY and JPY 1,518,657/QALY, respectively. The PSA showed that the cost-effectiveness of difamilast 1% compared with delgocitinib 0.5% and placebo had a 66.6% and 99.6% probability of being below the JPY 5 million/QALY threshold, respectively.</p><p><strong>Conclusion: </strong>The results suggest that difamilast 1% is a more cost-effective treatment option compared with delgocitinib 0.5% in Japanese adult patients with moderate-to-severe AD and compared with placebo in adult patients with all-severity AD from a Japanese public health-care perspective.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":null,"pages":null},"PeriodicalIF":3.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142564189","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Patient and Healthcare Provider Perspectives on Disease Burden of Seborrheic Dermatitis in the United States: Results from a National Survey. 美国患者和医护人员对脂溢性皮炎疾病负担的看法:全国调查结果。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-10-28 DOI: 10.1007/s13555-024-01288-9
Meredith T Polaskey, Lakshi Aldredge, Candrice Heath, Moises Acevedo, David H Chu, Diane Hanna, Melissa S Seal, Matthew Zirwas, Raj Chovatiya

Introduction: Seborrheic dermatitis (SD) is a common, chronic inflammatory skin disease, but the physical and emotional burden of patients with SD experience has not been well characterized.

Methods: The Harris Poll conducted online surveys of US patients and healthcare providers (HCPs) from December 2021 to January 2022.

Results: Almost half of patients reported that SD negatively impacts their emotional and physical well-being "a lot/a great deal"; HCPs underestimate the level of impact on patients. Most patients with SD reported a significant mental health impact, including anxiety, depression, anxiety about interacting with other people, and isolation. Two-thirds of patients said they did not know anyone else who had been diagnosed with SD, and even after diagnosis, less than half of patients still said they did not know anyone else with SD. Nearly all patients and HCPs agreed that it was challenging to hide SD symptoms, and most patients felt embarrassed when people commented on their SD symptoms. Most patients agreed that they would be further along in their career if they did not have SD, and SD symptoms made them less confident at work and less likely to want to interact with people at work. Almost half of patients reported ever missing work as a result of SD symptoms.

Conclusion: These insights emphasize the physical and emotional patient burden associated with SD, impacting all aspects of patients' lives. Graphical abstract available for this article.

导言:脂溢性皮炎(SD)是一种常见的慢性炎症性皮肤病,但SD患者的身体和精神负担尚未得到很好的描述:哈里斯民意调查公司于 2021 年 12 月至 2022 年 1 月对美国患者和医疗保健提供者(HCPs)进行了在线调查:结果:近一半的患者表示 SD 对他们的情绪和身体健康造成了 "很大/非常大 "的负面影响;医疗保健提供者低估了对患者的影响程度。大多数 SD 患者表示心理健康受到严重影响,包括焦虑、抑郁、与他人交往焦虑和孤独。三分之二的患者表示他们不认识其他被诊断出患有 SD 的人,即使在确诊后,仍有不到一半的患者表示他们不认识其他患有 SD 的人。几乎所有患者和保健医生都认为,隐藏 SD 症状是一项挑战,当人们评论他们的 SD 症状时,大多数患者都会感到尴尬。大多数患者都认为,如果他们没有 SD 症状,他们在职业生涯中会走得更远,SD 症状会让他们在工作中更不自信,也更不愿意在工作中与人交流。近一半的患者表示曾因 SD 症状而缺勤:这些见解强调了SD给患者带来的身体和精神负担,影响了患者生活的方方面面。本文有图表摘要。
{"title":"Patient and Healthcare Provider Perspectives on Disease Burden of Seborrheic Dermatitis in the United States: Results from a National Survey.","authors":"Meredith T Polaskey, Lakshi Aldredge, Candrice Heath, Moises Acevedo, David H Chu, Diane Hanna, Melissa S Seal, Matthew Zirwas, Raj Chovatiya","doi":"10.1007/s13555-024-01288-9","DOIUrl":"https://doi.org/10.1007/s13555-024-01288-9","url":null,"abstract":"<p><strong>Introduction: </strong>Seborrheic dermatitis (SD) is a common, chronic inflammatory skin disease, but the physical and emotional burden of patients with SD experience has not been well characterized.</p><p><strong>Methods: </strong>The Harris Poll conducted online surveys of US patients and healthcare providers (HCPs) from December 2021 to January 2022.</p><p><strong>Results: </strong>Almost half of patients reported that SD negatively impacts their emotional and physical well-being \"a lot/a great deal\"; HCPs underestimate the level of impact on patients. Most patients with SD reported a significant mental health impact, including anxiety, depression, anxiety about interacting with other people, and isolation. Two-thirds of patients said they did not know anyone else who had been diagnosed with SD, and even after diagnosis, less than half of patients still said they did not know anyone else with SD. Nearly all patients and HCPs agreed that it was challenging to hide SD symptoms, and most patients felt embarrassed when people commented on their SD symptoms. Most patients agreed that they would be further along in their career if they did not have SD, and SD symptoms made them less confident at work and less likely to want to interact with people at work. Almost half of patients reported ever missing work as a result of SD symptoms.</p><p><strong>Conclusion: </strong>These insights emphasize the physical and emotional patient burden associated with SD, impacting all aspects of patients' lives. Graphical abstract available for this article.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":null,"pages":null},"PeriodicalIF":3.5,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142521339","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Matching-Adjusted Indirect Comparison of Risankizumab Versus Deucravacitinib in Patients with Moderate-to-Severe Plaque Psoriasis. 中重度斑块状银屑病患者中利桑单抗与度氯伐他替尼的匹配调整间接对比研究
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-10-25 DOI: 10.1007/s13555-024-01293-y
April W Armstrong, Ahmed M Soliman, Paolo Gisondi, Siran Fang, Manish Patel, Bruce Strober

Introduction: Despite advancements in the treatment of psoriasis (PsO), there are few head-to-head studies assessing comparative effectiveness of the newest therapies approved to treat PsO. Our objective was to assess the comparative clinical effectiveness of risankizumab and deucravacitinib in patients with moderate-to-severe PsO.

Methods: This placebo-anchored matching-adjusted indirect comparison (MAIC) analysis utilized data from UltIMMa-1/2 risankizumab and POETYK PSO-1/2 deucravacitinib trials. Individual patient data from UltiMMA-1/2 were weighted via propensity score to match POETYK PSO-1/2 published summary data. Rate differences between risankizumab and deucravacitinib were assessed for Psoriasis Area and Severity Index (PASI) 75/90/100, the Static Physician Global Assessment (sPGA = 0 or 0/1), and the Dermatology Life Quality Index (DLQI) 0/1.

Results: At 16 weeks, risankizumab-treated patients demonstrated statistically significantly higher rates of skin clearance and greater improvement in quality of life (QoL) compared to those treated with deucravacitinib. Across all outcomes, risankizumab demonstrated a lower number needed to treat compared to deucravacitinib. Limitations are potential bias due to unobserved/unmeasurable differences and limited generalizability of the results.

Conclusions: This indirect comparison demonstrates that risankizumab has higher rates of skin clearance and greater improvements in QoL than deucravacitinib. This study will help inform healthcare providers in their treatment and management strategy of PsO.

简介:尽管银屑病(PsO)的治疗取得了进展,但很少有头对头研究对已获批治疗银屑病的最新疗法的疗效进行比较评估。我们的目的是评估利桑单抗和去氯伐他汀对中重度银屑病患者的临床疗效比较:这项安慰剂锚定匹配调整间接比较(MAIC)分析利用了 UltIMMa-1/2 risankizumab 和 POETYK PSO-1/2 deucravacitinib 试验的数据。UltiMMA-1/2试验的单个患者数据通过倾向得分加权,以匹配POETYK PSO-1/2试验公布的汇总数据。评估了利桑单抗和德拉瓦替尼在银屑病面积和严重程度指数(PASI)75/90/100、静态医生总体评估(sPGA = 0或0/1)和皮肤科生活质量指数(DLQI)0/1方面的比率差异:16周时,与接受去氯伐替尼治疗的患者相比,利桑单抗治疗患者的皮肤清除率和生活质量(QoL)改善率均有显著统计学意义。在所有结果中,与去氯伐他替尼相比,利妥珠单抗的治疗所需人数更少。不足之处在于,未观察到/无法测量的差异可能导致偏倚,而且结果的推广性有限:这项间接比较结果表明,与deucravacitinib相比,利辛单抗的皮肤清除率更高,QoL改善幅度更大。这项研究将有助于医疗服务提供者制定PsO的治疗和管理策略。
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引用次数: 0
Development and Validation of a Patient-Reported Outcome Measure of the Impact of Chronic Hand Eczema on Health-Related Quality of Life: the Hand Eczema Impact Scale (HEIS). 慢性手部湿疹对健康相关生活质量影响的患者报告结果测量方法:手部湿疹影响量表 (HEIS) 的开发与验证。
IF 3.5 3区 医学 Q1 DERMATOLOGY Pub Date : 2024-10-21 DOI: 10.1007/s13555-024-01267-0
Elke Weisshaar, Yasemin Topal Yüksel, Tove Agner, Lotte Seiding Larsen, Laura Grant, Rob Arbuckle, Amy M Jones, Piper Fromy, Cherry Lou Balita-Crisostomo, Nanna Nyholm Mathiasen, Henrik Thoning, Christian Apfelbacher

Introduction: Chronic Hand Eczema (CHE) is an inflammatory skin disease that causes significant impact on health-related quality of life (HRQoL). The Hand Eczema Impact Scale (HEIS) is a new patient-reported outcome (PRO) measure designed to assess the impact of CHE on key domains of HRQoL. This study aimed to develop and evaluate content and psychometric validity of the HEIS.

Methods: The HEIS was initially developed on the basis of a literature review and concept elicitation interviews. Qualitative cognitive debriefing interviews (n = 20) were conducted with patients with CHE to assess relevance and understanding of items, response options, and recall period. Psychometric properties (item performance, dimensionality, reliability, validity, responsiveness, and estimation of meaningful change thresholds) were then assessed using data (n = 258) from a phase 2b trial (NCT03683719).

Results: Cognitive debriefing confirmed all items were understood and relevant to patients. Inter-item correlations (all > 0.50) and confirmatory factor analysis (factor loadings ≥ 0.80) supported unidimensionality of the HEIS score, and mostly provided support for the HEIS Proximal Daily Activity Limitations (PDAL) score, with only one item loading below the prespecified threshold. Item properties and previous qualitative work supported retaining this item in the total score but removed from the HEIS PDAL domain. Internal consistency (Cronbach's alpha ≥ 0.89) and test-retest reliability (intra-class correlation coefficient ≥ 0.79) results were very strong. Strong correlations with concurrent measures (0.66-0.87) and significant differences between severity groups (p < 0.001) supported construct validity. Large effect sizes for mean change scores in participants that improved and significant differences between groups indicated ability to detect change. Anchor-based analyses supported within-individual responder definitions of ≥ 1.3 points for improvements in both HEIS score and HEIS PDAL score (covering three items) and of ≥ 1.5 points for HEIS embarrassment with the appearance of hands (Emb) score (covering two items).

Conclusions: The 9-item HEIS is the first CHE-specific PRO measure developed and validated according to regulatory guidance for assessment of the impact of CHE on key domains of HRQoL. This article provides evidence of strong content and psychometric validity and shows improvements of ≥ 1.3 points in HEIS score and HEIS PDAL score, and improvements of ≥ 1.5 points in HEIS Emb score represent clinically meaningful, important changes.

Trial registration: NCT03683719.

简介:慢性手部湿疹(CHE)是一种炎症性皮肤病,会对健康相关生活质量(HRQoL)造成严重影响。手部湿疹影响量表(HEIS)是一种新的患者报告结果(PRO)测量方法,旨在评估手部湿疹对健康相关生活质量(HRQoL)关键领域的影响。本研究旨在开发和评估 HEIS 的内容和心理测量有效性:HEIS 最初是在文献综述和概念激发访谈的基础上开发的。对 CHE 患者进行了定性认知汇报访谈(n = 20),以评估项目的相关性和理解程度、回答选项和回忆期。然后,利用一项 2b 期试验(NCT03683719)的数据(n = 258)对心理计量特性(项目表现、维度、可靠性、有效性、反应性和有意义变化阈值的估计)进行了评估:结果:认知汇报确认了所有项目都能被患者理解并与之相关。项目间相关性(均大于 0.50)和确认性因子分析(因子载荷≥ 0.80)支持 HEIS 评分的单维性,并且大部分支持 HEIS 日常活动近端限制 (PDAL) 评分,只有一个项目的载荷低于预设阈值。项目属性和之前的定性工作支持将该项目保留在总分中,但从 HEIS PDAL 领域中删除。内部一致性(Cronbach's alpha ≥ 0.89)和测试-再测可靠性(类内相关系数≥ 0.79)结果都非常好。与同期测量结果的相关性很强(0.66-0.87),严重程度组之间存在显著差异(p 结论:HEIS 的 9 个条目测量结果与同期测量结果的相关性很强(0.66-0.87):9个项目的HEIS是首个针对CHE的PRO测量方法,是根据监管指南开发和验证的,用于评估CHE对HRQoL关键领域的影响。这篇文章提供了强有力的内容和心理测量有效性的证据,表明 HEIS 评分和 HEIS PDAL 评分提高≥1.3 分,HEIS Emb 评分提高≥1.5 分,代表了有临床意义的重要变化:试验注册:NCT03683719。
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引用次数: 0
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Dermatology and Therapy
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