Stephanie Dauth, Ann Christina Foldenauer, Konstantin Hallmann, Christina Kunz, Anke König, Isabel Haferland, Christine Möser, Michaela Koehm, Andreas Pinter
Introduction: Brodalumab, a human monoclonal antibody that selectively inhibits the interleukin (IL)-17 receptor subunit A, has been approved for the treatment of moderate-to-severe plaque psoriasis. The treatment benefit of brodalumab has been clearly demonstrated in multiple clinical studies. However, data on effectiveness for difficult-to-treat body regions, especially in everyday clinical practice, are still limited.
Methods: In this exploratory observational clinical study, psoriasis patients suffering from nail and scalp involvement who received brodalumab during routine clinical care were enrolled at 7 centers in Germany. Patients were observed over 60 weeks. The co-primary endpoints were 75% improvement in Psoriasis Scalp Severity Index (PSSI75) at week 12 and 75% improvement in Nail Psoriasis Severity Index (NAPSI75) at week 24. Secondary endpoints included assessment of general skin and disease outcomes, quality-of-life, and patient satisfaction with treatment.
Results: Eighty-seven patients were included. Mean age was 46.8 years, 70.1% patients were male, and mean body mass index was 28.9 kg/m². The co-primary endpoints were achieved by more than 90% of patients who met criteria for effectiveness analyses (n=62): 93.6% of patients achieved PSSI75 at week 12 and 90.3% of patients achieved NAPSI75 at week 24. Median body surface area involvement improved from 14% at baseline to 1.5% and 1% at weeks 12 and 24, respectively. Median Dermatology Life Quality Index scores improved from 16 at baseline to 2 and 1 at weeks 12 and 24, respectively. Improvements were maintained in the majority of patients throughout the 60-week study. Brodalumab was well tolerated and patients were highly satisfied with treatment.
Conclusion: Outcomes assessed in this study, including assessments of scalp and nail symptoms, improved following initiation of brodalumab therapy. This study of psoriasis patients in a real-world setting supports the long-term clinical effectiveness of brodalumab on difficult-to-treat body regions.
{"title":"Brodalumab is Effective for Psoriasis Patients with Difficult-to-treat Body Regions: Results from an Observational Clinical Study.","authors":"Stephanie Dauth, Ann Christina Foldenauer, Konstantin Hallmann, Christina Kunz, Anke König, Isabel Haferland, Christine Möser, Michaela Koehm, Andreas Pinter","doi":"10.1159/000542348","DOIUrl":"https://doi.org/10.1159/000542348","url":null,"abstract":"<p><strong>Introduction: </strong>Brodalumab, a human monoclonal antibody that selectively inhibits the interleukin (IL)-17 receptor subunit A, has been approved for the treatment of moderate-to-severe plaque psoriasis. The treatment benefit of brodalumab has been clearly demonstrated in multiple clinical studies. However, data on effectiveness for difficult-to-treat body regions, especially in everyday clinical practice, are still limited.</p><p><strong>Methods: </strong>In this exploratory observational clinical study, psoriasis patients suffering from nail and scalp involvement who received brodalumab during routine clinical care were enrolled at 7 centers in Germany. Patients were observed over 60 weeks. The co-primary endpoints were 75% improvement in Psoriasis Scalp Severity Index (PSSI75) at week 12 and 75% improvement in Nail Psoriasis Severity Index (NAPSI75) at week 24. Secondary endpoints included assessment of general skin and disease outcomes, quality-of-life, and patient satisfaction with treatment.</p><p><strong>Results: </strong>Eighty-seven patients were included. Mean age was 46.8 years, 70.1% patients were male, and mean body mass index was 28.9 kg/m². The co-primary endpoints were achieved by more than 90% of patients who met criteria for effectiveness analyses (n=62): 93.6% of patients achieved PSSI75 at week 12 and 90.3% of patients achieved NAPSI75 at week 24. Median body surface area involvement improved from 14% at baseline to 1.5% and 1% at weeks 12 and 24, respectively. Median Dermatology Life Quality Index scores improved from 16 at baseline to 2 and 1 at weeks 12 and 24, respectively. Improvements were maintained in the majority of patients throughout the 60-week study. Brodalumab was well tolerated and patients were highly satisfied with treatment.</p><p><strong>Conclusion: </strong>Outcomes assessed in this study, including assessments of scalp and nail symptoms, improved following initiation of brodalumab therapy. This study of psoriasis patients in a real-world setting supports the long-term clinical effectiveness of brodalumab on difficult-to-treat body regions.</p>","PeriodicalId":11185,"journal":{"name":"Dermatology","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142589734","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}
John R Ingram, Vincenzo Bettoli, Jasmine I Espy, Georgios Kokolakis, Antonio Martorell, Axel P Villani, Hayley Wallinger, Isabel Truman, Emily Coak, Torben Kasparek, Elisa Muscianisi, Craig Richardson, Alexa B Kimball
Introduction Hidradenitis suppurativa (HS) is a debilitating, inflammatory skin disorder. Treatment strategies in patients with HS are challenging; real-world evidence in a HS population is warranted for greater disease understanding. The objective of this analysis was to describe real-world treatment patterns and treatment satisfaction in patients with HS. Methods This was a cross-sectional market research survey with retrospective data collection in patients with HS from the United States and five European countries (France, Germany, Italy, Spain, United Kingdom) between November 2020 and April 2021, using physician- and patient-reported surveys. Eligible physicians were general dermatologists actively managing patients with HS; dermatologists were required to have consulted with ≥2 patients with HS in the previous 12 months. Adult (≥18 years) and adolescent (10‒17 years) HS patients visiting a participating dermatologist were included. Outcomes included treatment patterns, flare status, treatments prescribed in response to flares, previous surgeries, barriers to biologics, and patient- and physician-reported satisfaction with the disease control provided by treatment. Results Survey data from 1787 patients were collected from 312 dermatologists. The most frequently prescribed treatments were topicals, oral antibiotics, and antiseptic washes/creams at diagnosis and sampling. At sampling, biologics were more frequently prescribed in patients with more severe disease (prescribed in 26.6%, 31.0% and 52.4% of patients with mild, moderate, and severe disease, respectively); oral antibiotics (48.8%), topicals (37.4%), and biologics (34.3%) were the most frequently prescribed treatment classes in response to a flare. Of patients currently not receiving a biologic, dermatologists reported that 18.9% of patients' condition warranted their use. Approximately one quarter of dermatologists (24.5%) and patients (27.4%) were not satisfied with current treatment; of patients who were dissatisfied, 12.8% reported they would never raise their dissatisfaction with their doctor. Conclusion These real-world data suggest a high disease burden and potential undertreatment in patients with HS. Patients received multiple treatments, and a notable proportion underwent surgery. Robustly integrating the patient voice in HS treatment decisions may lead to better outcomes and improved treatment satisfaction.
{"title":"Treatment satisfaction in patients with hidradenitis suppurativa: A real-world survey from the EU5 and US.","authors":"John R Ingram, Vincenzo Bettoli, Jasmine I Espy, Georgios Kokolakis, Antonio Martorell, Axel P Villani, Hayley Wallinger, Isabel Truman, Emily Coak, Torben Kasparek, Elisa Muscianisi, Craig Richardson, Alexa B Kimball","doi":"10.1159/000542343","DOIUrl":"https://doi.org/10.1159/000542343","url":null,"abstract":"<p><p>Introduction Hidradenitis suppurativa (HS) is a debilitating, inflammatory skin disorder. Treatment strategies in patients with HS are challenging; real-world evidence in a HS population is warranted for greater disease understanding. The objective of this analysis was to describe real-world treatment patterns and treatment satisfaction in patients with HS. Methods This was a cross-sectional market research survey with retrospective data collection in patients with HS from the United States and five European countries (France, Germany, Italy, Spain, United Kingdom) between November 2020 and April 2021, using physician- and patient-reported surveys. Eligible physicians were general dermatologists actively managing patients with HS; dermatologists were required to have consulted with ≥2 patients with HS in the previous 12 months. Adult (≥18 years) and adolescent (10‒17 years) HS patients visiting a participating dermatologist were included. Outcomes included treatment patterns, flare status, treatments prescribed in response to flares, previous surgeries, barriers to biologics, and patient- and physician-reported satisfaction with the disease control provided by treatment. Results Survey data from 1787 patients were collected from 312 dermatologists. The most frequently prescribed treatments were topicals, oral antibiotics, and antiseptic washes/creams at diagnosis and sampling. At sampling, biologics were more frequently prescribed in patients with more severe disease (prescribed in 26.6%, 31.0% and 52.4% of patients with mild, moderate, and severe disease, respectively); oral antibiotics (48.8%), topicals (37.4%), and biologics (34.3%) were the most frequently prescribed treatment classes in response to a flare. Of patients currently not receiving a biologic, dermatologists reported that 18.9% of patients' condition warranted their use. Approximately one quarter of dermatologists (24.5%) and patients (27.4%) were not satisfied with current treatment; of patients who were dissatisfied, 12.8% reported they would never raise their dissatisfaction with their doctor. Conclusion These real-world data suggest a high disease burden and potential undertreatment in patients with HS. Patients received multiple treatments, and a notable proportion underwent surgery. Robustly integrating the patient voice in HS treatment decisions may lead to better outcomes and improved treatment satisfaction.</p>","PeriodicalId":11185,"journal":{"name":"Dermatology","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142581484","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}
Aviël Ragamin, Karlijn F van Halewijn, Renske Schappin, Willemijn C A M Witkam, Nicolette J T Arends, Jaap Hoogeterp, Arthur M Bohnen, Gijs Elshout, Marie L A Schuttelaar, Suzanne G M A Pasmans
Background: Many healthcare professionals (HCPs) deliver care for patients with atopic dermatitis (AD). Although pivotal, management strategies and the relation with corticophobia among HCPs have not been investigated. This study aimed to investigate management strategies for AD and its relation with corticophobia among HCPs.
Methods: Dutch general practitioners (GPs), youth healthcare physicians (YHPs), pediatricians, dermatologists, pharmacists, and pharmacy assistants participated in a survey on management strategies and corticophobia. The Topical Corticosteroid Phobia questionnaire for professionals (TOPICOP-P) was used to measure attitudes toward topical corticosteroids (TCS). Higher scores reflect a more negative attitude.
Results: A total of 407 HCPs (124 GPs, 33 YHPs, 51 pediatricians, 56 dermatologists, 58 pharmacists, and 85 pharmacy assistants) participated. Compared to dermatologists other HCPs were more reluctant with TCS as illustrated by the portion (50%) of GPs that reported to prescribe TCS of only mild potency for infants with severe AD, compared to dermatologists (9%). Dermatologists had lowest TOPICOP-P scores (median: 19, IQR:12-28). GPs and pharmacy assistants had highest scores (GPs median: 36, IQR:31-44, pharmacy assistants: median: 36, IQR:31-42). More corticophobia was significantly associated with prescription of a lower TC potency class (B -0.04, 95%CI: -0.07-0.01, P=0.01), and a trend was found between more corticophobia and longer perceived durability of one TCS tube.
Conclusions: This study shows the differences in management of AD and reluctance towards TCS in HCPs. Furthermore, corticophobia among HCPs and its effect on management of AD was confirmed. To reduce corticophobia and improve care for AD, more education is needed.
背景:许多医疗保健专业人员(HCPs)为特应性皮炎(AD)患者提供护理服务。尽管管理策略至关重要,但尚未对医护人员的管理策略及其与恐皮质症的关系进行调查。本研究旨在调查特应性皮炎的管理策略及其与卫生保健人员恐皮质症的关系:荷兰全科医生(GPs)、青年保健医生(YHPs)、儿科医生、皮肤科医生、药剂师和药剂助理参与了一项关于管理策略和皮质恐惧症的调查。专业人员外用皮质类固醇恐惧症问卷(TOPICOP-P)用于测量对外用皮质类固醇(TCS)的态度。得分越高,说明态度越消极:共有 407 名高级保健医生(124 名全科医生、33 名青年保健医生、51 名儿科医生、56 名皮肤科医生、58 名药剂师和 85 名药房助理)参加了调查。与皮肤科医生相比,其他高级保健医生更不愿意使用TCS,这体现在全科医生(50%)与皮肤科医生(9%)相比,只为患有严重AD的婴儿开具温和药效的TCS处方。皮肤科医生的 TOPICOP-P 得分最低(中位数:19,IQR:12-28)。全科医生和药房助理的得分最高(全科医生中位数:36,IQR:31-44;药房助理中位数:36,IQR:31-42)。更多的皮质恐惧症与处方较低的三氯化碳效力等级明显相关(B -0.04,95%CI:-0.07-0.01,P=0.01),并且发现更多的皮质恐惧症与一个三氯化碳管的感知持久性更长之间存在趋势:本研究显示了HCP在管理AD和不愿使用TCS方面的差异。此外,HCPs 中的皮质恐惧症及其对 AD 管理的影响也得到了证实。为了减少恐皮质症并改善对 AD 的护理,需要开展更多的教育。
{"title":"Management strategies and corticophobia among healthcare professionals involved in the care for atopic dermatitis: a Dutch survey.","authors":"Aviël Ragamin, Karlijn F van Halewijn, Renske Schappin, Willemijn C A M Witkam, Nicolette J T Arends, Jaap Hoogeterp, Arthur M Bohnen, Gijs Elshout, Marie L A Schuttelaar, Suzanne G M A Pasmans","doi":"10.1159/000542421","DOIUrl":"https://doi.org/10.1159/000542421","url":null,"abstract":"<p><strong>Background: </strong>Many healthcare professionals (HCPs) deliver care for patients with atopic dermatitis (AD). Although pivotal, management strategies and the relation with corticophobia among HCPs have not been investigated. This study aimed to investigate management strategies for AD and its relation with corticophobia among HCPs.</p><p><strong>Methods: </strong>Dutch general practitioners (GPs), youth healthcare physicians (YHPs), pediatricians, dermatologists, pharmacists, and pharmacy assistants participated in a survey on management strategies and corticophobia. The Topical Corticosteroid Phobia questionnaire for professionals (TOPICOP-P) was used to measure attitudes toward topical corticosteroids (TCS). Higher scores reflect a more negative attitude.</p><p><strong>Results: </strong>A total of 407 HCPs (124 GPs, 33 YHPs, 51 pediatricians, 56 dermatologists, 58 pharmacists, and 85 pharmacy assistants) participated. Compared to dermatologists other HCPs were more reluctant with TCS as illustrated by the portion (50%) of GPs that reported to prescribe TCS of only mild potency for infants with severe AD, compared to dermatologists (9%). Dermatologists had lowest TOPICOP-P scores (median: 19, IQR:12-28). GPs and pharmacy assistants had highest scores (GPs median: 36, IQR:31-44, pharmacy assistants: median: 36, IQR:31-42). More corticophobia was significantly associated with prescription of a lower TC potency class (B -0.04, 95%CI: -0.07-0.01, P=0.01), and a trend was found between more corticophobia and longer perceived durability of one TCS tube.</p><p><strong>Conclusions: </strong>This study shows the differences in management of AD and reluctance towards TCS in HCPs. Furthermore, corticophobia among HCPs and its effect on management of AD was confirmed. To reduce corticophobia and improve care for AD, more education is needed.</p>","PeriodicalId":11185,"journal":{"name":"Dermatology","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142575394","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}
Joanna Ka Man Ng, Agnes Wai Sze Chan, Christina Man-Tung Cheung, Edric Chi-Ching Ip, Paul Cheung Lung Choi, Wendy Wan Hang Lau, Jacqueline Ho Sze Lee, Joshua Jing Xi Li
Introduction Extramammary Paget disease (EMPD) is an uncommon malignant cutaneous neoplasm that are divided into primary and secondary forms. In this multicenter study, histologically proven cases of primary and secondary EMPD were reviewed for clinical outcomes with subgroup analysis for secondary EMPD. Methodology Cases of EMPD were identified from pathology report of the involved institutions over a period of over two decades. Cases of secondary EMPD were identified review of case notes, radiology, and pathology reports. Clinicopathological and outcome data were retrieved for statistical analysis. Results A total of 109 cases were retrieved, including 19 cases of secondary EMPD, most commonly associated with colorectal (n=6), anal (n=5) and prostatic carcinomas (n=3). A difference was observed between older age and secondary (versus primary) EMPD (p=0.016), but no differences were seen in other clinico-demographical parameters. Male sex (p=0.018), age over 60 years old (p=0.004) and involvement of margins (resectable) (p=0.018) were associated with shorter OS. For DSS, involvement of margins (p=0.009) was an adverse predictor. Secondary EMPD had a shorter DSS than primary EMPD (p=0.005). Multivariable analysis confirmed all above associations (p<0.05). In subgroup analysis for secondary EMPD, margin involvement remained associated with shorter OS (p = 0.007) and DSS (p = 0.003). Conclusions Secondary EMPD is associated with poorer outcomes. Margin involvement is strong and independent indicator of shorter OS and DSS, including secondary EMPD. Resectability is a strong predictor of favorable outcome and excision with clear margins should be attempted when surgically feasible.
{"title":"A territory wide follow-up of primary and secondary extramammary Paget disease of two decades - effects of local disease on survival.","authors":"Joanna Ka Man Ng, Agnes Wai Sze Chan, Christina Man-Tung Cheung, Edric Chi-Ching Ip, Paul Cheung Lung Choi, Wendy Wan Hang Lau, Jacqueline Ho Sze Lee, Joshua Jing Xi Li","doi":"10.1159/000541394","DOIUrl":"https://doi.org/10.1159/000541394","url":null,"abstract":"<p><p>Introduction Extramammary Paget disease (EMPD) is an uncommon malignant cutaneous neoplasm that are divided into primary and secondary forms. In this multicenter study, histologically proven cases of primary and secondary EMPD were reviewed for clinical outcomes with subgroup analysis for secondary EMPD. Methodology Cases of EMPD were identified from pathology report of the involved institutions over a period of over two decades. Cases of secondary EMPD were identified review of case notes, radiology, and pathology reports. Clinicopathological and outcome data were retrieved for statistical analysis. Results A total of 109 cases were retrieved, including 19 cases of secondary EMPD, most commonly associated with colorectal (n=6), anal (n=5) and prostatic carcinomas (n=3). A difference was observed between older age and secondary (versus primary) EMPD (p=0.016), but no differences were seen in other clinico-demographical parameters. Male sex (p=0.018), age over 60 years old (p=0.004) and involvement of margins (resectable) (p=0.018) were associated with shorter OS. For DSS, involvement of margins (p=0.009) was an adverse predictor. Secondary EMPD had a shorter DSS than primary EMPD (p=0.005). Multivariable analysis confirmed all above associations (p<0.05). In subgroup analysis for secondary EMPD, margin involvement remained associated with shorter OS (p = 0.007) and DSS (p = 0.003). Conclusions Secondary EMPD is associated with poorer outcomes. Margin involvement is strong and independent indicator of shorter OS and DSS, including secondary EMPD. Resectability is a strong predictor of favorable outcome and excision with clear margins should be attempted when surgically feasible.</p>","PeriodicalId":11185,"journal":{"name":"Dermatology","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142575284","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}
Anouk E M Nouwen, Aviël Ragamin, Maria J Knol, Hagen Ott, Lisa Weibel, Cristina Has, Alain Hovnanian, Amy S Paller, Christine Bodemer, Virgil A S H Dalm, Suzanne G M A Pasmans, Renske Schappin
Introduction: Netherton syndrome (NS; OMIM#256500) is a rare and severe disorder of epidermal maturation and keratinization caused by pathogenic variants in the serine protease inhibitor Kazal type 5 (SPINK5), leading to severe skin barrier impairment. Although effective treatment is crucial for NS patients, there is a lack of knowledge on what the best treatment options are for these patients. Large heterogeneity in reported outcomes and measurement instruments hinders accurate comparison of treatment results across studies and the development of a treatment guideline. Therefore, we aimed to develop a core outcome set (COS) for NS that can be used in clinical care and research.
Methods: This study was performed in accordance with the recommendations of the Core Outcome Measures in Effectiveness Trials (COMET) initiative. After identification of outcomes through a literature search and classification based on the International Classification of Functioning and taxonomies published by the COMET initiative, discussion groups were organized at the 2nd International Netherton Congress 2022 to finalize the provisional outcome list. Through a 2-round e-Delphi, 41 stakeholders (patients and family members, professionals, and representatives of industry) from 14 countries rated the importance of the outcomes using a 9-point Likert scale. An online consensus meeting attended by 14 stakeholders finalized the COS.
Results: The core outcome set for NS comprised 21 outcomes in 10 domains. These included four 'skin' outcomes, two 'sensation' outcomes, two 'side-effects of treatment' outcomes, one 'vitality' outcome, one 'emotional functioning' outcome, two 'physical development' outcomes, two 'nutrition' outcomes, two 'infections' outcomes, two 'allergies' outcomes, and three 'assessment results' outcomes.
Conclusion: In this study, consensus was reached on 21 outcomes to be included in the COS for NS. The selection of outcomes in the COS underlines that NS not only affects the skin, but is a disease requiring a broad multidisciplinary approach in clinical care and research. International implementation of this COS will lead to more uniform reporting, thereby enabling comparison of study results, which may facilitate future treatment guideline development. The next step is to further conceptually define the outcomes and reach consensus on how the measure these.
{"title":"Developing a core outcome set for Netherton syndrome: An international multi-stakeholder e-Delphi consensus study.","authors":"Anouk E M Nouwen, Aviël Ragamin, Maria J Knol, Hagen Ott, Lisa Weibel, Cristina Has, Alain Hovnanian, Amy S Paller, Christine Bodemer, Virgil A S H Dalm, Suzanne G M A Pasmans, Renske Schappin","doi":"10.1159/000542215","DOIUrl":"https://doi.org/10.1159/000542215","url":null,"abstract":"<p><strong>Introduction: </strong>Netherton syndrome (NS; OMIM#256500) is a rare and severe disorder of epidermal maturation and keratinization caused by pathogenic variants in the serine protease inhibitor Kazal type 5 (SPINK5), leading to severe skin barrier impairment. Although effective treatment is crucial for NS patients, there is a lack of knowledge on what the best treatment options are for these patients. Large heterogeneity in reported outcomes and measurement instruments hinders accurate comparison of treatment results across studies and the development of a treatment guideline. Therefore, we aimed to develop a core outcome set (COS) for NS that can be used in clinical care and research.</p><p><strong>Methods: </strong>This study was performed in accordance with the recommendations of the Core Outcome Measures in Effectiveness Trials (COMET) initiative. After identification of outcomes through a literature search and classification based on the International Classification of Functioning and taxonomies published by the COMET initiative, discussion groups were organized at the 2nd International Netherton Congress 2022 to finalize the provisional outcome list. Through a 2-round e-Delphi, 41 stakeholders (patients and family members, professionals, and representatives of industry) from 14 countries rated the importance of the outcomes using a 9-point Likert scale. An online consensus meeting attended by 14 stakeholders finalized the COS.</p><p><strong>Results: </strong>The core outcome set for NS comprised 21 outcomes in 10 domains. These included four 'skin' outcomes, two 'sensation' outcomes, two 'side-effects of treatment' outcomes, one 'vitality' outcome, one 'emotional functioning' outcome, two 'physical development' outcomes, two 'nutrition' outcomes, two 'infections' outcomes, two 'allergies' outcomes, and three 'assessment results' outcomes.</p><p><strong>Conclusion: </strong>In this study, consensus was reached on 21 outcomes to be included in the COS for NS. The selection of outcomes in the COS underlines that NS not only affects the skin, but is a disease requiring a broad multidisciplinary approach in clinical care and research. International implementation of this COS will lead to more uniform reporting, thereby enabling comparison of study results, which may facilitate future treatment guideline development. The next step is to further conceptually define the outcomes and reach consensus on how the measure these.</p>","PeriodicalId":11185,"journal":{"name":"Dermatology","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142575339","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}
Nikolaj Holgersen, Valdemar Wendelboe Nielsen, Nana Aviaaja Lippert Rosenø, Hans Christian Ring, Signe Holm Nielsen, Julia-Tatjana Maul, Jacob P Thyssen, Alexander Egeberg, Simon Francis Thomsen
{"title":"The Copenhagen Hidradenitis Suppurativa Cohort: Insights from the first 8 years.","authors":"Nikolaj Holgersen, Valdemar Wendelboe Nielsen, Nana Aviaaja Lippert Rosenø, Hans Christian Ring, Signe Holm Nielsen, Julia-Tatjana Maul, Jacob P Thyssen, Alexander Egeberg, Simon Francis Thomsen","doi":"10.1159/000541612","DOIUrl":"https://doi.org/10.1159/000541612","url":null,"abstract":"","PeriodicalId":11185,"journal":{"name":"Dermatology","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544325","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}
Jacob P Thyssen, David Rosmarin, Antonio Costanzo, Richard Warren, Chia-Yu Chu, Raj Chovatiya, Barry Ladizinski, Xiaofei Hu, Yingyi Liu, Brian Calimlim, Chudi Nduaka, Namita Vigna, April Armstrong
Introduction: Upadacitinib has demonstrated high and rapid rates of efficacy in adolescent and adult patients with moderate-to-severe atopic dermatitis (AD) as assessed by the Eczema Area and Severity Index (EASI). This post hoc analysis assessed the EASI response in four anatomical regions for patients with moderate-to-severe AD treated with upadacitinib compared to dupilumab over 24 weeks.
Methods: Data from patients randomised 1:1 to receive upadacitinib 30 mg extended-release tablet orally once daily or dupilumab 300 mg by subcutaneous injection every 2 weeks after a loading dose of 600 mg in the Heads Up study were analysed for achievement of ≥75%, ≥90%, or 100% reduction of EASI in four body regions: 1) head and neck, 2) trunk (including genitals), 3) upper limbs, and 4) lower limbs (including buttocks) at each study visit through week 24. Patient response data from the Head and Neck Patient Global Impression of Severity (HN-PGIS) were also analysed at each study visit for comparison of upadacitinib to dupilumab.
Results: Greater proportions of patients treated with upadacitinib versus dupilumab achieved skin clearance rates of ≥75% (EASI 75) at week 1 and higher clearance rates of ≥90% (EASI 90) or 100% (EASI 100) by week 4 or earlier in all four body regions. This difference was maintained at each visit through week 24 for both EASI 90 and EASI 100. Patient responses on the HN-PGIS indicated that a greater proportion of patients (nominal p-value <0.05) treated with upadacitinib compared to dupilumab reported that AD symptoms in the head and neck region were absent or minimal as early as week 1.
Conclusion: Compared to dupilumab, upadacitinib treatment provided higher rates of rapid, sustained efficacy for the head and neck, trunk, upper limbs, and lower limbs for the treatment of moderate-to-severe AD as measured by the EASI and supported by patient responses.
{"title":"Efficacy and Safety of Upadacitinib Versus Dupilumab Treatment for Moderate to Severe Atopic Dermatitis in Four Body Regions: Analysis From the Heads-Up Study.","authors":"Jacob P Thyssen, David Rosmarin, Antonio Costanzo, Richard Warren, Chia-Yu Chu, Raj Chovatiya, Barry Ladizinski, Xiaofei Hu, Yingyi Liu, Brian Calimlim, Chudi Nduaka, Namita Vigna, April Armstrong","doi":"10.1159/000542275","DOIUrl":"https://doi.org/10.1159/000542275","url":null,"abstract":"<p><strong>Introduction: </strong>Upadacitinib has demonstrated high and rapid rates of efficacy in adolescent and adult patients with moderate-to-severe atopic dermatitis (AD) as assessed by the Eczema Area and Severity Index (EASI). This post hoc analysis assessed the EASI response in four anatomical regions for patients with moderate-to-severe AD treated with upadacitinib compared to dupilumab over 24 weeks.</p><p><strong>Methods: </strong>Data from patients randomised 1:1 to receive upadacitinib 30 mg extended-release tablet orally once daily or dupilumab 300 mg by subcutaneous injection every 2 weeks after a loading dose of 600 mg in the Heads Up study were analysed for achievement of ≥75%, ≥90%, or 100% reduction of EASI in four body regions: 1) head and neck, 2) trunk (including genitals), 3) upper limbs, and 4) lower limbs (including buttocks) at each study visit through week 24. Patient response data from the Head and Neck Patient Global Impression of Severity (HN-PGIS) were also analysed at each study visit for comparison of upadacitinib to dupilumab.</p><p><strong>Results: </strong>Greater proportions of patients treated with upadacitinib versus dupilumab achieved skin clearance rates of ≥75% (EASI 75) at week 1 and higher clearance rates of ≥90% (EASI 90) or 100% (EASI 100) by week 4 or earlier in all four body regions. This difference was maintained at each visit through week 24 for both EASI 90 and EASI 100. Patient responses on the HN-PGIS indicated that a greater proportion of patients (nominal p-value <0.05) treated with upadacitinib compared to dupilumab reported that AD symptoms in the head and neck region were absent or minimal as early as week 1.</p><p><strong>Conclusion: </strong>Compared to dupilumab, upadacitinib treatment provided higher rates of rapid, sustained efficacy for the head and neck, trunk, upper limbs, and lower limbs for the treatment of moderate-to-severe AD as measured by the EASI and supported by patient responses.</p>","PeriodicalId":11185,"journal":{"name":"Dermatology","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544324","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}
Introduction While an association between hidradenitis suppurativa (HS) and inflammatory arthritis has been reported in clinical studies, the potential link between HS and gout remains uncertain. As HS and gout share common immunological pathways, we conducted a retrospective cohort study to determine whether HS patients are at an increased risk of developing gout in the future. Methods This retrospective multicenter cohort study obtained information through the US collaborative network, a subset of the TriNetX research network. Patients diagnosed with HS between January 01, 2005, and December 31, 2017, were recruited, and a 1:1 propensity score matching was conducted to identify appropriate controls. The hazard ratio for the new-onset of gout in HS patients was subsequently calculated. Results Compared to individuals without HS, those with HS were associated with a 1.39-fold higher risk (95% CI, 1.20, 1.62) of developing new-onset gout within five years after the index date. This association remained significant in shorter follow-up times and sensitivity analyses utilizing different matching models. For both male and female HS patients, the risk of developing new-onset gout within 5 years after the index date was statistically significant, with respective hazard ratios of 1.61 (95% CI, 1.28,2.02) for males and 1.41 (95% CI, 1.11,1.78) for females. Conclusion HS patients are at a high risk of developing gout within five years after an HS diagnosis while comparing with non-HS controls.
{"title":"Association between hidradenitis suppurativa and gout: a propensity-score-matched cohort study.","authors":"Hui-Chin Chang, Tsu-Man Chiu, Ru-Yin Tsai, Chen-Pi Li, Yu-Lun Wu, Shiu-Jau Chen, Shuo-Yan Gau","doi":"10.1159/000541969","DOIUrl":"https://doi.org/10.1159/000541969","url":null,"abstract":"<p><p>Introduction While an association between hidradenitis suppurativa (HS) and inflammatory arthritis has been reported in clinical studies, the potential link between HS and gout remains uncertain. As HS and gout share common immunological pathways, we conducted a retrospective cohort study to determine whether HS patients are at an increased risk of developing gout in the future. Methods This retrospective multicenter cohort study obtained information through the US collaborative network, a subset of the TriNetX research network. Patients diagnosed with HS between January 01, 2005, and December 31, 2017, were recruited, and a 1:1 propensity score matching was conducted to identify appropriate controls. The hazard ratio for the new-onset of gout in HS patients was subsequently calculated. Results Compared to individuals without HS, those with HS were associated with a 1.39-fold higher risk (95% CI, 1.20, 1.62) of developing new-onset gout within five years after the index date. This association remained significant in shorter follow-up times and sensitivity analyses utilizing different matching models. For both male and female HS patients, the risk of developing new-onset gout within 5 years after the index date was statistically significant, with respective hazard ratios of 1.61 (95% CI, 1.28,2.02) for males and 1.41 (95% CI, 1.11,1.78) for females. Conclusion HS patients are at a high risk of developing gout within five years after an HS diagnosis while comparing with non-HS controls.</p>","PeriodicalId":11185,"journal":{"name":"Dermatology","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142521338","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}
Rui Chen, Laura Loman, Lian F van der Gang, Manon M Sloot, Marjolein S de Bruin-Weller, Marie L A Schuttelaar
Introduction: Atopic dermatitis (AD) is a chronic inflammatory skin disease, placing a significant burden on patients' quality of life (QoL). The validated Atopic Dermatitis Control Tool (ADCT) is recommended to assess AD control in adults. The aim of this study was to assess AD control and explore associations with demographic characteristics, patient-reported outcome measures (PROMs), and treatment.
Methods: In this cross-sectional study, questionnaires were sent to 2,066 adults from two tertiary referral centers who had previously physician-diagnosed AD and had visited the outpatient clinic at least once between 2020 and 2022. Questionnaires were completed between May and October 2022. AD control was assessed by the ADCT, with a score ≥7 indicating uncontrolled AD. AD severity, QoL, and weekly average pruritus were simultaneously measured using the Patient-Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI), and numeric rating scale (NRS), respectively, with higher scores indicating more severe symptoms. Moreover, treatment-related questions were included. Associations between uncontrolled AD, age, sex, and treatment were explored using multivariate logistic regression analysis.
Results: In total, 863 patients (41.8%) filled out the questionnaire and 812 were included in the analysis, of which 59% reported controlled AD. Uncontrolled AD was associated with higher PROM scores and receiving topical anti-inflammatories only (adjusted odds ratio [95% confidence interval] ranged from 1.33 [0.995-1.88] to 2.55 [2.21-2.86]). Of those treated with topical anti-inflammatories only, 54% reported uncontrolled AD.
Conclusion: The majority of the patients reported controlled AD. Patients with uncontrolled AD often reported more severe symptoms and were more likely to receive topical anti-inflammatories only. It could be considered to shift patients with uncontrolled AD from topical to systemic treatment.
{"title":"Assessing Disease Control in Patients with Atopic Dermatitis by Using the Atopic Dermatitis Control Tool in Daily Practice.","authors":"Rui Chen, Laura Loman, Lian F van der Gang, Manon M Sloot, Marjolein S de Bruin-Weller, Marie L A Schuttelaar","doi":"10.1159/000541466","DOIUrl":"https://doi.org/10.1159/000541466","url":null,"abstract":"<p><strong>Introduction: </strong>Atopic dermatitis (AD) is a chronic inflammatory skin disease, placing a significant burden on patients' quality of life (QoL). The validated Atopic Dermatitis Control Tool (ADCT) is recommended to assess AD control in adults. The aim of this study was to assess AD control and explore associations with demographic characteristics, patient-reported outcome measures (PROMs), and treatment.</p><p><strong>Methods: </strong>In this cross-sectional study, questionnaires were sent to 2,066 adults from two tertiary referral centers who had previously physician-diagnosed AD and had visited the outpatient clinic at least once between 2020 and 2022. Questionnaires were completed between May and October 2022. AD control was assessed by the ADCT, with a score ≥7 indicating uncontrolled AD. AD severity, QoL, and weekly average pruritus were simultaneously measured using the Patient-Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI), and numeric rating scale (NRS), respectively, with higher scores indicating more severe symptoms. Moreover, treatment-related questions were included. Associations between uncontrolled AD, age, sex, and treatment were explored using multivariate logistic regression analysis.</p><p><strong>Results: </strong>In total, 863 patients (41.8%) filled out the questionnaire and 812 were included in the analysis, of which 59% reported controlled AD. Uncontrolled AD was associated with higher PROM scores and receiving topical anti-inflammatories only (adjusted odds ratio [95% confidence interval] ranged from 1.33 [0.995-1.88] to 2.55 [2.21-2.86]). Of those treated with topical anti-inflammatories only, 54% reported uncontrolled AD.</p><p><strong>Conclusion: </strong>The majority of the patients reported controlled AD. Patients with uncontrolled AD often reported more severe symptoms and were more likely to receive topical anti-inflammatories only. It could be considered to shift patients with uncontrolled AD from topical to systemic treatment.</p>","PeriodicalId":11185,"journal":{"name":"Dermatology","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496846","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}
Tetracyclines are a class of broad-spectrum antibiotics favored by dermatologists. Over the last decade, the clinical efficacy of tetracyclines has expanded into various dermatoses. This review tries to encompass the possible indications of tetracycline in the field of dermatology and possible mechanisms of action. This comprehensive review encompasses all possible indications of tetracyclines besides acne vulgaris and rosacea: hidradenitis suppurativa, autoimmune bullous dermatoses, vitiligo, alopecia, prurigo pigmentosa, granulomatous dermatoses, Kaposi sarcoma, cold urticaria, atopic dermatitis, scrub typhus, scarring, and miscellaneous dermatoses. We also focus on the recently approved sarecycline, a third generation narrow-spectrum tetracycline, and its clinical efficacy and potential impact on the microbiome. Our review provides a better understanding of this extremely familiar drug class and encourages its use in a wider spectrum of dermatologic diseases and symptoms.
{"title":"Tetracyclines revisited: tetracyclines in the field of dermatology.","authors":"Yoon-Seob Kim, Hei Sung Kim","doi":"10.1159/000542006","DOIUrl":"https://doi.org/10.1159/000542006","url":null,"abstract":"<p><p>Tetracyclines are a class of broad-spectrum antibiotics favored by dermatologists. Over the last decade, the clinical efficacy of tetracyclines has expanded into various dermatoses. This review tries to encompass the possible indications of tetracycline in the field of dermatology and possible mechanisms of action. This comprehensive review encompasses all possible indications of tetracyclines besides acne vulgaris and rosacea: hidradenitis suppurativa, autoimmune bullous dermatoses, vitiligo, alopecia, prurigo pigmentosa, granulomatous dermatoses, Kaposi sarcoma, cold urticaria, atopic dermatitis, scrub typhus, scarring, and miscellaneous dermatoses. We also focus on the recently approved sarecycline, a third generation narrow-spectrum tetracycline, and its clinical efficacy and potential impact on the microbiome. Our review provides a better understanding of this extremely familiar drug class and encourages its use in a wider spectrum of dermatologic diseases and symptoms.</p>","PeriodicalId":11185,"journal":{"name":"Dermatology","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142460191","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}