Pub Date : 2024-09-11DOI: 10.1001/jamadermatol.2024.3054
Aaron M. Drucker, Isabelle J. C. Thibau, Bryan Mantell, Katie N. Dainty, Matthew Wyke, Wendy Smith Begolka
ImportanceFlare is a term commonly used in atopic dermatitis (AD) care settings and clinical research, but little consensus exists on what it means. Meanwhile, flare management is an important unmet research and treatment need. Understanding how various therapies might comparatively improve AD flares as a measure of treatment effectiveness may facilitate shared decision-making and enable assessment of effectiveness within and outside clinical settings.ObjectiveTo identify patient-reported attributes associated with an AD flare to develop a patient-centered, consensus-based working definition.Design, Setting, and ParticipantsThis consensus survey study used a modified eDelphi method involving consensus-building focus groups and a survey conducted from January 10 through October 24, 2023. Focus groups were conducted virtually, and the online survey was advertised to National Eczema Association members. US adults aged 18 years or older with AD were recruited via convenience sampling.ExposureLived experience of AD.Main Outcomes and MeasuresThe main outcome was consensus on which attributes of AD to include in a patient-centric definition of flare. Using a rating scale (range, 1-9), consensus for the modified eDelphi statement rating was defined as at least 70% of participants rating a statement as 7 to 9 (critical to a flare definition) and less than 15% rating it as 1 to 3 (not important).ResultsTwenty-six participants with AD who completed focus group activities (24 aged 18-44 years [92.3%] and 2 aged 45-64 years [7.7%]; 18 women [69.2%]) and 631 participants with AD (mean [SD] age, 45.5 [18.1] years; 533 women [84.5%]) who completed the survey were included in the analysis. Fifteen statements reached consensus from the focus groups, and of those, 12 reached consensus from survey participants. More than half (334 of 631 [52.9%]) of survey participants reported alignment with their health care practitioner on what a flare is, and most (478 of 616 [77.6%]) reported that a patient-centered definition would be useful when communicating with their health care practitioner about their condition.Conclusions and RelevanceIn this study, participants with AD reached consensus on what an AD flare means from the patient perspective. This understanding may improve research and care by addressing this key patient-centered aspect of evaluating treatment effectiveness.
{"title":"Consensus on a Patient-Centered Definition of Atopic Dermatitis Flare","authors":"Aaron M. Drucker, Isabelle J. C. Thibau, Bryan Mantell, Katie N. Dainty, Matthew Wyke, Wendy Smith Begolka","doi":"10.1001/jamadermatol.2024.3054","DOIUrl":"https://doi.org/10.1001/jamadermatol.2024.3054","url":null,"abstract":"Importance<jats:italic>Flare</jats:italic> is a term commonly used in atopic dermatitis (AD) care settings and clinical research, but little consensus exists on what it means. Meanwhile, flare management is an important unmet research and treatment need. Understanding how various therapies might comparatively improve AD flares as a measure of treatment effectiveness may facilitate shared decision-making and enable assessment of effectiveness within and outside clinical settings.ObjectiveTo identify patient-reported attributes associated with an AD flare to develop a patient-centered, consensus-based working definition.Design, Setting, and ParticipantsThis consensus survey study used a modified eDelphi method involving consensus-building focus groups and a survey conducted from January 10 through October 24, 2023. Focus groups were conducted virtually, and the online survey was advertised to National Eczema Association members. US adults aged 18 years or older with AD were recruited via convenience sampling.ExposureLived experience of AD.Main Outcomes and MeasuresThe main outcome was consensus on which attributes of AD to include in a patient-centric definition of flare. Using a rating scale (range, 1-9), consensus for the modified eDelphi statement rating was defined as at least 70% of participants rating a statement as 7 to 9 (critical to a flare definition) and less than 15% rating it as 1 to 3 (not important).ResultsTwenty-six participants with AD who completed focus group activities (24 aged 18-44 years [92.3%] and 2 aged 45-64 years [7.7%]; 18 women [69.2%]) and 631 participants with AD (mean [SD] age, 45.5 [18.1] years; 533 women [84.5%]) who completed the survey were included in the analysis. Fifteen statements reached consensus from the focus groups, and of those, 12 reached consensus from survey participants. More than half (334 of 631 [52.9%]) of survey participants reported alignment with their health care practitioner on what a flare is, and most (478 of 616 [77.6%]) reported that a patient-centered definition would be useful when communicating with their health care practitioner about their condition.Conclusions and RelevanceIn this study, participants with AD reached consensus on what an AD flare means from the patient perspective. This understanding may improve research and care by addressing this key patient-centered aspect of evaluating treatment effectiveness.","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":"19 1","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142176173","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-11DOI: 10.1001/jamadermatol.2024.3178
Angelo Massimiliano D’Erme, Cristian Fidanzi, Matteo Bevilacqua, Thomas Bieber, Cristina Tuoni, Aldo Paolicchi, Maria Franzini, Riccardo Morganti, Francesca Papadia, Agata Janowska, Valentina Dini, Marco Romanelli
ImportanceAtopic dermatitis (AD) is the most prevalent chronic skin condition characterized by inflammation and itching. Currently, there is no reliable method for identifying which newborns might have an increased risk of developing AD.ObjectiveTo evaluate the predictive value of serological biomarkers, such as CCL17/thymus- and activation-regulated chemokine, CCL18, CCL22, CCL27, IL-31, and thymus stromal lymphopoietin, with transepidermal water loss (TEWL) and hydration rate and the development of AD in infants.Design, Setting, and ParticipantsThis observational prospective study included 40 consecutive full-term newborns from a single university hospital in Pisa, Italy. The cutaneous markers of infants were assessed at 1, 6, and 12 months of age, while the biomarkers from the 10-mL sample of cord blood taken at birth were measured after delivery. Data were collected from March to December 2018 and analyzed from January to April 2019.Main Outcomes and MeasuresLevel of serological biomarkers associated with TEWL and hydration rate, as well as the emergence of AD during the first 12 months of life.ResultsAll 40 included infants (27 male [68%]) completed the study. At 6 months, 16 infants presented symptoms and signs of AD (AD group) and 24 did not (non-AD group). Infants with AD signs had statistically significant anterior cubital fossa TEWL values at 1, 6, and 12 months of age compared to those without AD signs. No statistically significant correlations were observed between the TEWL measured at the anterior part of knee and hydration rate at the anterior cubital fossa at first month in the 2 groups. With regard to the blood biomarkers, at birth those in the AD group vs the non-AD group had statistically significant higher levels of CCL17/thymus- and activation-regulated chemokine (median [IQR], 716 [509-951] pg/mL vs 419 [24-566] pg/mL; P = .003) and IL-31 (median [IQR], 212 [114-409] pg/mL vs 97 [52-277] pg/mL; P = .04); in contrast, no statistically significant serum level differences were registered for thymus stromal lymphopoietin (median [IQR], 105 [66-295] pg/mL vs 88 [43-187] pg/mL), CCL18 (median [IQR], 1236 [1115-1605] pg/mL vs 1255 [1188-1677] pg/mL), CCL22 (median [IQR], 1032 [936-1454] pg/mL vs 1096 [932-1536] pg/mL), and CCL27 (median [IQR], 172 [122-251] pg/mL vs 120 [90-265] pg/mL).Conclusions and RelevanceIn this observational study, the analysis of TEWL at the anterior cubital fossa area occurred prior to and correlated with the clinical signs of AD. Quantification of cytokines indicated that assessing cord blood serum levels of CCL17 and IL-31 could offer new perspectives in identifying newborns who might be susceptible to AD. Larger studies are needed to validate these findings.
重要性特应性皮炎（AD）是以炎症和瘙痒为特征的最常见慢性皮肤病。目的 评估血清学生物标志物（如 CCL17/胸腺和活化调节趋化因子、CCL18、CCL22、CCL27、IL-31 和胸腺基质淋巴细胞生成素）与经表皮失水率 (TEWL) 和水合率以及婴儿 AD 发病的预测价值。这项前瞻性观察研究包括来自意大利比萨一家大学医院的 40 名连续足月新生儿。在婴儿1、6和12个月大时对其皮肤标记物进行评估，同时在分娩后测量出生时采集的10毫升脐带血样本中的生物标记物。数据收集时间为 2018 年 3 月至 12 月，分析时间为 2019 年 1 月至 4 月。主要结果和测量与 TEWL 和水合率相关的血清学生物标志物水平，以及出生后前 12 个月出现 AD 的情况。结果所有 40 名纳入研究的婴儿（27 名男性 [68%]）均完成了研究。6 个月大时，16 名婴儿出现注意力缺失症的症状和体征（注意力缺失症组），24 名婴儿没有（非注意力缺失症组）。与无 AD 征兆的婴儿相比，有 AD 征兆的婴儿在 1、6 和 12 个月大时肘窝前 TEWL 值具有统计学意义。在两组中，膝关节前部测量的 TEWL 与 1 个月大时肘窝前部的水合率之间没有统计学意义上的相关性。在血液生物标志物方面，出生时，AD 组与非 AD 组相比，CCL17/胸腺和活化调节趋化因子（中位数 [IQR], 716 [509-951] pg/mL vs 419 [24-566] pg/mL；P = .003）和 IL-31 （中位数 [IQR], 212 [114-409] pg/mL vs 97 [52-277] pg/mL；P = .04);相反，胸腺基质淋巴细胞生成素（中位数 [IQR], 105 [66-295] pg/mL vs 88 [43-187] pg/mL）、CCL18（中位数 [IQR]、1236 [1115-1605] pg/mL vs 1255 [1188-1677] pg/mL）、CCL22（中位数[IQR]，1032 [936-1454] pg/mL vs 1096 [932-1536] pg/mL）和 CCL27（中位数[IQR]，172 [122-251] pg/mL vs 120 [90-265] pg/mL）。结论和相关性在这项观察性研究中，对肘窝前区 TEWL 的分析发生在 AD 临床症状出现之前，并与之相关。细胞因子的定量分析表明，评估脐带血血清中 CCL17 和 IL-31 的水平可为识别可能易患 AD 的新生儿提供新的视角。还需要更大规模的研究来验证这些发现。
{"title":"Cord Blood Serum Levels of IL-31 and CCL17, Cutaneous Markers, and Development of Atopic Dermatitis","authors":"Angelo Massimiliano D’Erme, Cristian Fidanzi, Matteo Bevilacqua, Thomas Bieber, Cristina Tuoni, Aldo Paolicchi, Maria Franzini, Riccardo Morganti, Francesca Papadia, Agata Janowska, Valentina Dini, Marco Romanelli","doi":"10.1001/jamadermatol.2024.3178","DOIUrl":"https://doi.org/10.1001/jamadermatol.2024.3178","url":null,"abstract":"ImportanceAtopic dermatitis (AD) is the most prevalent chronic skin condition characterized by inflammation and itching. Currently, there is no reliable method for identifying which newborns might have an increased risk of developing AD.ObjectiveTo evaluate the predictive value of serological biomarkers, such as CCL17/thymus- and activation-regulated chemokine, CCL18, CCL22, CCL27, IL-31, and thymus stromal lymphopoietin, with transepidermal water loss (TEWL) and hydration rate and the development of AD in infants.Design, Setting, and ParticipantsThis observational prospective study included 40 consecutive full-term newborns from a single university hospital in Pisa, Italy. The cutaneous markers of infants were assessed at 1, 6, and 12 months of age, while the biomarkers from the 10-mL sample of cord blood taken at birth were measured after delivery. Data were collected from March to December 2018 and analyzed from January to April 2019.Main Outcomes and MeasuresLevel of serological biomarkers associated with TEWL and hydration rate, as well as the emergence of AD during the first 12 months of life.ResultsAll 40 included infants (27 male [68%]) completed the study. At 6 months, 16 infants presented symptoms and signs of AD (AD group) and 24 did not (non-AD group). Infants with AD signs had statistically significant anterior cubital fossa TEWL values at 1, 6, and 12 months of age compared to those without AD signs. No statistically significant correlations were observed between the TEWL measured at the anterior part of knee and hydration rate at the anterior cubital fossa at first month in the 2 groups. With regard to the blood biomarkers, at birth those in the AD group vs the non-AD group had statistically significant higher levels of CCL17/thymus- and activation-regulated chemokine (median [IQR], 716 [509-951] pg/mL vs 419 [24-566] pg/mL; <jats:italic>P</jats:italic> = .003) and IL-31 (median [IQR], 212 [114-409] pg/mL vs 97 [52-277] pg/mL; <jats:italic>P</jats:italic> = .04); in contrast, no statistically significant serum level differences were registered for thymus stromal lymphopoietin (median [IQR], 105 [66-295] pg/mL vs 88 [43-187] pg/mL), CCL18 (median [IQR], 1236 [1115-1605] pg/mL vs 1255 [1188-1677] pg/mL), CCL22 (median [IQR], 1032 [936-1454] pg/mL vs 1096 [932-1536] pg/mL), and CCL27 (median [IQR], 172 [122-251] pg/mL vs 120 [90-265] pg/mL).Conclusions and RelevanceIn this observational study, the analysis of TEWL at the anterior cubital fossa area occurred prior to and correlated with the clinical signs of AD. Quantification of cytokines indicated that assessing cord blood serum levels of CCL17 and IL-31 could offer new perspectives in identifying newborns who might be susceptible to AD. Larger studies are needed to validate these findings.","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":"11 1","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142176174","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-01DOI: 10.1001/jamadermatol.2024.2623
Rachel R Lin, Kimberly N Williams, Peyton V Warp, David Alvarez Cespedes, Scott A Elman, Andrea D Maderal
{"title":"Characteristics of Hispanic Patients With Dermatomyositis.","authors":"Rachel R Lin, Kimberly N Williams, Peyton V Warp, David Alvarez Cespedes, Scott A Elman, Andrea D Maderal","doi":"10.1001/jamadermatol.2024.2623","DOIUrl":"10.1001/jamadermatol.2024.2623","url":null,"abstract":"","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":"1006-1007"},"PeriodicalIF":11.5,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11325236/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141975736","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-01DOI: 10.1001/jamadermatol.2024.2056
Reineke Soegiharto, Mehran Alizadeh Aghdam, Jennifer Astrup Sørensen, Esmee van Lindonk, Ferhan Bulut Demir, Nasser Mohammad Porras, Yoshimi Matsuo, Lea Kiefer, André C Knulst, Marcus Maurer, Carla Ritchie, Michael Rudenko, Emek Kocatürk, Roberta F J Criado, Stamatis Gregoriou, Tatjana Bobylev, Andreas Kleinheinz, Shunsuke Takahagi, Michihiro Hide, Ana M Giménez-Arnau, Andaç Salman, Rabia O Kara, Bahar Sevimli Dikicier, Martijn B A van Doorn, Simon F Thomsen, Juul M P A van den Reek, Heike Röckmann
<p><strong>Importance: </strong>Treating patients with chronic urticaria using omalizumab has been shown to be safe and effective in randomized clinical trials. Multinational studies on long-term omalizumab performance in chronic urticaria in clinical practice settings are lacking, especially on drug survival. Drug survival, which refers to the length of time that patients are treated with a specific drug, is a comprehensive outcome covering effectiveness, safety, and patient and physician preferences. Furthermore, little is known about the reasons and potential predictors for omalizumab discontinuation.</p><p><strong>Objective: </strong>To investigate omalizumab drug survival as well as reasons and potential predictors for discontinuation in a large, diverse population.</p><p><strong>Design, setting, and participants: </strong>This international multicenter cohort study was conducted at 14 Urticaria Centers of Reference and Excellence in 10 countries, including all patients with chronic urticaria from these centers who were ever treated with omalizumab.</p><p><strong>Main outcomes and measures: </strong>Drug survival analysis was performed to assess time to discontinuation. Patient characteristics and treatment protocols were investigated by Cox regression analysis to identify potential predictors for omalizumab discontinuation.</p><p><strong>Results: </strong>In 2325 patients with chronic urticaria who started omalizumab between June 2009 and July 2022, the mean (SD) age of the cohort was 42 (6) years, and 1650 participants (71%) were female. Overall omalizumab survival rates decreased from 76% to 39% after 1 to 7 years, respectively (median survival time, 3.3 [95 % CI, 2.9-4.0] years), primarily due to discontinuation from well-controlled disease in 576 patients (65%). Ineffectiveness and adverse effects were reasons for discontinuation in a far smaller proportion of patients, totaling 164 patients (18%) and 31 patients (4%), respectively. Fast treatment response was associated with higher rates of omalizumab discontinuation due to well-controlled disease (hazard ratio, 1.45 [95% CI, 1.20-1.75]), and disease duration of more than 2 years was associated with lower rates of discontinuation due to well-controlled disease (HR, 0.81 [95% CI, 0.67-0.98]). Immunosuppressive cotreatment at the start of omalizumab and autoimmune disease was associated with a higher risk for discontinuation due to ineffectiveness (HR, 1.65 [95% CI, 1.12-2.42]). The presence of spontaneous wheals (HR, 0.62 [95% CI, 0.41-0.93]) and access to higher dosages (HR, 0.40 [95% CI, 0.27-0.58) were both associated with a lower risk for discontinuation of omalizumab due to ineffectiveness.</p><p><strong>Conclusion and relevance: </strong>This multinational omalizumab drug survival cohort study demonstrated that treatment of chronic urticaria with omalizumab in a clinical setting is effective and safe, and well-controlled disease is the main reason for treatment discontinuation. Th
{"title":"Multinational Drug Survival Study of Omalizumab in Patients With Chronic Urticaria and Potential Predictors for Discontinuation.","authors":"Reineke Soegiharto, Mehran Alizadeh Aghdam, Jennifer Astrup Sørensen, Esmee van Lindonk, Ferhan Bulut Demir, Nasser Mohammad Porras, Yoshimi Matsuo, Lea Kiefer, André C Knulst, Marcus Maurer, Carla Ritchie, Michael Rudenko, Emek Kocatürk, Roberta F J Criado, Stamatis Gregoriou, Tatjana Bobylev, Andreas Kleinheinz, Shunsuke Takahagi, Michihiro Hide, Ana M Giménez-Arnau, Andaç Salman, Rabia O Kara, Bahar Sevimli Dikicier, Martijn B A van Doorn, Simon F Thomsen, Juul M P A van den Reek, Heike Röckmann","doi":"10.1001/jamadermatol.2024.2056","DOIUrl":"10.1001/jamadermatol.2024.2056","url":null,"abstract":"<p><strong>Importance: </strong>Treating patients with chronic urticaria using omalizumab has been shown to be safe and effective in randomized clinical trials. Multinational studies on long-term omalizumab performance in chronic urticaria in clinical practice settings are lacking, especially on drug survival. Drug survival, which refers to the length of time that patients are treated with a specific drug, is a comprehensive outcome covering effectiveness, safety, and patient and physician preferences. Furthermore, little is known about the reasons and potential predictors for omalizumab discontinuation.</p><p><strong>Objective: </strong>To investigate omalizumab drug survival as well as reasons and potential predictors for discontinuation in a large, diverse population.</p><p><strong>Design, setting, and participants: </strong>This international multicenter cohort study was conducted at 14 Urticaria Centers of Reference and Excellence in 10 countries, including all patients with chronic urticaria from these centers who were ever treated with omalizumab.</p><p><strong>Main outcomes and measures: </strong>Drug survival analysis was performed to assess time to discontinuation. Patient characteristics and treatment protocols were investigated by Cox regression analysis to identify potential predictors for omalizumab discontinuation.</p><p><strong>Results: </strong>In 2325 patients with chronic urticaria who started omalizumab between June 2009 and July 2022, the mean (SD) age of the cohort was 42 (6) years, and 1650 participants (71%) were female. Overall omalizumab survival rates decreased from 76% to 39% after 1 to 7 years, respectively (median survival time, 3.3 [95 % CI, 2.9-4.0] years), primarily due to discontinuation from well-controlled disease in 576 patients (65%). Ineffectiveness and adverse effects were reasons for discontinuation in a far smaller proportion of patients, totaling 164 patients (18%) and 31 patients (4%), respectively. Fast treatment response was associated with higher rates of omalizumab discontinuation due to well-controlled disease (hazard ratio, 1.45 [95% CI, 1.20-1.75]), and disease duration of more than 2 years was associated with lower rates of discontinuation due to well-controlled disease (HR, 0.81 [95% CI, 0.67-0.98]). Immunosuppressive cotreatment at the start of omalizumab and autoimmune disease was associated with a higher risk for discontinuation due to ineffectiveness (HR, 1.65 [95% CI, 1.12-2.42]). The presence of spontaneous wheals (HR, 0.62 [95% CI, 0.41-0.93]) and access to higher dosages (HR, 0.40 [95% CI, 0.27-0.58) were both associated with a lower risk for discontinuation of omalizumab due to ineffectiveness.</p><p><strong>Conclusion and relevance: </strong>This multinational omalizumab drug survival cohort study demonstrated that treatment of chronic urticaria with omalizumab in a clinical setting is effective and safe, and well-controlled disease is the main reason for treatment discontinuation. Th","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":"927-935"},"PeriodicalIF":11.5,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11255966/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141626752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-01DOI: 10.1001/jamadermatol.2024.2298
Hessah BinJadeed, Han Zhang Huang, Maxine Joly-Chevrier, Gazal Javed, Elena Netchiporouk
{"title":"Favorable Response to Type 2 Inhibitors in Patients With Darier Disease.","authors":"Hessah BinJadeed, Han Zhang Huang, Maxine Joly-Chevrier, Gazal Javed, Elena Netchiporouk","doi":"10.1001/jamadermatol.2024.2298","DOIUrl":"10.1001/jamadermatol.2024.2298","url":null,"abstract":"","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":"1007-1009"},"PeriodicalIF":11.5,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141751734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-01DOI: 10.1001/jamadermatol.2024.2192
Aaron M Drucker, Megan Lam, David Prieto-Merino, Rayka Malek, Alexandra G Ellis, Zenas Z N Yiu, Bram Rochwerg, Sonya Di Giorgio, Bernd W M Arents, Tanya Mohan, Tim Burton, Phyllis I Spuls, Jochen Schmitt, Carsten Flohr
<p><strong>Importance: </strong>There are multiple approved systemic treatments for atopic dermatitis. Lebrikizumab is a newly licensed biologic medication that has been compared to placebo in clinical trials but not to other systemic treatments.</p><p><strong>Objective: </strong>To compare reported measures of efficacy and safety of lebrikizumab to other systemic treatments for atopic dermatitis in a living systematic review and network meta-analysis.</p><p><strong>Data sources: </strong>The Cochrane Central Register of Controlled Trials, MEDLINE, Embase, the Latin American and Caribbean Health Science Information database, the Global Resource of Eczema Trials database, and trial registries were searched from inception through November 3, 2023.</p><p><strong>Study selection: </strong>Randomized clinical trials evaluating 8 or more weeks of treatment with systemic immunomodulatory medications for moderate to severe atopic dermatitis. Titles, abstracts, and full texts were screened in duplicate.</p><p><strong>Data extraction and synthesis: </strong>Data were abstracted in duplicate and random-effects bayesian network meta-analyses were performed. Minimal important differences were used to define important differences between medications. Certainty of evidence was assessed using the GRADE approach (Grading of Recommendations Assessment, Development and Evaluation). The updated analysis was completed from December 13, 2023, to February 20, 2024.</p><p><strong>Main outcome measures: </strong>Efficacy outcomes were the Eczema Area and Severity Index (EASI), the Patient Oriented Eczema Measure (POEM) Dermatology Life Quality Index (DLQI), and Peak Pruritus Numeric Rating Scales (PP-NRS) and were compared using mean difference (MD) with 95% credible intervals (CrI). Safety outcomes were serious adverse events and withdrawal due to adverse events. Other outcomes included the proportion of participants with 50%, 75%, and 90% improvement in EASI (EASI-50, -75, -90) and the proportion with success on the Investigator Global Assessment compared using odds ratios with 95% CrI.</p><p><strong>Results: </strong>The study sample included 97 eligible trials, with a total of 24 679 patients. Lebrikizumab was associated with no important difference in change in EASI (MD, -2.0; 95% CrI, -4.5 to 0.3; moderate certainty), POEM (MD, -1.1; 95% CrI -2.5 to 0.2; moderate certainty), DLQI (MD, -0.2; 95% CrI -2.1 to 1.6; moderate certainty), or PP-NRS (MD, 0.1; 95% CrI -0.4, 0.6; high certainty) compared to dupilumab among adults with atopic dermatitis who were treated for up to 16 weeks. Dupilumab was associated with higher odds of efficacy in binary outcomes compared with lebrikizumab. The relative efficacy of other approved systemic medications was similar to that found by previous updates of this living study, with high-dose upadacitinib and abrocitinib demonstrating numerically highest relative efficacy. For safety outcomes, low event rates limited useful comparisons.</
{"title":"Systemic Immunomodulatory Treatments for Atopic Dermatitis: Living Systematic Review and Network Meta-Analysis Update.","authors":"Aaron M Drucker, Megan Lam, David Prieto-Merino, Rayka Malek, Alexandra G Ellis, Zenas Z N Yiu, Bram Rochwerg, Sonya Di Giorgio, Bernd W M Arents, Tanya Mohan, Tim Burton, Phyllis I Spuls, Jochen Schmitt, Carsten Flohr","doi":"10.1001/jamadermatol.2024.2192","DOIUrl":"10.1001/jamadermatol.2024.2192","url":null,"abstract":"<p><strong>Importance: </strong>There are multiple approved systemic treatments for atopic dermatitis. Lebrikizumab is a newly licensed biologic medication that has been compared to placebo in clinical trials but not to other systemic treatments.</p><p><strong>Objective: </strong>To compare reported measures of efficacy and safety of lebrikizumab to other systemic treatments for atopic dermatitis in a living systematic review and network meta-analysis.</p><p><strong>Data sources: </strong>The Cochrane Central Register of Controlled Trials, MEDLINE, Embase, the Latin American and Caribbean Health Science Information database, the Global Resource of Eczema Trials database, and trial registries were searched from inception through November 3, 2023.</p><p><strong>Study selection: </strong>Randomized clinical trials evaluating 8 or more weeks of treatment with systemic immunomodulatory medications for moderate to severe atopic dermatitis. Titles, abstracts, and full texts were screened in duplicate.</p><p><strong>Data extraction and synthesis: </strong>Data were abstracted in duplicate and random-effects bayesian network meta-analyses were performed. Minimal important differences were used to define important differences between medications. Certainty of evidence was assessed using the GRADE approach (Grading of Recommendations Assessment, Development and Evaluation). The updated analysis was completed from December 13, 2023, to February 20, 2024.</p><p><strong>Main outcome measures: </strong>Efficacy outcomes were the Eczema Area and Severity Index (EASI), the Patient Oriented Eczema Measure (POEM) Dermatology Life Quality Index (DLQI), and Peak Pruritus Numeric Rating Scales (PP-NRS) and were compared using mean difference (MD) with 95% credible intervals (CrI). Safety outcomes were serious adverse events and withdrawal due to adverse events. Other outcomes included the proportion of participants with 50%, 75%, and 90% improvement in EASI (EASI-50, -75, -90) and the proportion with success on the Investigator Global Assessment compared using odds ratios with 95% CrI.</p><p><strong>Results: </strong>The study sample included 97 eligible trials, with a total of 24 679 patients. Lebrikizumab was associated with no important difference in change in EASI (MD, -2.0; 95% CrI, -4.5 to 0.3; moderate certainty), POEM (MD, -1.1; 95% CrI -2.5 to 0.2; moderate certainty), DLQI (MD, -0.2; 95% CrI -2.1 to 1.6; moderate certainty), or PP-NRS (MD, 0.1; 95% CrI -0.4, 0.6; high certainty) compared to dupilumab among adults with atopic dermatitis who were treated for up to 16 weeks. Dupilumab was associated with higher odds of efficacy in binary outcomes compared with lebrikizumab. The relative efficacy of other approved systemic medications was similar to that found by previous updates of this living study, with high-dose upadacitinib and abrocitinib demonstrating numerically highest relative efficacy. For safety outcomes, low event rates limited useful comparisons.</","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":"936-944"},"PeriodicalIF":11.5,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11255974/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141626755","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-01DOI: 10.1001/jamadermatol.2024.1832
Yiqun Chen, Haiwen Gui, Hanqi Yao, Joel Adu-Brimpong, Sigi Javitz, Val Golovko, Justin Ko, Roxana Daneshjou, Albert S Chiou
Importance: Access to timely dermatologic care remains a challenge, especially for patients with new skin lesions. Assessing the efficiency of new triage pathways may assist in better resource allocation and shorter time to care.
Objective: To evaluate whether a rule-based triage system was associated with better skin cancer risk stratification of patients and reduced wait times.
Design, setting, and participants: This retrospective quality improvement cohort study of patients referred to Stanford University dermatology clinics was conducted between November 2017 and January 2023. A rules-based triage system based on a priori-determined high-risk lesion characteristics was implemented.
Exposures: Referral reasons and risk factors of patients provided by their primary care physicians.
Main outcomes and measures: Biopsy results of patients (diagnosis of any skin cancer and melanoma) at their visit or within 6 months after the visit. Regression models were used to assess the association between risk factors at referral and (1) biopsy outcomes and (2) time to first visit, adjusting for sociodemographic factors.
Results: Among 37 478 patients (mean [SD] age, 54 (18) years; 21 292 women [57%]), the rates of aggregate biopsy, malignant biopsy specimens, and melanoma were comparable across patients seen after (n = 12 302) and before (n = 25 176) the implementation of the new triage pathway. Patients seen through the lesion pathway had a higher risk of having malignant biopsy results (adjusted risk ratio [aRR], 1.6; 95% CI, 1.4-1.9) and melanoma (aRR, 2.0; 95% CI, 1.2-3.2) than those not seen through the pathway. Lesions that were concerning to referring clinicians for skin cancer were associated with an increased risk of skin cancer (all skin cancer: aRR, 2.8; 95% CI, 2.2-3.5; melanoma: aRR, 2.02; 95% CI, 1.1-3.7). Patients in the 3 high-risk lesion groups were seen faster in the new triage pathway (mean reduction, 26 days; 95% CI, 18-34 days).
Conclusions and relevance: In this study, a new automated, rules-based referral pathway was implemented that expedited care for patients with high-risk skin cancer. This reform may have contributed to improving patient stratification, reducing the time from referral to first encounter, and maintaining accuracy in identifying malignant lesions. The findings highlight the potential to optimize clinical resource allocation by better risk stratification of referred patients.
{"title":"Single-Lesion Skin Cancer Risk Stratification Triage Pathway.","authors":"Yiqun Chen, Haiwen Gui, Hanqi Yao, Joel Adu-Brimpong, Sigi Javitz, Val Golovko, Justin Ko, Roxana Daneshjou, Albert S Chiou","doi":"10.1001/jamadermatol.2024.1832","DOIUrl":"10.1001/jamadermatol.2024.1832","url":null,"abstract":"<p><strong>Importance: </strong>Access to timely dermatologic care remains a challenge, especially for patients with new skin lesions. Assessing the efficiency of new triage pathways may assist in better resource allocation and shorter time to care.</p><p><strong>Objective: </strong>To evaluate whether a rule-based triage system was associated with better skin cancer risk stratification of patients and reduced wait times.</p><p><strong>Design, setting, and participants: </strong>This retrospective quality improvement cohort study of patients referred to Stanford University dermatology clinics was conducted between November 2017 and January 2023. A rules-based triage system based on a priori-determined high-risk lesion characteristics was implemented.</p><p><strong>Exposures: </strong>Referral reasons and risk factors of patients provided by their primary care physicians.</p><p><strong>Main outcomes and measures: </strong>Biopsy results of patients (diagnosis of any skin cancer and melanoma) at their visit or within 6 months after the visit. Regression models were used to assess the association between risk factors at referral and (1) biopsy outcomes and (2) time to first visit, adjusting for sociodemographic factors.</p><p><strong>Results: </strong>Among 37 478 patients (mean [SD] age, 54 (18) years; 21 292 women [57%]), the rates of aggregate biopsy, malignant biopsy specimens, and melanoma were comparable across patients seen after (n = 12 302) and before (n = 25 176) the implementation of the new triage pathway. Patients seen through the lesion pathway had a higher risk of having malignant biopsy results (adjusted risk ratio [aRR], 1.6; 95% CI, 1.4-1.9) and melanoma (aRR, 2.0; 95% CI, 1.2-3.2) than those not seen through the pathway. Lesions that were concerning to referring clinicians for skin cancer were associated with an increased risk of skin cancer (all skin cancer: aRR, 2.8; 95% CI, 2.2-3.5; melanoma: aRR, 2.02; 95% CI, 1.1-3.7). Patients in the 3 high-risk lesion groups were seen faster in the new triage pathway (mean reduction, 26 days; 95% CI, 18-34 days).</p><p><strong>Conclusions and relevance: </strong>In this study, a new automated, rules-based referral pathway was implemented that expedited care for patients with high-risk skin cancer. This reform may have contributed to improving patient stratification, reducing the time from referral to first encounter, and maintaining accuracy in identifying malignant lesions. The findings highlight the potential to optimize clinical resource allocation by better risk stratification of referred patients.</p>","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":"972-976"},"PeriodicalIF":11.5,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11209189/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141450499","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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