JAMA dermatology最新文献

{"title":"Ivarmacitinib for Moderate to Severe Atopic Dermatitis in Adults and Adolescents: A Phase 3 Randomized Clinical Trial.","authors":"Yan Zhao, Melinda Gooderham, Bin Yang, Jiyuan Wu, Liming Wu, Wei Jing Loo, Darryl Toth, Maxwell Sauder, Jingyi Li, Aijun Chen, Xiaohua Tao, Jianyun Lu, Zhiqiang Song, Jiande Han, Hongyi Li, Yijing Li, Lihong Xu, Jianzhong Zhang","doi":"10.1001/jamadermatol.2025.0982","DOIUrl":"https://doi.org/10.1001/jamadermatol.2025.0982","url":null,"abstract":"<p><strong>Importance: </strong>Ivarmacitinib, a selective oral Janus kinase 1 (JAK1) inhibitor, has demonstrated efficacy for treating adults with moderate to severe atopic dermatitis (AD) in a phase 2 trial.</p><p><strong>Objective: </strong>To evaluate the efficacy and adverse events of ivarmacitinib in adolescents and adults with moderate to severe AD.</p><p><strong>Design, setting, and participants: </strong>This multicenter, double-blind, placebo-controlled phase 3 randomized clinical trial included patients aged 12 to 75 years with moderate to severe AD. Patients were enrolled from 53 sites in Canada and China from April 2021 to April 2022. Data were analyzed from July 11 to September 27, 2023.</p><p><strong>Interventions: </strong>Patients were randomized (1:1:1) to receive once-daily 4- or 8-mg ivarmacitinib or placebo for 16 weeks.</p><p><strong>Main outcomes and measures: </strong>Co-primary end points were the proportions of patients achieving an Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline and an Eczema Area and Severity Index score improvement of 75% (EASI-75) at week 16.</p><p><strong>Results: </strong>Of 336 randomized patients (mean [SD] age, 31.1 [15.4] years; 213 [63.4%] male; 286 [85.1%] Asian), 113 received 4-mg ivarmacitinib, 112 received 8-mg ivarmacitinib, and 111 received placebo. At week 16, significantly more patients in the 4-mg ivarmacitinib group (41 of 113 [36.3%]; 95% CI, 27.5%-45.9%; P < .001) and the 8-mg ivarmacitinib group (47 of 112 [42.0%]; 95% CI, 32.7%-51.7%; P < .001) achieved an IGA score of 0 or 1 with at least a 2-grade improvement compared to the placebo group (10 of 111 [9.0%]; 95% CI, 4.4%-15.9%). EASI-75 responses were also significantly higher in the ivarmacitinib groups: 61 patients (54.0%; 95% CI, 44.4%-63.4%; P < .001) in the 4-mg group, and 74 (66.1%; 95% CI, 56.5%-74.8%; P < .001) in 8-mg group compared to 24 patients (21.6%; 95% CI, 14.4%-30.4%) in the placebo group. Treatment-emergent adverse events were reported by 78 patients (69.0%) in the 4-mg group, 74 (66.1%) in the 8-mg group, and 72 (64.9%) in the placebo group. Serious treatment-emergent adverse events occurred in 3 patients (2.7%) in the 4-mg group, 2 (1.8%) in the 8-mg group, and 3 (2.7%) in the placebo group.</p><p><strong>Conclusions and relevance: </strong>This phase 3 randomized clinical trial determined that once-daily ivarmacitinib demonstrated significant efficacy and a favorable risk-benefit profile for treating moderate to severe AD in adults and adolescents. These results support the potential of ivarmacitinib as a new therapeutic option.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT04875169.</p>","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12044538/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144021036","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}

{"title":"Melanoma-Associated Leukoderma.","authors":"Husna Moola, Willem Izak Visser","doi":"10.1001/jamadermatol.2025.0429","DOIUrl":"https://doi.org/10.1001/jamadermatol.2025.0429","url":null,"abstract":"","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144036049","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}

{"title":"Secondary Cancer Risk Among Patients With Primary Cutaneous B-cell Lymphoma.","authors":"Vrusha K Shah, Sara Behbahani, Jeffrey Barnes, Katherine Perlman, Steven T Chen","doi":"10.1001/jamadermatol.2025.0924","DOIUrl":"https://doi.org/10.1001/jamadermatol.2025.0924","url":null,"abstract":"","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12044536/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144014303","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}

{"title":"Error in Author Affiliation.","authors":"","doi":"10.1001/jamadermatol.2025.1299","DOIUrl":"https://doi.org/10.1001/jamadermatol.2025.1299","url":null,"abstract":"","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12044535/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143984005","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}

{"title":"Cutaneous Mycobacterium marinum Treated With Photodynamic Therapy Alone and Combined With Antibiotics.","authors":"Wenlong Hu, Qiunan Yao, Yue Mou, Chaochao Ji, Wenhao Cheng, Renqiong Chen, Jiaqi Liu, Xudong Mou, Di Cao, Hong Ren","doi":"10.1001/jamadermatol.2025.0645","DOIUrl":"https://doi.org/10.1001/jamadermatol.2025.0645","url":null,"abstract":"","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12019672/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144024665","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}

{"title":"Error in Supplement 2.","authors":"","doi":"10.1001/jamadermatol.2025.1153","DOIUrl":"https://doi.org/10.1001/jamadermatol.2025.1153","url":null,"abstract":"","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12019669/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144025671","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}

{"title":"Rilzabrutinib in Antihistamine-Refractory Chronic Spontaneous Urticaria: The RILECSU Phase 2 Randomized Clinical Trial.","authors":"Ana Giménez-Arnau, Silvia Ferrucci, Moshe Ben-Shoshan, Vincent Mikol, Laurence Lucats, Iris Sun, Leda Mannent, Jessica Gereige","doi":"10.1001/jamadermatol.2025.0733","DOIUrl":"https://doi.org/10.1001/jamadermatol.2025.0733","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Importance: &lt;/strong&gt;Chronic spontaneous urticaria (CSU) is a skin disease driven mainly by the activation of cutaneous mast cells through various mechanisms. Bruton tyrosine kinase (BTK), expressed in B cells and mast cells, plays a critical role in multiple immune-mediated disease processes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To determine the efficacy and risk profile of rilzabrutinib (SAR444671), an oral, reversible, covalent, next-generation BTK inhibitor, in treating patients with CSU.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;The Rilzabrutinib Efficacy and Safety in CSU (RILECSU) randomized clinical trial was a 52-week phase 2 study comprising a 12-week, double-blind, placebo-controlled, dose-ranging period, followed by a 40-week open-label extension. The trial was conducted from November 24, 2021, through April 23, 2024. Fifty-one centers enrolled and randomized participants across 12 countries in Asia, Europe, North America, and South America. The trial participants included adults aged 18 to 80 years with moderate to severe CSU (weekly Urticaria Activity Score [UAS7] of 16 or more; weekly Itch Severity Score [ISS7] of 8 or more) not adequately controlled with H1-antihistamine treatment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interventions: &lt;/strong&gt;Patients were randomized 1:1:1:1 to rilzabrutinib, 400 mg, once every evening (400 mg/d), twice per day (800 mg/d), 3 times per day (1200 mg/d), or matching placebo.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcomes: &lt;/strong&gt;The primary end point was change from baseline at week 12 in ISS7 (for US and US reference countries) or UAS7 (for non-US reference countries).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 160 omalizumab-naive and omalizumab-incomplete responders were randomized (mean [SD] age, 44.1 [13.4] years; 112 [70.0%] female). The primary analysis population included only the 143 omalizumab-naive patients. Significant reductions at week 12 were observed with rilzabrutinib, 1200 mg/d, vs placebo from baseline in ISS7 (least squares [LS] mean, -9.21 vs -5.77; difference, -3.44 [95% CI, -6.25 to -0.62]; P = .02) and UAS7 (LS mean, -16.89 vs -10.14; difference, -6.75 [95% CI, -12.23 to -1.26]; P = .02). In addition, improvements in weekly Hives Severity Score (HSS7) and weekly Angioedema Activity Score (AAS7) were observed. Improvements in ISS7, UAS7, HSS7, and AAS7 were observed as early as week 1. CSU-related biomarkers, including soluble Mas-related G protein-coupled receptor X2, immunoglobulin (Ig)-G antithyroid peroxidase, IgG anti-Fc-ε receptor 1, and interleukin-31, were reduced compared to placebo at week 12. Rilzabrutinib demonstrated a favorable risk-benefit profile; adverse events occurring at a higher frequency with rilzabrutinib vs placebo included diarrhea, nausea, and headache.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions and relevance: &lt;/strong&gt;The results of the RILECSU randomized clinical trial demonstrated efficacy and rapid onset of action of rilzabrutinib, 1200 mg/d, over 12 weeks, in addition to an accept","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12019677/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143967649","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}

{"title":"Acne Conglobata and Bimekizumab.","authors":"Matiar Madanchi, Florence Jeker, Hazem A Juratli, Riccardo Curatolo","doi":"10.1001/jamadermatol.2025.0416","DOIUrl":"https://doi.org/10.1001/jamadermatol.2025.0416","url":null,"abstract":"","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144025669","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}

{"title":"IL-5 Inhibitor Treatment in Drug Reaction With Eosinophilia and Systemic Symptoms.","authors":"Baraa Hijaz, Vinod E Nambudiri, Sotonye Imadojemu","doi":"10.1001/jamadermatol.2025.0441","DOIUrl":"https://doi.org/10.1001/jamadermatol.2025.0441","url":null,"abstract":"","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12004240/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143984085","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}

{"title":"Use and Cost of First-Line Biologic Medications to Treat Plaque Psoriasis in the US.","authors":"Benjamin N Rome, Jihye Han, Helen Mooney, Aaron S Kesselheim","doi":"10.1001/jamadermatol.2025.0669","DOIUrl":"https://doi.org/10.1001/jamadermatol.2025.0669","url":null,"abstract":"<p><strong>Importance: </strong>Plaque psoriasis is increasingly managed using anti-inflammatory biologic medications, including tumor necrosis factor (TNF)-α and interleukin (IL) 12/23, IL-17, and IL-23 inhibitors. How these differently priced biologics are used has implications for the overall cost of care in the US.</p><p><strong>Objective: </strong>To measure trends in the use and cost of first-line biologic treatments for plaque psoriasis from 2007 to 2021.</p><p><strong>Design, setting, and participants: </strong>This was a cross-sectional study using a national commercial claims dataset (2007-2021) of biologic medication-naive patients with plaque psoriasis who initiated a biologic medication from 1 of 4 mechanistic classes, including 4 TNF-α inhibitors, 1 IL-12/IL-23 inhibitors, 3 IL-17 inhibitors, and 3 IL-23 inhibitors. Data analyses were performed from August 2023 to October 2024.</p><p><strong>Exposures: </strong>Patient demographic characteristics (sex, age, geographic location, insurance type) and clinical characteristics (comorbidities, previous nonbiologic treatments for plaque psoriasis).</p><p><strong>Outcomes: </strong>Trends in the proportion of patients initiating each biologic medication and the average estimated annual treatment costs over time, using commercial estimates of net prices accounting for average manufacturer rebates. Logistic regression was used to evaluate demographic and clinical characteristics associated with initiating TNF-α vs IL inhibitors. Estimated savings were calculated for patients who had initiated the lowest-cost treatment within each class.</p><p><strong>Results: </strong>Among 76 781 patients with plaque psoriasis who initiated biologic medications, 50.4% were female and 49.6% male, 71.8% were age 30 to 59 years, and 30% had concurrent inflammatory arthritis. From 2007 to 2021, the proportion of patients initiating IL rather than TNF-α inhibitors increased; in 2021, 42% initiated IL-23 inhibitors and 21% initiated IL-17 inhibitors. The average annual treatment cost increased from $21 236 in 2007 to $47 125 in 2021. In 2021, costs ranged from $12 413 (infliximab) to $70 043 (risankizumab). If patients initiated the lowest-cost medication in each class, the average annual treatment cost would have been 44% lower in 2021 ($26 363). Patients who were male, older, residing in the Northeast, and did not have comorbid arthritis or inflammatory bowel disease had higher odds of initiating IL inhibitors than TNF-α inhibitors.</p><p><strong>Conclusions and relevance: </strong>This cross-sectional study found that from 2007 to 2021, treatment costs increased for biologic medications used to treat plaque psoriasis. Substantial savings are available if more patients and physicians use the lowest-cost options and/or if drug prices were better aligned with the comparative effectiveness and safety of each medication.</p>","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12004245/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143996740","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}