JAMA dermatology最新文献

{"title":"Improving Diversity in a Novel Psoriasis Study: VISIBLE as a Framework for Clinical Trial Quality Improvement.","authors":"Andrew Alexis, Amy McMichael, Neelam Vashi, Tina Bhutani, Adrian O Rodriguez, Jensen Yeung, Olivia Choi, Daphne Chan, Theodore Alkousakis, Denise N Bronner, Laura Park-Wyllie, Long-Long Gao, Pearl Grimes, Mona Shahriari, Geeta Yadav, Chesahna Kindred, Susan C Taylor, Seemal R Desai","doi":"10.1001/jamadermatol.2024.5103","DOIUrl":"https://doi.org/10.1001/jamadermatol.2024.5103","url":null,"abstract":"<p><strong>Importance: </strong>Diverse racial and ethnic representation in clinical trials has been limited, not representative of the US population, and the subject of pending US Food and Drug Administration guidance. Psoriasis presentation and disease burden can vary by skin pigmentation, race and ethnicity, and socioeconomic differences. Overall, there are limited primary data on clinical response, genetics, and quality of life in populations with psoriasis and skin of color (SoC). The Varying Skin Tones in Body and Scalp Psoriasis: Guselkumab Efficacy and Safety trial (VISIBLE) is underway and uses strategies aimed at addressing this persistent gap.</p><p><strong>Objective: </strong>To assess the innovative strategies used in the VISIBLE trial to recruit and retain diverse participants in a randomized clinical trial of psoriasis in participants with SoC.</p><p><strong>Design, setting, and participants: </strong>This was an ad hoc quality improvement assessment of participant recruitment and retention approaches used by the VISIBLE trial. VISIBLE enrolled and randomized 211 participants (mean [SD] age, 43 [13] years; 75 females [36%] and 136 males [64%]) with SoC and moderate to severe plaque psoriasis from August 2022 to March 2023 to evaluate guselkumab treatment. The self-identified race and ethnicity of the participants was: 1 American Indian/Alaska Native (0.5%), 63 Asian (29.9%), 24 Black (11.4%), 94 Hispanic/Latino (44.5%), 13 Middle Eastern (6.2%), 1 Pacific Islander/Native Hawaiian (0.5%), 12 multiracial (5.7%), and 3 of other race and/or ethnicity (1.4%). Using a combination of objective (colorimetry to determine Fitzpatrick skin type) and self-reported (race and ethnicity consistent with SoC) parameters, VISIBLE sought to broaden inclusion of participants from various backgrounds.</p><p><strong>Results: </strong>Observed improvements were that participant enrollment occurred approximately 7 times faster than anticipated (vs historical recruitment data for psoriasis studies); 211 participants (100%) self-identified themselves as a race or ethnicity other than White; and more than 50% had skin tone in the darker half of the Fitzpatrick skin type spectrum (type IV-VI). Innovations implemented by VISIBLE were (1) assessment of the natural history of postinflammatory pigment alteration and improvements over time using combined objective colorimetry and clinician- and patient-reported outcomes; (2) evaluation of genetic and comorbidity biomarkers relevant to participants with SoC; (3) a diverse demographic-driven approach to site selection (emphasizing investigator and staff diversity and experience with populations with SoC); (4) provision of cultural competency training to enhance participant enrollment and retention; (5) collection of patient-reported outcomes data in participants' primary language; and (6) periodic, blinded central review and feedback on investigator efficacy scoring to promote consistency and accuracy in evaluating ","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142807129","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":"Risk of Death Due to Melanoma and Other Causes in Patients With Thin Cutaneous Melanomas.","authors":"Serigne N Lo, Gabrielle J Williams, Anne E Cust, David W Ollila, Alexander H R Varey, Sydney Ch'ng, Richard A Scolyer, John F Thompson","doi":"10.1001/jamadermatol.2024.4900","DOIUrl":"https://doi.org/10.1001/jamadermatol.2024.4900","url":null,"abstract":"<p><strong>Importance: </strong>Most patients who present with primary cutaneous melanomas have thin tumors (≤1.0 mm in Breslow thickness, ie, pT1a and pT1b). Although their prognosis is generally considered to be excellent, there is limited precise information on the association of risk of death with specific Breslow measurements in thin lesions.</p><p><strong>Objective: </strong>To assess the relative effect of a 0.8-mm Breslow thickness threshold with respect to the incidence of both melanoma-related and nonmelanoma-related death.</p><p><strong>Design, setting, and participants: </strong>Registry data for all Australians diagnosed with thin invasive primary melanomas between 1982 and 2014 were analyzed. Data were extracted from all 8 Australian state and territory population-based cancer registries. Dates and causes of death were obtained from the Australian National Death Index. Adults diagnosed with a first invasive primary melanoma of 1.0 mm or smaller in thickness were included.</p><p><strong>Exposure: </strong>First invasive primary melanoma between 1982 and 2014.</p><p><strong>Main outcomes and measures: </strong>The primary outcomes were melanoma-related deaths and nonmelanoma-related deaths. Competing-risk regression analyses and cause-specific analyses were performed to investigate the relationships between Breslow thickness subcategory (<0.8 mm versus ≥0.8 mm by 0.1-mm increments) and the primary outcomes.</p><p><strong>Results: </strong>Overall, a cohort of 144 447 participants was included. The median (range) age was 56 (18-101) years and 78 014 (54.0%) were men. Median (IQR) follow-up was 15.0 (9.5-23.3) years. Crude incidence rates of melanoma-related death 20 years after diagnosis were 6.3% (95% CI, 6.1%-6.5%) for the whole cohort, 6.0% (95% CI, 5.7%-6.2%) for tumors smaller than 0.8 mm, and 12.0% (95% CI, 11.4%-12.6%) for tumors 0.8 to 1.0 mm. The corresponding 20-year melanoma-specific survival rates were 91.9% (95% CI, 91.6%-92.1%), 94.2% (95% CI, 94.0%-94.4%), and 87.8% (95% CI, 87.3%-88.3%), respectively. On multivariable analysis, tumor thickness of 0.8 to 1.0 mm was significantly associated with both a greater absolute risk of melanoma-related death (subdistribution hazard ratio, 2.92; 95% CI, 2.74-3.12) and a greater rate of melanoma-related death (hazard ratio, 2.98; 95% CI, 2.79-3.18) than thinner tumors (<0.8 mm). Risk of death from nonmelanoma-related causes was not associated with Breslow thickness.</p><p><strong>Conclusions and relevance: </strong>In this study, the risk of melanoma-related death increased significantly for patients with primary tumors of 0.8 to 1.0 mm in thickness. The risk of death from nonmelanoma-ralated causes was similar across Breslow thicknesses of 0.1 to 1.0 mm. This analysis suggests that a 0.8-mm threshold for guiding the care of patients with thin primary melanomas.</p>","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142807241","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":"Melanoma Tumor Mutational Burden and Indoor Tanning Exposure.","authors":"Grace B Hanrahan, Anita Giobbie-Hurder, Blair Allais, Jayne Vogelzang, Christopher Fay, Hillary C Tsibris","doi":"10.1001/jamadermatol.2024.4819","DOIUrl":"https://doi.org/10.1001/jamadermatol.2024.4819","url":null,"abstract":"<p><strong>Importance: </strong>UV-induced mutagenesis leads to a higher tumor mutational burden (TMB) in cutaneous melanoma relative to other cancer types. TMB is an important prognostic marker in advanced melanoma; higher TMB is associated with greater clinical response to immune checkpoint inhibition and improved survival.</p><p><strong>Objective: </strong>To evaluate the association between cutaneous melanoma TMB and indoor tanning exposure, as well as other demographic, dermatologic, and tumor characteristics.</p><p><strong>Design, setting, and participants: </strong>This retrospective cohort study took place at Dana-Farber Cancer Institute, a tertiary-care cancer treatment center in Boston, Massachusetts, between 2013 and 2022. Patients with a diagnosis of cutaneous melanoma for whom next-generation sequencing data and tanning bed exposure history were available were included.</p><p><strong>Exposures: </strong>Indoor tanning exposure history, tumor characteristics, demographics, and dermatologic history were collected via retrospective medical record review.</p><p><strong>Main outcomes and measures: </strong>The association of tanning bed use with TMB was modeled using inverse probability of treatment weighted, multivariable modeling.</p><p><strong>Results: </strong>Among 617 patients (median [IQR] age at diagnosis, 61 [50-71] years; 337 [62.9%] male), there was no association between indoor tanning exposure and TMB after adjustment for demographic, tumor, and dermatologic characteristics (yes vs no: log2 TMB [SE], 4.07 [0.44] vs 3.97 [0.45]; P = .39). However, there was a statistically significant association between higher TMB and older age at diagnosis, history of nonmelanoma skin cancer, and head and neck tumors relative to other primary sites. Average TMB was statistically significantly lower in patients with a history of abnormal nevi (yes vs no: log2 TMB [SE], 3.89 [0.44] vs 4.15 [0.44]; P = .01).</p><p><strong>Conclusions and relevance: </strong>This cohort study suggests that indoor tanning exposure, while known to increase risk of melanoma, may not be meaningfully associated with melanoma TMB. Additional characteristics were associated with higher TMB and, thus, potentially improved immune checkpoint inhibitor response.</p>","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142807196","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":"Successful Treatment of Mogamulizumab-Associated Rash With Upadacitinib: Evidence From 2 Cases.","authors":"Daniel Martín-Torregrosa, Ignacio Torres-Navarro, Miguel Mansilla-Polo, Fernando Navarro-Blanco, Blanca de Unamuno-Bustos, Vicent Martínez I Cózar, Rafael Botella-Estrada","doi":"10.1001/jamadermatol.2024.4582","DOIUrl":"https://doi.org/10.1001/jamadermatol.2024.4582","url":null,"abstract":"","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142807253","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":"Safety and Efficacy of Anti-IL-23 Monoclonal Antibody QX004N for Patients With Psoriasis: A Randomized Clinical Trial.","authors":"Xiaojiao Li, Bing Li, Deming Yang, Meng Wang, Qianqian Li, Nan Wang, Min Fang, Jingrui Liu, Hong Zhang, Min Wu, Cuiyun Li, Xiaoxue Zhu, Yanhua Ding, Shanshan Li","doi":"10.1001/jamadermatol.2024.5059","DOIUrl":"https://doi.org/10.1001/jamadermatol.2024.5059","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Importance: &lt;/strong&gt;Psoriasis is a chronic, immune-mediated skin disease with an unmet need for biologic treatment options.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To assess the safety, pharmacokinetics, and efficacy of QX004N in healthy individuals and patients with moderate to severe plaque psoriasis in China.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;This randomized clinical trial was composed of 2 parts. Part 1 was a first-in-human, single-ascending-dose, phase 1a clinical trial conducted from November 2, 2021, to January 16, 2023. Part 2 was a double-blind, multiple dose-escalation, phase 1b clinical trial conducted from February 15, 2023, to January 5, 2024, at 5 clinical centers in China, involving patients with moderate to severe plaque psoriasis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interventions: &lt;/strong&gt;In part 1, healthy participants in each cohort were assigned in a 4:1 ratio to receive a single subcutaneous injection of QX004N (ranging from 10 mg to 600 mg) or placebo. In part 2, patients in each cohort were assigned in a 4:1 ratio to receive QX004N or placebo at doses of 150 mg, 300 mg, and 600 mg once every 2 weeks.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcomes and measures: &lt;/strong&gt;For part 1, the primary outcome was the safety of a single dose of QX004N in healthy participants, and the secondary outcome was the pharmacokinetic profile. For part 2, the primary efficacy end point was the proportion of patients achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) by week 12; other efficacy end points were considered secondary.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The phase 1a clinical trial (part 1) enrolled 55 healthy participants (mean [SD] age, 35.9 [6.0] years; 30 [54.5%] female), and the phase 1b clinical trial (part 2) enrolled 30 patients with moderate to severe plaque psoriasis. The mean (SD) age of QX004N-treated participants in part 2 was 41.4 (7.5) years, and 19 of 24 QX004N-treated participants (79.2%) were male. The mean (SD) age of the placebo cohort in part 2 was 35.3 (8.4) years, and 5 of 6 placebo-treated participants (83.3%) were male. QX004N exhibited linear pharmacokinetics and was tolerated well in both healthy participants and patients with psoriasis. Most adverse events were mild to moderate in severity, with no drug-related serious adverse events reported. The proportion of patients receiving QX004N who achieved PASI 75 at week 12 and PASI 90 (90% improvement in PASI) at week 16 in the 150-mg, 300-mg, and 600-mg cohorts was 100%, significantly higher than that in the placebo cohorts (33.3%). The maximum proportion of patients achieving Investigator's Global Assessment score of 0 or 1 was 100% in the 3 QX004N cohorts.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions and relevance: &lt;/strong&gt;In this randomized clinical trial, QX004N was well tolerated and demonstrated superior efficacy compared to placebo in patients with moderate to severe plaque psoriasis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;Chinese Clinical Trial Reg","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142807251","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":"Clinical and Genetic Findings in Patients With Palmoplantar Keratoderma.","authors":"Stine Bjørn Gram, Klaus Brusgaard, Ulrikke Lei, Mette Sommerlund, Gabrielle Randskov Vinding, Sondre Olai Kjellevold Sleire, Alex Hørby Christensen, Sanne Pedersen Fast, Rasmus Bach, Anette Bygum, Lilian Bomme Ousager","doi":"10.1001/jamadermatol.2024.4824","DOIUrl":"10.1001/jamadermatol.2024.4824","url":null,"abstract":"<p><strong>Importance: </strong>Palmoplantar keratoderma poses diagnostic challenges due to its clinical and genetic heterogeneity, and knowledge on the value of systematic genetic testing on clinically well-described patient cohorts is sparse.</p><p><strong>Objective: </strong>To improve knowledge of the clinical and genetic spectrum of patients with palmoplantar keratoderma.</p><p><strong>Design, setting, and participants: </strong>This cohort study prospectively recruited patients and affected family members with palmoplantar keratoderma between September 1, 2016, and December 31, 2022. Patients were recruited from private practitioners in dermatology and dermatology departments in Denmark. Study participants were patients 18 years or older either newly diagnosed with palmoplantar keratoderma or being followed up for the disease at referral centers.</p><p><strong>Main outcomes and measures: </strong>Phenotypes and clinical subtypes were classified. Genetic testing was performed by whole-exome or genome sequencing using an in silico panel containing genes related to palmoplantar keratoderma, or by Sanger sequencing for specific variants. Descriptive analysis, such as proportions and frequency, were used to describe clinical characteristics, distribution of disease-causing variants, and genotype-phenotype associations.</p><p><strong>Results: </strong>This study included 142 study participants from 76 families (90 [63%] female; median [range] age, 52 [18-92] years). Clinical subtypes included 42 punctate (55%), 26 diffuse (34%), 5 focal (7%), and 3 striate (4%). A genetic diagnosis was found in 63 of 76 families (83%), including 27 disease-causing variants within 13 different genes: AAGAB (n = 39), DSG1 (n = 8), KRT1 (n = 3), DSP (n = 2), KRT9 (n = 2), AQP5 (n = 2), KRT16 (n = 1), SERPINA12 (n = 1), ABCA12 (n = 1), COL7A1 (n = 1), CARD14 (n = 1), DST (n = 1), and LORICRIN (n = 1). All participants with AAGAB variants presented with punctate palmoplantar keratoderma, showing a clear genotype-phenotype correlation. The other subtypes (diffuse, focal, and striate) proved more challenging to clinically subclassify, and disease-causing variants were identified in 12 genes, contributing to more complex genotype-phenotype patterns. Patients with palmoplantar keratoderma due to DSP variants were found, which is important to identify because of an associated risk of cardiomyopathy.</p><p><strong>Conclusion and relevance: </strong>This study provides novel insights into the clinical and genetic spectrum of patients with palmoplantar keratoderma. It demonstrates the value of genetic testing for accurate diagnoses and to distinguish between different subtypes. The established and well-described cohort lays the foundation for future research in palmoplantar keratoderma.</p>","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11618570/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142768991","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":"Incidence and Prevalence of Atherosclerotic Cardiovascular Disease in Cutaneous Lupus Erythematosus.","authors":"Henry W Chen, Jialiang Liu, Donghan M Yang, Yang Xie, Eric D Peterson, Ann Marie Navar, Benjamin F Chong","doi":"10.1001/jamadermatol.2024.4991","DOIUrl":"10.1001/jamadermatol.2024.4991","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Importance: &lt;/strong&gt;Autoimmune diseases such as systemic lupus erythematosus (SLE) and psoriasis have been previously associated with an increased risk of atherosclerotic cardiovascular disease (ASCVD). Whether similar increased ASCVD risk is seen with cutaneous lupus erythematosus (CLE) remains unclear.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To evaluate the incidence and prevalence of ASCVD among those with CLE, SLE, and psoriasis compared with a disease-free control group.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;This retrospective, matched longitudinal cohort study used data from January 2018 to December 2020 in the IBM MarketScan Commercial Claims and Encounters Database. The control population included individuals free of CLE, SLE, and psoriasis, matched 10:1 with the CLE population on age, sex, insurance type, and enrollment duration. Data were analyzed from September 2022 to April 2024.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcomes and measures: &lt;/strong&gt;Prevalent ASCVD was defined as coronary artery disease, prior myocardial infarction, or cerebrovascular accident. Incident ASCVD was assessed through the number of hospitalization events through the end of follow-up (up to 3 years) in each group. Multivariable logistic regression and Cox proportional hazards models were performed to compare the prevalence and incidence of ASCVD between exposure groups, adjusting for age, sex, and cardiovascular risk factors.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 8138 persons with CLE (median [IQR] age, 49 [40-47] years; 6618 [81%] female), 24 675 with SLE (median [IQR] age, 46 [36-54] years; 22 432 [91%] female), 192 577 persons with psoriasis (median [IQR] age, 48 [36-56] years; 106 631 [55%] female), and 81 380 control individuals (49 [40-57] years; 66 180 [81%] female) were identified. In multivariable analysis, the odds of ASCVD were higher than control for CLE (odds ratio [OR], 1.72 [95% CI, 1.45-2.02]; P &lt; .001) and SLE (OR, 2.41 [95% CI, 2.14-2.70]; P &lt; .001), but not psoriasis (OR, 1.03 [95% CI, 0.95-1.11]; P = .48). At median 3 years follow-up, incidence rates of ASCVD were highest for SLE (24.8 [95% CI, 23.3-26.4] per 1000 person-years), followed by CLE (15.2 [95% CI, 13.1-17.7] per 1000 person-years), psoriasis (14.0 [95% CI, 13.5-14.4] per 1000 person-years), and then controls (10.3 [95% CI, 9.77-10.94] per 1000 person-years). In multivariable Cox proportional regression modeling with the control group as a reference group, the highest risk of incident ASCVD was in those with SLE (hazard ratio [HR], 2.23 [95% CI, 2.05-2.43]; P &lt; .001), followed by CLE (HR, 1.32 [95% CI, 1.13-1.55]; P &lt; .001), and psoriasis (HR, 1.06 [95% CI, 0.99-1.13]; P = .09).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions and relevance: &lt;/strong&gt;In this retrospective matched longitudinal cohort study, CLE was associated with an increased risk for ASCVD, similar to the risk in SLE but higher than the risk in psoriasis. The role of comorbidities that augment ASCVD risk like smoking sta","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.5,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11618573/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142768996","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":"Monilethrix.","authors":"Vincenzo Piccolo, Giuseppe Argenziano","doi":"10.1001/jamadermatol.2024.3892","DOIUrl":"10.1001/jamadermatol.2024.3892","url":null,"abstract":"","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":"1353-1354"},"PeriodicalIF":11.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142500739","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":"Madelung Disease.","authors":"Hong-Hao Hu, Cheng-Cheng Liu, Jiu-Hong Li","doi":"10.1001/jamadermatol.2024.4217","DOIUrl":"10.1001/jamadermatol.2024.4217","url":null,"abstract":"","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":"1355-1356"},"PeriodicalIF":11.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583291","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":"Pregabalin for Neuropathic Pain and Itch in Recessive Dystrophic Epidermolysis Bullosa: A Randomized Crossover Trial.","authors":"Margarita Calvo, Macarena Tejos-Bravo, Alvaro Passi-Solar, Fernanda Espinoza, Ignacia Fuentes, Irene Lara-Corrales, Elena Pope","doi":"10.1001/jamadermatol.2024.3767","DOIUrl":"10.1001/jamadermatol.2024.3767","url":null,"abstract":"<p><strong>Importance: </strong>Patients with recessive dystrophic epidermolysis bullosa (RDEB) experience neuropathic pain and itch. There is a lack of evidence on any treatment for these symptoms in patients with RDEB.</p><p><strong>Objectives: </strong>To test the efficacy of pregabalin in the treatment of neuropathic pain and itch in patients with RDEB.</p><p><strong>Design, setting, and participants: </strong>A randomized, double-blinded, crossover trial of oral pregabalin (50-300 mg/d) vs placebo was conducted at 2 sites, Toronto (Canada) and Santiago (Chile) from January 1, 2019, to December 31, 2020. Patients eligible to participate were diagnosed with RDEB, aged 8 to 40 years, not pregnant or lactating (if female), and had evidence of probable neuropathic pain and itching defined as distal thermal sensory loss (confirmed by thermal roller), score of 4 or greater on the Douleur Neuropathique 4 questionnaire (DN4), and score greater than 4 on the 10-point visual analog scale [VAS]). Patients with a clinically important or poorly controlled medical or psychiatric condition or pregabalin intolerance or allergy were excluded. Of 41 patients screened, 3 were not eligible and 28 declined enrollment. Data analyses were performed in 2021 through 2023.</p><p><strong>Intervention: </strong>Participants received both pregabalin and matched placebo (titrated to a maximum-tolerated dose of 300 mg/day) in a randomized sequence so that comparisons could be made within participants and between groups.</p><p><strong>Main outcomes and measures: </strong>Difference in the mean pain and itch scores between pregabalin and placebo treatment (measured using VAS) before and after intervention.</p><p><strong>Results: </strong>In all, 10 participants were randomized to 2 groups, 6 patients (mean [SD] age, 26.7 [8.1] years; 3 females [50%]) in group 1, and 4 patients (mean [SD] age, 26.5 [7.8] years, 2 females [50%]) in group 2. Group 1 received a sequence of pregabalin-placebo while group 2 received placebo-pregabalin. Pregabalin significantly reduced mean (SD) pain scores by 1.9 (1.5) points when controlling for sequence and treatment period vs baseline, while placebo had 0.1 (2.0) points of reduction. The effect of pregabalin was a mild but significant reduction in itch compared to baseline (mean [SD] points, 0.9 [2.2]), whereas the placebo produced no reduction (0.1 [2.5]). The mean pregabalin dose was generally well tolerated.</p><p><strong>Conclusions and relevance: </strong>The results of this randomized crossover trial indicate that pregabalin significantly reduced pain and itch scores from baseline compared to placebo in patients with RDEB. This feasibility study provided preliminary data on the efficacy of pregabalin in managing pain and itch in RDEB and gathered essential data to inform the design of a larger cohort trial.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT03928093.</p>","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":"1314-1319"},"PeriodicalIF":11.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11581501/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142500740","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}