JAMA dermatology最新文献

{"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":"10.1001/jamadermatol.2024.5059","url":null,"abstract":"<p><strong>Importance: </strong>Psoriasis is a chronic, immune-mediated skin disease with an unmet need for biologic treatment options.</p><p><strong>Objective: </strong>To assess the safety, pharmacokinetics, and efficacy of QX004N in healthy individuals and patients with moderate to severe plaque psoriasis in China.</p><p><strong>Design, setting, and participants: </strong>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.</p><p><strong>Interventions: </strong>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.</p><p><strong>Main outcomes and measures: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions and relevance: </strong>In this randomized clinical trial, QX004N was well tolerated and demonstrated superior efficacy compared to placebo in patients with moderate to severe plaque psoriasis.</p><p><strong>Trial registration: </strong>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":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11840649/pdf/","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":"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}

{"title":"Peristomal Erosion in a Man With Crohn Disease.","authors":"Valentina Caputo, Paolo Romanelli, Franco Rongioletti","doi":"10.1001/jamadermatol.2024.2770","DOIUrl":"10.1001/jamadermatol.2024.2770","url":null,"abstract":"","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":"1357-1358"},"PeriodicalIF":11.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142390629","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":"Low-Dose Naltrexone Use in Biopsy-Proven Lichen Planus of the Nails.","authors":"Eric R Bray, Brian W Morrison","doi":"10.1001/jamadermatol.2024.4098","DOIUrl":"10.1001/jamadermatol.2024.4098","url":null,"abstract":"<p><strong>Importance: </strong>Nail lichen planus has the potential to cause permanent destruction of the nail unit and remains challenging to treat. Studies suggest that low-dose naltrexone is a safe and potentially effective treatment for other dermatologic conditions, including lichen planopilaris.</p><p><strong>Objective: </strong>To assess the effectiveness of low-dose naltrexone in treating nail lichen planus.</p><p><strong>Design, setting, and participants: </strong>This case series evaluates 7 adult patients with biopsy-proven nail lichen planus who were treated with low-dose naltrexone (3 mg per day) at the University of Miami dermatologic clinics from November 2022 to December 2023. The data were analyzed in March 2024. Patients were treated for at least 2 months and had in-person follow-up evaluation while receiving treatment.</p><p><strong>Main outcomes and measures: </strong>The main outcome was posttreatment clinical nail lichen planus severity index, which was scored as clear, mild, moderate, or severe. Patients were evaluated for oral and cutaneous disease during the course of treatment. Tolerance and adverse events were noted.</p><p><strong>Results: </strong>A total of 7 patients (mean [range] age, 60 [38-77] years; 3 female individuals) were included. All but 1 patient had been previously treated and did not respond to at least 1 prior treatment (median [range], 2.5 [0-4.0] treatments). Treatment duration ranged from 2 to 11 months. Clinical response was observed in 4 of 7 patients, with an overall 35% reduction in nail lichen planus severity index. Two patients with severe disease achieved a reduction to mild severity. None of the patients had to discontinue low-dose naltrexone due to adverse events, and no adverse events were reported.</p><p><strong>Conclusions and relevance: </strong>The results of this study suggest that low-dose naltrexone may be a therapeutic approach for treating nail lichen planus. Further controlled studies are warranted to better understand its clinical efficacy and safety profile in treating nail lichen planus.</p>","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":"1334-1337"},"PeriodicalIF":11.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11581650/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545565","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":"Successful Treatment of Recalcitrant Chloracne With Adalimumab in an Older Man.","authors":"Poonam Saini, Nitish Kumar, Naveen Kumar Kansal, Ashok Singh, Elumalai Gnanamani, Naveen Kumar, Riti Bhatia","doi":"10.1001/jamadermatol.2024.4263","DOIUrl":"10.1001/jamadermatol.2024.4263","url":null,"abstract":"","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":"1367-1369"},"PeriodicalIF":11.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545568","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":"Prevalence and Patient Characteristics of Pachyonychia Congenita.","authors":"Sara Rønde Andersen, Laura Krogh Herlin, Sigrun A J Schmidt, Mette Sommerlund","doi":"10.1001/jamadermatol.2024.3727","DOIUrl":"10.1001/jamadermatol.2024.3727","url":null,"abstract":"","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":"1364-1366"},"PeriodicalIF":11.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11581489/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142500741","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":"Long-Term Risk of Autoimmune and Autoinflammatory Connective Tissue Disorders Following COVID-19.","authors":"Yeon-Woo Heo, Jae Joon Jeon, Min Chul Ha, You Hyun Kim, Solam Lee","doi":"10.1001/jamadermatol.2024.4233","DOIUrl":"10.1001/jamadermatol.2024.4233","url":null,"abstract":"<p><strong>Importance: </strong>Few studies have investigated the association between COVID-19 and autoimmune and autoinflammatory connective tissue disorders; however, research with long-term observation remains insufficient.</p><p><strong>Objective: </strong>To investigate the long-term risk of autoimmune and autoinflammatory diseases after COVID-19 over an extended observation period.</p><p><strong>Design, setting, and participants: </strong>This retrospective nationwide population-based study investigated the Korea Disease Control and Prevention Agency-COVID-19-National Health Insurance Service (K-COV-N) cohort. Individuals with confirmed COVID-19 from October 8, 2020, to December 31, 2022, and controls identified among individuals who participated in the general health examination in 2018 were included in the analysis.</p><p><strong>Exposures: </strong>Confirmed COVID-19.</p><p><strong>Main outcomes and measures: </strong>Incidence and risk of autoimmune and autoinflammatory connective tissue disorders in patients after COVID-19. Various covariates, such as demographic characteristics, general health data, socioeconomic status, and comorbidity profiles, were balanced using inverse probability weighting.</p><p><strong>Results: </strong>A total of 6 912 427 participants (53.6% male; mean [SD] age, 53.39 [20.13] years) consisting of 3 145 388 with COVID-19 and 3 767 039 controls with an observational period of more than 180 days were included. Alopecia areata (adjusted hazard ratio [AHR], 1.11 [95% CI, 1.07-1.15]), alopecia totalis (AHR, 1.24 [95% CI, 1.09-1.42]), vitiligo (AHR, 1.11 [95% CI, 1.04-1.19]), Behçet disease (AHR, 1.45 [95% CI, 1.20-1.74]), Crohn disease (AHR, 1.35 [95% CI, 1.14-1.60]), ulcerative colitis (AHR, 1.15 [95% CI, 1.04-1.28]), rheumatoid arthritis (AHR, 1.09 [95% CI, 1.06-1.12]), systemic lupus erythematosus (AHR, 1.14 [95% CI, 1.01-1.28]), Sjögren syndrome (AHR, 1.13 [95% CI, 1.03-1.25]), ankylosing spondylitis (AHR, 1.11 [95% CI, 1.02-1.20]), and bullous pemphigoid (AHR, 1.62 [95% CI, 1.07-2.45]) were associated with higher risk in the COVID-19 group. Subgroup analyses revealed that demographic factors, including male and female sex, age younger than 40 years, and age 40 years and older, exhibited diverse associations with the risk of autoimmune and autoinflammatory outcomes. In addition, severe COVID-19 infection requiring intensive care unit admission, the Delta period, and not being vaccinated were associated with higher risk.</p><p><strong>Conclusions and relevance: </strong>This retrospective cohort study with an extended follow-up period found associations between COVID-19 and the long-term risk of various autoimmune and autoinflammatory connective tissue disorders. Long-term monitoring and care of patients is crucial after COVID-19, considering demographic factors, disease severity, and vaccination status, to mitigate these risks.</p>","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":"1278-1287"},"PeriodicalIF":11.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11541739/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583289","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":"Lipodermatosclerosis and Pulmonary Hypertension in Systemic Sclerosis.","authors":"Srijana Davuluri, Puneet Kapoor, Swarna Nandyala, Shufeng Li, Julia Simard, Matthew Lewis, David Fiorentino, Lorinda Chung","doi":"10.1001/jamadermatol.2024.3929","DOIUrl":"10.1001/jamadermatol.2024.3929","url":null,"abstract":"<p><strong>Importance: </strong>Lipodermatosclerosis (LDS) stems from vascular dysfunction and dermal inflammation and thereby is mechanistically similar to systemic sclerosis (SSc). The association of LDS with SSc in the clinical setting has not been well characterized in the literature.</p><p><strong>Objective: </strong>To evaluate the prevalence of LDS in SSc and the association of LDS with vascular complications, particularly pulmonary hypertension, in patients with SSc.</p><p><strong>Design, setting, and participants: </strong>This retrospective cohort study used prospectively collected longitudinal data from a cohort of patients from the multidisciplinary rheumatology and dermatology clinic at a single tertiary care center from November 2004 to November 2022. Adult patients (aged ≥18 years at the time of cohort entry) with SSc were included.</p><p><strong>Exposure: </strong>Clinical diagnosis of LDS based on expert opinion or histopathologic findings.</p><p><strong>Main outcomes and measures: </strong>The main outcomes included prevalence of LDS, the association of LDS with the macrovascular complications, including pulmonary hypertension, digital gangrene and/or scleroderma renal crisis. Disease complications, including cardiac arrhythmias and heart failure, were compared among patients with and without LDS.</p><p><strong>Results: </strong>Among 567 patients with SSc (494 [87.1%] female; mean [SD] age, 53.4 [14.4] years), 25 (4.4%) had LDS and 542 (95.6%) did not have LDS. Skin ulceration occurred in 8 patients with LDS (32.0%). Patients with LDS had higher frequencies of cardiac arrhythmia (11 of 24 [45.8%] vs 145 of 539 [26.9%]), heart failure (7 [28.0%] vs 55 [10.1%]), and pulmonary hypertension (12 [48.0%] vs 137 of 541 [25.3%]) compared with patients without LDS. Frequency of scleroderma renal crisis and digital gangrene did not differ significantly between patients with and without LDS (0 vs 37 [6.8%] and 4 [16.0%] vs 69 of 538 [12.8%], respectively). Among patients with LDS, 9 (36.0%) were either discharged to hospice or died during follow-up compared with 115 patients without LDS (21.2%). Lipodermatosclerosis was associated with pulmonary hypertension (adjusted prevalence odds ratio, 3.10; 95% CI, 1.33-7.25).</p><p><strong>Conclusions and relevance: </strong>In this cohort study, LDS was a rare clinical manifestation in patients with SSc but was associated with pulmonary hypertension. Therefore, patients with LDS should be closely monitored and screened for pulmonary hypertension.</p>","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":"1329-1333"},"PeriodicalIF":11.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11581578/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465896","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}