Pub Date : 2026-02-18DOI: 10.1001/jamadermatol.2025.6055
Matthias Augustin, Steven R Feldman, Richard B Warren, April Armstrong, Ronald Vender, Anna López-Ferrer, William H Dawe, Jérémy Lambert, Balint Szilagyi, Bengt Hoepken, Rhys Warham, Alice B Gottlieb
<p><strong>Importance: </strong>Patient-reported outcome (PRO) assessments alongside clinical parameters help to holistically determine treatment benefits.</p><p><strong>Objective: </strong>To assess PROs among bimekizumab-treated patients with moderate to severe plaque psoriasis.</p><p><strong>Design, setting, and participants: </strong>The BE RADIANT multicenter, phase 3b randomized clinical trial and open-label extension (OLE) had a 48-week double-blinded period and 96-week OLE (3 years' total treatment). Patients initially received bimekizumab or secukinumab. At year 1 (week 48/OLE entry), bimekizumab-randomized patients continued bimekizumab treatment (continuous bimekizumab-treated patients) and secukinumab-randomized patients switched to bimekizumab (secukinumab/bimekizumab-treated patients).</p><p><strong>Interventions: </strong>Continuous bimekizumab-treated patients received bimekizumab, 320 mg, every 4 weeks to week 16, then every 4 weeks or every 8 weeks to 1 year and into the OLE. Secukinumab/bimekizumab-treated patients received secukinumab, 300 mg, every 4 weeks to 1 year, then switched to bimekizumab, 320 mg, every 4 weeks or every 8 weeks. All received bimekizumab every 8 weeks by week 64.</p><p><strong>Main outcomes and measures: </strong>Patient-reported itching/skin pain/scaling (Psoriasis Symptoms and Impacts Measure [P-SIM]) and concurrent achievement of Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores are reported (nonresponder imputation to 1 year; modified nonresponder imputation to 1-3 years).</p><p><strong>Results: </strong>A total of 373 bimekizumab-treated and 370 secukinumab-treated patients were randomized at baseline; 336 and 318, respectively, entered the OLE. Among bimekizumab-randomized and secukinumab-randomized patients, 127 (34.0%) and 93 (25.1%) reported no itching; 278 (74.5%) and 222 (60.0%) no skin pain; and 172 (46.1%) and 80 (21.6%) no scaling at week 4, respectively; at year 1, rates remained higher in bimekizumab-randomized vs secukinumab-randomized patients (itching: 227 [60.9%] vs 178 [48.1%]; nominal P < .001; skin pain: 293 [78.6%] vs 262 [70.8%]; nominal P = .01; scaling: 263 [70.5%] vs 184 [49.7%]; nominal P < .001). Bimekizumab-randomized patients had greater concurrent achievement rates of PASI = 0 and DLQI 0/1 vs secukinumab-randomized patients (week 4: 43 [11.5%] vs 17 [4.6%]; nominal P < .001; year 1: 230 [61.7%] vs 158 [42.7%]; nominal P < .001). In patients entering the OLE, high P-SIM = 0 rates were maintained to year 3. At OLE entry, concurrent achievement of PASI = 0 and DLQI 0/1 was reported in 69.2% continuous bimekizumab-treated and 48.5% secukinumab/bimekizumab-treated patients. After switching, secukinumab/bimekizumab responses increased, and high rates were maintained to year 3 for both continuous bimekizumab and secukinumab/bimekizumab (62.2% and 63.8%, respectively).</p><p><strong>Conclusions and relevance: </strong>In this randomized cl
重要性：患者报告的结果（PRO）评估与临床参数一起有助于整体确定治疗益处。目的：评价比美珠单抗治疗中重度斑块型银屑病患者的PROs。设计，环境和参与者：BE RADIANT多中心，3b期随机临床试验和开放标签扩展（OLE）有48周的双盲期和96周的OLE（3年总治疗）。患者最初接受比美珠单抗或secukinumab治疗。在第1年（第48周/OLE进入期），比美单抗随机患者继续比美单抗治疗（持续比美单抗治疗患者），而secukinumab随机患者切换到比美单抗治疗（secukinumab/比美单抗治疗患者）。干预措施：持续比美单抗治疗的患者接受比美单抗，320 mg，每4周至第16周，然后每4周或每8周至1年进入OLE。Secukinumab/bimekizumab治疗的患者接受Secukinumab， 300毫克，每4周至1年，然后切换到比美珠单抗，320毫克，每4周或每8周。所有患者每8周接受一次比美珠单抗治疗，直至第64周。主要结局和测量方法：报告患者报告的瘙痒/皮肤疼痛/结屑（Psoriasis Symptoms and Impacts Measure [P-SIM]），同时报告银屑病面积和严重程度指数（PASI）和皮肤病生活质量指数（DLQI）评分的实现情况（1年无应答应答；1-3年修正无应答应答）。结果：共有373名接受比美单抗治疗的患者和370名接受secukinumab治疗的患者在基线时随机化；分别有336和318人进入OLE。在比美单抗随机组和塞肯单抗随机组患者中，127例（34.0%）和93例（25.1%）报告无瘙痒；无皮肤疼痛278例（74.5%），222例（60.0%）；第4周未结垢者分别为172例（46.1%）和80例（21.6%）；结论和相关性：在这项随机临床试验和OLE中，比美珠单抗快速和持久地改善了3年的症状/与健康相关的生活质量，表明临床疗效转化为生活质量的改善。secukinumab随机患者报告了改用比美珠单抗后的改善。试验注册：ClinicalTrials.gov标识符：NCT03536884。
{"title":"Three-Year Patient-Reported Outcomes From Bimekizumab for Plaque Psoriasis: The BE RADIANT Randomized Clinical Trial With Open-Label Extension.","authors":"Matthias Augustin, Steven R Feldman, Richard B Warren, April Armstrong, Ronald Vender, Anna López-Ferrer, William H Dawe, Jérémy Lambert, Balint Szilagyi, Bengt Hoepken, Rhys Warham, Alice B Gottlieb","doi":"10.1001/jamadermatol.2025.6055","DOIUrl":"10.1001/jamadermatol.2025.6055","url":null,"abstract":"<p><strong>Importance: </strong>Patient-reported outcome (PRO) assessments alongside clinical parameters help to holistically determine treatment benefits.</p><p><strong>Objective: </strong>To assess PROs among bimekizumab-treated patients with moderate to severe plaque psoriasis.</p><p><strong>Design, setting, and participants: </strong>The BE RADIANT multicenter, phase 3b randomized clinical trial and open-label extension (OLE) had a 48-week double-blinded period and 96-week OLE (3 years' total treatment). Patients initially received bimekizumab or secukinumab. At year 1 (week 48/OLE entry), bimekizumab-randomized patients continued bimekizumab treatment (continuous bimekizumab-treated patients) and secukinumab-randomized patients switched to bimekizumab (secukinumab/bimekizumab-treated patients).</p><p><strong>Interventions: </strong>Continuous bimekizumab-treated patients received bimekizumab, 320 mg, every 4 weeks to week 16, then every 4 weeks or every 8 weeks to 1 year and into the OLE. Secukinumab/bimekizumab-treated patients received secukinumab, 300 mg, every 4 weeks to 1 year, then switched to bimekizumab, 320 mg, every 4 weeks or every 8 weeks. All received bimekizumab every 8 weeks by week 64.</p><p><strong>Main outcomes and measures: </strong>Patient-reported itching/skin pain/scaling (Psoriasis Symptoms and Impacts Measure [P-SIM]) and concurrent achievement of Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores are reported (nonresponder imputation to 1 year; modified nonresponder imputation to 1-3 years).</p><p><strong>Results: </strong>A total of 373 bimekizumab-treated and 370 secukinumab-treated patients were randomized at baseline; 336 and 318, respectively, entered the OLE. Among bimekizumab-randomized and secukinumab-randomized patients, 127 (34.0%) and 93 (25.1%) reported no itching; 278 (74.5%) and 222 (60.0%) no skin pain; and 172 (46.1%) and 80 (21.6%) no scaling at week 4, respectively; at year 1, rates remained higher in bimekizumab-randomized vs secukinumab-randomized patients (itching: 227 [60.9%] vs 178 [48.1%]; nominal P < .001; skin pain: 293 [78.6%] vs 262 [70.8%]; nominal P = .01; scaling: 263 [70.5%] vs 184 [49.7%]; nominal P < .001). Bimekizumab-randomized patients had greater concurrent achievement rates of PASI = 0 and DLQI 0/1 vs secukinumab-randomized patients (week 4: 43 [11.5%] vs 17 [4.6%]; nominal P < .001; year 1: 230 [61.7%] vs 158 [42.7%]; nominal P < .001). In patients entering the OLE, high P-SIM = 0 rates were maintained to year 3. At OLE entry, concurrent achievement of PASI = 0 and DLQI 0/1 was reported in 69.2% continuous bimekizumab-treated and 48.5% secukinumab/bimekizumab-treated patients. After switching, secukinumab/bimekizumab responses increased, and high rates were maintained to year 3 for both continuous bimekizumab and secukinumab/bimekizumab (62.2% and 63.8%, respectively).</p><p><strong>Conclusions and relevance: </strong>In this randomized cl","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.0,"publicationDate":"2026-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12917748/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146219589","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 : 2026-02-18DOI: 10.1001/jamadermatol.2025.6094
Q Wilton Sun, Jeffrey M Cohen
{"title":"Racial and Ethnic Patterns in Continuity of Psoriasis Biologic Therapy in Medicaid Beneficiaries.","authors":"Q Wilton Sun, Jeffrey M Cohen","doi":"10.1001/jamadermatol.2025.6094","DOIUrl":"10.1001/jamadermatol.2025.6094","url":null,"abstract":"","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.0,"publicationDate":"2026-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12917739/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146219489","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 : 2026-02-11DOI: 10.1001/jamadermatol.2025.5912
Robyn Okereke, Wenelia Baghoomian, Rachel R Dunlap, Alex D Chang, Michael E Jacobson, Erin Foster, Milie M Fang, Eric L Simpson
Importance: Patient decision aids (PDAs) are tools that facilitate medical discourse between patients and clinicians, enabling patients to make informed choices among treatment options. While PDAs have been developed for other dermatologic conditions, to our knowledge, none exist for adults with atopic dermatitis (AD).
Objective: To develop a PDA that assists adult patients with moderate to severe AD in selecting systemic treatment options.
Design, setting, and participants: For this qualitative study, the PDA was developed per International Patient Decision Aid Standards Collaboration guidelines. The development process used a systematic approach following designated phases: scoping and design, prototype development, alpha testing, beta testing, and finalization. A steering group was used for all stages of development except for beta testing, which used participants outside of the steering group. The study was conducted from 2020 to 2025 at Oregon Health & Science University's Department of Dermatology in both in-person and virtual environments. The steering groups consisted of 10 adult patients with moderate to severe AD and 6 dermatology clinicians for prototype development, 8 patients and 5 clinicians for alpha testing, and 5 patients and 2 clinicians for finalization of the PDA (performed after beta testing, which included 8 new patients and 6 clinicians).
Main outcomes and measures: PDA content and quality assessments occurred through qualitative thematic analysis performed on open-ended feedback question responses from patients and clinicians.
Results: Among the 10 patients in the initial steering group, the mean (range) age was 38.7 (20-74) years, and 8 were female. Patients valued transparent and organized visual formatting, simplified language, and focused content themes, such as efficacy, dosing frequency, route of administration, relevant adverse effects, and relative costs. Dermatology clinicians prioritized laboratory monitoring, efficacy, and adverse effect data. Patients preferred simplicity, whereas clinicians preferred an emphasis on detail. The finalized International Patient Decision Aid Standards Collaboration-adherent PDA used a staged approach to balance these preferences.
Conclusions and relevance: This qualitative study supports prior findings that when formulating PDAs, authors should prioritize simplicity to enable patient comprehension in clinician-led discussions. This study found that a staged approach may help to deliver complex treatment information in a patient-centered manner, enhancing patient-clinician discussions, and facilitating shared decision-making in adults with AD.
{"title":"Development of a Patient Decision Aid for Atopic Dermatitis Systemic Treatments in Adults.","authors":"Robyn Okereke, Wenelia Baghoomian, Rachel R Dunlap, Alex D Chang, Michael E Jacobson, Erin Foster, Milie M Fang, Eric L Simpson","doi":"10.1001/jamadermatol.2025.5912","DOIUrl":"10.1001/jamadermatol.2025.5912","url":null,"abstract":"<p><strong>Importance: </strong>Patient decision aids (PDAs) are tools that facilitate medical discourse between patients and clinicians, enabling patients to make informed choices among treatment options. While PDAs have been developed for other dermatologic conditions, to our knowledge, none exist for adults with atopic dermatitis (AD).</p><p><strong>Objective: </strong>To develop a PDA that assists adult patients with moderate to severe AD in selecting systemic treatment options.</p><p><strong>Design, setting, and participants: </strong>For this qualitative study, the PDA was developed per International Patient Decision Aid Standards Collaboration guidelines. The development process used a systematic approach following designated phases: scoping and design, prototype development, alpha testing, beta testing, and finalization. A steering group was used for all stages of development except for beta testing, which used participants outside of the steering group. The study was conducted from 2020 to 2025 at Oregon Health & Science University's Department of Dermatology in both in-person and virtual environments. The steering groups consisted of 10 adult patients with moderate to severe AD and 6 dermatology clinicians for prototype development, 8 patients and 5 clinicians for alpha testing, and 5 patients and 2 clinicians for finalization of the PDA (performed after beta testing, which included 8 new patients and 6 clinicians).</p><p><strong>Main outcomes and measures: </strong>PDA content and quality assessments occurred through qualitative thematic analysis performed on open-ended feedback question responses from patients and clinicians.</p><p><strong>Results: </strong>Among the 10 patients in the initial steering group, the mean (range) age was 38.7 (20-74) years, and 8 were female. Patients valued transparent and organized visual formatting, simplified language, and focused content themes, such as efficacy, dosing frequency, route of administration, relevant adverse effects, and relative costs. Dermatology clinicians prioritized laboratory monitoring, efficacy, and adverse effect data. Patients preferred simplicity, whereas clinicians preferred an emphasis on detail. The finalized International Patient Decision Aid Standards Collaboration-adherent PDA used a staged approach to balance these preferences.</p><p><strong>Conclusions and relevance: </strong>This qualitative study supports prior findings that when formulating PDAs, authors should prioritize simplicity to enable patient comprehension in clinician-led discussions. This study found that a staged approach may help to deliver complex treatment information in a patient-centered manner, enhancing patient-clinician discussions, and facilitating shared decision-making in adults with AD.</p>","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.0,"publicationDate":"2026-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12895322/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146157126","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 : 2026-02-11DOI: 10.1001/jamadermatol.2025.5920
Alice Horisberger, Katharina S Shaw, Rochelle Castillo, Eilish Dillon, Kathryne E Marks, Ifeoluwakiisi Adejoorin, Emily G Oakes, Heather L Roland, Julia Caldropoli, Karen H Costenbader, Avery LaChance, Ruth Ann Vleugels, Deepak A Rao
{"title":"SIGLEC-1 Expression in a Cohort of Patients With Lupus Erythematosus Treated With Anifrolumab.","authors":"Alice Horisberger, Katharina S Shaw, Rochelle Castillo, Eilish Dillon, Kathryne E Marks, Ifeoluwakiisi Adejoorin, Emily G Oakes, Heather L Roland, Julia Caldropoli, Karen H Costenbader, Avery LaChance, Ruth Ann Vleugels, Deepak A Rao","doi":"10.1001/jamadermatol.2025.5920","DOIUrl":"10.1001/jamadermatol.2025.5920","url":null,"abstract":"","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":""},"PeriodicalIF":11.0,"publicationDate":"2026-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12895313/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146157102","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 : 2026-02-01DOI: 10.1001/jamadermatol.2025.4950
Sonja Ständer, Gil Yosipovitch, Howard Sofen, Daniel Abramzon, Joshua Galanter, Sheldon Wang, John F Paolini
<p><strong>Importance: </strong>Prurigo nodularis (PN) is a chronic inflammatory skin disease characterized by severe pruritus and nodule formation, significantly affecting patients' quality of life. There is an unmet need for effective therapies to address both symptoms and disease progression.</p><p><strong>Objective: </strong>To evaluate the efficacy, safety, tolerability, and pharmacokinetics of monthly dosed vixarelimab in participants with moderate to severe PN.</p><p><strong>Design, setting, and participants: </strong>This double-blind (DB), placebo-controlled, phase 2b randomized clinical trial was conducted from December 1, 2020, to August 24, 2023, across 72 centers in the US, Canada, Europe, and Asia. The study included male and female participants aged 18 to 80 years with physician-diagnosed PN of at least 6 months' duration and moderate to severe pruritus. Data were analyzed from October 2023 to March 2024.</p><p><strong>Interventions: </strong>Participants were randomized into 4 arms during the 16-week DB period: vixarelimab, 540 mg (high-dose group); vixarelimab, 360 mg (mid-dose group); vixarelimab, 120 mg (low-dose group); or placebo. Vixarelimab and placebo were administered subcutaneously every 4 weeks. During the 36-week open-label extension, all participants received vixarelimab, 360 mg, every 2 weeks.</p><p><strong>Main outcomes and measures: </strong>Key outcomes included percentage change from baseline in the Worst Itch Numeric Rating Scale (WI-NRS) at week 16, the proportion of participants achieving at least a 4-point reduction in WI-NRS at week 16, and the proportion achieving scores of 0 or 1 in the PN Investigator Global Assessment at week 16.</p><p><strong>Results: </strong>Of 190 randomized participants, 189 received 1 or more doses of the study drug (141 vixarelimab, 48 placebo). A total of 114 (60.3%) were female, 75 (39.7%) were male, and the mean (SD) age was 55.4 (13.8) years. There were 47 participants in the high-dose vixarelimab group, 47 in the mid-dose group, 47 in the low-dose group, and 48 in the placebo group. Vixarelimab significantly reduced mean (SE) WI-NRS scores at week 16 compared with placebo across all doses (vixarelimab at high-dose, mid-dose, and low-dose levels: -56.2% [4.84], -51.0% [4.83], and -33.0% [4.86], respectively; placebo, -14.5% [4.76]). Clinically meaningful 4-point or greater reductions in WI-NRS were achieved by 31 (66.0%), 29 (61.7%), and 14 (29.8%) in the high-dose, mid-dose, and low-dose vixarelimab groups, respectively, compared with 8 (16.7%) in the placebo group. PN Investigator Global Assessment scores of 0 or 1 were also higher in vixarelimab groups (high-dose group, 18 [38.3%]; mid-dose group, 14 [29.8%]; low-dose group, 7 [14.9%]; placebo group, 5 [10.4%]). No fatal or serious drug-related treatment-emergent adverse events were reported during the study, and no serious treatment-related treatment-emergent adverse events were observed during the DB period.</p><p><strong
{"title":"Vixarelimab in Patients With Prurigo Nodularis: A Randomized Clinical Trial.","authors":"Sonja Ständer, Gil Yosipovitch, Howard Sofen, Daniel Abramzon, Joshua Galanter, Sheldon Wang, John F Paolini","doi":"10.1001/jamadermatol.2025.4950","DOIUrl":"10.1001/jamadermatol.2025.4950","url":null,"abstract":"<p><strong>Importance: </strong>Prurigo nodularis (PN) is a chronic inflammatory skin disease characterized by severe pruritus and nodule formation, significantly affecting patients' quality of life. There is an unmet need for effective therapies to address both symptoms and disease progression.</p><p><strong>Objective: </strong>To evaluate the efficacy, safety, tolerability, and pharmacokinetics of monthly dosed vixarelimab in participants with moderate to severe PN.</p><p><strong>Design, setting, and participants: </strong>This double-blind (DB), placebo-controlled, phase 2b randomized clinical trial was conducted from December 1, 2020, to August 24, 2023, across 72 centers in the US, Canada, Europe, and Asia. The study included male and female participants aged 18 to 80 years with physician-diagnosed PN of at least 6 months' duration and moderate to severe pruritus. Data were analyzed from October 2023 to March 2024.</p><p><strong>Interventions: </strong>Participants were randomized into 4 arms during the 16-week DB period: vixarelimab, 540 mg (high-dose group); vixarelimab, 360 mg (mid-dose group); vixarelimab, 120 mg (low-dose group); or placebo. Vixarelimab and placebo were administered subcutaneously every 4 weeks. During the 36-week open-label extension, all participants received vixarelimab, 360 mg, every 2 weeks.</p><p><strong>Main outcomes and measures: </strong>Key outcomes included percentage change from baseline in the Worst Itch Numeric Rating Scale (WI-NRS) at week 16, the proportion of participants achieving at least a 4-point reduction in WI-NRS at week 16, and the proportion achieving scores of 0 or 1 in the PN Investigator Global Assessment at week 16.</p><p><strong>Results: </strong>Of 190 randomized participants, 189 received 1 or more doses of the study drug (141 vixarelimab, 48 placebo). A total of 114 (60.3%) were female, 75 (39.7%) were male, and the mean (SD) age was 55.4 (13.8) years. There were 47 participants in the high-dose vixarelimab group, 47 in the mid-dose group, 47 in the low-dose group, and 48 in the placebo group. Vixarelimab significantly reduced mean (SE) WI-NRS scores at week 16 compared with placebo across all doses (vixarelimab at high-dose, mid-dose, and low-dose levels: -56.2% [4.84], -51.0% [4.83], and -33.0% [4.86], respectively; placebo, -14.5% [4.76]). Clinically meaningful 4-point or greater reductions in WI-NRS were achieved by 31 (66.0%), 29 (61.7%), and 14 (29.8%) in the high-dose, mid-dose, and low-dose vixarelimab groups, respectively, compared with 8 (16.7%) in the placebo group. PN Investigator Global Assessment scores of 0 or 1 were also higher in vixarelimab groups (high-dose group, 18 [38.3%]; mid-dose group, 14 [29.8%]; low-dose group, 7 [14.9%]; placebo group, 5 [10.4%]). No fatal or serious drug-related treatment-emergent adverse events were reported during the study, and no serious treatment-related treatment-emergent adverse events were observed during the DB period.</p><p><strong","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":"133-141"},"PeriodicalIF":11.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12712829/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145768218","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 : 2026-02-01DOI: 10.1001/jamadermatol.2025.4892
Peyton V Warp, Karishma R Desai, Alvaro J Alencar, Jonathan J Cohen, Andrea D Maderal
{"title":"Zanubrutinib for Immunoglobulin A Vasculitis With Monoclonal Gammopathy.","authors":"Peyton V Warp, Karishma R Desai, Alvaro J Alencar, Jonathan J Cohen, Andrea D Maderal","doi":"10.1001/jamadermatol.2025.4892","DOIUrl":"10.1001/jamadermatol.2025.4892","url":null,"abstract":"","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":"212-214"},"PeriodicalIF":11.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145911553","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 : 2026-02-01DOI: 10.1001/jamadermatol.2025.4792
Deonna M Ackermann, Ellie Medcalf, Robin M Turner, Jolyn K Hersch, Monika Janda, Pascale Guitera, H Peter Soyer, Karen Bracken, Linda K Martin, Victoria Mar, Katy J L Bell
<p><strong>Importance: </strong>Patient-performed teledermoscopy may improve access to dermatologic care, but evidence to guide dermatoscope selection for patient use is limited.</p><p><strong>Objective: </strong>To compare a lower-cost, ambient-light, nonpolarized dermatoscope with a higher-cost, illuminated, polarized dermatoscope for patient-performed teledermoscopy following treatment for early-stage melanoma.</p><p><strong>Design, setting, and participants: </strong>This randomized study within a trial was embedded within the MEL-SELF trial and recruited adults previously treated for early-stage melanoma (American Joint Committee on Cancer stages 0-II) in the patient-led surveillance arm of MEL-SELF from specialist and general practitioner-led skin cancer clinics in Australia from December 2021 to June 2024 with 12-month follow-up. Data were analyzed from February 6, 2025, to August 15, 2025.</p><p><strong>Interventions: </strong>Participants were randomized (1:1) to receive a polarized (128 [51.0%]) or ambient-light (123 [49.0%]) dermatoscope smartphone attachment. Optional online training was provided. Participants submitted clinician-identified and self-detected lesion images via a secure teledermatology platform at 3-month intervals.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was the proportion of participants submitting baseline images of sufficient quality for a teledermatologist to provide a management recommendation. Secondary outcomes included the proportion receiving a management recommendation for at least 1 image during the study period, per-image recommendation proportions, device costs, and qualitative assessments of image quality and usability.</p><p><strong>Results: </strong>Of 251 participants (mean [SD] age, 56.0 [11.6] years; 147 female individuals [59%]), 175 (69.7%) received a teledermatologist management recommendation for baseline images (polarized: 92 [71.9%]; ambient light: 83 [67.5%]; difference, 4.4%; 95% CI, -7.0% to 15.8%). By 12 months, the proportion receiving at least 1 recommendation was similar between groups (polarized: 104 of 128 [81.3%]; ambient light: 94 of 123 [76.4%]; difference, 4.3%; 95% CI, -8.1% to 16.6%). However, a per-image analysis showed more polarized images (913 of 961 [95.0%]) than ambient-light images (706 of 775 [91.1%]) were reportable and supported a recommendation (difference, 3.9%; 95% CI, 1.5% to 6.3%; self-directed lesions: 6.8%; 95% CI, 3.3% to 10.2%). Teledermatologists provided more positive feedback for polarized images; blurriness (n = 14 vs 9) and poor lighting (n = 6 vs 0) were more frequent with ambient-light images. Patient usability ratings were similar (moderately/very easy: 39.8% vs 36.6%; difference, 3.2%; 95% CI, -8.8% to 15.3%), but ambient-light dermatoscope users reported more image quality issues. The polarized device was more expensive ($324.16 vs $35.40).</p><p><strong>Conclusions and relevance: </strong>The results of this study withi
重要性：患者进行的远镜检查可以改善皮肤科护理的可及性，但指导患者使用的远镜选择的证据有限。目的：比较低成本、环境光、非偏光的皮肤镜与高成本、照明、偏光的皮肤镜在早期黑色素瘤治疗后患者进行远镜检查的效果。设计、环境和参与者：该试验中的随机研究嵌入MEL-SELF试验中，招募了2021年12月至2024年6月期间在澳大利亚专科医生和全科医生主导的皮肤癌诊所接受过早期黑色素瘤（美国癌症0-II期联合委员会）患者主导的MEL-SELF监测组中接受过治疗的成年人，随访12个月。数据分析时间为2025年2月6日至2025年8月15日。干预措施：参与者随机（1:1）接受偏振光（128[51.0%]）或环境光（123[49.0%]）皮肤镜智能手机附件。提供了可选的在线培训。参与者每隔3个月通过安全的远程皮肤科平台提交临床识别和自我检测的病变图像。主要结果和测量：主要结果是参与者提交足够质量的基线图像的比例，以便远程皮肤科医生提供管理建议。次要结果包括在研究期间接受至少1张图像管理推荐的比例，每张图像推荐比例，设备成本以及图像质量和可用性的定性评估。结果：251名参与者（平均[SD]年龄56.0[11.6]岁；147名女性[59%]）中，175名（69.7%）接受了远程皮肤科医生的基线图像管理建议（偏光：92[71.9%]；环境光：83[67.5%]；差异为4.4%；95% CI为-7.0%至15.8%）。到12个月时，接受至少1项建议的比例在两组之间相似（偏光：128 / 104[81.3%]；环境光：123 / 94[76.4%]；差异为4.3%；95% CI为-8.1%至16.6%）。然而，单幅图像分析显示，报告的极化图像（961张中的913张[95.0%]）比环境光图像（775张中的706张[91.1%]）更多，并支持推荐（差异为3.9%;95% CI， 1.5%至6.3%；自定向病变：6.8%;95% CI， 3.3%至10.2%）。远程皮肤科医生对偏光图像提供了更多的积极反馈；模糊（n = 14 vs 9）和光线不足（n = 6 vs 0）在环境光图像中更为常见。患者可用性评分相似（中度/非常容易：39.8% vs 36.6%；差异，3.2%;95% CI, -8.8%到15.3%），但环境光皮肤镜用户报告了更多的图像质量问题。偏光装置更贵（324.16美元对35.40美元）。结论和相关性：本研究在一项试验中的结果表明，这两种设备使患者能够进行皮肤镜检查并接受远程皮肤病学建议。偏振器件的适度图像质量优势必须与其高得多的成本相权衡。试验注册：anzctr.org.au标识符：ACTRN12621000176864。
{"title":"Mobile Dermatoscope Type in Patient-Performed Teledermoscopy: A Study Within A Trial.","authors":"Deonna M Ackermann, Ellie Medcalf, Robin M Turner, Jolyn K Hersch, Monika Janda, Pascale Guitera, H Peter Soyer, Karen Bracken, Linda K Martin, Victoria Mar, Katy J L Bell","doi":"10.1001/jamadermatol.2025.4792","DOIUrl":"10.1001/jamadermatol.2025.4792","url":null,"abstract":"<p><strong>Importance: </strong>Patient-performed teledermoscopy may improve access to dermatologic care, but evidence to guide dermatoscope selection for patient use is limited.</p><p><strong>Objective: </strong>To compare a lower-cost, ambient-light, nonpolarized dermatoscope with a higher-cost, illuminated, polarized dermatoscope for patient-performed teledermoscopy following treatment for early-stage melanoma.</p><p><strong>Design, setting, and participants: </strong>This randomized study within a trial was embedded within the MEL-SELF trial and recruited adults previously treated for early-stage melanoma (American Joint Committee on Cancer stages 0-II) in the patient-led surveillance arm of MEL-SELF from specialist and general practitioner-led skin cancer clinics in Australia from December 2021 to June 2024 with 12-month follow-up. Data were analyzed from February 6, 2025, to August 15, 2025.</p><p><strong>Interventions: </strong>Participants were randomized (1:1) to receive a polarized (128 [51.0%]) or ambient-light (123 [49.0%]) dermatoscope smartphone attachment. Optional online training was provided. Participants submitted clinician-identified and self-detected lesion images via a secure teledermatology platform at 3-month intervals.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was the proportion of participants submitting baseline images of sufficient quality for a teledermatologist to provide a management recommendation. Secondary outcomes included the proportion receiving a management recommendation for at least 1 image during the study period, per-image recommendation proportions, device costs, and qualitative assessments of image quality and usability.</p><p><strong>Results: </strong>Of 251 participants (mean [SD] age, 56.0 [11.6] years; 147 female individuals [59%]), 175 (69.7%) received a teledermatologist management recommendation for baseline images (polarized: 92 [71.9%]; ambient light: 83 [67.5%]; difference, 4.4%; 95% CI, -7.0% to 15.8%). By 12 months, the proportion receiving at least 1 recommendation was similar between groups (polarized: 104 of 128 [81.3%]; ambient light: 94 of 123 [76.4%]; difference, 4.3%; 95% CI, -8.1% to 16.6%). However, a per-image analysis showed more polarized images (913 of 961 [95.0%]) than ambient-light images (706 of 775 [91.1%]) were reportable and supported a recommendation (difference, 3.9%; 95% CI, 1.5% to 6.3%; self-directed lesions: 6.8%; 95% CI, 3.3% to 10.2%). Teledermatologists provided more positive feedback for polarized images; blurriness (n = 14 vs 9) and poor lighting (n = 6 vs 0) were more frequent with ambient-light images. Patient usability ratings were similar (moderately/very easy: 39.8% vs 36.6%; difference, 3.2%; 95% CI, -8.8% to 15.3%), but ambient-light dermatoscope users reported more image quality issues. The polarized device was more expensive ($324.16 vs $35.40).</p><p><strong>Conclusions and relevance: </strong>The results of this study withi","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":"124-132"},"PeriodicalIF":11.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12676473/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145668078","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 : 2026-02-01DOI: 10.1001/jamadermatol.2025.5205
Christopher Willy Schwarz, Nikolai Loft, Lars Erik Bryld, Christoffer Valdemar Nissen, Kawa Khaled Ajgeiy, Trine Bertelsen, Kasper Fjellhaugen Hjuler, Tomas Norman Dam, Lars Iversen, Mads Kirchheiner Rasmussen, Lone Skov
<p><strong>Importance: </strong>Drug survival is an important measure to help guide treatment selection. However, clinical evidence for newer biologics, including bimekizumab, is limited.</p><p><strong>Objective: </strong>To determine the drug survival of biologics used for treating psoriasis in a routine clinical practice setting.</p><p><strong>Design, setting, and participants: </strong>This cohort study was based on data from the DERMBIO registry, which includes all patients treated with biologics for psoriasis in Denmark. All adult patients enrolled in DERMBIO from its inception in May 2007 until June 2025 were assessed for eligibility. Data were extracted in June 2025 and analyzed separately among those without previous biologic exposure (bionaive patients) and those with previous biologic exposure (bioexperienced patients).</p><p><strong>Exposures: </strong>Adalimumab, secukinumab, and ustekinumab among bionaive patients and adalimumab, bimekizumab, brodalumab, guselkumab, ixekizumab, risankizumab, secukinumab, and ustekinumab among bioexperienced patients.</p><p><strong>Main outcomes and measures: </strong>The main outcome was standardized absolute risks of treatment discontinuation at 1, 2, and 5 years. Kaplan-Meier estimator was used to determine crude drug survival estimates and the Aalen-Johansen estimator was used to determine crude cause-specific absolute risks.</p><p><strong>Results: </strong>The study included 4438 unique patients with psoriasis (2717 [61.2%] male; mean [SD] age, 45.0 [14.6] years at the time of their first treatment included in the study), 1039 (23.4%) of whom had comorbid psoriatic arthritis. A total of 3790 treatment series from bionaive patients were analyzed: 2646 were with adalimumab, 377 with secukinumab, and 767 with ustekinumab. The 5-year standardized risk of discontinuing ustekinumab was 0.37 (95% CI, 0.33-0.41), which was significantly lower than the standardized risks for adalimumab (0.51; 95% CI, 0.49-0.54) and secukinumab (0.54; 95% CI, 0.48-0.60). A total of 3403 treatment series from bioexperienced patients were analyzed: 790 were with adalimumab, 376 with bimekizumab, 192 with brodalumab, 218 with guselkumab, 556 with ixekizumab, 78 with risankizumab, 466 with secukinumab, and 727 with ustekinumab. The 2-year standardized absolute risk of discontinuing ustekinumab was 0.39 (95% CI, 0.36-0.43). Only bimekizumab (0.27; 95% CI, 0.20-0.34), guselkumab (0.29; 95% CI, 0.22-0.36), and risankizumab (0.25; 95% CI, 0.15-0.36) were associated with a significantly lower standardized absolute risk of discontinuation compared with ustekinumab.</p><p><strong>Conclusions and relevance: </strong>In this cohort study in Denmark, among bionaive patients with psoriasis, ustekinumab had superior drug survival compared with adalimumab and secukinumab, and among bioexperienced patients with psoriasis, bimekizumab, guselkumab, and risankizumab had superior drug survival. These results offer insight into the performance o
{"title":"Drug Survival of Biologics in Bionaive and Bioexperienced Patients With Psoriasis.","authors":"Christopher Willy Schwarz, Nikolai Loft, Lars Erik Bryld, Christoffer Valdemar Nissen, Kawa Khaled Ajgeiy, Trine Bertelsen, Kasper Fjellhaugen Hjuler, Tomas Norman Dam, Lars Iversen, Mads Kirchheiner Rasmussen, Lone Skov","doi":"10.1001/jamadermatol.2025.5205","DOIUrl":"10.1001/jamadermatol.2025.5205","url":null,"abstract":"<p><strong>Importance: </strong>Drug survival is an important measure to help guide treatment selection. However, clinical evidence for newer biologics, including bimekizumab, is limited.</p><p><strong>Objective: </strong>To determine the drug survival of biologics used for treating psoriasis in a routine clinical practice setting.</p><p><strong>Design, setting, and participants: </strong>This cohort study was based on data from the DERMBIO registry, which includes all patients treated with biologics for psoriasis in Denmark. All adult patients enrolled in DERMBIO from its inception in May 2007 until June 2025 were assessed for eligibility. Data were extracted in June 2025 and analyzed separately among those without previous biologic exposure (bionaive patients) and those with previous biologic exposure (bioexperienced patients).</p><p><strong>Exposures: </strong>Adalimumab, secukinumab, and ustekinumab among bionaive patients and adalimumab, bimekizumab, brodalumab, guselkumab, ixekizumab, risankizumab, secukinumab, and ustekinumab among bioexperienced patients.</p><p><strong>Main outcomes and measures: </strong>The main outcome was standardized absolute risks of treatment discontinuation at 1, 2, and 5 years. Kaplan-Meier estimator was used to determine crude drug survival estimates and the Aalen-Johansen estimator was used to determine crude cause-specific absolute risks.</p><p><strong>Results: </strong>The study included 4438 unique patients with psoriasis (2717 [61.2%] male; mean [SD] age, 45.0 [14.6] years at the time of their first treatment included in the study), 1039 (23.4%) of whom had comorbid psoriatic arthritis. A total of 3790 treatment series from bionaive patients were analyzed: 2646 were with adalimumab, 377 with secukinumab, and 767 with ustekinumab. The 5-year standardized risk of discontinuing ustekinumab was 0.37 (95% CI, 0.33-0.41), which was significantly lower than the standardized risks for adalimumab (0.51; 95% CI, 0.49-0.54) and secukinumab (0.54; 95% CI, 0.48-0.60). A total of 3403 treatment series from bioexperienced patients were analyzed: 790 were with adalimumab, 376 with bimekizumab, 192 with brodalumab, 218 with guselkumab, 556 with ixekizumab, 78 with risankizumab, 466 with secukinumab, and 727 with ustekinumab. The 2-year standardized absolute risk of discontinuing ustekinumab was 0.39 (95% CI, 0.36-0.43). Only bimekizumab (0.27; 95% CI, 0.20-0.34), guselkumab (0.29; 95% CI, 0.22-0.36), and risankizumab (0.25; 95% CI, 0.15-0.36) were associated with a significantly lower standardized absolute risk of discontinuation compared with ustekinumab.</p><p><strong>Conclusions and relevance: </strong>In this cohort study in Denmark, among bionaive patients with psoriasis, ustekinumab had superior drug survival compared with adalimumab and secukinumab, and among bioexperienced patients with psoriasis, bimekizumab, guselkumab, and risankizumab had superior drug survival. These results offer insight into the performance o","PeriodicalId":14734,"journal":{"name":"JAMA dermatology","volume":" ","pages":"166-175"},"PeriodicalIF":11.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12780981/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145911482","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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