Jonathan I Silverberg, Christopher G Bunick, H Chih-Ho Hong, Pedro Mendes-Bastos, Linda Stein Gold, Antonio Costanzo, Nadia Ibrahim, Cristina Sancho, Xiaoqiang Wu, Yu Han, Gweneth Levy, Kathy Altman, Brian Calimlim, Kilian Eyerich
{"title":"Efficacy and safety of upadacitinib versus dupilumab in adults and adolescents with moderate-to-severe atopic dermatitis: week 16 results of an open-label randomized efficacy assessor-blinded head-to-head phase IIIb/IV study (Level Up).","authors":"Jonathan I Silverberg, Christopher G Bunick, H Chih-Ho Hong, Pedro Mendes-Bastos, Linda Stein Gold, Antonio Costanzo, Nadia Ibrahim, Cristina Sancho, Xiaoqiang Wu, Yu Han, Gweneth Levy, Kathy Altman, Brian Calimlim, Kilian Eyerich","doi":"10.1093/bjd/ljae404","DOIUrl":"10.1093/bjd/ljae404","url":null,"abstract":"<p><strong>Background: </strong>Atopic dermatitis (AD) is a chronic skin disease characterized by intense itch and eczematous skin lesions. Some patients with AD continue to experience flares and substantial clinical burden, despite ongoing systemic treatment.</p><p><strong>Objectives: </strong>To assess the efficacy and safety of once-daily upadacitinib (UPA), initiated at 15 mg and dose-escalated to 30 mg based on clinical response, compared with dupilumab (DUPI) as per its label, and present the week 16 primary analysis results.</p><p><strong>Methods: </strong>Level Up is a phase IIIb/IV global randomized open-label efficacy assessor-blinded study evaluating UPA vs. DUPI in adolescents and adults with moderate-to-severe AD who had an inadequate response to systemic therapy or when use was inadvisable. Patients were randomized to UPA or DUPI for 16 weeks of treatment (period 1). Patients on UPA were started on 15 mg and dose-escalated to 30 mg if they did not achieve an Eczema Area and Severity Index reduction of at least 50% (EASI 50) or a ≥ 4-point Worst Pruritus Numerical Rating Scale (WP-NRS) improvement on or after week 4, or an EASI reduction of at least 75% (EASI 75) on or after week 8. The primary endpoint was simultaneous achievement of an EASI reduction of at least 90% (EASI 90) and WP-NRS 0/1 at week 16. Ranked secondary endpoints included skin and itch responses at varying response levels and timepoints. Safety measures were assessed throughout the study.</p><p><strong>Results: </strong>Superior efficacy in achieving simultaneous EASI 90 and WP-NRS 0/1 response at week 16 was demonstrated with UPA vs. DUPI (19.9% vs 8.9%, respectively; P < 0.001). UPA showed superiority over DUPI for all ranked secondary endpoints, with post hoc analyses exhibiting higher itch response rates as early as day 2. No new safety signals were identified in this period.</p><p><strong>Conclusions: </strong>Treatment of moderate-to-severe AD with UPA, initiated at 15 mg and dose-escalated based on clinical response, demonstrated superiority over DUPI per its label for the primary endpoint of simultaneous achievement of near-complete skin clearance (EASI 90) and little-to-no itch (WP-NRS 0/1) at week 16, with all ranked secondary endpoints demonstrating superiority at varying skin and itch response levels and timepoints. No new safety signals were identified vs. the previously reported safety profiles of UPA and DUPI.</p>","PeriodicalId":9238,"journal":{"name":"British Journal of Dermatology","volume":" ","pages":"36-45"},"PeriodicalIF":11.0,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142495464","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}
Fanny C Kpenou, Carle Paul, Julien Seneschal, Nicolas Andreu, Sébastien Barbarot, Marie Tauber, Pierre-André Natella, Jason Shourick, Khaled Ezzedine
{"title":"The atopic dermatitis patient journey: insights from a qualitative study.","authors":"Fanny C Kpenou, Carle Paul, Julien Seneschal, Nicolas Andreu, Sébastien Barbarot, Marie Tauber, Pierre-André Natella, Jason Shourick, Khaled Ezzedine","doi":"10.1093/bjd/ljae329","DOIUrl":"10.1093/bjd/ljae329","url":null,"abstract":"","PeriodicalId":9238,"journal":{"name":"British Journal of Dermatology","volume":" ","pages":"162-163"},"PeriodicalIF":11.0,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141999423","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}
Alia Ahmed, Padma Mohandas, Ruth Taylor, Iyas Assalman, Anthony Bewley
{"title":"'Psycholag': a new term to describe the delay between physical and psychological improvement in patients with skin disease.","authors":"Alia Ahmed, Padma Mohandas, Ruth Taylor, Iyas Assalman, Anthony Bewley","doi":"10.1093/bjd/ljae333","DOIUrl":"10.1093/bjd/ljae333","url":null,"abstract":"","PeriodicalId":9238,"journal":{"name":"British Journal of Dermatology","volume":" ","pages":"1-3"},"PeriodicalIF":11.0,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142035314","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}
Mackenzie O Gipple, Ramneek K Dhami, Emile Latour, Jesse J Keller
{"title":"Patients with Morgellons disease have a lower quality of life than patients with psoriasis, atopic dermatitis and prurigo nodularis.","authors":"Mackenzie O Gipple, Ramneek K Dhami, Emile Latour, Jesse J Keller","doi":"10.1093/bjd/ljae335","DOIUrl":"10.1093/bjd/ljae335","url":null,"abstract":"","PeriodicalId":9238,"journal":{"name":"British Journal of Dermatology","volume":" ","pages":"163-165"},"PeriodicalIF":11.0,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142016429","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}
Heidi Oi-Yee Li, Elena Pastukhova, Olivier Brandts-Longtin, Adrian Bailey, Marcus G Tan, Mark G Kirchhof
{"title":"Sexual dysfunction following retinoid treatment: a systematic review.","authors":"Heidi Oi-Yee Li, Elena Pastukhova, Olivier Brandts-Longtin, Adrian Bailey, Marcus G Tan, Mark G Kirchhof","doi":"10.1093/bjd/ljae361","DOIUrl":"10.1093/bjd/ljae361","url":null,"abstract":"","PeriodicalId":9238,"journal":{"name":"British Journal of Dermatology","volume":" ","pages":"175-177"},"PeriodicalIF":11.0,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142280495","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":"Levelling up outcomes in atopic dermatitis through personalized dosing of upadacitinib.","authors":"John S Barbieri","doi":"10.1093/bjd/ljae410","DOIUrl":"10.1093/bjd/ljae410","url":null,"abstract":"","PeriodicalId":9238,"journal":{"name":"British Journal of Dermatology","volume":" ","pages":"5"},"PeriodicalIF":11.0,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142458451","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}
Delwyn Zhi Jie Lim, Yong Yao Chun, Faith Nicole Shih Yun Tan, Amelia Yuting Monteiro, Hui Mei Cheng, Jia Yi Lee, Yingrou Tan, Timothy T Y Tan, Hong Liang Tey
{"title":"Small interfering RNA microneedle patches versus silicone sheets in reducing postoperative scars: a randomized single-blinded intraindividually controlled clinical trial.","authors":"Delwyn Zhi Jie Lim, Yong Yao Chun, Faith Nicole Shih Yun Tan, Amelia Yuting Monteiro, Hui Mei Cheng, Jia Yi Lee, Yingrou Tan, Timothy T Y Tan, Hong Liang Tey","doi":"10.1093/bjd/ljae347","DOIUrl":"10.1093/bjd/ljae347","url":null,"abstract":"<p><strong>Background: </strong>A common complication of wounds is the excessive production of fibrotic scar tissue, which can lead to hypertrophic scars or keloids. Currently, no treatments with good evidence for preventing excessive scar tissue formation are available. We explored the use of microneedle patches containing small interfering RNA (siRNA) to inhibit SPARC mRNA in reducing the volume of postoperative scars.</p><p><strong>Objectives: </strong>To compare differences in postoperative scar volume with the daily application of siRNA-embedded dissolving microneedle patches vs. silicone sheets.</p><p><strong>Methods: </strong>This was an 8-week, single-blinded intraindividually controlled randomized trial at a tertiary dermatological centre. Patients with 2-week-old postoperative wounds were included. Each half of the scar was randomly assigned to the microneedle patch or silicone sheet. Three-dimensional (3D) volumes were obtained from the scars via a high-resolution scanner at days 0, 30 and 60. The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12622000558729).</p><p><strong>Results: </strong>At day 30, scars treated with microneedle patches had a lower geometric mean volume of 0.79 mm3 vs. scars treated with silicone sheets, with a difference in mean percentage volume reduction of 10.7%. At day 60, scars treated with microneedle patches had a statistically significant lower volume (8.88 mm3) compared with the side treated with silicone sheets (12.77 mm3; P = 0.005), with a difference in mean percentage reduction of 9.7%. Additionally, there was also a statistically significant difference between the percentage reduction in scar volume vs. baseline on the side treated with microneedle patches (mean 83.8%) compared with the side treated with silicone sheets (mean 74.1%).</p><p><strong>Conclusions: </strong>There was a significantly greater reduction in the volume of postoperative scars on the side of the scar treated with microneedle patches compared with the side treated with silicone sheets. This demonstrates the use of transdermal gene-silencing technology in scar inhibition and that siRNA microneedle patches can be effective and safe in reducing scar tissue formation.</p>","PeriodicalId":9238,"journal":{"name":"British Journal of Dermatology","volume":" ","pages":"19-26"},"PeriodicalIF":11.0,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142124875","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}
Viktoria Eleftheriadou, Alia Ahmed, John Nesnas, Ranjit Nagra
{"title":"The lifetime risk and impact of vitiligo across sociodemographic groups: a UK population-based cohort study.","authors":"Viktoria Eleftheriadou, Alia Ahmed, John Nesnas, Ranjit Nagra","doi":"10.1093/bjd/ljae282","DOIUrl":"10.1093/bjd/ljae282","url":null,"abstract":"<p><strong>Background: </strong>Vitiligo is an autoimmune skin disorder characterized by depigmented patches of skin, which can have significant psychological impacts.</p><p><strong>Objectives: </strong>To estimate the lifetime incidence of vitiligo, overall, by ethnicity and across other sociodemographic subgroups, and to investigate the impacts of vitiligo on mental health, work and healthcare utilization.</p><p><strong>Methods: </strong>Incident cases of vitiligo were identified in the Optimum Patient Care Database of primary care records in the UK between 1 January 2004 and 31 December 2020. The lifetime incidence of vitiligo was estimated at age 80 years using modified time-to-event models with age as the timescale, overall and stratified by ethnicity, sex and deprivation. Depression, anxiety, sleep disturbance, healthcare utilization and work-related outcomes were assessed in the 2 years after vitiligo diagnosis and compared with matched controls without vitiligo. The study protocol for this retrospective observational study was registered with ClinicalTrials.gov (NCT06097494).</p><p><strong>Results: </strong>In total, 9460 adults and children were newly diagnosed with vitiligo during the study period. The overall cumulative lifetime incidence was 0.92% at 80 years of age [95% confidence interval (CI) 0.90-0.94]. Cumulative incidence was similar in female (0.94%, 95% CI 0.92-0.97) and male patients (0.89%, 95% CI 0.86-0.92). There were substantial differences in lifetime incidence across ethnic groups, listed by Office for National Statistics criteria [Asian 3.58% (95% CI 3.38-3.78); Black 2.18% (95% CI 1.85-2.50); Mixed/multiple 2.03% (95% CI 1.58-2.47); Other 1.05% (95% CI 0.94-1.17); and White 0.73% (95% CI 0.71-0.76)]. Compared with matched controls, people with vitiligo had an increased risk of depression [adjusted odds ratio (aOR) 1.08, 95% CI 1.01-1.15]; anxiety (aOR 1.19, 95% CI 1.09-1.30); depression or anxiety (aOR 1.10, 95% CI 1.03-1.17); and sleep disturbance [adjusted hazard ratio (aHR) 1.15, 95% CI 1.02-1.31]. People with vitiligo also had a greater number of primary care encounters (adjusted incidence rate ratio 1.29, 95% CI 1.26-1.32) and a greater risk of time off work (aHR 1.15, 95% CI 1.06-1.24). There was little evidence of disparities in vitiligo-related impacts across ethnic subgroups.</p><p><strong>Conclusions: </strong>Clinicians should be aware of the markedly increased incidence of vitiligo in people belonging to Asian, Black, Mixed/multiple and Other groups. The negative impact of vitiligo on mental health, work and healthcare utilization highlights the importance of monitoring people with vitiligo to identify those who need additional support.</p>","PeriodicalId":9238,"journal":{"name":"British Journal of Dermatology","volume":" ","pages":"63-71"},"PeriodicalIF":11.0,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141626012","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}
Cristina Grechin, Li Jie Helena Yoo, Stephanie Lynn Ryan, Síona Ní Raghallaigh
{"title":"Mycosis fungoides: an unwelcome guest in my life.","authors":"Cristina Grechin, Li Jie Helena Yoo, Stephanie Lynn Ryan, Síona Ní Raghallaigh","doi":"10.1093/bjd/ljae349","DOIUrl":"10.1093/bjd/ljae349","url":null,"abstract":"","PeriodicalId":9238,"journal":{"name":"British Journal of Dermatology","volume":" ","pages":"152-153"},"PeriodicalIF":11.0,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142124874","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}