Pub Date : 2025-12-04DOI: 10.1016/j.ad.2025.104522
M. Zhou , M. Mansilla-Polo , P. Fernandez-Peñas
Chronic graft-versus-host disease (cGVHD) is a major multiple organ complication of allogeneic hematopoietic stem cell transplantation, and skin involvement is associated with substantial mortality, morbidity and reduction in quality of life. However, more than half of patients are refractory to current first-line therapy and there is still a lack of high-level evidence regarding alternative therapeutic agents. This systematic review was conducted by two independent reviewers who searched and screened records published from database inception to May 2024 in PubMed, Embase, and the Cochrane Central Register of Controlled Trials, using prespecified inclusion and exclusion criteria aligned with the study objective. Two reviewers assessed the risk of bias and quality of evidence of trials eligible for review. Seven randomized controlled trials of extracorporeal photopheresis (ECP) with standard therapy, imatinib, entospletinib with prednisone, ruxolitinib, and ibrutinib with prednisone were eligible for inclusion. Ruxolitinib demonstrated superiority versus standard therapy and placebo with an overall response rate of 41.5% and a reduction in body surface area affected from 14.5% down to 6.2%. No other treatments conferred a statistically significant benefit versus standard therapy or placebo. Entospletinib was markedly inferior to placebo. Although all 7 trials demonstrated some risk of bias, they were found to have a moderate-to-high quality of evidence. In conclusion, of all therapeutic agents reviewed, only ruxolitinib demonstrated high-level evidence of a modest efficacy in treating cutaneous cGVHD and should be considered as a line of therapy in addition to current first-line therapy. Further high-level studies are needed to identify alternative therapeutic agents and validate their efficacy profile.
{"title":"A Systematic Review of Treatments for Cutaneous Chronic Graft-versus-Host Disease","authors":"M. Zhou , M. Mansilla-Polo , P. Fernandez-Peñas","doi":"10.1016/j.ad.2025.104522","DOIUrl":"10.1016/j.ad.2025.104522","url":null,"abstract":"<div><div>Chronic graft-versus-host disease (cGVHD) is a major multiple organ complication of allogeneic hematopoietic stem cell transplantation, and skin involvement is associated with substantial mortality, morbidity and reduction in quality of life. However, more than half of patients are refractory to current first-line therapy and there is still a lack of high-level evidence regarding alternative therapeutic agents. This systematic review was conducted by two independent reviewers who searched and screened records published from database inception to May 2024 in PubMed, Embase, and the Cochrane Central Register of Controlled Trials, using prespecified inclusion and exclusion criteria aligned with the study objective. Two reviewers assessed the risk of bias and quality of evidence of trials eligible for review. Seven randomized controlled trials of extracorporeal photopheresis (ECP) with standard therapy, imatinib, entospletinib with prednisone, ruxolitinib, and ibrutinib with prednisone were eligible for inclusion. Ruxolitinib demonstrated superiority versus standard therapy and placebo with an overall response rate of 41.5% and a reduction in body surface area affected from 14.5% down to 6.2%. No other treatments conferred a statistically significant benefit versus standard therapy or placebo. Entospletinib was markedly inferior to placebo. Although all 7 trials demonstrated some risk of bias, they were found to have a moderate-to-high quality of evidence. In conclusion, of all therapeutic agents reviewed, only ruxolitinib demonstrated high-level evidence of a modest efficacy in treating cutaneous cGVHD and should be considered as a line of therapy in addition to current first-line therapy. Further high-level studies are needed to identify alternative therapeutic agents and validate their efficacy profile.</div></div>","PeriodicalId":7173,"journal":{"name":"Actas dermo-sifiliograficas","volume":"117 2","pages":"Article 104522"},"PeriodicalIF":2.8,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145695692","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-04DOI: 10.1016/j.ad.2025.104524
S Beà Ardébol, G M Pérez Pastor, R Fernández-de-Misa, R Botella Estrada, V Ruiz-Salas, Á Flórez, M Mayor Arenal, M J Fuente González, P Bassas-Freixas, A Toll Abelló, P Valerón Almazán, R Arntz, J Malvehy Guilera
Background: This study aims to present an interim analysis of safety data from the Spanish cohort of the NISSO post-authorization safety study on the long-term tolerability of sonidegib in patients with locally advanced basal cell carcinoma (laBCC ).
Methods: NISSO is a non-interventional, multinational, post-authorization safety study (NCT04066504). Patients with laBCC were administered sonidegib 200 mg/day and monitored for 3 years. Dose adjustments were permitted according to the Spanish prescribing information.
Results: Between January 8th, 2021, and March 7th, 2022, a total of 51 patients with laBCC were enrolled in the study in Spain (data cut June 22nd, 2023). Treatment was discontinued in 39 patients (76.5%), primarily due to treatment success (n = 11, 21.6%), patient or guardian decision (n = 8, 15.7%), and physician decision (n = 8, 15.7%). The median duration of exposure was 6.5 months (IQR, 5.69-11.91 months). A total of 45 (88.2%) patients experienced at least one treatment-emergent adverse event (TEAE). The most common TEAEs were muscle spasms (n = 23, 45.1%), alopecia (n = 23, 45.1%), and dysgeusia (n = 23, 45.1%). Cumulative rates of the above-mentioned TEAEs at 3 months were 27.5%, 11.8%, and 29.4%, respectively. Most TEAEs were grade ≤ 2. TEAEs led to treatment discontinuation in 10 patients (19.6%), while 8 (15.7%) required dose modifications due to adverse events. Serious drug-related TEAEs were reported in 2 patients (3.9%).
Conclusions: Most patients experienced grade ≤ 2 common TEAEs, such as muscle spasms, dysgeusia, and alopecia that mostly manifested 3 months into therapy. These interim results confirm the safety profile observed in the BOLT study, demonstrating that sonidegib is well-tolerated in a real-world setting in Spain.
{"title":"Postauthorization safety study (NISSO) assessing the long-term safety profile of sonidegib in patients with locally advanced basal cell carcinoma: interim analysis from the Spanish cohort.","authors":"S Beà Ardébol, G M Pérez Pastor, R Fernández-de-Misa, R Botella Estrada, V Ruiz-Salas, Á Flórez, M Mayor Arenal, M J Fuente González, P Bassas-Freixas, A Toll Abelló, P Valerón Almazán, R Arntz, J Malvehy Guilera","doi":"10.1016/j.ad.2025.104524","DOIUrl":"https://doi.org/10.1016/j.ad.2025.104524","url":null,"abstract":"<p><strong>Background: </strong>This study aims to present an interim analysis of safety data from the Spanish cohort of the NISSO post-authorization safety study on the long-term tolerability of sonidegib in patients with locally advanced basal cell carcinoma (laBCC ).</p><p><strong>Methods: </strong>NISSO is a non-interventional, multinational, post-authorization safety study (NCT04066504). Patients with laBCC were administered sonidegib 200 mg/day and monitored for 3 years. Dose adjustments were permitted according to the Spanish prescribing information.</p><p><strong>Results: </strong>Between January 8<sup>th</sup>, 2021, and March 7<sup>th</sup>, 2022, a total of 51 patients with laBCC were enrolled in the study in Spain (data cut June 22<sup>nd</sup>, 2023). Treatment was discontinued in 39 patients (76.5%), primarily due to treatment success (n = 11, 21.6%), patient or guardian decision (n = 8, 15.7%), and physician decision (n = 8, 15.7%). The median duration of exposure was 6.5 months (IQR, 5.69-11.91 months). A total of 45 (88.2%) patients experienced at least one treatment-emergent adverse event (TEAE). The most common TEAEs were muscle spasms (n = 23, 45.1%), alopecia (n = 23, 45.1%), and dysgeusia (n = 23, 45.1%). Cumulative rates of the above-mentioned TEAEs at 3 months were 27.5%, 11.8%, and 29.4%, respectively. Most TEAEs were grade ≤ 2. TEAEs led to treatment discontinuation in 10 patients (19.6%), while 8 (15.7%) required dose modifications due to adverse events. Serious drug-related TEAEs were reported in 2 patients (3.9%).</p><p><strong>Conclusions: </strong>Most patients experienced grade ≤ 2 common TEAEs, such as muscle spasms, dysgeusia, and alopecia that mostly manifested 3 months into therapy. These interim results confirm the safety profile observed in the BOLT study, demonstrating that sonidegib is well-tolerated in a real-world setting in Spain.</p>","PeriodicalId":7173,"journal":{"name":"Actas dermo-sifiliograficas","volume":" ","pages":"104524"},"PeriodicalIF":2.8,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145695675","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-03DOI: 10.1016/j.ad.2025.104502
P. López Sanz , D. Barco
{"title":"CO2 Laser Ablation for Multiple Miliary Osteoma Cutis: Diagnostic and Procedural Role of the “Spark Sign”","authors":"P. López Sanz , D. Barco","doi":"10.1016/j.ad.2025.104502","DOIUrl":"10.1016/j.ad.2025.104502","url":null,"abstract":"","PeriodicalId":7173,"journal":{"name":"Actas dermo-sifiliograficas","volume":"117 1","pages":"Article 104502"},"PeriodicalIF":2.8,"publicationDate":"2025-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145686794","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-03DOI: 10.1016/j.ad.2025.104501
M. Cotarelo Hernández , T. Puerta López , J.A. Pérez-García
{"title":"Facial Lesions Transmission in the Context of Sexual Relations","authors":"M. Cotarelo Hernández , T. Puerta López , J.A. Pérez-García","doi":"10.1016/j.ad.2025.104501","DOIUrl":"10.1016/j.ad.2025.104501","url":null,"abstract":"","PeriodicalId":7173,"journal":{"name":"Actas dermo-sifiliograficas","volume":"117 1","pages":"Article 104501"},"PeriodicalIF":2.8,"publicationDate":"2025-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145686724","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-03DOI: 10.1016/j.ad.2025.104506
A. Barrutia-Etxebarria, R.M. Escribano De La Torre, J. Gimeno Castillo
{"title":"Arborizing Vessels and Whitish Shiny Structures on a Salmon-colored Background: A Diagnostic Framework","authors":"A. Barrutia-Etxebarria, R.M. Escribano De La Torre, J. Gimeno Castillo","doi":"10.1016/j.ad.2025.104506","DOIUrl":"10.1016/j.ad.2025.104506","url":null,"abstract":"","PeriodicalId":7173,"journal":{"name":"Actas dermo-sifiliograficas","volume":"117 1","pages":"Article 104506"},"PeriodicalIF":2.8,"publicationDate":"2025-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145686747","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-03DOI: 10.1016/j.ad.2025.104497
P. Aarts, H.H. van der Zee
{"title":"Perianal Comedones: A Case Series of Five Patients and a Possible Association With Previously Described Perianal Cysts","authors":"P. Aarts, H.H. van der Zee","doi":"10.1016/j.ad.2025.104497","DOIUrl":"10.1016/j.ad.2025.104497","url":null,"abstract":"","PeriodicalId":7173,"journal":{"name":"Actas dermo-sifiliograficas","volume":"117 1","pages":"Article 104497"},"PeriodicalIF":2.8,"publicationDate":"2025-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145686722","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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