Pub Date : 2026-01-01DOI: 10.1016/j.ad.2025.104487
S. Vañó-Galván , I. Figueras-Nart , C. Serrano , M.P. Fortes , V. Herrera-Lasso , R. Botella-Estrada
Alopecia areata (AA) is a dermatological disease of immune origin characterized by partial or total hair loss of the scalp (alopecia totalis) or the whole body (alopecia universalis). Current therapeutic options, both topical and systemic, use nonspecific immunosuppressive or immunomodulatory management strategies. The crucial role of Janus kinases (JAK) in the pathogenesis of the disease has led to a change in the therapeutic landscape, opening new approaches in the management of this disease. Ritlecitinib, a JAK3/TEC kinase inhibitor, has recently been approved for the treatment of severe AA in patients aged 12 and older. This review analyses the mechanism of action of ritlecitinib and the evidence for its safety and efficacy profile in patients with severe AA.
{"title":"Ritlecitinib: Efficacy of a Novel Therapy for Severe Alopecia Areata in Patients Aged 12 Years and Older","authors":"S. Vañó-Galván , I. Figueras-Nart , C. Serrano , M.P. Fortes , V. Herrera-Lasso , R. Botella-Estrada","doi":"10.1016/j.ad.2025.104487","DOIUrl":"10.1016/j.ad.2025.104487","url":null,"abstract":"<div><div>Alopecia areata (AA) is a dermatological disease of immune origin characterized by partial or total hair loss of the scalp (<em>alopecia totalis</em>) or the whole body (<em>alopecia universalis</em>). Current therapeutic options, both topical and systemic, use nonspecific immunosuppressive or immunomodulatory management strategies. The crucial role of Janus kinases (JAK) in the pathogenesis of the disease has led to a change in the therapeutic landscape, opening new approaches in the management of this disease. Ritlecitinib, a JAK3/TEC kinase inhibitor, has recently been approved for the treatment of severe AA in patients aged 12 and older. This review analyses the mechanism of action of ritlecitinib and the evidence for its safety and efficacy profile in patients with severe AA.</div></div>","PeriodicalId":7173,"journal":{"name":"Actas dermo-sifiliograficas","volume":"117 1","pages":"Article 104487"},"PeriodicalIF":2.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145676166","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 : 2026-01-01DOI: 10.1016/j.ad.2025.104490
N.F. Fernández-Martínez , D. Redondo-Sánchez , A. Ameijide , M. Carulla , J. Rubió-Casadevall , R. Marcos-Gragera , M. Guevara , A. Gasque , I. García-Doval , S. Arias-Santiago , J. Galceran , M.J. Sánchez
Background
Cutaneous squamous cell carcinoma (cSCC) constitutes a serious public health problem, as it is the 2nd most frequent skin cancer. Few studies have assessed epidemiological indicators of cSCC in Southern Europe. The objectives of this study were to analyze its incidence rate and estimate survival of cSCC cases from all Spanish population-based cancer registries that register this cancer.
Materials and methods
We conducted a retrospective descriptive study of all incident first cSCC cases registered in Girona, Granada, Navarre and Tarragona (Spain) from 1994 to 2017. Crude and age-standardized (ASR-E) incidence rates were calculated. Incidence trends were analyzed using joinpoint regression. Observed survival was estimated using the Kaplan–Meier method and relative survival was estimated using the Ederer II method.
Results
A total of 22,434 cSCC cases (61.5% men) were registered, accounting for 20.3% of all skin cancers. The most common anatomical site was the skin of face, scalp and neck (59.1%) and the incidence rate increased exponentially with age. The annual ASR-E per 100,000 inhabitants was 25.0 in women and 56.6 in men. Both sexes showed a significant upward incidence trend, with an annual percent change of +2.0% (95%CI, +1.6% to +2.4%). The 5-year relative survival rate was 93.5% (95%CI, 92.5–94.6%), slightly higher in women, and did not seem to increase over time.
Conclusions
This study provides an updated description of cSCC incidence and survival, which are key indicators to frame the scenario of this cancer in Spain. Overall, results are consistent with former studies, showing a rising trend in the incidence rate alongside high survival rates. Further research is warranted to elucidate the causes underlying these findings.
{"title":"Incidence and Survival of Cutaneous Squamous Cell Carcinoma: A Spanish Multicenter Population-Based Study","authors":"N.F. Fernández-Martínez , D. Redondo-Sánchez , A. Ameijide , M. Carulla , J. Rubió-Casadevall , R. Marcos-Gragera , M. Guevara , A. Gasque , I. García-Doval , S. Arias-Santiago , J. Galceran , M.J. Sánchez","doi":"10.1016/j.ad.2025.104490","DOIUrl":"10.1016/j.ad.2025.104490","url":null,"abstract":"<div><h3>Background</h3><div>Cutaneous squamous cell carcinoma (cSCC) constitutes a serious public health problem, as it is the 2nd most frequent skin cancer. Few studies have assessed epidemiological indicators of cSCC in Southern Europe. The objectives of this study were to analyze its incidence rate and estimate survival of cSCC cases from all Spanish population-based cancer registries that register this cancer.</div></div><div><h3>Materials and methods</h3><div>We conducted a retrospective descriptive study of all incident first cSCC cases registered in Girona, Granada, Navarre and Tarragona (Spain) from 1994 to 2017. Crude and age-standardized (ASR-E) incidence rates were calculated. Incidence trends were analyzed using joinpoint regression. Observed survival was estimated using the Kaplan–Meier method and relative survival was estimated using the Ederer II method.</div></div><div><h3>Results</h3><div>A total of 22,434 cSCC cases (61.5% men) were registered, accounting for 20.3% of all skin cancers. The most common anatomical site was the skin of face, scalp and neck (59.1%) and the incidence rate increased exponentially with age. The annual ASR-E per 100,000 inhabitants was 25.0 in women and 56.6 in men. Both sexes showed a significant upward incidence trend, with an annual percent change of +2.0% (95%CI, +1.6% to +2.4%). The 5-year relative survival rate was 93.5% (95%CI, 92.5–94.6%), slightly higher in women, and did not seem to increase over time.</div></div><div><h3>Conclusions</h3><div>This study provides an updated description of cSCC incidence and survival, which are key indicators to frame the scenario of this cancer in Spain. Overall, results are consistent with former studies, showing a rising trend in the incidence rate alongside high survival rates. Further research is warranted to elucidate the causes underlying these findings.</div></div>","PeriodicalId":7173,"journal":{"name":"Actas dermo-sifiliograficas","volume":"117 1","pages":"Article 104490"},"PeriodicalIF":2.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145676202","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 : 2026-01-01DOI: 10.1016/j.ad.2025.104492
J.M. Villa-Gonzalez , M.R. Gonzalez-Hermosa , M. Ardigò , S. Gonzalez
In vivo reflectance confocal microscopy (RCM) enables monitoring of non-melanocytic skin cancers (NMSC) treated with non-invasive or minimally invasive therapies. This systematic review analyzed studies on NMSC treated with these therapies and monitored by RCM. A total of 56 articles were included, with 40 focusing on squamous conditions, such as actinic keratosis and squamous cell carcinoma, 15 on basal cell carcinoma (BCC), and 1 on extramammary Paget's disease. Evaluated therapies included ablative laser, cryosurgery, photodynamic therapy, 5-fluorouracil, imiquimod, and tirbanibulin, among others. RCM demonstrated complete response in squamous conditions with normalization of the honeycomb pattern and reduction of scaling and parakeratosis, frequently allowing for detection of subclinical malignancy. In BCC, RCM showed complete response as disappearance of tumor islands. RCM allows treatment optimization and early monitoring, even when inflammation hinders clinical assessment. It is recommended that RCM evaluations be performed starting at least 1 month after treatment for squamous conditions and 3 months for BCC.
{"title":"Monitoring the Effectiveness of Noninvasive or Minimally Invasive Therapies for Nonmelanocytic Lesions Using Reflectance Confocal Microscopy: A Systematic Review","authors":"J.M. Villa-Gonzalez , M.R. Gonzalez-Hermosa , M. Ardigò , S. Gonzalez","doi":"10.1016/j.ad.2025.104492","DOIUrl":"10.1016/j.ad.2025.104492","url":null,"abstract":"<div><div>In vivo reflectance confocal microscopy (RCM) enables monitoring of non-melanocytic skin cancers (NMSC) treated with non-invasive or minimally invasive therapies. This systematic review analyzed studies on NMSC treated with these therapies and monitored by RCM. A total of 56 articles were included, with 40 focusing on squamous conditions, such as actinic keratosis and squamous cell carcinoma, 15 on basal cell carcinoma (BCC), and 1 on extramammary Paget's disease. Evaluated therapies included ablative laser, cryosurgery, photodynamic therapy, 5-fluorouracil, imiquimod, and tirbanibulin, among others. RCM demonstrated complete response in squamous conditions with normalization of the honeycomb pattern and reduction of scaling and parakeratosis, frequently allowing for detection of subclinical malignancy. In BCC, RCM showed complete response as disappearance of tumor islands. RCM allows treatment optimization and early monitoring, even when inflammation hinders clinical assessment. It is recommended that RCM evaluations be performed starting at least 1 month after treatment for squamous conditions and 3 months for BCC.</div></div>","PeriodicalId":7173,"journal":{"name":"Actas dermo-sifiliograficas","volume":"117 1","pages":"Article 104492"},"PeriodicalIF":2.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145686806","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 : 2026-01-01DOI: 10.1016/j.ad.2025.104485
P. Balado-Simó , S. Gomez-Martinez , D. Morgado-Carrasco
Tranexamic acid (TXA) is a synthetic lysine analog with antifibrinolytic properties used to reduce bleeding during various surgical procedures. In dermatologic surgery, it is often applied topically (soaked gauze), subcutaneously (intralesional with local anesthesia), and intravenously. We conducted a narrative review on the utility of TXA in dermatologic surgery, both oncologic and esthetic. Therefore, we conducted a literature search across PubMed and Google Scholar during March 2025, including retrospective and prospective studies, and systematic reviews. We eventually found multiple randomized clinical trials demonstrating a reduction in intra- and postoperative bleeding, ecchymosis, and minor hematomas, especially in Mohs surgery, blepharoplasty, and facial rhytidectomy (facelift), and reduced surgical duration during blepharoplasty and rhytidectomy. The safety profile of TXA is highly favorable, with no observed increase in thromboembolic events. However, optimal dosing and routes of administration have yet to be established.
{"title":"Tranexamic Acid in Cutaneous Oncologic and Cosmetic Surgery: A Comprehensive Narrative Review","authors":"P. Balado-Simó , S. Gomez-Martinez , D. Morgado-Carrasco","doi":"10.1016/j.ad.2025.104485","DOIUrl":"10.1016/j.ad.2025.104485","url":null,"abstract":"<div><div>Tranexamic acid (TXA) is a synthetic lysine analog with antifibrinolytic properties used to reduce bleeding during various surgical procedures. In dermatologic surgery, it is often applied topically (soaked gauze), subcutaneously (intralesional with local anesthesia), and intravenously. We conducted a narrative review on the utility of TXA in dermatologic surgery, both oncologic and esthetic. Therefore, we conducted a literature search across PubMed and Google Scholar during March 2025, including retrospective and prospective studies, and systematic reviews. We eventually found multiple randomized clinical trials demonstrating a reduction in intra- and postoperative bleeding, ecchymosis, and minor hematomas, especially in Mohs surgery, blepharoplasty, and facial rhytidectomy (facelift), and reduced surgical duration during blepharoplasty and rhytidectomy. The safety profile of TXA is highly favorable, with no observed increase in thromboembolic events. However, optimal dosing and routes of administration have yet to be established.</div></div>","PeriodicalId":7173,"journal":{"name":"Actas dermo-sifiliograficas","volume":"117 1","pages":"Article 104485"},"PeriodicalIF":2.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145676246","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 : 2026-01-01DOI: 10.1016/j.ad.2025.104488
R. Rivera-Diaz , B. Joven , G. Hernandez-Ibarburu , C. García-Donoso , J.L. Pablos , P.L. Ortiz-Romero
Introduction
Psoriatic arthritis (PsA) is an inflammatory condition associated with psoriasis (PsO), with variable prevalence ranging from 6% to 42%. Despite the known link between PsO and PsA, reliable biomarkers for predicting PsA onset remain elusive. Recent research has identified risk determinants including obesity, onychopathy, PsO severity, and familial predisposition. Detecting PsO patients at risk of developing PsA is crucial given the disparity in treatment efficacy post-PsA establishment.
Objective
This study evaluates the rate of PsA among PsO patients undergoing targeted biologic therapy as first- or second-line therapy.
Material and methods
We conducted a retrospective cohort study utilizing TriNetX database and identified PsO patients receiving biologic therapy. Propensity score matching was applied to adjust for potential confounders. Patients were followed for 5 years, and the incidence rate of PsA was determined. Statistical analyses were performed to estimate relative risks and hazard ratios.
Results
Among 1,175,000 PsO patients, 41,990 received first-line biologic therapy. Following matching, patients initiating IL12/23i or IL23i exhibited a lower PsA incidence rate vs TNFi. Second-line IL12/23i and IL23i treatment also showed a lower PsA risk vs TNFi. IL17i did not significantly differ from TNFi in PsA risk.
Conclusion
This study highlights differential PsA risk among PsO patients on biologic therapy, suggesting potential benefits of IL12/23i and IL23i in PsA prevention. Prospective studies are needed to confirm these findings and optimize PsA prevention strategies.
{"title":"Evaluation of the Risk of Psoriatic Arthritis in Patients With Psoriasis Undergoing Biological Treatment. Global Population Study (TRINETX)","authors":"R. Rivera-Diaz , B. Joven , G. Hernandez-Ibarburu , C. García-Donoso , J.L. Pablos , P.L. Ortiz-Romero","doi":"10.1016/j.ad.2025.104488","DOIUrl":"10.1016/j.ad.2025.104488","url":null,"abstract":"<div><h3>Introduction</h3><div>Psoriatic arthritis (PsA) is an inflammatory condition associated with psoriasis (PsO), with variable prevalence ranging from 6% to 42%. Despite the known link between PsO and PsA, reliable biomarkers for predicting PsA onset remain elusive. Recent research has identified risk determinants including obesity, onychopathy, PsO severity, and familial predisposition. Detecting PsO patients at risk of developing PsA is crucial given the disparity in treatment efficacy post-PsA establishment.</div></div><div><h3>Objective</h3><div>This study evaluates the rate of PsA among PsO patients undergoing targeted biologic therapy as first- or second-line therapy.</div></div><div><h3>Material and methods</h3><div>We conducted a retrospective cohort study utilizing TriNetX database and identified PsO patients receiving biologic therapy. Propensity score matching was applied to adjust for potential confounders. Patients were followed for 5 years, and the incidence rate of PsA was determined. Statistical analyses were performed to estimate relative risks and hazard ratios.</div></div><div><h3>Results</h3><div>Among 1,175,000 PsO patients, 41,990 received first-line biologic therapy. Following matching, patients initiating IL12/23i or IL23i exhibited a lower PsA incidence rate vs TNFi. Second-line IL12/23i and IL23i treatment also showed a lower PsA risk vs TNFi. IL17i did not significantly differ from TNFi in PsA risk.</div></div><div><h3>Conclusion</h3><div>This study highlights differential PsA risk among PsO patients on biologic therapy, suggesting potential benefits of IL12/23i and IL23i in PsA prevention. Prospective studies are needed to confirm these findings and optimize PsA prevention strategies.</div></div>","PeriodicalId":7173,"journal":{"name":"Actas dermo-sifiliograficas","volume":"117 1","pages":"Article 104488"},"PeriodicalIF":2.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145686755","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 : 2026-01-01DOI: 10.1016/j.ad.2025.104486
D. Saceda-Corralo , A. Combalia , P. Fernandez-Crehuet , G. Garnacho , C. Pindado-Ortega , M.L. Porriño-Bustamante , C. Serrano , S. Vañó-Galván , Spanish Working group on trichology and onychology
Frontal fibrosing alopecia (FFA) is a scarring alopecia first described in 1994. Due to its increasing incidence rate in dermatology clinics, and the scarcity of approved specific treatments, the diagnosis and treatment of FFA can be an increasingly common challenge for dermatologists in their routine daily practice.
This FFA management consensus was produced via a Delphi methodology involving 22 dermatologists from the Spanish working group on trichology and onychology of the AEDV.
Because hair loss is irreversible, multimodal therapy with complementary mechanisms and routes should be used starting with oral dutasteride along with topical and/or intralesional agents; if inflammation persists, hydroxychloroquine should be added to the mix.
{"title":"Consensus Document on the Clinical Management of Frontal Fibrosing Alopecia: Recommendations From Spanish Working Group on Trichology and Onychology of the AEDV","authors":"D. Saceda-Corralo , A. Combalia , P. Fernandez-Crehuet , G. Garnacho , C. Pindado-Ortega , M.L. Porriño-Bustamante , C. Serrano , S. Vañó-Galván , Spanish Working group on trichology and onychology","doi":"10.1016/j.ad.2025.104486","DOIUrl":"10.1016/j.ad.2025.104486","url":null,"abstract":"<div><div>Frontal fibrosing alopecia (FFA) is a scarring alopecia first described in 1994. Due to its increasing incidence rate in dermatology clinics, and the scarcity of approved specific treatments, the diagnosis and treatment of FFA can be an increasingly common challenge for dermatologists in their routine daily practice.</div><div>This FFA management consensus was produced via a Delphi methodology involving 22 dermatologists from the Spanish working group on trichology and onychology of the AEDV.</div><div>Because hair loss is irreversible, multimodal therapy with complementary mechanisms and routes should be used starting with oral dutasteride along with topical and/or intralesional agents; if inflammation persists, hydroxychloroquine should be added to the mix.</div></div>","PeriodicalId":7173,"journal":{"name":"Actas dermo-sifiliograficas","volume":"117 1","pages":"Article 104486"},"PeriodicalIF":2.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145676243","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 : 2026-01-01DOI: 10.1016/j.ad.2025.104491
S. Haselgruber , D. Muñoz-Barba , A. Soto-Moreno , C. Cuenca-Barrales , S. Arias-Santiago , A. Molina-Leyva
Background and objectives
Evidence for secukinumab and bimekizumab in hidradenitis suppurativa (HS) primarily comes from randomized clinical trials with selected patient populations. Conversely, real-world evidence (RWE) studies reflect broader patient demographics and clinical practice. This study aims to summarize RWE on the safety and efficacy profile of secukinumab and bimekizumab for HS through a systematic review and meta-analysis.
Methods
We conducted a comprehensive search using the Medline and Scopus databases. Eligible studies reported RWE on secukinumab or bimekizumab in HS. Furthermore, we conducted a meta-analysis to estimate the proportion of patients achieving HiSCR with secukinumab.
Results
A total of 13 studies were included, with 347 HS patients. The meta-analysis showed that 50.31% (95%CI, 37.41–63.18%) of patients on secukinumab achieved HiSCR at the longest follow-up available. While HiSCR was not reported for bimekizumab studies, significant improvements in IHS4 and pain-NRS were observed. Both drugs were well-tolerated, with adverse event rates of 8.22% for secukinumab and 5.45% for bimekizumab, most being mild and manageable.
Conclusions
IL-17 inhibitors provide moderate response rates and are valuable options for patients refractory to other therapies, with low incidences of mild adverse events. More RWE studies are essential to better understand their safety and efficacy profile.
{"title":"Real World Evidence of Secukinumab and Bimekizumab in Hidradenitis Suppurativa: A Systematic Review and Meta-Analysis","authors":"S. Haselgruber , D. Muñoz-Barba , A. Soto-Moreno , C. Cuenca-Barrales , S. Arias-Santiago , A. Molina-Leyva","doi":"10.1016/j.ad.2025.104491","DOIUrl":"10.1016/j.ad.2025.104491","url":null,"abstract":"<div><h3>Background and objectives</h3><div>Evidence for secukinumab and bimekizumab in hidradenitis suppurativa (HS) primarily comes from randomized clinical trials with selected patient populations. Conversely, real-world evidence (RWE) studies reflect broader patient demographics and clinical practice. This study aims to summarize RWE on the safety and efficacy profile of secukinumab and bimekizumab for HS through a systematic review and meta-analysis.</div></div><div><h3>Methods</h3><div>We conducted a comprehensive search using the Medline and Scopus databases. Eligible studies reported RWE on secukinumab or bimekizumab in HS. Furthermore, we conducted a meta-analysis to estimate the proportion of patients achieving HiSCR with secukinumab.</div></div><div><h3>Results</h3><div>A total of 13 studies were included, with 347 HS patients. The meta-analysis showed that 50.31% (95%CI, 37.41–63.18%) of patients on secukinumab achieved HiSCR at the longest follow-up available. While HiSCR was not reported for bimekizumab studies, significant improvements in IHS4 and pain-NRS were observed. Both drugs were well-tolerated, with adverse event rates of 8.22% for secukinumab and 5.45% for bimekizumab, most being mild and manageable.</div></div><div><h3>Conclusions</h3><div>IL-17 inhibitors provide moderate response rates and are valuable options for patients refractory to other therapies, with low incidences of mild adverse events. More RWE studies are essential to better understand their safety and efficacy profile.</div></div>","PeriodicalId":7173,"journal":{"name":"Actas dermo-sifiliograficas","volume":"117 1","pages":"Article 104491"},"PeriodicalIF":2.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145686779","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 : 2026-01-01DOI: 10.1016/j.ad.2025.104489
M. Munera-Campos , A. González Quesada , M. Espasandín Arias , M.A. Lasheras-Pérez , P. de la Cueva Dobao , T. Montero-Vilchez , R. Ruiz-Villaverde , P. Chicharro , Y. Gilaberte , M. Elosua-González , L. Curto Barredo , J.J. Pereyra-Rodríguez , J.F. Silvestre Salvador , A. Batalla , S. Arias-Santiago , F.J. Navarro Triviño , A. Navarro Bielsa , G. Roustan Gullón , M. Bertolín-Colilla , I. Betlloch-Mas , J.M. Carrascosa Carrillo
Background
Randomized clinical trials (RCTs) supporting advanced treatments for atopic dermatitis (AD) involve highly selected patients, limiting their generalizability.
Objective
To determine the proportion of adults on advanced systemic therapy for AD in clinical practice who are underrepresented in RCTs and compare the safety and drug survival of these treatments between RCT-eligible and RCT-ineligible patients.
Material and methods
Descriptive and comparative analysis of data from the Spanish Atopic Dermatitis registry BIOBADATOP. Patients were deemed RCT-ineligible if they met, at least, 1 of 8 common exclusion factors: age ≥ 65 years; pregnancy desire pregnancy or lactation; uncontrolled hypertension, cardiovascular disease, or diabetes; chronic kidney disease; cancer diagnosis; liver disease; history of tuberculosis, human immunodeficiency virus or hepatitis B or C infection; and active or acute infection.
Results
Of the 366 adults in BIOBADATOP on advanced systemic therapies for AD, 18.3% would be considered ineligible to participate in RCTs. Ineligible patients were older and had more comorbidities than eligible patients. Inclusion of an EASI score < 16 at baseline in the sensitivity analysis increased the proportion of ineligible patients to 37.2%. Janus kinase inhibitors were used less often as a first-line therapy in RCT-ineligible patients. Although serious adverse events were significantly more common in ineligible patients, this difference was lost after adjusting for age, sex, and comorbidities.
Conclusions
Overall, 18.3% of real-world patients with AD—and 37.2% including those with EASI < 16—are underrepresented in RCTs. Age and comorbidities influence safety outcomes and should be considered when taking treatment decisions and designing RCTs.
{"title":"Characteristics, Treatment, and Safety Profile of Patients With Atopic Dermatitis According to Eligibility for Randomized Clinical Trials: An Analysis From the Spanish Atopic Dermatitis Registry (BIOBADATOP)","authors":"M. Munera-Campos , A. González Quesada , M. Espasandín Arias , M.A. Lasheras-Pérez , P. de la Cueva Dobao , T. Montero-Vilchez , R. Ruiz-Villaverde , P. Chicharro , Y. Gilaberte , M. Elosua-González , L. Curto Barredo , J.J. Pereyra-Rodríguez , J.F. Silvestre Salvador , A. Batalla , S. Arias-Santiago , F.J. Navarro Triviño , A. Navarro Bielsa , G. Roustan Gullón , M. Bertolín-Colilla , I. Betlloch-Mas , J.M. Carrascosa Carrillo","doi":"10.1016/j.ad.2025.104489","DOIUrl":"10.1016/j.ad.2025.104489","url":null,"abstract":"<div><h3>Background</h3><div>Randomized clinical trials (RCTs) supporting advanced treatments for atopic dermatitis (AD) involve highly selected patients, limiting their generalizability.</div></div><div><h3>Objective</h3><div>To determine the proportion of adults on advanced systemic therapy for AD in clinical practice who are underrepresented in RCTs and compare the safety and drug survival of these treatments between RCT-eligible and RCT-ineligible patients.</div></div><div><h3>Material and methods</h3><div>Descriptive and comparative analysis of data from the Spanish Atopic Dermatitis registry BIOBADATOP. Patients were deemed RCT-ineligible if they met, at least, 1 of 8 common exclusion factors: age<!--> <!-->≥<!--> <!-->65 years; pregnancy desire pregnancy or lactation; uncontrolled hypertension, cardiovascular disease, or diabetes; chronic kidney disease; cancer diagnosis; liver disease; history of tuberculosis, human immunodeficiency virus or hepatitis B or C infection; and active or acute infection.</div></div><div><h3>Results</h3><div>Of the 366 adults in BIOBADATOP on advanced systemic therapies for AD, 18.3% would be considered ineligible to participate in RCTs. Ineligible patients were older and had more comorbidities than eligible patients. Inclusion of an EASI score<!--> <!--><<!--> <!-->16 at baseline in the sensitivity analysis increased the proportion of ineligible patients to 37.2%. Janus kinase inhibitors were used less often as a first-line therapy in RCT-ineligible patients. Although serious adverse events were significantly more common in ineligible patients, this difference was lost after adjusting for age, sex, and comorbidities.</div></div><div><h3>Conclusions</h3><div>Overall, 18.3% of real-world patients with AD—and 37.2% including those with EASI<!--> <!--><<!--> <!-->16—are underrepresented in RCTs. Age and comorbidities influence safety outcomes and should be considered when taking treatment decisions and designing RCTs.</div></div>","PeriodicalId":7173,"journal":{"name":"Actas dermo-sifiliograficas","volume":"117 1","pages":"Article 104489"},"PeriodicalIF":2.8,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145676218","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}