165 results on '"P. de la Cueva"'
Search Results
2. Pharmacogenetic biomarkers for secukinumab response in psoriasis patients in real-life clinical practice.
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Muñoz-Aceituno E, Butrón-Bris B, Ovejero-Benito MC, Sahuquillo-Torralba A, Baniandrés Rodríguez O, Herrera-Acosta E, Rivera-Diaz R, Ferran M, Sánchez-Carazo JL, Riera-Monroig J, Pujol-Montcusí J, Vidal D, de la Cueva P, García-Bustinduy M, Ruiz-Villaverde R, Ballescà F, Llamas-Velasco M, Navares M, Palomar-Moreno I, Sánchez-García I, García-Martínez J, Novalbos J, Zubiaur P, Abad-Santos F, Daudén-Tello E, and de la Fuente H
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- Humans, Female, Male, Middle Aged, Adult, Dermatologic Agents therapeutic use, MicroRNAs genetics, Severity of Illness Index, Treatment Outcome, Psoriasis drug therapy, Psoriasis genetics, Antibodies, Monoclonal, Humanized therapeutic use, Polymorphism, Single Nucleotide
- Abstract
Background: Prediction of the response to a biological treatment in psoriasis patients would allow efficient treatment allocation., Objective: To identify polymorphisms associated with secukinumab response in psoriasis patients in a daily practice setting., Methods: We studied 180 SNPs in patients with moderate-to-severe plaque psoriasis recruited from 15 Spanish hospitals. Treatment effectiveness was evaluated by absolute PASI ≤3 and ≤1 at 6 and 12 months. Individuals were genotyped using a custom Taqman array. Multiple logistic regression models were generated. Sensitivity, specificity and area under the curve (AUC) were analysed., Results: A total of 173 patients were studied at 6 months, (67% achieved absolute PASI ≤ 3 and 65% PASI ≤ 1) and 162 at 12 months (75% achieved absolute PASI ≤ 3 and 64% PASI ≤ 1). Multivariable analysis showed the association of different sets of SNPs with the response to secukinumab. The model of absolute PASI≤3 at 6 months showed best values of sensitivity and specificity. Four SNPs were associated with the capability of achieving absolute PASI ≤ 3 at 6 months. rs1801274 (FCGR2A), rs2431697 (miR-146a) and rs10484554 (HLCw6) were identified as risk factors for failure to achieve absolute PASI≤3, while rs1051738 (PDE4A) was protective. AUC including these genotypes, weight of patients and history of biological therapy was 0.88 (95% CI 0.83-0.94), with a sensitivity of 48.6% and specificity of 95.7% to discriminate between both phenotypes., Conclusion: We have identified a series of polymorphisms associated with the response to secukinumab capable of predicting the potential response/non-response to this drug in patients with plaque psoriasis., (© 2024 European Academy of Dermatology and Venereology.)
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- 2024
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3. Genetic polymorphisms to identify patients with an optimal response to tildrakizumab in psoriasis patients from real-life clinical practice.
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Butrón-Bris B, Llamas-Velasco M, Ovejero-Benito MC, Santos-Juanes J, Martínez-López A, Ruiz-Villaverde R, Roustan G, Baniandrés O, Izu-Belloso R, de la Cueva P, Sahuquillo-Torralba A, Gónzalez-Quesada A, Vilarrasa-Rull E, Pujol-Montcusí J, García-Martínez J, Navares M, Palomar-Moreno I, Novalbos J, Abad-Santos F, Daudén E, and de la Fuente H
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- Humans, Female, Male, Middle Aged, Adult, Polymorphism, Single Nucleotide, Treatment Outcome, Genotype, Aged, Polymorphism, Genetic, Psoriasis drug therapy, Psoriasis genetics, Antibodies, Monoclonal, Humanized therapeutic use
- Abstract
Detecting the association of genetic variants to the response of biological therapy represents an important advance in developing a personalized therapy. The aim of this work was to study the association of polymorphisms with an optimal response to tildrakizumab in patients with psoriasis in a real-life clinical practice. Ninety patients with plaque psoriasis recruited from-Spanish hospitals receiving tildrakizumab for at least 24 weeks were genotyped for 180 polymorphisms. Optimal response to tildrakizumab was evaluated by absolute PASI ≤1 at 6 and 12 months. Polymorphisms corrected for weight and disease duration with an FDR <0.15 were included in a multiple regression model. Sixty three percent of patients achieved an absolute PASI ≤1 at 6 months, while 71% did so after 12 months. Disease duration (>27 years) and weight (>76 kg) were associated with treatment response; after correcting by these factors, no association (FDR >0.15) was found for any polymorphism and response to tildrakizumab at 6 months. The analysis at 12 months identified the genotype GG for rs610604 (TNFAIP3), CT for rs9373839 (ATG5), and delCTGT/delCTGT for rs72167053 (PDE4D) as risk factors to not achieve an optimal response (PASI ≤1), while CT for rs708567 (IL17RC) was protective, independently of weight and disease duration (FDR <0.15). The final multivariable model at 12 months showed an AUC of 0.90 (95% CI 0.82 to -0.98). We identified a set of polymorphisms that could be helpful to identify psoriatic patients with an optimal response to tildrakizumab at 12 months in real-world practice conditions., (© 2024 The Author(s). Experimental Dermatology published by John Wiley & Sons Ltd.)
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- 2024
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4. Consensus Statement from the Spanish Academy of Dermatology and Venereology (AEDV) Psoriasis Working Group (SWG) and Pediatric Working Group (PWG) on the Management of Pediatric Psoriasis.
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Vicente A, Pérez-Ferriols A, Batalla A, García-Fernandez L, Pérez B, Eiris N, de Lucas R, De La Cueva P, and Carrascosa JM
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Justification and Objectives: The Spanish Academy of Dermatology and Venereology (AEDV) Psoriasis and Pediatric Working Groups (PSW and PWG) have developed a set of recommendations for the management of pediatric psoriasis based on the best available evidence and experts' opinion., Methodology: The methodology of nominal groups was followed, with help from a scoping review. A coordinator was designated, and a group of experts was selected based on their experience and knowledge on the management of psoriasis. The coordinator defined both the objectives and the key points of the document. Then, with help from a documentalist, a systematic literature review was conducted across Medline, Embase and Cochrane Library until May 2023. Systematic literature reviews, meta-analyses, and observational studies were included. National and international clinical practice guidelines and consensus documents were reviewed. With this information, the coordinator proposed preliminary recommendations that were discussed and modified in a nominal group meeting with all experts. After several review processes, which included an external review, the final document was generated., Results: Practical recommendations on the evaluation and management of patients with pediatric psoriasis are presented in association with other AEDV documents. The evaluation of the pediatric patient, the definition of the therapeutic objectives, the criteria for indication and selection of treatment are addressed. Practical issues such as therapeutic failure, response maintenance, comorbidity and risk management are also included., (Copyright © 2024 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)
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- 2024
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5. [Translated article] Validation of the Spanish Version of the PURE-4 Questionnaire for the Early Detection of Psoriatic Arthritis in Psoriatic Patients.
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Belinchón-Romero I, López-Ferrer A, Ferrán I Farrés M, Rivera-Díaz R, Vidal-Sarro D, Rodríguez Fernández-Freire L, de la Cueva-Dobao P, Santos-Juanes J, Rocamora-Durán V, Martín-Vázquez V, Gómez-Labradror L, and Queiro-Silva R
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- Humans, Female, Cross-Sectional Studies, Male, Middle Aged, Adult, Surveys and Questionnaires, Reproducibility of Results, Translations, Sensitivity and Specificity, Spain, Feasibility Studies, Language, Arthritis, Psoriatic diagnosis, Early Diagnosis, Psoriasis diagnosis
- Abstract
Background and Objective: Psoriasis often precedes the onset of psoriatic arthritis (PsA), so dermatologists often face the challenge of early identifying signs of PsA in patients with psoriasis. Our aim was to validate the Spanish version of the PURE-4 questionnaire as a screening tool for PsA, evaluate its performance in terms of sensitivity, specificity, feasibility, reliability, and build validity., Methods: This was a cross-sectional, observational, multicenter trial of adult patients with psoriasis. Initially, patients were assessed by a dermatologist and completed 2 self-administered versions (in print and online) of the PURE-4 questionnaire. Afterwards, the rheumatologist, blinded to the PURE-4 results, assessed the presence/absence of PsA, being the reference to determine the performance of the PURE-4 questionnaire., Results: A total of 268 patients were included (115 [42.9%] women; mean age, 47.1±12.6). The prevalence of PsA according to rheumatologist diagnosis was 12.7% (34 patients). The mean PURE-4 score for patients with psoriasis diagnosed with PsA was 2.3±1.1, and 1.3±1.3 for patients without PsA (P<.001). The cutoff value ≥2 demonstrated the best performance for detecting PsA, with a negative predictive value of 95.1% (95% confidence interval, 90.3-97.6)., Conclusions: The PURE-4 questionnaire demonstrated good performance in detecting PsA, with an optimal cutoff point ≥2. This simple tool could facilitate early referral of patients to the rheumatology unit., (Copyright © 2024 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)
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- 2024
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6. [Translated article] Recommendations from the Spanish Academy of Dermatology and Venereology Psoriasis Working Group on the Management of Patients with Cancer and Psoriasis.
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Puig L, Notario J, López-Ferrer A, Scheneller-Pavelescu L, Pérez B, Galache C, de la Cueva P, and Carrascosa JM
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- Humans, Delphi Technique, Spain, Dermatology standards, Comorbidity, Psoriasis drug therapy, Psoriasis therapy, Neoplasms complications, Neoplasms therapy
- Abstract
Several studies suggest that patients with psoriasis have a higher incidence of neoplasms, especially of the skin, which could be associated with the use of therapies to treat psoriasis. Furthermore, the evidence available on the safety profile of some treatments in this context, and the management of these patients is scarce, which is why clinical practice guidelines with recommendations on the management of psoriasis in cancer patients are ambiguous. This study provides recommendations on the management and use of the therapies currently available for these patients. They are the result of a Delphi consensus reached by 45 dermatologists of the Spanish Academy of Dermatology and Venereology Psoriasis Working Group, and their goal is to help specialists in the field in their decision-making processes., (Copyright © 2024 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)
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- 2024
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7. Defining well-being in psoriasis: A Delphi consensus among healthcare professionals and patients.
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Daudén E, Belinchón I, Colominas-González E, Coto P, de la Cueva P, Gallardo F, Poveda JL, Ramírez E, Ros S, Ruíz-Villaverde R, Comellas M, and Lizán L
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- Humans, Female, Male, Surveys and Questionnaires, Adult, Quality of Life, Middle Aged, Self Concept, Psoriasis psychology, Health Personnel psychology, Delphi Technique, Consensus
- Abstract
Psoriasis is a chronic skin disease that negatively impacts on patient's life. A holistic approach integrating well-being assessment could improve disease management. Since a consensus definition of well-being in psoriasis is not available, we aim to achieve a multidisciplinary consensus on well-being definition and its components. A literature review and consultation with psoriasis patients facilitated the design of a two-round Delphi questionnaire targeting healthcare professionals and psoriasis patients. A total of 261 panellists (65.1% patients with psoriasis, 34.9% healthcare professionals) agreed on the dimensions and components that should integrate the concept of well-being: emotional dimension (78.9%) [stress (83.9%), mood disturbance (85.1%), body image (83.9%), stigma/shame (75.1%), self-esteem (77.4%) and coping/resilience (81.2%)], physical dimension (82.0%) [sleep quality (81.6%), pain/discomfort (80.8%), itching (83.5%), extracutaneous manifestations (82.8%), lesions in visible areas (84.3%), lesions in functional areas (85.8%), and sex life (78.2%)], social dimension (79.5%) [social relationships (80.8%), leisure/recreational activities (80.3%), support from family/friends (76.6%) and work/academic life (76.5%)], and satisfaction with disease management (78.5%) [treatment (78.2%), information received (75.6%) and medical care provided by the dermatologist (80.1%)]. This well-being definition reflects patients' needs and concerns. Therefore, addressing them in psoriasis will optimise management, contributing to better outcomes and restoring normalcy to the patient's life., (© 2024. The Author(s).)
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- 2024
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8. Mohs micrographic surgery in immunosuppressed vs immunocompetent patients: Results of a prospective nationwide cohort study (REGESMOHS, Spanish registry of Mohs surgery).
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Abril-Pérez C, Mansilla-Polo M, Escutia-Muñoz B, Sanmartín O, Garcés JR, Rodríguez-Prieto MA, Ruiz-Salas V, de Eusebio-Murillo E, Miñano-Medrano R, González-Sixto B, Artola-Igarza JL, Alfaro-Rubio A, Redondo P, Delgado-Jiménez Y, Sánchez-Schmidt JM, Allende-Markixana I, Alonso-Pacheco ML, García-Bracamonte B, de la Cueva-Dobao P, Navarro-Tejedor R, Ciudad-Blanco C, Carnero-González L, Vázquez-Veiga H, Cano-Martínez N, Serra-Guillén C, Vilarrasa E, Sánchez-Sambucety P, López-Estebaranz JL, Flórez-Menéndez Á, Martorell-Calatayud A, Gil P, Morales-Gordillo V, Toll A, Ocerin-Guerra I, Mayor-Arenal M, Suárez-Fernández R, Sainz-Gaspar L, Descalzo MA, Garcia-Doval I, and Botella-Estrada R
- Abstract
Background: Immunosuppressed (IS) patients, particularly solid organ transplant recipients and those on immunosuppressive therapy, face a higher incidence and recurrence of nonmelanoma skin cancers (NMSC), including basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). Mohs micrographic surgery (MMS) is the preferred treatment for high-risk NMSC due to its high cure rate and margin examination capabilities. However, IS patients may experience more complications, such as surgical site infections, and a greater risk of recurrence, making their outcomes a subject of interest., Objectives: This study aimed to compare IS and immunocompetent (IC) patients undergoing MMS for NMSC in terms of baseline characteristics, intra- and post-surgical complications, and postoperative recurrence rates., Methods: The study utilized data from the REGESMOHS registry, a 7-year prospective cohort study in Spain. It included 5226 patients, categorizing them into IC (5069) and IS (157) groups. IS patients included solid organ transplant recipients, those on immunosuppressive treatments, individuals with haematological tumours and HIV-positive patients. Patient data, tumour characteristics, surgical details and outcomes were collected and analysed., Results: IS patients demonstrated a higher proportion of SCC, multiple synchronous tumours and tumours invading deeper structures. Complex closures, unfinished MMS and more surgical sections were observed in the IS group. Although intra-operative morbidity was higher among IS patients, this difference became non-significant when adjusted for other variables such as year of surgery, antiplatelet/anticoagulant treatment or type of closure. Importantly, IS patients had a substantially higher recurrence rate (IRR 2.79) compared to IC patients., Conclusions: This study suggests that IS patients may be at a higher risk of development of AE such as bleeding or tumour necrosis and are at a higher risk of tumour recurrence. Close follow-up and consideration of the specific characteristics of NMSC in IS patients are crucial. Further research with extended follow-up is needed to better understand the long-term outcomes for this patient group., (© 2024 European Academy of Dermatology and Venereology.)
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- 2024
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9. Approach to the Epidemiology, Disease Management, and Current Challenges in the Management of Generalized Pustular Psoriasis Through a Survey Conducted Among Spanish Dermatologists.
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Vilarrasa E, Rivera R, Eiris N, Carretero G, de la Cueva P, and Carrascosa JM
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- Humans, Spain epidemiology, Prevalence, Health Care Surveys, Practice Patterns, Physicians' statistics & numerical data, Dermatology statistics & numerical data, Incidence, Dermatologists statistics & numerical data, Disease Management, Delphi Technique, Male, Cyclosporine therapeutic use, Female, Retinoids therapeutic use, Psoriasis therapy, Psoriasis drug therapy, Psoriasis epidemiology
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Background: Generalized pustular psoriasis (GPP) is a rare and severe inflammatory skin disease characterised by recurrent or intermittent flares. Epidemiological and disease management data in Spain are limited. Our goal was to estimate the epidemiology of GPP, explore its management, and reach consensus on the current challenges faced in Spain., Methods: An electronic survey was submitted to dermatologists from the Spanish Academy of Dermatology and Venereology Psoriasis Working Group. This group is experienced in the management of GPP. It included a Delphi consensus to establish the current challenges., Results: A total of 33 dermatologists responded to the survey. A 5-year prevalence and incidence of 13.05 and 7.01 cases per million inhabitants, respectively, were estimated. According to respondents, the most common GPP symptoms are pustules, erythema, and desquamation, while 45% of patients present > 1 annual flares. A total of 45% of respondents indicated that flares often require a length of stay between 1 and 2 weeks. In the presence of a flare, 67% of respondents often or always prescribe a non-biological systemic treatment as the first-line therapy [cyclosporine (55%); oral retinoid (30%)], and 45% a biological treatment [anti-TNFα (52%); anti-IL-17 (39%)]. The dermatologists agreed that the main challenges are to define and establish specific therapeutic goals to treat the disease including the patients' perspective on the management of the disease., Conclusion: Our study describes the current situation on the management of GPP in Spain, increasing the present knowledge on the disease, and highlighting the current challenges faced at the moment., (Copyright © 2023. Publicado por Elsevier España, S.L.U.)
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- 2024
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10. Dose reduction is a feasible strategy in patients with plaque psoriasis who achieve sustained response with secukinumab: a retrospective, multicenter cohort study in daily practice setting.
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Daudén E, Escario E, Martos-Cabrera L, Armesto S, Herrera-Acosta E, Vidal D, Vilarrasa E, Rivera R, de la Cueva P, Martorell A, Ballesca F, Belinchón I, Carretero G, Rodríguez L, Romero-Maté A, Pujol-Montcusí J, Salgado L, Sahuquillo-Torralba A, Coto-Segura P, Baniandrés O, Feltes R, Riera-Monroig J, Garrido J, and Llamas-Velasco M
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- Humans, Cohort Studies, Drug Tapering, Retrospective Studies, Severity of Illness Index, Treatment Outcome, Antibodies, Monoclonal adverse effects, Antibodies, Monoclonal, Humanized, Psoriasis drug therapy, Psoriasis chemically induced
- Abstract
Background: Biological therapy dose modification is a common practice in the long-term treatment of plaque psoriasis., Objective: The objective of the study was to determine prevalence, characteristics of patients, effectiveness, treatment survival of secukinumab dose reduction (SEC-DR) strategy and assess its safety and cost implications., Methods: A retrospective, observational, multicenter cohort study was conducted in patients with plaque psoriasis treated with secukinumab and up to 2 years of follow-up., Results: In 63/347 patients with an initial standard dose regimen, SEC-DR was tried at any moment in 18.2% of them after sustained response. In 51 patients, the interval between administrations was increased while in 12 patients, monthly dose was reduced to 150 mg. Successful SEC-DR was achieved in 77.8% of the patients, with sustained PASI response to the end of the study. Survival of secukinumab treatment and safety profile were not compromised by DR. The use of DR saved 33% of the cost, including failures in which standard treatment was resumed., Limitations: The proper of the study designed and the arbitrary definition of "DR success.", Conclusion: Off-label SEC-DR strategy was used in patients with sustained response to standard dose regimen; this strategy showed long-term efficacy without compromising treatment survival or worsening the safety profile while also being cost saving., (© 2024 the International Society of Dermatology.)
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- 2024
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11. Drug Survival in Cyclosporine Treatment for Moderate to Severe Atopic Dermatitis: Analysis of the Spanish Atopic Dermatitis Registry (BIOBADATOP).
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Couselo-Rodríguez C, Batalla A, Carrascosa JM, Chicharro P, González-Quesada A, de la Cueva P, Giménez-Arnau AM, Gilaberte Y, Rodríguez-Serna M, Montero-Vilchez T, Ruiz-Villaverde R, Elosua-González M, Silvestre-Salvador JF, Munera-Campos M, Sánchez-Pérez J, Carretero G, Mauleón-Fernández C, Curto-Barredo L, Ballano-Ruiz A, Botella-Estrada R, Arias-Santiago S, Navarro-Triviño FJ, Roustan-Gullón G, Betlloch I, Del Alcázar E, Abalde-Pintos MT, Suárez-Perez J, García-Doval I, Descalzo MÁ, and Flórez Á
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- Humans, Cyclosporine therapeutic use, Immunosuppressive Agents therapeutic use, Prospective Studies, Registries, Treatment Outcome, Dermatitis, Atopic drug therapy, Psoriasis drug therapy
- Abstract
Background: The past 5 years have seen a proliferation of new treatments for atopic dermatitis (AD). We analyzed recent drug survival data for cyclosporine in this setting. Because the Spanish National Healthcare system requires patients with AD to be treated with cyclosporine before they can be prescribed other systemic treatments, drug survival for cyclosporine may be shorter than in other diseases., Material and Method: Multicenter, observational, prospective cohort study using data from the Spanish Atopic Dermatitis Registry (BIOBADATOP). Data from the Spanish Registry of Systemic Treatments in Psoriasis (BIOBADADERM) were used to create a comparison cohort., Results: We analyzed data for 130 patients with AD treated with cyclosporine (median drug survival, 1 year). Median cyclosporine survival in the psoriasis comparison group (150 patients) was 0.37 years. Drug survival was significantly longer in AD than in psoriasis (P<.001)., Conclusion: Drug survival of cyclosporine in the BIOBADATOP registry is similar to that described in other series of patients with AD and longer than that observed in the BIOBADADERM psoriasis registry., (Copyright © 2023 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)
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- 2024
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12. Real-world Safety and Efficacy of Risankizumab in Psoriatic Patients: A Multicenter, Retrospective, and Not-interventional Study.
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Martorell A, Santos-Alarcón S, Sahuquillo-Torralba A, Rivera-Díaz R, Belinchón-Romero I, Ruiz-Genao D, Romero-Maté A, Ruiz-Villaverde R, Ferran-Farrés M, Gallardo-Hernández F, Almenara-Blasco M, Suarez-Perez JA, González-Cantero Á, Martínez-Lorenzo E, Fernández-Armenteros JM, Del Alcázar-Viladomiu E, García-Latasa J, Rocamora-Durant V, Ara-Martín M, Mateu-Puchades A, Llamas-Velasco M, Vilarrasa E, Velasco-Pastor M, De la Cueva P, Carrascosa JM, and Magdaleno-Tapial J
- Abstract
Background and Objective: Risankizumab - a humanized monoclonal antibody that targets the p19 subunit of IL-23 - has been recently approved to treat moderate-to-severe plaque psoriasis. Real-world data based on a representative pool of patients are currently lacking., Objective: To assess the mid- and long-term safety and efficacy profile of risankizumab in patients with moderate-to-severe psoriasis in the routine clinical practice., Methods: This was a retrospective and multicenter study of consecutive psoriatic patients on risankizumab from April 2020 through November 2022. The primary endpoint was the number of patients who achieved a 100% improvement in their Psoriasis Area and Severity Index (PASI) (PASI100) on week 52., Results: A total of 510 patients, 198 (38.8%) women and 312 (61.2%) men were included in the study. The mean age was 51.7±14.4 years. A total of 227 (44.5%) study participants were obese (body mass index [BMI] >30kg/m
2 ). The mean baseline PASI score was 11.4±7.2, and the rate of patients who achieved PASI100 on week 52, 67.0%. Throughout the study follow-up, 21%, 50.0%, 59.0%, and 66% of the patients achieved PASI100 on weeks 4, 16, 24, and 40, respectively. The number of patients who achieved a PASI ≤2 was greater in the group with a BMI ≤30kg/m2 on weeks 4 (P=.04), 16 (P=.001), and 52 (P=.002). A statistically significantly greater number of patients achieved PASI100 in the treatment-naïve group on weeks 16 and 52 (P=.001 each, respectively). On week 16 a significantly lower number of participants achieved PASI100 in the group with psoriatic arthropathy (P=.04). Among the overall study sample, 22 (4.3%) patients reported some type of adverse event and 20 (3.9%) discontinued treatment., Conclusions: Risankizumab proved to be a safe and effective therapy for patients with moderate-to-severe psoriasis in the routine clinical practice., (Copyright © 2024 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)- Published
- 2024
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13. Safety of biologic therapy in combination with methotrexate in moderate to severe psoriasis: a cohort study from the BIOBADADERM registry.
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Lluch-Galcerá JJ, Carrascosa JM, González-Quesada A, Rivera-Díaz R, Sahuquillo-Torralba A, Llamas-Velasco M, Gómez-García FJ, Herrera-Acosta E, de la Cueva P, Baniandrés-Rodríguez O, Lopez-Estebaranz JL, Belinchón I, Ferrán M, Mateu A, Rodríguez L, Riera-Monroig J, Abalde-Pintos MT, Carretero G, García-Donoso C, Pujol-Marco C, Del Alcázar E, Santamaría-Domínguez C, Suárez-Pérez JA, Nieto-Benito LM, Ruiz-Genao DP, Salgado-Boquete L, Descalzo MÁ, and García-Doval I
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- Humans, Methotrexate, Cohort Studies, Registries, Biological Therapy, Psoriasis pathology, Biological Products adverse effects
- Abstract
Background: Safety is an important consideration in decisions on treatment for patients with moderate-to-severe psoriasis and the study of drug safety is the main purpose of the BIOBADADERM registry. The combination of a biologic agent and a conventional systemic drug [generally methotrexate (MTX)] is a common treatment in clinical practice. However, there is a paucity of evidence from real-world practice on the safety of such combination regimens in the treatment of psoriasis., Objectives: The primary objective of this study was to ascertain whether the use of regimens combining biologic drugs with MTX in the management of moderate-to-severe psoriasis increases the risk of adverse events (AEs) or serious AEs (SAEs). We compared monotherapy using tumour necrosis factor (TNF), interleukin (IL)-17 and IL-23 inhibitors with the use of the same drugs in combination with MTX., Methods: Using data from the BIOBADADERM registry, we compared biologic monotherapies with therapies that were combined with MTX. We estimated adjusted incidence rate ratios (aIRR) using a random effects Poisson regression with 95% confidence intervals for all AEs, SAEs, infections and serious infections and other AEs by system organ class., Results: We analysed data from 2829 patients and 5441 treatment cycles, a total of 12 853 patient-years. The combination of a biologic with MTX was not associated with statistically significant increases in overall risk of AEs or SAEs in any treatment group. No increase in the total number of infections or serious infections in patients receiving combined therapy was observed for any group. However, treatment with a TNF inhibitor combined with MTX was associated with an increase in the incidence of gastrointestinal AEs (aIRR 2.50, 95% CI 1.57-3.98; P < 0.002)., Conclusions: The risk of AEs and SAEs was not significantly increased in patients with moderate-to-severe psoriasis receiving different classes of biologic drugs combined with MTX compared with those on biologic monotherapy., Competing Interests: Conflicts of interest J.M.C. has participated as a speaker and/or advisor and/or principal investigator/senior investigator in clinical trials sponsored by for Celgene, Janssen, Lilly, Leo Pharma, Novartis, Pfizer, MSD, Biogen, Mylan, Amgen, AbbVie and Sandoz. A.G.-Q. acted as consultant and/or speaker for and/or participated in clinical trials as principal investigator and subinvestiator for AbbVie, Almirall, Amgen, Boehringer, Janssen, Leo Pharma, Lilly, Novartis, MSD, Pfizer-Wyeth and UCB. R.R.-D. acted as consultant and/or speaker for and/or participated in clinical trials as principal investigator for AbbVie, Almirall, Amgen, Boehringer, Janssen, Leo Pharma, Lilly, Novartis, MSD, Pfizer-Wyeth and UCB. A.S.-T. has served as a consultant and/or paid speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Celgene, Janssen-Cilag, LEO Pharma, Lilly, Novartis and Pfizer. M.L.-V. acted as a consultant and speaker and participated in clinical trials for Janssen-Cilag, AbbVie, Boehringer, Celgene, Pfizer, Novartis, Lilly, Almirall, UCB, Kyowa Kirin and Leo Pharma. E.H.-A. has served as consultant and/or speaker with Leo Pharma, Novartis, Janssen, Lilly, Celgene and AbbVie. P.d.l.C. acted as a consultant and/or speaker for Janssen-Cilag, AbbVie, MSD, Pfizer, Novartis, Lilly, Almirall, UCB, Biogen, Celgene, Amgen, Sandoz, Sanofi and Leo Pharma. O.B.-R. acted as a consultant and/or speaker for Janssen-Cilag, AbbVie, Pfizer, Novartis, Lilly, Celgene, Leo Pharma, Amgen, Boehringer, UCB and Almirall. L.L.-E. participated as advisory board member and received educational grants from Janssen, AbbVie, MSD, Lilly, Novartis, LeoPharma and Pfizer. I.B. acted as a consultant and/or speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including Janssen Pharmaceuticals Inc., Almirall SA, Lilly, AbbVie, Novartis, Celgene, Biogen Amgen, Leo Pharma, UCB, Pfizer-Wyeth and MSD. M.F. has participated as speaker and/or advisor for Janssen, Lilly, Novartis, Pfizer, MSD, AbbVie Celgene and Almirall. A.M. acted as consultant and/or speaker for AbbVie, Almirall, Celgene, Janssen, Leo Pharma, Lilly, Novartis. L.R. acted as a consultant and speaker for Janssen-Cilag, AbbVie, MSD, Pfizer, Novartis, Lilly, Almirall, Celgene and Leo Pharma. J.R.-M. acted as a consultant and/or speaker for and/or participated in clinical trials sponsored by AbbVie, Almirall, Janssen, Leo Pharma, Novartis, UCB, Pfizer, Lilly, Amgen and Boehringer Ingelheim. G.C. has been reimbursed by Janssen, AbbVie, Novartis, Pfizer, MSD and Celgene for advisory service and conference attendance. C.G.-D. participated as advisory board member for AbbVie, Almirall and speaker for Janssen, Lilly and Celgene. C.P.-M. acted as a consultant and/or speaker for Janssen-Cilag, AbbVie, MSD, Pfizer, Novartis, Lilly, Almirall, UCB, Celgene and Leo Pharma. E.D.A. has participated as a speaker and/or and/or PI/SI clinical trials sponsored by Amgen, Almirall, Janssen, Lilly, Leo Pharma, Novartis, UCB and AbbVie. J.A.S.-P. has served as consultant and/or speaker with Leo Pharma, Novartis, Janssen, Lilly, Celgene, AbbVie, Amgen, Sanofi, Almirall and Pfizer. D.P.R.-G. has been reimbursed by Pfizer, Janssen, Celgene, AbbVie, Novartis and LeoPharma for advisory services and conference attendance. I.G.D. received travel grants for congresses from AbbVie, MSD, Pfizer and Sanofi., (© The Author(s) 2023. Published by Oxford University Press on behalf of British Association of Dermatologists. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2024
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14. [Odontogenic cutaneous fistula as a simulator of a cutaneous tumor].
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Del Río Pena E, Díez Madueño K, Zuazua-González A, and de la Cueva Dobao P
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- Humans, Cutaneous Fistula etiology, Cutaneous Fistula pathology, Skin Neoplasms diagnosis
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- 2024
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15. Family Planning Concerns Among Women With Psoriasis: A Descriptive, Cross-Sectional, Multicenter Study.
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Jiménez Gómez N, González-Cantero Á, Ruiz-Villaverde R, Llamas-Velasco M, de la Cueva Dobao P, Rivera Díaz R, Martínez Lorenzo E, Alonso Pacheco ML, Baniandrés Rodríguez O, Mollet Sánchez J, Pitarch Bort G, Izu Belloso RM, and Jaén Olasolo P
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- Humans, Female, Pregnancy, Adult, Cross-Sectional Studies, Quality of Life, Surveys and Questionnaires, Family Planning Services, Psoriasis drug therapy
- Abstract
Background and Objective: A significant proportion of women of childbearing age have psoriasis. The aim of this study was to examine family planning concerns in this population., Material and Methods: Observational, descriptive, cross-sectional, multicenter study conducted between March 2020 and October 2021. We collected sociodemographic data and analyzed responses to a family planning questionnaire administered to women aged 18 to 45 years with plaque psoriasis who were candidates for systemic treatment., Results: We studied 153 patients (mean [SD] age, 35.4 [8.0] years; mean disease duration, 16.7 years) being treated at 11 Spanish hospitals. Overall, 38.4% of women were considered to have moderate to severe psoriasis by their physicians; perceived severity ratings were significantly higher among women. Psoriasis affected the women's desire to become pregnant or led to their delaying pregnancy in 1 in 3 respondents. They were concerned that their condition might worsen if they had to discontinue or switch treatment or that the treatment might harm the baby. Approximately half of the women had not received family planning counseling from their physicians, and this was more likely to be the case among never-pregnant women. Women on biologic therapy (58.7%) had better psoriasis control and a better quality of life than women on other treatments. Their sexual health was also less affected., Conclusions: Women with psoriasis have numerous family planning concerns, which in some cases can lead them to delay pregnancy or affect their desire to become pregnant. Dermatologists need to receive better training regarding family planning in women with psoriasis so that they can provide their patients with more and better information., (Copyright © 2023 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)
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- 2024
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16. Glucagon-Like Peptide-1 Agonists for Treating Obesity in Patients With Immune-Mediated Skin Diseases.
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Vilarrasa E, Nicolau J, de la Cueva P, Goday A, Gallardo F, Martorell A, and Carrascosa JM
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- Humans, Hypoglycemic Agents pharmacology, Hypoglycemic Agents therapeutic use, Liraglutide therapeutic use, Obesity complications, Obesity drug therapy, Diabetes Mellitus, Type 2, Skin Diseases drug therapy, Skin Diseases etiology
- Abstract
Psoriasis and hidradenitis suppurativa are often associated with obesity. Because chronic low-grade inflammation underlies these 2 diseases, they can progress to more severe forms in patients with obesity if weight-reduction measures are not taken. This review covers pharmacologic alternatives for treating obesity, with emphasis on the benefits associated with the novel use of glucagon-like peptide-1 (GLP-1) agonists that act on satiety receptors. These drugs have led to greater weight loss in clinical trials and real-world settings than orlistat, which until recently was the only drug approved for treating obesity in the European Union. Although experience with GLP-1 agonists in patients with obesity and inflammatory skin diseases is currently scarce, the promising results reported suggest they may offer a useful tool for managing obesity., (Copyright © 2023 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)
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- 2024
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17. Giant Cellulitis-like Sweet Syndrome: Contribution of a New Case and Medical Literature Review.
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Díez-Madueño K, Buendía Castaño D, Roldán Cortés D, and de la Cueva Dobao P
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- 2023
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18. Effectiveness of secukinumab for the treatment of erythrodermic psoriasis: Multicentre study in daily practice.
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Reymundo A, Armesto S, Rodríguez L, Baniandrés O, Sahuquillo-Torralba A, Torres T, de la Cueva P, Llamas-Velasco M, and Daudén E
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- Humans, Severity of Illness Index, Treatment Outcome, Antibodies, Monoclonal, Humanized therapeutic use, Psoriasis complications, Psoriasis drug therapy
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- 2023
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19. Criteria used to define tumor necrosis factor-alpha inhibitors failure in patients with moderate-to-severe psoriasis: a systematic literature review.
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Belinchon Romero I, Mateu Puchades A, Ribera Pibernat M, Ruiz Genao DP, de la Cueva Dobao P, and Carrascosa JM
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- Humans, Tumor Necrosis Factor-alpha therapeutic use, Tumor Necrosis Factor Inhibitors therapeutic use, Treatment Outcome, Antibodies, Monoclonal therapeutic use, Psoriasis drug therapy, Psoriasis pathology
- Abstract
Background: Determining tumor necrosis factor-alpha inhibitors (anti-TNF-α) failure is still a challenge in the management of moderate-to-severe psoriasis. Thus, our comprehensive systematic literature review aimed to gather information on the criteria used to define anti-TNF-α failure. We also aimed to discover the main reasons for anti-TNF-α failure and define subsequently administered treatments., Materials and Methods: We conducted a systematic review following review and reporting guidelines (Cochrane and PRISMA). International (Medline/PubMed and Cochrane Library) and Spanish databases (MEDES, IBECS), and gray literature were consulted to identify publications issued until April 2021 in English or Spanish., Results: Our search yielded 58 publications. Of these, 37 (63.8%) described the criteria used to define anti-TNF-α primary or secondary failure. Criteria varied across studies, although around 60% considered Psoriasis Area and Severity Index (PASI)-50 criteria. Nineteen (32.8%) reported the reasons for treatment failure, including the lack or loss of efficacy and safety-related problems, mainly infections. Finally, 29 (50%) publications outlined the treatments administered after anti-TNF-α: 62.5% reported a switch to another anti-TNF-α and 37.5% to interleukin (IL)-inhibitors., Our findings suggest a need to standardize the management of anti-TNF-α failure and reflect the incorporation of new targets, such as IL-inhibitors, in the treatment sequence.KEY MESSAGESIn the treatment of psoriasis, the primary and secondary anti-TNF-α failure criteria differ widely in the scientific literature.The strictest efficacy criteria for defining anti-TNF-α failure, or those recommended by guidelines such as PASI75, were underused both in clinical trials and observational studies.Most studies failed to consider patient-reported outcomes in assessing psoriasis treatment efficacy, which contrasts with recent recommendations on the inclusion of patient-reported HRQoL as a supporting criterion when considering clinical outcomes.
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- 2023
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20. Effectiveness and safety of tildrakizumab for the treatment of psoriasis in real-world settings at 24 weeks: A retrospective, observational, multicentre study by the Spanish Psoriasis Group.
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Berenguer-Ruiz S, Aparicio-Domínguez M, Herranz-Pinto P, Ruíz-Villaverde R, López-Ferrer A, Santos-Juanes J, Rodríguez Fernández-Freire L, Hospital-Gil M, Arias-Santiago S, Carretero-Hernández G, Mateu-Puchades A, Ferran M, Del Alcázar E, Santos-Alarcón S, Garcia-Latasa de Aranibar FJ, Belinchón-Romero I, González-Cantero Á, Ruíz-Genao D, Eiris-Salvado N, Rocamora-Durán V, Rivera-Diaz R, de la Cueva P, Daudén E, Salgado-Boquete L, and Llamas-Velasco M
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- Female, Humans, Male, Middle Aged, Retrospective Studies, Severity of Illness Index, Treatment Outcome, Arthritis, Psoriatic drug therapy, Psoriasis drug therapy
- Abstract
Background: Tildrakizumab is a humanized, IgG1/κ antibody that interacts with the p19 subunit of interleukin 23. It is approved for the treatment of moderate-to-severe plaque psoriasis. Real-world evidence on the effectiveness and safety of tildrakizumab is limited., Objectives: To assess the effectiveness and safety of tildrakizumab at 24 weeks in patients with moderate-to-severe plaque psoriasis in routine clinical practice., Methods: Retrospective, observational, multicentre study including adult patients with moderate-to-severe plaque psoriasis treated with tildrakizumab under real-life conditions. Patient data were extracted from anonymized electronic medical records. Statistical analysis was performed using SPSS22., Results: A total of 190 patients were included. About 53.9% were men with a mean age of 51.45 (SD 3.9) and a mean BMI of 29.13 (SD 6.21). About 79.8% (132 out of 190) of patients had previously received biological therapy (BT) and 17.3% (33 out of 191) had psoriatic arthritis. Baseline PASI was 10.7 (SD 6.53). Up to 109 patients reached Week 24 and at this point mean baseline PASI decreased to 1.7 (SD 4.8), representing an 88.79% mean PASI reduction. At 6 months, 87.1% and 40.3% of the treated patients achieved PASI ≤3 and ≤1, respectively. At Week 24 mean BSA decreased from 13.2 (SD 10.07) to 1.6 (SD 4.40) and mean DLQI went from 12.5 (SD 7.12) to 1.2 (SD 3.27). Multivariate analysis showed no differences when effectiveness was correlated with gender, obesity, psoriatic arthritis or prior exposure to BT. The rate of adverse events (AE) was 5.9% (11 out of 190), where infections were the most frequent AE (4 out of 11). One patient suffered a haemorrhagic ictus and one patient died due to causes unrelated to the study., Conclusion: Tildrakizumab was effective and safe in a large cohort of patients with moderate-to-severe plaque psoriasis treated in a routine clinical setting., (© 2023 European Academy of Dermatology and Venereology.)
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- 2023
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21. Selection of Quality Indicators for the Certification of Psoriasis Units: The CUDERMA Project Delphi Consensus Study.
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Salgado-Boquete L, Arias-Santiago S, Belinchón-Romero I, de la Cuadra-Grande A, de la Cueva P, Gilaberte Y, Notario J, Rivera-Díaz R, Ruiz-Villaverde R, and Carrascosa JM
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- Humans, Delphi Technique, Quality Indicators, Health Care, Psoriasis therapy
- Abstract
Defining quality indicators is a key strategy for ensuring the quality and standardization of health care. The CUDERMA project, an initiative of the Spanish Academy of Dermatology and Venerology (AEDV), was undertaken to define quality indicators for the certification of specialized units in dermatology; the first 2 areas selected were psoriasis and dermato-oncology. The aim of this study was to reach a consensus on what should be assessed by the indicators used to certify psoriasis units. The structured process used to do this comprised a literature review to identify potential indicators, the selection of an initial set of indicators to be evaluated by a multidisciplinary group of experts and, finally, a Delphi consensus study. A panel of 39 dermatologists evaluated the selected indicators and classified them as either "essential" or "of excellence". Consensus was finally reached on 67 indicators, which will be standardized and used to develop the certification standard for psoriasis units., (Copyright © 2023. Publicado por Elsevier España, S.L.U.)
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- 2023
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22. Effectiveness and safety of brodalumab in the treatment of plaque, scalp and palmoplantar psoriasis: A multicentre retrospective study in a Spanish population.
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Sahuquillo-Torralba A, Hospital-Gil M, Vilarrasa-Rull E, Llamas-Velasco M, Rivera R, Carrascosa JM, de la Cueva-Dovao P, Armesto-Santos S, Ruíz-Villaverde R, Velasco-Pastor M, Magdaleno-Tapial J, Yanguas-Bayona JI, Ribera-Pibernat M, Salgado-Boquete L, Herranz-Pinto P, Romero-Mate A, Martínez-Lorenzo E, López-Estebaranz JL, Ballescá-López F, and Botella-Estrada R
- Subjects
- Adult, Humans, Retrospective Studies, Scalp, Treatment Outcome, Severity of Illness Index, Immunoglobulin A, Antibodies, Monoclonal adverse effects, Psoriasis drug therapy, Psoriasis chemically induced
- Abstract
Background and Objective: The data in clinical practice regarding the effectiveness and safety of brodalumab in psoriasis are scarce, especially at scalp and palmoplantar locations. The main objective was the percentage of patients achieving absolute PASI ≤3/ ≤1/ =0 for plaque psoriasis and the percentage of patients achieving an IGA 0-1/IGA 0 for the special locations at Week 52 of treatment., Patients and Methods: Observational retrospective multicentre study in 28 Spanish Hospitals that included adult patients with plaque psoriasis treated with brodalumab, from September 2018 until March 2021., Results: A total of 200 patients were included. The mean baseline PASI was 10.97 (±6.28) with a mean basal scalp (n = 58) and palmoplantar (n = 40) IGA of 2.10 (±0.97) and 2.15 (±1.26), respectively. At Week 52, 93.98%/75.90%/68.67% of patients reached an absolute PASI ≤3/ ≤1/ =0 in plaque psoriasis (n = 83), with a percentage of patients achieving scalp (n = 27) and palmoplantar (n = 19) IGA 0-1/IGA 0 of 96.3%/88.9% and 100%/88.9%, respectively. Fifteen per cent of patients reported any adverse events with candidiasis being the most reported (6%), but only 6% of the adverse events required the withdrawal., Conclusions: Brodalumab demonstrated high PASI and IGA responses and was well tolerated in clinical practice in plaque, scalp and palmoplantar psoriasis., (© 2023 The Australasian College of Dermatologists.)
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- 2023
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23. Moderate to Severe Psoriasis in Older Adults: Recommendations on Management from the Psoriasis Working Group of the Spanish Academy of Dermatology and Venereology (AEDV).
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Mataix J, García L, Belinchón I, Ruiz Carrascosa JC, de la Cueva P, and Carrascosa JM
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- Humans, Aged, Venereology, Dermatology, Psoriasis drug therapy
- Abstract
Managing moderate to severe psoriasis in older adults is complex due to factors characteristic of the later years of life, such as associated comorbidity, polypharmacy, and immunosenescence. This consensus statement discusses 17 recommendations for managing treatment for moderate to severe psoriasis in patients older than 65 years. The recommendations were proposed by a committee of 6 dermatologists who reviewed the literature. Fifty-one members of the Psoriasis Working Group of the Spanish Academy of Dermatology and Venereology (AEDV) then applied the Delphi process in 2 rounds to reach consensus on which principles to adopt. The recommendations can help to improve management, outcomes, and prognosis for older adults with moderate to severe psoriasis., (Copyright © 2023 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)
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- 2023
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24. Treatment of severe atopic dermatitis with tralokinumab in clinical practice: short-term effectiveness and safety results.
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Pereyra-Rodríguez JJ, Herranz P, Ruiz-Villaverde R, Elosua-González M, Galán-Gutiérrez M, Figueras-Nart I, Miquel J, de la Cueva P, Serra-Baldrich E, Munera-Campos M, Melé-Ninot G, Expósito-Serrano V, Perez B, Serrano A, Ortiz de Frutos JF, and Armario-Hita JC
- Subjects
- Adult, Humans, Quality of Life, Retrospective Studies, Treatment Outcome, Pruritus drug therapy, Severity of Illness Index, Double-Blind Method, Dermatitis, Atopic drug therapy
- Abstract
Background: Tralokinumab was recently approved for the treatment of moderate-to-severe atopic dermatitis (AD) and is the first selective interleukin (IL)-13 inhibitor that specifically neutralizes IL-13 with high affinity., Objectives: To determine the real-life short-term effectiveness and safety of tralokinumab treatment in patients with moderate-to-severe AD., Methods: A multicentre retrospective study was conducted including adult patients with moderate-to-severe AD who started tralokinumab treatment from 1 April to 30 June 2022 in 16 Spanish hospitals. Demographic and disease characteristics, severity and quality of life scales were collected at the baseline visit and at weeks 4 and 16., Results: Eighty-five patients were included. Twenty-seven patients (32%) were non-naive to advanced therapy (biological or Janus kinase inhibitors inhibitors). All included patients had severe disease with baseline Eczema Area and Severity Index (EASI) scores of 25.4 (SD 8.1), Dermatology Life Quality Index (DLQI) 15.8 (5.4) and peak pruritus numerical rating scale (PP-NRS) 8.1 (1.8) and 65% had an Investigator's Global Assessment (IGA) of 4. At week 16, there was improvement on all scales. The mean EASI decreased to 7.5 (SD 6.9, 70% improvement), SCORing Atopic Dermatitis improved 64% and PP-NRS, 57%. Also, 82%, 58% and 21% of the patients achieved EASI 50, 75 and 90, respectively. The percentage of EASI 75 responders was significantly higher among the naive vs. non-naive groups (67% vs. 41%). The safety profile was acceptable., Conclusions: Patients, with a long history of disease and prior multidrug failure, showed a good response to tralokinumab, confirming clinical trial results., Competing Interests: Conflicts of interest: J.J.P.-R. has received honoraria for research from Novartis, AbbVie and Sanofi and for lecturing and other financial benefit from AbbVie, Almirall, Galderma, Janssen, Gebro-Pharma, Leo Pharma, Novartis, Lilly, Novartis, Pfizer, Sanofi and UCB. P.H. has been an investigator, speaker, and/or consultant for: AbbVie, Almirall, Amgen, Bristol Myers Squibb, Janssen, Lilly, Galderma, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi Genzyme and UCB Pharma. R.R.-V. has received honoraria for research from AbbVie, and lecturing and other financial benefits from Sanofi, AbbVie, Leo, MSD, Pfizer, Lilly, UCB, Janssen and Almirall. M.E.-G. has been an investigator and/or speaker for AbbVie, Lilly, Galderma, Leo Pharma, Pfizer, UCB Pharma and Sanofi Genzyme. M.G.-G. has received honoraria for research from Sanofi and AbbVie, and lecturing and other financial benefits from Sanofi, AbbVie, Leo Pharma, MSD, Pfizer, Celgene, Janssen, UCB Pharma, Lilly and Almirall. I.F.N. has been an investigator, speaker, and/or advisor for: AbbVie, Amgen, Lilly, Galderma, Pierre Fabre, Leo Pharma, Novartis, Regeneron and Sanofi Genzyme. J.M. has received speaker and consultancy fees from AbbVie, Leo Pharma, Novartis, Sanofi, UCB, Janssen, AMGEN and Lilly, and has participated as principal investigator in clinical trials sponsored by AbbVie, AMGEN and Novartis. P.d.l.C. has received consulting fees; payment or honoraria for lectures, presentations, speaker bureaus, manuscript writing or educational events; support for attending meetings and/or travel; participation on a Data safety monitoring board or advisory board from AbbVie, Pfizer, UCB, Leo Pharma, Almirall S.A., Lilly, Sanofi, MSD, BMS, Novartis and Janssen. E.S.-B. has been an investigator, speaker, and/or advisor for: AbbVie, Amgen, Sanofi and Lilly. M.M.-C. has participated as an investigator in clinical trials sponsored by Sanofi, AbbVie, Lilly, Leo Pharma, Pfizer, Almirall, Galderma and Novartis and has received speaker and consultant fees from, Leo Pharma, AbbVie and Galderma. G.M.-N. has been a medical advisor for AbbVie, Leo Pharma, Lilly, Sanofi and Novartis and undertaken educational activities for Almirall, Avène, AbbVie, Laboratorio Reig Jofre, Leo Pharma, Lilly, Meda, Novartis, Sanofi and Uriage. V.E.-S. has been an investigator, speaker, and/or advisor for AbbVie, Lilly, Leo Pharma, Novartis and Sanofi Genzyme. B.P. has received honoraria as speaker and/or advisor as well as funding to attend conferences for Sanofi, AbbVie, Boheringer Ingelheim, Lilly, Galderma, Leo Pharma, Pierre Fabre, Meda Pharma and FAES Pharma. J.O.d.F. has received speaker and consultancy fees from AbbVie, Leo Pharma, Novartis, Sanofi, Pfizer and Lilly, and has participated as principal investigator in clinical trials sponsored by AbbVie, Sanofi, Pfizer, Leo Pharma, Lilly and Novartis. J.C.A.-H. with funding for research from Novartis, AbbVie and Sanofi, and lecturing and other financial benefits from AbbVie, Almirall, Galderma, Janssen, Gebro-Pharma, Leo Pharma, Novartis, Lilly, Novartis, Pfizer, Sanofi and UCB. A.S. declares they have no conflicts of interest., (© The Author(s) 2023. Published by Oxford University Press on behalf of British Association of Dermatologists. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2023
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25. Selection of Quality Indicators for the Certification of Dermato-Oncology Units: The CUDERMA Project Delphi Consensus Study.
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Martínez de Espronceda Ezquerro I, Podlipnik S, Cañueto J, de la Cuadra-Grande A, Serra-Guillén C, Moreno D, Ferrándiz L, Domínguez-Cruz J, de la Cueva P, Gilaberte Y, and Arias-Santiago S
- Subjects
- Humans, Delphi Technique, Consensus, Certification, Quality Indicators, Health Care, Dermatology
- Abstract
Quality indicators are crucial for standardizing and guaranteeing the quality of health care practices. The Spanish Academy of Dermatology and Venereology (AEDV) launched the CUDERMA Project to define quality indicators for the certification of specialized units in dermatology; the first 2areas selected were psoriasis and dermato-oncology. The aim of this study was to achieve consensus on what should be evaluated by these indicators using a structured process comprising a literature review and selection of an initial list of indicators to be evaluated in a Delphi consensus study following review by a multidisciplinary group of experts. The selected indicators were evaluated by a panel of 28 dermatologists and classified as either «essential» or «of excellence». The panel agreed on 84 indicators, which will be standardized and used to develop the certification standard for dermato-oncology units., (Copyright © 2023 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)
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- 2023
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26. Epidemiological and Clinical Characteristics of Patients Admitted to a Secondary Hospital with Suspected MPOX Virus Infection: Is HIV Playing a Role?
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Estévez S, Vara M, Gamo M, Manzano S, Troya J, Botezat E, Jiménez E, Pedrero-Tomé R, Martin MÁ, de la Cueva P, Fernández E, Fernández B, Brown DE, Palma E, and Simón A
- Abstract
MPOX (monkeypox) is a zoonotic viral disease, endemic in some Central and West African countries. However, in May 2022, cases began to be reported in non-endemic countries, demonstrating community transmission. Since the beginning of the outbreak, different epidemiological and clinical behaviors have been observed. We conducted an observational study at a secondary hospital in Madrid to characterize suspected and confirmed cases of MPOX epidemiologically and clinically. Besides the general descriptive analysis, we compared data between HIV-positive and HIV-negative subjects; 133 patients were evaluated with suspected MPOX, of which 100 were confirmed. Regarding positive cases, 71.0% were HIV positive, and 99.0% were men with a mean age of 33. In the previous year, 97.6% reported having sex with men, 53.6% used apps for sexual encounters, 22.9% practiced chemsex, and 16.7% went to saunas. Inguinal adenopathies were significantly higher in MPOX cases (54.0% vs. 12.1%, p < 0.001), as the involvement of genital and perianal area (57.0% vs. 27.3% and 17.0% vs. 1.0%, p = 0.006 and p = 0.082 respectively). Pustules were the most common skin lesion (45.0%). In HIV-positive cases, only 6.9% had a detectable viral load, and the mean CD4 count was 607.0/mm
3 . No significant differences were observed in the disease course, except for a greater tendency towards the appearance of perianal lesions. In conclusion, the MPOX 2022 outbreak in our area has been related to sexual intercourse among MSM, with no severe clinical cases nor apparent differences in HIV and non-HIV patients.- Published
- 2023
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27. BIOBADATOP Spanish Atopic Dermatitis Registry: Description and Early Findings.
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Munera-Campos M, Chicharro P, Gonzalez Quesada A, Flórez Menéndez Á, de la Cueva Dobao P, Gimenez Arnau AM, Gilaberte Calzada Y, Rodríguez Serna M, Montero-Vilchez T, Silvestre JF, Elosua-González M, Del Alcázar E, Santamaría C, Sánchez-Pérez J, Carretero Hernández G, Batalla A, Jin Suh Oh H, Mauleón Fernández C, Curto Barredo L, Bertolín-Colilla M, Navarro Bielsa A, Ballano Ruiz A, Botella Estrada R, Arias Santiago S, Betlloch I, Roustan Gullón G, Rosell Díaz A, Descalzo MA, García-Doval I, and Carrascosa JM
- Subjects
- Humans, Prospective Studies, Cyclosporine therapeutic use, Administration, Cutaneous, Registries, Treatment Outcome, Severity of Illness Index, Dermatitis, Atopic drug therapy, Dermatitis, Atopic epidemiology
- Abstract
Background: In recent years, remarkable improvements in our understanding of atopic dermatitis (AD) have revolutionized treatment perspectives, but access to reliable data from clinical practice is essential., Materials and Method: The Spanish Atopic Dermatitis Registry, BIOBADATOP, is a prospective, multicenter database that collects information on patients of all ages with AD requiring systemic therapy with conventional or novel drugs. We analyzed the registry to describe patient characteristics, diagnoses, treatments, and adverse events (AEs)., Results: We studied data entries for 258 patients who had received 347 systemic treatments for AD. Treatment was discontinued in 29.4% of cases, mostly due to a lack of effectiveness (in 10.7% of cases). A total of 132 AEs were described during follow-up. Eighty-six AEs (65%) were linked to a systemic treatment, most commonly dupilumab (39AEs) and cyclosporine (38AEs). The most common AEs were conjunctivitis (11patients), headache (6), hypertrichosis (5), and nausea (4). There was 1severe AE (acute mastoiditis) associated with cyclosporine., Conclusions: Initial findings on AEs from the Spanish BIOBADATOP registry are limited by short follow-up times precluding comparisons or calculation of crude and adjusted incidence rates. At the time of our analysis, no severe AEs had been reported for novel systemic therapies. BIOBADATOP will help answer questions on the effectiveness and safety of conventional and novel systemic therapies in AD., (Copyright © 2023 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)
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- 2023
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28. Updated Position of the Spanish Psoriasis Group (GPs) on the Use of Biosimilar Drugs in Moderate to Severe Psoriasis.
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Ruiz-Villaverde R, Galán-Gutiérrez M, Llamas-Velasco M, Salgado-Boquete L, Puig L, de la Cueva P, and Carrascosa JM
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- Humans, Severity of Illness Index, Biosimilar Pharmaceuticals therapeutic use, Psoriasis drug therapy
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The advent of biosimilar drugs and their use in routine clinical practice has revolutionized the management of moderate to severe psoriasis and led to changes in the positioning of the existing molecules used to control this condition. Evidence from clinical trials complemented by real-world experience has helped to clarify concepts and has significantly changed the use and positioning of biologic agents in this setting. The present document is an update on the position of the Spanish Psoriasis Working Group regarding the use of biosimilar drugs, which takes into account this new situation., (Copyright © 2023 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)
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- 2023
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29. Interdisciplinary management of mpox-related local complications: report on a series of cases.
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Gamo Guerrero M, Simón Gozalbo A, Martín Díaz M, Díez Madueño K, Del Río Pena E, De la Cueva P, Talaván T, Jiménez E, Torres J, Valencia J, Cuevas G, Bibiano C, and Ryan P
- Abstract
Monkeypox (mpox) is a viral zoonosis, and human-to-human transmission can result from close contact with the respiratory secretions and mucocutaneous lesions of an infected person. The prodromal phase is followed by an eruptive phase, with skin and/or mucosal lesions that progress through several stages at different sites. In this study, we describe the importance of interdisciplinary care management and follow-up of patients with complicated mpox. A cross-sectional study was conducted from May 2022 until August 2022 at a secondary hospital in Madrid (Spain). Out of 100 patients with mpox seen at this institution, we selected and analyzed 11 with local complications. All the patients were male at birth, and the mean age was 32 (30-42) years. The clinical manifestations included skin rash or mucosal lesions, fever, myalgia and lymphadenopathies. The most frequent local complications were pharyngitis associated with dysphagia, penile edema, infection of the mucocutaneous lesions, and ulceration of the genital lesions. A multidisciplinary team was created for the care of patients with complications secondary to mpox. The team comprised dermatologists and specialists in infectious diseases, preventive medicine, and emergency medicine. This approach improved the ability to diagnose and treat early with supportive, topical, and systemic treatment. In our center most of the cases were self-limiting, and none were life-threatening. An interdisciplinary response to a public health alert enhances the management of complex patients and should be implemented in successive outbreaks of mpox., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Gamo Guerrero, Simón Gozalbo, Martín Díaz, Díez Madueño, Del Río Pena, De la Cueva, Talaván, Jiménez, Torres, Valencia, Cuevas, Bibiano and Ryan.)
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- 2023
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30. Cardiovascular Screening Practices and Statin Prescription Habits in Patients with Psoriasis among Dermatologists, Rheumatologists and Primary Care Physicians.
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Berna-Rico E, Abbad-Jaime de Aragon C, Garcia-Aparicio A, Palacios-Martinez D, Ballester-Martinez A, Carrascosa JM, De la Cueva P, Anton C, Azcarraga-Llobet C, Garcia-Mouronte E, De Nicolas-Ruanes B, Puig L, Jaen P, Mehta NN, Gelfand JM, and Gonzalez-Cantero A
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- Humans, Rheumatologists, Dermatologists, Prescriptions, Habits, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Physicians, Primary Care, Psoriasis diagnosis, Psoriasis drug therapy, Psoriasis epidemiology, Hypertension, Diabetes Mellitus, Cardiovascular Diseases diagnosis, Cardiovascular Diseases epidemiology, Cardiovascular Diseases prevention & control
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Patients with psoriasis have a higher prevalence of cardiovascular risk factors. This study evaluated cardiovascular screening practices and statin prescribing habits among dermatologists, rheumatologists and primary care physicians (PCPs) through an online questionnaire, which was distributed through the Spanish scientific societies of the above-mentioned specialties. A total of 299 physicians (103 dermatologists, 94 rheumatologists and 102 PCPs) responded to the questionnaire. Of these, 74.6% reported screening for smoking, 37.8% for hypertension, 80.3% for dyslipidaemia, and 79.6% for diabetes mellitus. Notably, only 28.4% performed global screening, defined as screening for smoking, hypertension, dyslipidaemia, and diabetes mellitus by the same physician, and 24.4% reported calculating 10-year cardiovascular disease (CVD) risk, probably reflecting a lack of comprehensive cardiovascular risk assessment in these patients. This study also identified unmet needs for awareness of cardiovascular comorbidities in psoriasis and corresponding screening and treatment recommendations among PCPs. Of PCPs, 61.2% reported not being aware of the association between psoriasis and CVD and/or not being aware of its screening recommendations, and 67.6% did not consider psoriasis as a risk-enhancing factor when deciding on statin prescription. Thirteen dermatologists (12.6%) and 35 rheumatologists (37.2%) reported prescribing statins. Among those who do not prescribe, 49.7% would be willing to start their prescription.
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- 2023
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31. Development and validation of a model to predict complex Mohs micrographic surgery in clinical practice: REGESMOSH scale.
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Montero-Vilchez T, Garcés JR, Rodríguez-Prieto MA, Ruiz-Salas V, de Eusebio-Murillo E, Miñano-Medrano R, Escutia-Muñoz B, González-Sixto B, Artola-Igarza JL, Alfaro-Rubio A, Redondo P, Delgado-Jiménez Y, Sánchez-Schmidt JM, Allende-Markixana I, Alonso-Pacheco ML, García-Bracamonte B, de la Cueva-Dobao P, Navarro-Tejedor R, Ciudad-Blanco C, Carnero-González L, Vázquez-Veiga H, Cano-Martínez N, Vilarrasa E, Sánchez-Sambucety P, López-Estebaranz JL, Botella-Estrada R, Feal-Cortizas JC, Martorell-Calatayud A, Gil P, Morales-Gordillo V, Toll-Abelló A, Ocerin-Guerra I, Mayor-Arenal M, Suárez-Fernández R, Sainz-Gaspar L, Descalzo MA, Garcia-Doval I, and Sanmartin-Jiménez O
- Abstract
Introduction: There is still a need to develop a simple algorithm to identify patients likely to need complex Mohs micrographic surgery (MMS) and optimize MMS schedule. The main objectives of this study are to identify factors associated with a complex MMS and develop a predictor model of the number of stages needed in surgery and the need for a complex closure., Materials and Methods: A nationwide prospective cohort study (REGESMOHS, the Spanish Mohs surgery registry) was conducted including all patients with a histological diagnosis of basal cell carcinoma (BCC). Factors related to three or more stages and a complex closure (that needing a flap and/or a graft) were explored and predictive models were constructed and validated to construct the REGESMOSH scale., Results: A total of 5226 patients that underwent MMS were included in the REGESMOHS registry, with 4402 (84%) having a histological diagnosis of BCC. A total of 3689 (88.9%) surgeries only needed one or two stages and 460 (11.1%) required three or more stages. A model to predict the need for three or more stages included tumour dimension, immunosuppression, recurrence, location in risk areas, histological aggressiveness and previous surgery. Regarding the closure type, 1616 (38.8%) surgeries were closed using a non-complex closure technique and 2552 (61.2%) needed a complex closure. A model to predict the need for a complex closure included histological aggressiveness, evolution time, patient age, maximum tumour dimension and location., Conclusion: We present a model to predict MMS needing ≥3 stages and a complex closure based on epidemiological and clinical data validated in a large population (with real practice variability) including different centres that could be easily implemented in clinical practice. This model could be used to optimize surgery schedule and properly inform patients about the surgery duration., (© 2023 European Academy of Dermatology and Venereology.)
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- 2023
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32. High adherence to secukinumab in patients with moderate to severe psoriasis: a long-term multicenter study in a daily practice setting.
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Martos-Cabrera L, Llamas-Velasco M, Armesto S, Herrera-Acosta E, Vidal D, Vilarrasa E, Rivera-Diaz R, de la Cueva P, Martorell-Calatayud A, Ballescá F, Belinchón I, Carretero G, Rodríguez L, Romero-Maté A, Pujol-Montcusí J, Salgado-Boquete L, Sahuquillo-Torralba A, Coto-Segura P, Baniandrés O, Feltes R, Alsina M, and Daudén E
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- Humans, Antibodies, Monoclonal, Severity of Illness Index, Treatment Outcome, Double-Blind Method, Antibodies, Monoclonal, Humanized, Psoriasis
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- 2023
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33. Punch grafting in postsurgical wounds.
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Conde-Montero E, Jerónimo LP, Vázquez AP, Marín LR, Sanabria Villarpando PE, and de la Cueva Dobao P
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- Humans, Skin Transplantation, Wound Healing, Leg Ulcer
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- 2023
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34. Efficacy and Safety of Dimethyl Fumarate in Patients with Moderate-to-Severe Plaque Psoriasis: Results from a 52-Week Open-Label Phase IV Clinical Trial (DIMESKIN 1).
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Daudén E, de la Cueva P, Salgado-Boquete L, Llamas-Velasco M, Fonseca E, Pau-Charles I, Asensio D, Guilà M, and Carrascosa JM
- Abstract
Introduction: Although dimethyl fumarate (DMF) has been approved since 2017 for treatment of moderate-to-severe plaque psoriasis, limited data on its safety and efficacy are available in clinical practice. The objective was to assess the efficacy and safety of DMF in patients with moderate-to-severe plaque psoriasis through 52 weeks in conditions close to real clinical practice., Methods: DIMESKIN 1 was a 52-week, open-label, phase IV clinical trial conducted at 36 Spanish sites. Adults with diagnosis of moderate-to-severe plaque psoriasis, treated with DMF as per its summary of product characteristics and with ≥ 1 post-baseline Psoriasis Area and Severity Index (PASI) value were included [intention-to-treat (ITT) population]. Efficacy analyses were performed for ITT population and are based on multiple imputation., Results: Overall, 282 and 274 patients were included in the safety and ITT populations, respectively. At week 24, 46.0%/24.8%/10.9% of patients achieved PASI 75/90/100 response, respectively. At week 52, these percentages were 46.0%/21.9%/10.9%, respectively. Mean body surface area affected decreased from 17.4% to 6.9%/7.3% after 24/52 weeks (p < 0.001, both). A total of 42.9%/49.4% of patients had a Physician's Global Assessment 0-1 at week 24/52, respectively. Mean pruritus visual analogue scale (VAS) significantly decreased after 24 and 52 weeks (p < 0.001, both), with 56.5% and 67.6% of patients, respectively, rating a pruritus VAS < 3. At week 24/52, 61.3%/73.4% patients had a Dermatology Life Quality Index (DLQI) ≤ 5 and 34.7%/32.1% had a DLQI 0-1. The most frequent adverse events were gastrointestinal disorders (mainly diarrhea/abdominal pain in 50.0%/35.1% of patients, respectively), flushing (28.0%), and lymphopenia (31.2%), mostly mild/moderate., Conclusions: DMF significantly improves main severity and extension indexes and rates, as well as patient-reported outcomes such as pruritus and quality of life in patients with moderate-to-severe psoriasis after 24 weeks of treatment. These improvements are sustained through 52 weeks. The safety profile of DMF is similar to that previously described for fumarates., Eudract Number: 2017-00136840., (© 2022. The Author(s).)
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- 2023
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35. Secukinumab is effective and safe in the long-term treatment of plaque psoriasis in a daily practice setting: Multicenter study in 384 Spanish patients.
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Chicharro P, Llamas-Velasco M, Armesto S, Herrera Acosta E, Vidal D, Vilarrasa E, Rivera-Diaz R, De-la-Cueva P, Martorell-Calatayud A, Ballescà F, Belinchon I, Carretero G, Rodriguez L, Romero-Maté A, Pujol-Montcusí J, Salgado L, Sahuquillo-Torralba A, Coto-Segura P, Baniandrés Rodríguez O, Feltes R, Riera-Monroig J, and Dauden E
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- Humans, Retrospective Studies, Cohort Studies, Treatment Outcome, Severity of Illness Index, Antibodies, Monoclonal adverse effects, Psoriasis diagnosis, Psoriasis drug therapy, Psoriasis chemically induced
- Abstract
The aim of the study was to assess the long-term effectiveness and safety of secukinumab in Spanish patients with moderate-to-severe psoriasis in a daily practice setting. Nationwide multicenter, observational, retrospective, non-interventional, single-cohort study including patients who initiated treatment with secukinumab in daily clinical practice conditions. Subjects were followed for a minimum of 3 months and a maximum of 24 months. Psoriasis Area Severity Index (PASI), Body Surface Area and Physician's Global Assessments were collected at baseline and months 3, 6, 12, 18 and 24 during treatment. Adverse events and reasons for secukinumab withdrawal were collected and classified for analyses. A total of 384 patients were enrolled in the study. Median PASI declined rapidly from 14.3 at baseline to 2.7 at month 3, 2.1 at month 12, and remained low (2.8) at month 24. Within the group of patients with PASI ≥10 at baseline (n = 278), 58.3%, 60.4% and 56.5% achieved a PASI90 response at months 3, 12 and 24, respectively. As for absolute PASI, 86.5%, 69.5%, 42.7% and 37% achieved PASI <5, < 3, < 1 and 0, respectively, at month 3. Secukinumab was more effective in biologic-naïve patients and in those with lower Body Mass Index. Secukinumab presented a good long-term safety profile. Secukinumab was effective and safe in a routine clinical setting, in a large cohort of patients with moderate-to-severe plaque psoriasis, in the short-, medium- and long-term (up to 24 months)., (© 2022 Wiley Periodicals LLC.)
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- 2022
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36. Perforating folliculitis.
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Díez-Madueño K, Buendía Castaño D, Alonso-García S, and de la Cueva Dobao P
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- Humans, Skin, Folliculitis diagnosis
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- 2022
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37. Upadacitinib for the Treatment of Atopic Dermatitis in a Spanish Cohort-Real Life: Fifty-Two-Week Follow-up Results.
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Pereyra-Rodriguez JJ, Herranz P, Figuras-Nart I, Perez B, Elosua M, Munera-Campos M, Melgosa-Ramos J, Zaragoza Ninet V, Silvestre JF, Campos-Domínguez M, Guilabert A, Miquel J, Alcantara-Luna S, de la Cueva P, Serra-Baldrich E, and Armario-Hita JC
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- Humans, Follow-Up Studies, Heterocyclic Compounds, 3-Ring, Cohort Studies, Treatment Outcome, Dermatitis, Atopic drug therapy
- Abstract
Competing Interests: J.J.P.-R. has received honoraria for research from Novartis, AbbVie, and Sanofi and for lecturing and other financial benefit from AbbVie, Almirall, Galderma, Janssen, Gebro-Pharma, Leo-Pharma Novartis, Lilly, Novartis, Pfizer, Sanofi, and UCB. P.H. has been an investigator, speaker, and/or consultant for AbbVie, Almirall, Amgen, Bristol Myers Squibb, Janssen, Lilly, Galderma, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi Genzyme, and UCB Pharma. I.F.-N. has been an investigator, speaker, and/or advisor for AbbVie, Amgen, Lilly, Galderma, Pierre Fabre, LEO Pharma, Novartis, Regeneron, and Sanofi Genzyme. B.P. has received honoraria for speaker and/or advisor and funding to attend conferences for Sanofi, AbbVie, Boheringer Ingelheim, Lilly, Galderma, Leo Pharma, Pierre Fabre, Meda Pharma, and FAES Pharma. M.E. has been an investigator and/or speaker for AbbVie, Lilly, Galderma, LEO Pharma, Pfizer, UCB Pharma, and Sanofi Genzyme. V.Z.N. has been an investigator, speaker, and/or advisor for AbbVie, Amgen, LEO Pharma, Novartis, Pfizer, and Sanofi Genzyme. J.F.S. has been an investigator, speaker, and/or advisor for AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Lilly, Galderma, Incyte, LEO Pharma, Novartis, Pfizer, Regeneron, and Sanofi Genzyme. J.M. has received speaker and consultancy fees from AbbVie, Leo Pharma, Novartis, Sanofi, UCB, Janssen, and Lilly and has participated as a principal investigator in clinical trials sponsored by AbbVie and Novartis. S.A.-L. has received honoraria for research from AbbVie and lecturing and other financial benefits from Sanofi, AbbVie, LEO, Lilly, and Almirall; P.d.l.C. has received consulting fees; payment or honoraria for lectures, presentations, speaker's bureaus, manuscript writing, or educational events; support for attending meetings and/or travel; and participation on a data safety monitoring board or advisory board from AbbVie, Pfizer, UCB, Leo Pharma, Almirall S.A., Lilly, Sanofi, MSD, BMS, Novartis, and Janssen. E.S.-B. has been an investigator, speaker, and/or advisor for AbbVie, Amgen, Lilly, Galderma, Pierre Fabre, LEO Pharma, Novartis, Regeneron, and Sanofi Genzyme. J.C.A.-H. research from Novartis, AbbVie, and Sanofi and lecturing and other financial benefits from AbbVie, Almirall, Galderma, Janssen, Gebro-Pharma, Leo-Pharma Novartis, Lilly, Novartis, Pfizer, Sanofi, and UCB. M.M.-C., M.C.-D., A.G., and J.M.R. have no funding or conflicts of interest to declare.
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- 2022
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38. Ustekinumab to guselkumab transitions: A series of 54 patients emulating the navigate trial in real life.
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Berenguer-Ruiz S, Rivera R, Herranz P, De la Cueva P, Hospital M, Ruiz-Genao D, Roustan G, Daudén E, and Llamas-Velasco M
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- Clinical Trials as Topic, Humans, Treatment Outcome, Antibodies, Monoclonal, Humanized therapeutic use, Psoriasis drug therapy, Ustekinumab therapeutic use
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NAVIGATE clinical trial demonstrated a higher rate of Psoriasis Assesment Severity Index (PASI)90 response in patients treated with guselkumab when compared to ustekinumab and an improved response in those who switched from ustekinumab to guselkumab due to partial response. The objective of the study is to describe ustekinumab to guselkumab switching in clinical practice. Observational, multicentric, descriptive study including 54 psoriasis patients who switched to guselkumab after treatment with ustekinumab from March 2019 to February 2021. Mean basal PASI with ustekinumab (16.7) was higher than with guselkumab (7.2). Up to 49.01% of patients were able to reach PASI90 with ustekinumab and up to 21.56% had a less frequent dosage regime vs. summary of product characteristics. Main reason to start guselkumab was a loss of ustekinumab cutaneous or articular response (82.36%) but up to 17.64% were switched in order to increase dosage regime efficiency. Six months after starting guselkumab, the absolute PASI was lower than 2 in 72% of patients and 38.5% of them were treated with a reduced dosage regime. Guselkumab doses used by our cohort were 19.5% lower than the expected according to the summary of product characteristics. No adverse events reported. There is no real-world evidence regarding patients who switched from ustekinumab to guselkumab. A short paragraph in the article by Fougerousse et al, reported 63 patients with a mean basal PASI of 5.3 and similar efficacy rate at week 16 to NAVIGATE. Our study adds practical information regarding efficacy, safety and efficiency through dose optimization in a real-world cohort., (© 2022 Wiley Periodicals LLC.)
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- 2022
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39. Fast and sustained improvement of patient-reported outcomes in psoriatic patients treated with secukinumab in a daily practice setting.
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Chicharro P, Llamas-Velasco M, Armesto S, Herrera-Acosta E, Vidal D, Vilarrasa E, Rivera R, De la Cueva P, Martorell-Calatayud A, Ballescà F, Belinchón I, Carretero G, Rodríguez L, Romero-Maté A, Pujol-Montcusí J, Salgado L, Sahuquillo-Torralba A, Coto-Segura P, Baniandrés-Rodríguez O, Feltes R, Alsina M, and Daudén E
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- Antibodies, Monoclonal, Humanized, Cohort Studies, Humans, Patient Reported Outcome Measures, Retrospective Studies, Severity of Illness Index, Treatment Outcome, Psoriasis diagnosis, Psoriasis drug therapy, Quality of Life
- Abstract
Psoriasis is a chronic dermatological disease with great impact on patients' quality of life (QoL). The main objective of this study was to assess the impact of secukinumab treatment on different patient-reported outcomes (PROs) during a long-term follow-up in Spanish patients with moderate-to-severe psoriasis under real-world conditions. Retrospective, observational, open-label, nationwide multicenter cohort study that included patients who initiated treatment with secukinumab in daily clinical practice conditions. PROs assessing disease impact and QoL included Dermatology Life Quality Index (DLQI), Patient's Global Psoriasis Assessment, Itch Numerical Rating Scale and EuroQoL Thermometer Visual Analogue Scale. Outcomes, including PROs and Psoriasis Area and Severity Index (PASI), were assessed at months 3, 6, 12, 18, and 24 during treatment. A total of 238 patients were enrolled in the study. Patients had a mean DLQI score of 14.9 at baseline; 78.3%, 73.7%, and 71.7% of them achieved a DLQI 0/1 response at months 6, 12, and 24, respectively. DLQI score was lower in the long term for naïve patients. A sharp decrease in mean DLQI was observed during the first 3 months, reaching a plateau that was maintained until the end of follow-up. Similar findings were observed for the rest of QoL assessments. There was a close association between improvement in QoL and skin clearance (PASI), which progressively increased during follow-up. In this study, secukinumab sustainably improved patient's QoL during a 24-month follow-up, with strongest effects in patients naïve to biological therapies and with a direct correlation with PASI improvement., (© 2022 Wiley Periodicals LLC.)
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- 2022
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40. Implementation of Recommendations for the Management of Psoriasis During Preconception, Pregnancy, Postpartum, Breastfeeding, and Perinatal Care.
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Belinchón I, Armesto S, de la Cueva P, Ferrándiz L, Rivera Díaz R, and Carrascosa JM
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- Breast Feeding, Certolizumab Pegol therapeutic use, Child, Female, Humans, Infant, Newborn, Male, Perinatal Care, Postpartum Period, Pregnancy, Maternal Health Services, Psoriasis drug therapy
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Objective: To analyze degree of implementation of recommendations on the management of psoriasis during preconception, pregnancy, postpartum, breastfeeding, and perinatal care published by the Psoriasis Working Group of the Spanish Academy of Dermatology and Venereology (AEDV)., Methods: We designed a structured online survey consisting of closed questions. A link was emailed to all the members of the Psoriasis Working Group to collect their anonymous responses. We also collected sociodemographic, professional, and practice-related data related to the goals of the study and then compiled descriptive statistics to analyze the survey findings., Results: We received 53 responses for analysis. Overall, 96% of respondents were familiar with the recommendations, but very few of them worked in multidisciplinary maternity care units or had access to specific protocols on the management of psoriasis before, during, and after pregnancy in their departments. Seventy percent of dermatologists regularly ask their patients about pregnancy plans, but only 46% ask both men and women. Women also receive more preconception advice than men (54% vs. 19%). Significant variations were observed in the type of advice given. Ninety percent of the dermatologists interrupt topical treatments during pregnancy, and nearly all suspend conventional systemic drugs with the exception of cyclosporin A. Most biologics are also being discontinued in the third trimester, with the exception of certolizumab pegol. Almost all the respondents indicated that they use topical treatments, phototherapy, and certolizumab pegol in breastfeeding mothers. The main barriers to implementing the working group's recommendations are a lack of time, a lack of support, and a lack of robust data., Conclusions: Although the AEDV psoriasis working group's recommendations are widely known, areas for improvement remain., (Copyright © 2022 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)
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- 2022
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41. The risk of hepatic adverse events of systemic medications for psoriasis: a prospective cohort study using the BIOBADADERM registry.
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Munera-Campos M, Vilar-Alejo J, Rivera R, Carrascosa JM, Daudén E, Herrera-Acosta E, Sahuquillo-Torralba A, Gómez-García FJ, Baniandrés-Rodríguez O, de la Cueva P, López-Estebaranz JL, Belinchón I, Ferran M, Riera-Monroig J, Rodriguez L, Carretero G, García-Donoso C, Ballescá F, Llamas-Velasco M, Herrera-Ceballos E, Pujol-Marco C, Nieto-Benito LM, Ruiz-Genao DP, Alsina M, Descalzo MA, and García-Doval I
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- Humans, Prospective Studies, Registries, Tumor Necrosis Factor Inhibitors, Non-alcoholic Fatty Liver Disease chemically induced, Non-alcoholic Fatty Liver Disease epidemiology, Psoriasis drug therapy
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Background: Limited information is available regarding the risk of incident liver disease in patients with psoriasis receiving systemic therapies., Objectives: To describe the liver safety findings of conventional and modern systemic therapies for moderate-to-severe psoriasis, and to compare the relative incidence rates of hepatic adverse events (AEs) for each drug., Methods: All the patients on the BIOBADADERM registry were included. Crude and adjusted incidence rate ratios (cIRR and aIRR, respectively) of hepatic AEs, using anti-TNF drugs as reference, were determined. Outcomes of interest were hypertransaminasemia, nonalcoholic fatty liver disease (NADFLD) and a group of other, less represented, hepatic AEs., Results: Our study included 3,171 patients exposed to systemic drugs (6279 treatment cycles). Incident hypertransaminasemia was the most frequent hepatic AE (incidence rate of 21 per 1000 patients-years [CI 95% 18-23]), followed by NAFLD (8 cases per 1000 patients-years [95% CI 6-10]). Methotrexate (aIRR 3.06 [2.31-4.4]; p = 0.000) and cyclosporine (aIRR 2.37 [1.05-5.35]; p = .0378) were associated with an increased risk for hypertransaminasemia when compared to anti-TNF-α agents. No differences were observed between different groups of biologics. Conventional therapies were not associated with new incident NAFLD., Conclusions: Comparative information of the incidence of hepatic AEs could facilitate drug selection in moderate-to-severe psoriasis.
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- 2022
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42. Practical Update of the Guidelines Published by the Psoriasis Group of the Spanish Academy of Dermatology and Venereology (GPs) on the Treatment of Psoriasis With Biologic Agents: Part 2 - Management of Special Populations, Patients With Comorbid Conditions, and Risk.
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Carrascosa JM, Puig L, Romero IB, Salgado-Boquete L, Del Alcázar E, Lencina JJA, Moreno D, and de la Cueva P
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- Biological Factors therapeutic use, Humans, Severity of Illness Index, Dermatology, Psoriasis drug therapy, Venereology
- Abstract
Background and Objectives: Since its inception, the Psoriasis Group (GPs) of the Spanish Academy of Dermatology and Venereology (AEDV) has worked to continuously update recommendations for the treatment of psoriasis based on the best available evidence and incorporating proposals arising from and aimed at clinical practice. An updated GPs consensus document on the treatment of moderate to severe psoriasis was needed because of changes in the treatment paradigm and the approval in recent years of a large number of new biologic agents., Methodology: The consensus document was developed using the nominal group technique complemented by a scoping review. First, a designated coordinator selected a group of GPs members for the panel based on their experience and knowledge of psoriasis. The coordinator defined the objectives and key points for the document and, with the help of a documentalist, conducted a scoping review of articles in Medline, Embase, and the Cochrane Library up to January 2021. The review included systematic reviews and meta-analyses as well as clinical trials not included in those studies and high-quality real-world studies. National and international clinical practice guidelines and consensus documents on the management of moderate to severe psoriasis were also reviewed. The coordinator then drew up a set of proposed recommendations, which were discussed and modified in a nominal group meeting. After several review processes, including external review by other GPs members, the final document was drafted., Results: The present guidelines include updated recommendations on assessing the severity of psoriasis and criteria for the indication of systemic treatment. They also include general principles for the treatment of patients with moderate to severe psoriasis and define treatment goals for these patients as well as criteria for the indication and selection of initial and subsequent therapies Practical issues, such as treatment failure and maintenance of response, are also addressed., (Copyright © 2022 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)
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- 2022
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43. Dermatology Care in Spanish Public Hospitals: A Mapping Study of Health Care Resources and Medical and Surgical Activity in Dermatology Departments in 2019.
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Cuenca-Barrales C, Molina-Leyva A, Moreno-Ramírez D, de la Cueva P, Gilaberte Y, and Arias-Santiago S
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- Cross-Sectional Studies, Delivery of Health Care, Hospitals, Public, Humans, Pandemics, COVID-19 epidemiology, Dermatology
- Abstract
Background and Objective: No recent data on health care resources and medical and surgical activity in Spanish dermatology departments are available in the literature. The aim of this study was to compile this information for 2019., Material and Methods: Cross-sectional study based on an online survey sent to the heads of dermatology departments at public hospitals in Spain., Results: Of the 162 department heads contacted, 59 answered the survey (participation rate, 36.4%). General findings included a shortage of staff, especially dermatologists, in hospitals of low and medium complexity. The main reason given for the shortage of dermatologists was a lack of interested applicants. Large hospital complexes had more infrastructure and equipment. Over 50% of the departments surveyed used a combination of in-person and virtual visits. Psoriasis units were the most common specialized care units. Approximately 75% of the hospitals had operating rooms with an anesthetist. More complex procedures such as sentinel lymph node biopsy and Mohs micrographic surgery were performed more often in large hospital complexes. Hospitalization and the presence of dermatology residents working call shifts were also more common in these hospitals. Teaching and research activity differed according to hospital complexity., Conclusions: We have mapped health care resource availability and medical and surgical activity in Spanish dermatology departments prior to the COVID-19 pandemic. Our findings could be useful for improving clinical management and defining future actions and areas for improvement., (Copyright © 2021 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)
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- 2022
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44. Risk of a Second Skin Cancer in a Cohort of Patients With Nonmelanoma Skin Cancer -Basal Cell Carcinoma or Squamous Cell Carcinoma-Treated With Mohs Micrographic Surgery: A National Prospective Cohort Study.
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Miñano Medrano R, López Estebaranz JL, Sanmartin-Jiménez O, Garcés JR, Rodríguez-Prieto MA, Vilarrasa-Rull E, de Eusebio-Murillo E, Escutia-Muñoz B, Flórez-Menéndez Á, Artola-Igarza JL, Alfaro-Rubio A, Redondo P, Delgado-Jiménez Y, Sánchez-Schmidt JM, Allende-Markixana I, Alonso-Pacheco ML, García-Bracamonte B, de la Cueva-Dobao P, Navarro-Tejedor R, Ciudad-Blanco C, Carnero-González L, Vázquez-Veiga H, Cano-Martínez N, Ruiz-Salas V, Sánchez-Sambucety P, Botella-Estrada R, González-Sixto B, Martorell-Calatayud A, Gil P, Morales-Gordillo V, Toll-Abelló A, Ocerin-Guerra I, Mayor-Arenal M, Suárez-Fernández R, Sainz-Gaspar L, Descalzo MA, and García-Doval I
- Subjects
- Cohort Studies, Female, Humans, Male, Mohs Surgery, Prospective Studies, Risk Factors, Carcinoma, Basal Cell epidemiology, Carcinoma, Basal Cell pathology, Carcinoma, Basal Cell surgery, Carcinoma, Squamous Cell epidemiology, Carcinoma, Squamous Cell pathology, Carcinoma, Squamous Cell surgery, Melanoma complications, Neoplasms, Basal Cell, Skin Neoplasms epidemiology, Skin Neoplasms etiology, Skin Neoplasms surgery
- Abstract
Objective: Patients with nonmelanoma skin cancer (NMSC)-ie, basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)-have an increased risk of developing a second skin cancer. The aim of this study was to describe the frequency, incidence per 1000 person-years, and predictors of a second skin cancer in a cohort of patients with NMSC treated with Mohs micrographic surgery (MMS)., Material and Methods: Prospective study of a national cohort of patients with NMSC who underwent MMS at 22 Spanish hospitals between July 2013 and February 2020; case data were recorded in the REGESMOHS registry. The study variables included demographic characteristics, frequency and incidence per 1000 person-years of second skin cancers diagnosed during the study period, and risk factors identified using mixed-effects logistic regression., Results: We analyzed data for 4768 patients who underwent MMS; 4397 (92%) had BCC and 371 (8%) had SCC. Mean follow-up was 2.4 years. Overall, 1201 patients (25%) developed a second skin cancer during follow-up; 1013 of the tumors were BCCs (21%), 154 were SCCs (3%), and 20 were melanomas (0.4%). The incidence was 107 per 1000 person-years (95% CI, 101-113) for any cancer, 90 per 1000 person-years (95% CI, 85-96) for BCC, 14 (95% CI, 12-16) per 1000 person-years for SCC, and 2 (95% CI, 1-3) per 1000 person-years for melanoma. More men than women developed a subsequent skin cancer (738 [61%] vs 463 [39%]). The main risk factors were a history of multiple tumors before diagnosis (relative risk [RR], 4.6; 95% CI, 2.9-7.1), immunosuppression (RR, 2.1; 95% CI, 1.4-3.1), and male sex (RR, 1.6; 95% CI, 1.4-1.9)., Conclusion: Patients have an increased risk of developing a second tumor after MMS treatment of NMSC. Risk factors are a history of multiple tumors at diagnosis, immunosuppression, and male sex., (Copyright © 2022. Publicado por Elsevier España, S.L.U.)
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- 2022
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45. International eDelphi Study to Reach Consensus on the Methotrexate Dosing Regimen in Patients With Psoriasis.
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van Huizen AM, Menting SP, Gyulai R, Iversen L, van der Kraaij GE, Middelkamp-Hup MA, Warren RB, Spuls PI, Schejtman AA, Egeberg A, Firooz A, Kumar AS, Oakley A, Foulkes A, Ramos AMC, Fougerousse AC, Carija A, Akman-Karakas A, Horváth B, Fábos B, Matlock BH, Claréus BW, Castro C, Ferrándiz C, Correa CC, Marchesi C, Goujon C, Gonzalez C, Maldonado-García C, Hong CH, Griffiths CEM, Vestergaard C, Echeverría CM, de la Cruz C, Conrad C, Törocsik D, Drvar DL, Balak D, Jullien D, Appelen D, Kim DH, de Jong EMGJ, El Gamal E, Laffitte E, Mahé E, Sonkoly E, Colombo EP, Vilarrasa E, Willaert F, Novoa FD, Handjani F, Valenzuela F, Vílchez-Márquez F, Gonzalez GO, Krisztián G, Damiani G, Krnjevic-Pezic G, Pellerano G, Carretero G, Hunter HJA, Riad H, Oon HH, Boonen HPJ, Moussa IO, García-Doval I, Csányi I, Brajac I, Turchin I, Grozdev I, Weinberg JM, Nicolopoulos J, Wells J, Lambert JLW, Ingram JR, Prinz JC, de Souza Sittart JA, Sanchez JL, Hsiao JP, Castro-Ayarza JR, Maul JT, van den Reek JMPA, Trcko K, Barber K, Reich K, Gebauer KA, Khobzei K, Maul LV, Massari LP, Fardet L, le Cleach L, Misery L, Chandrashekar L, Muresanu LI, Lecluse L, Skov L, Frez ML, Babic LT, Puig L, Gomez LC, Ramam M, Dutil M, El-Sayed MH, Olszewska M, Schram ME, Franco MD, Llamas-Velasco M, Gonçalo M, Velásquez-Lopera MM, Abad ME, de Oliveira MFSP, Seyger MMB, Kaštelan M, Rademaker M, Sikora M, Lebwohl M, Wiseman MC, Ferran M, van Doorn M, Danespazhooh M, Bylaite-Bucinskiene M, Gooderham MJ, Polic MV, de Rie MA, Zheng M, Gómez-Flores M, Salleras I Redonnet M, Silverberg NB, Doss N, Yawalkar N, Chosidow O, Zargari O, de la Cueva P, Fernandez-Peñas P, Cárdenas Rojas PJ, Gisondi P, Grewal P, Sator P, Luna PC, Félix PAO, Varela P, Holló P, Cetkovska P, Calzavara-Pinton P, Ghislain PD, Araujo RR, Romiti R, Kui R, Ceovic R, Vender R, Lafuente-Urrez RF, Del-Río R, Gulin SJ, Handa S, Mahil SK, Kolalapudi SA, Marrón SE, Azimi SZ, Janmohamed SR, da Cruz Costa SA, Choon SE, Urbancek S, Ayanlowo O, Margasin SM, Wong TW, Mälkönen T, Hurtová T, Reciné TR, Huldt-Nystrøm T, Torres T, Liu TY, Leonidze T, Sharma VK, Weightman W, Gulliver W, and Veldkamp W
- Subjects
- Adult, Child, Consensus, Folic Acid, Humans, Surveys and Questionnaires, Methotrexate, Psoriasis therapy
- Abstract
Importance: A clear dosing regimen for methotrexate in psoriasis is lacking, and this might lead to a suboptimal treatment. Because methotrexate is affordable and globally available, a uniform dosing regimen could potentially optimize the treatment of patients with psoriasis worldwide., Objective: To reach international consensus among psoriasis experts on a uniform dosing regimen for treatment with methotrexate in adult and pediatric patients with psoriasis and identify potential future research topics., Design, Setting, and Participants: Between September 2020 and March 2021, a survey study with a modified eDelphi procedure that was developed and distributed by the Amsterdam University Medical Center and completed by 180 participants worldwide (55 [30.6%] resided in non-Western countries) was conducted in 3 rounds. The proposals on which no consensus was reached were discussed in a conference meeting (June 2021). Participants voted on 21 proposals with a 9-point scale (1-3 disagree, 4-6 neither agree nor disagree, 7-9 agree) and were recruited through the Skin Inflammation and Psoriasis International Network and European Academy of Dermatology and Venereology in June 2020. Apart from being a dermatologist/dermatology resident, there were no specific criteria for participation in the survey. The participants worked mainly at a university hospital (97 [53.9%]) and were experienced in treating patients with psoriasis with methotrexate (163 [91.6%] had more than 10 years of experience)., Main Outcomes and Measures: In a survey with eDelphi procedure, we tried to reach consensus on 21 proposals. Consensus was defined as less than 15% voting disagree (1-3). For the consensus meeting, consensus was defined as less than 30% voting disagree., Results: Of 251 participants, 180 (71.7%) completed all 3 survey rounds, and 58 participants (23.1%) joined the conference meeting. Consensus was achieved on 11 proposals in round 1, 3 proposals in round 2, and 2 proposals in round 3. In the consensus meeting, consensus was achieved on 4 proposals. More research is needed, especially for the proposals on folic acid and the dosing of methotrexate for treating subpopulations such as children and vulnerable patients., Conclusions and Relevance: In this eDelphi consensus study, consensus was reached on 20 of 21 proposals involving methotrexate dosing in patients with psoriasis. This consensus may potentially be used to harmonize the treatment with methotrexate in patients with psoriasis.
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- 2022
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46. Pain control with punch grafting in ulcers with underlying arteriolosclerosis.
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Quintana-Castanedo L, Conde-Montero E, Recarte-Marín L, Peral-Vázquez A, Pérez-Jerónimo L, and de la Cueva-Dobao P
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- Aged, Humans, Pain, Quality of Life, Retrospective Studies, Skin Transplantation methods, Ulcer, Arteriolosclerosis, Leg Ulcer surgery, Skin Ulcer surgery
- Abstract
Objective: Martorell hypertensive ischaemic ulcers are often misdiagnosed and can be a clinical and therapeutic challenge. Controversy exists regarding both their underlying triggers and the type of treatment that should be carried out. This study was designed to compare the effectiveness of punch grafting and conventional therapy in pain reduction., Method: A single-centre retrospective study was performed, including 40 patients with a clinical diagnosis of a Martorell ulcer or post-traumatic ulcer secondary to arteriolopathy in the elderly, who were treated with punch grafting (n= 24) or conventional medical treatment (n=16)., Results: There was a statistically and clinically significant reduction in pain after punch grafting. The minimal overall reduction was of three points in visual analogue pain scores. Of the patients who received punch grafting, 80% reported a VAS pain score of 0 at the third follow-up, in contrast with the 44% (n=4) patients who were treated without punch grafting. The mean time to epithelialisation was 82.1 days in patients who received conventional treatment and 43.5 days in those who received punch grafts., Conclusion: Punch grafting is a simple, validated and cost-effective technique that can be performed on an outpatient basis, promotes wound healing and reduces pain. It may control pain and stimulate epithelialisation even if the wound does not present with optimum wound bed characteristics for graft taking. Pain reduction and faster epithelialisation are associated with improvements in patients' quality of life.
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- 2022
- Full Text
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47. Moderate to Severe Psoriasis in Pediatric and Young Patients: The BIOBADADERM Registry Experience.
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Nieto Benito LM, Carretero G, Rivera-Díaz R, Carrascosa JM, Daudén E, de la Cueva P, Sahuquillo-Torralba A, Herrera-Acosta E, Baniandrés-Rodríguez O, Lopez-Estebaranz JL, Belinchón I, Riera-Monroig J, Ferrán M, Gómez-García FJ, Mateu A, Rodríguez L, Vilar-Alejo J, García-Donoso C, Ballescá F, Velasco LM, Botella-Estrada R, Herrera-Ceballos E, Ruiz-Genao DP, Descalzo MA, and García-Doval I
- Subjects
- Adolescent, Child, Humans, Registries, Biological Products therapeutic use, Psoriasis chemically induced, Psoriasis drug therapy, Psoriasis epidemiology
- Abstract
Childhood-onset psoriasis generally follows an indolent course but patients with moderate or severe disease may require systemic treatment. The aim of this study was to determine the relative proportion of children and young people aged up to 21 years with moderate to severe psoriasis in the BIOBADADERM registry and to analyze the characteristics of these patients, treatments used, and adverse events. Of the 3946 patients in the registry, 24 were aged 21 years or younger. They had mean age of 16.1 years on starting treatment. When the registry was started, they had a Psoriasis Area and Severity Index of 9.4 and 67% were being treated with a conventional systemic drug. Treatment was discontinued in 14 patients (58%) due to adverse events or a loss or lack of effectiveness. In conclusion, the BIOBADADERM registry shows that young people account for a small proportion of psoriasis patients receiving systemic treatment, and they are more likely to be treated using conventional systemic drugs., (Copyright © 2021 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)
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- 2022
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48. Women with moderate-to-severe psoriasis in Spain (BIOBADADERM registry) breastfeed less when compared with general population.
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Rivera-Diaz R, Llamas-Velasco M, Carretero G, Ruíz-Genao D, Belinchón I, Riera-Monroig J, de la Cueva P, Ferrán M, de Vega M, and García-Doval I
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- Female, Humans, Registries, Severity of Illness Index, Spain epidemiology, Psoriasis epidemiology
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- 2022
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49. Practical update of the Recommendations Published by the Psoriasis Group of the Spanish Academy of Dermatology and Venereology (GPS) on the Treatment of Psoriasis with Biologic Therapy. Part 1. Concepts and General Management of Psoriasis with Biologic Therapy.
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Carrascosa JM, Puig L, Belinchón Romero I, Salgado-Boquete L, Del Alcázar E, Andrés Lencina JJ, Moreno D, and de la Cueva P
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- Biological Therapy, Humans, Severity of Illness Index, Dermatology, Psoriasis drug therapy, Venereology
- Abstract
Background and Objectives: A new, updated AEDV Psoriasis Group consensus document on the treatment of moderate to severe psoriasis was needed owing to the approval, in recent years, of a large number of new drugs and changes in the treatment paradigm., Methodology: The consensus document was developed using the nominal group technique and a scoping review. First, a designated coordinator selected a group of Psoriasis Group members for the panel. The coordinator defined the objectives and key points for the document and, with the help of a documentalist, conducted a scoping review of articles in Medline, Embase, and the Cochrane Library up to January 2021. The review included systematic reviews and meta-analyses as well as clinical trials not included in those studies and high-quality real-world studies. National and international clinical practice guidelines and consensus documents on the management of moderate to severe psoriasis were also reviewed. Based on these reviews, the coordinator drew up a set of proposed recommendations, which were then discussed and modified in a nominal group meeting. After several review processes, including external review by other GPs members, the final document was drafted., Results: The present guidelines include general principles for the treatment of patients with moderate to severe psoriasis and also define treatment goals and criteria for the indication of biologic therapy and the selection of initial and subsequent therapies. Practical issues, such as treatment failure and maintenance of response, are also addressed., (Copyright © 2021 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)
- Published
- 2022
- Full Text
- View/download PDF
50. Long-term topical management of psoriasis: the road ahead.
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Segaert S, Calzavara-Pinton P, de la Cueva P, Jalili A, Lons Danic D, Pink AE, Thaçi D, and Gooderham M
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- Administration, Topical, Humans, Dermatologic Agents therapeutic use, Psoriasis drug therapy
- Abstract
Topical therapies have been available for the treatment of psoriasis for several decades. Despite this and the availability of several types of topicals, with varying potency, and numerous vehicles of administration, the majority of clinical data and guidance is on short-term use in the management of psoriasis. The aim of this manuscript is to review the unmet needs that exist in the long-term management of psoriasis and provide the dermatology community with an understanding that a treatment regimen with topical therapies could be the best treatment option at least for some phases of this chronic relapsing disease. We present a 'call to action' on the need for clinical alignment on terminology in the field and recommend the term 'long-term management' be adopted as the most appropriate in the context of this manuscript. This expert opinion report provides a detailed review of the limited evidence available regarding long-term use of topical therapies for the management of psoriasis, alongside our key considerations and recommendations to assist dermatologists with the implementation of topicals as part of long-term management strategies. Long-term management should be considered mandatory to ensure patients receive appropriate proactive treatment which may help optimize adherence and long-term outcomes.
- Published
- 2022
- Full Text
- View/download PDF
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