[Translated article] Requirements for Accessing New Dermatology Drugs in Spain: Results of the EQUIDAD Study.

BACKGROUND: Although the Spanish Ministry of Health prepares national therapeutic positioning reports (TPRs) and drug reimbursement policies, each of the country's 17 autonomous communities (ACs) is responsible for health care services and prescription requirements in its territory. The aim of the EQUIDAD study was to describe and explore potential differences in prescription requirements for new dermatology drugs across the autonomous communities. MATERIAL AND METHODS: Cross-sectional study conducted in April and May, 2023. Two dermatologists with management responsibilities from each autonomous community reported on territorial and more local prescription requirements for drugs covered by national TPRs issued between 2016 and 2022. RESULTS: Thirty-three researchers from 17 autonomous communities participated. The data submitted revealed between-community inequities in access to new drugs. Overall, 64.7% of the regions imposed additional prescription requirements to those mentioned in the TPRs for psoriasis. This percentage was lower for atopic dermatitis (35.3%) and melanoma (11.8%). The most common requirement for accessing a new drug was a previous prescription for another drug. Differences and additional requirements were also detected at the local level (i.e., differences between hospitals within the same autonomous community). CONCLUSIONS: Spain's autonomous communities have multiple regional and local prescription requirements that are not aligned with national TPR recommendations. These differences result in inequitable access to new drugs for both patients and practitioners across Spain.

Requirements for Accessing New Dermatology Drugs in Spain: Results of the EQUIDAD Study. / Condicionantes de acceso a nuevos medicamentos dermatológicos en España: resultados del proyecto EQUIDAD.

BACKGROUND: Although the Spanish Ministry of Health prepares national therapeutic positioning reports (TPRs) and drug reimbursement policies, each of the country's 17 autonomous communities (ACs) is responsible for health care services and prescription requirements in its territory. The aim of the EQUIDAD study was to describe and explore potential differences in prescription requirements for new dermatology drugs across the autonomous communities. MATERIAL AND METHODS: Cross-sectional study conducted in April and May, 2023. Two dermatologists with management responsibilities from each autonomous community reported on territorial and more local prescription requirements for drugs covered by national TPRs issued between 2016 and 2022. RESULTS: Thirty-three researchers from 17 autonomous communities participated. The data submitted revealed between-community inequities in access to new drugs. Overall, 64.7% of the regions imposed additional prescription requirements to those mentioned in the TPRs for psoriasis. This percentage was lower for atopic dermatitis (35.3%) and melanoma (11.8%). The most common requirement for accessing a new drug was a previous prescription for another drug. Differences and additional requirements were also detected at the local level (i.e., differences between hospitals within the same autonomous community). CONCLUSIONS: Spain's autonomous communities have multiple regional and local prescription requirements that are not aligned with national TPR recommendations. These differences result in inequitable access to new drugs for both patients and practitioners across Spain.

Melanoma in Solid Organ Transplant Recipients. / Melanoma en pacientes receptores de un trasplante de órgano sólido.

In this review, we analyze the 3 clinical scenarios related to the development of melanoma in solid organ transplant recipients: melanoma in patients with a history of the tumor prior to a transplant, de novo melanoma following a transplant, and melanoma of donor origin. The main factors to consider in organ-transplant candidates with a history of melanoma are tumor stage, presence or absence of residual disease, and time from diagnosis to transplantation. Solid organ transplant recipients have a greater risk of melanoma than immunocompetent individuals. Mortality is also higher in this population, especially in patients with advanced melanoma, as treatment is especially challenging. Clinical history and physical examination provide the most useful information for preventing donor-to-recipient transmission of melanoma. Donor-derived melanoma has a very poor prognosis.

Anticoagulantes orales directos en cirugía dermatológica / Direct-acting Oral Anticoagulants in Dermatologic Surgery

Los anticoagulantes orales directos (ACOD) emergen como una alternativa más cómoda y segura que los clásicos antagonistas de la vitamina K (AVK); no precisan monitorización, poseen una ventana terapéutica más amplia y tienen menos interacciones farmacológicas. Sin embargo, a pesar de que su uso está cada vez más extendido, existe poco consenso sobre cuál es su manejo perioperatorio óptimo en cirugía dermatológica. En este artículo se describen las características de los ACOD y se revisa la evidencia disponible sobre su uso perioperatorio en la cirugía de la piel

Direct-acting oral anticoagulants (DOACs) have emerged as safer, easier-to-manage alternatives to traditional vitamin K antagonists and are used increasingly because they require no monitoring, have a wider therapeutic window, and react less with other drugs. However, there is little consensus on optimal perioperative management when these drugs are used in dermatologic surgery. This article describes the characteristics of DOACs and reviews current evidence on their use in this setting

Direct-acting Oral Anticoagulants in Dermatologic Surgery. / Anticoagulantes orales directos en cirugía dermatológica.

Direct-acting oral anticoagulants (DOACs) have emerged as safer, easier-to-manage alternatives to traditional vitamin K antagonists and are used increasingly because they require no monitoring, have a wider therapeutic window, and react less with other drugs. However, there is little consensus on optimal perioperative management when these drugs are used in dermatologic surgery. This article describes the characteristics of DOACs and reviews current evidence on their use in this setting.

Pápulas faciales induradas / Indurated Papules on the Face

No disponible

Inmunoterapia en cáncer cutáneo no melanoma / Immunotherapy in Nonmelanoma Skin Cancer

La inmunoterapia en el cáncer emerge como un tratamiento novedoso y prometedor en una gran variedad de tumores, incluido el cáncer cutáneo no melanoma. Los anticuerpos inhibidores de proteínas de control inmunitario están dirigidos fundamentalmente a las moléculas de superficie CTLA-4 (antígeno citotóxico de los linfocitos T) y PD-1 (molécula de muerte programada 1). En el presente artículo se revisan las vías de CTLA-4 y PD-1/PD-L1 (PD-1/ligando de la PD-1) y las evidencias actuales de tratamiento con inhibidores de puntos de control inmunitario en los principales tipos de cáncer cutáneo no melanoma

Immunotherapy is emerging as a new and promising treatment for a great variety of tumors, including nonmelanoma skin cancer. Checkpoint inhibitors -antibodies that block proteins that regulate the immune system- mainly target the surface protein CTLA-4 (cytotoxic T-lymphocyte-associated antigen 4) and the PD-1/PD-L1 (programmed cell death protein 1/PD-ligand 1) axis. We review the CTLA-4 and PD-1/PD-L1 pathways and current evidence supporting checkpoint inhibitor therapy in the main types of nonmelanoma skin cancer

Immunotherapy in Nonmelanoma Skin Cancer. / Inmunoterapia en cáncer cutáneo no melanoma.

Immunotherapy is emerging as a new and promising treatment for a great variety of tumors, including nonmelanoma skin cancer. Checkpoint inhibitors -antibodies that block proteins that regulate the immune system- mainly target the surface protein CTLA-4 (cytotoxic T-lymphocyte-associated antigen 4) and the PD-1/PD-L1 (programmed cell death protein 1/PD-ligand 1) axis. We review the CTLA-4 and PD-1/PD-L1 pathways and current evidence supporting checkpoint inhibitor therapy in the main types of nonmelanoma skin cancer.

Diseño y validación de un cuestionario para medir la satisfacción con el tratamiento del paciente con psoriasis moderada y grave: estudio NEODERMA / Design and Validation of a Questionnaire to Measure Treatment Satisfaction in Patients With Moderate-to-Severe Psoriasis: the NEODERMA Study

Introducción y objetivos: el objetivo del estudio fue diseñar y evaluar la validez, fiabilidad y sensibilidad al cambio de un cuestionario de satisfacción del tratamiento para el paciente con psoriasis moderada y grave, denominado CESTEP (Cuestionario Español de Satisfacción de Tratamiento en Psoriasis). Pacientes y métodos: se diseñó un estudio observacional, prospectivo, naturalístico y multicéntrico. El cuestionario estaba formado por 12 ítems, cada uno de los cuales se valoraba con una escala de tipo Likert con respuestas puntuables de 0 (muy satisfecho) a 5 (muy insatisfecho) (puntuación total de 0 a 48). Los pacientes cumplimentaron el cuestionario de satisfacción en la visita basal y a los 3, 6, 9 y 12 meses de seguimiento. En cada visita se recogieron también las variables clínicas (índice PASI), la adherencia con el tratamiento (cuestionario Morisky-Green) y la valoración global de la satisfacción con el tratamiento mediante una escala analógica visual (EAV) de 0 a 100. Resultados: se incluyeron un total de 423 pacientes, de los cuales el 68% finalizaron los 12 meses de seguimiento. El 98,8% de los pacientes completaron todas las preguntas del cuestionario. Los cambios en el cuestionario de satisfacción y en el índice PASI durante el estudio se correlacionaron de manera baja (r de 0,38 a 0,33), pero se observaron, en cambio, correlaciones altas con los cambios en la EAV de satisfacción (r de –0,75 a –0,81). Se obtuvo una buena consistencia interna (α de Cronbach de 0,92). El coeficiente de correlación intraclase era de 0,89, con una diferencia media en las puntuaciones, entre la visita a los 3 meses y a los 6 meses de 0,07 puntos. Conclusiones: los resultados obtenidos indican que el cuestionario CESTEP para la evaluación de la satisfacción del tratamiento en pacientes con psoriasis moderada y grave puede ser utilizado para tal finalidad, ya que se ha mostrado factible, válido y fiable (AU)

Background and objectives: the aim of this study was to design and assess the validity, reliability, and sensitivity to change of the Spanish Satisfaction With Treatment of Psoriasis Questionnaire (SSTPQ) for use in patients with moderate-to-severe psoriasis. Patients and methods: a prospective, multicenter, observational, naturalistic study was designed. The instrument consisted of 12 items scored on a 5-point Likert scale with scores from 0 (very satisfied) to 5 (very unsatisfied), generating a total score of 0 to 48. Patients completed the questionnaire at baseline and then at 3-, 6-, 9-, and 12-month follow-up. At each visit, data were also collected on the Psoriasis Area and Severity Index (PASI), treatment adherence (Morisky-Green questionnaire), and overall treatment satisfaction on a Visual Analogue Scale (VAS) from 0 to 100. Results: a total of 423 patients were included in the study and 68% completed 12 months of follow-up. Responses were provided to all items in 98.8% of cases. There was a weak correlation between changes in treatment satisfaction on the SSTPQ and changes in PASI score (r=0.38 to 0.33); in contrast, there were strong correlations with changes in the VAS score for overall treatment satisfaction (r=–0.75 to –0.81). Good internal consistency was observed (Cronbach α=0.92). The intraclass correlation coefficient was 0.89, with a mean difference in score at 3- and 6-month follow-up of 0.07. Conclusions: The results obtained suggest that the SSTPQ is a feasible, valid, and reliable tool for the assessment of treatment satisfaction in patients with moderate-to-severe psoriasis (AU)

[Long term efficacy and safety of etanercept in psoriasis]. / Eficacia y seguridad a largo plazo de etanercept en la psoriasis.

There are many studies that have shown that etanercept is an effective and safe drug for the short-term treatment of moderate to severe psoriasis. However, psoriasis is a disease with a chronic or recurrent course associated to arthritis and comorbidities that diminish the patient's health and quality of life and that often requires either continuous or intermittent long-term treatment. The data available on the use of etanercept in the long-term treatment of psoriasis, even at high doses, have shown that it has a good efficacy and safety profile. Half of the patients obtained a 75% improvement on the Psoriasis Area and Severity Index (PASI-75 during prolonged treatments of up to 96 months. The PASI 75 response is higher in continuous regimes than in intermittent ones (with pauses). Most of the patients maintain the response at long-term, although a decrease in efficacy is observed in some of them, as occurs with other tumor necrosis factor inhibitors. Accumulated experience with etanercept in other chronic inflammatory diseases also supports this good safety profile.

Eficacia y seguridad a largo plazo de etanercept en la psoriasis / Long term efficacy and safety of etanercept in psoriasis

Existen numerosos estudios que demuestran que etanercept es un medicamento eficaz y seguro para el tratamiento de la psoriasis moderada a grave a corto plazo. Sin embargo, la psoriasis es una enfermedad con curso crónico o recurrente, asociada a artritis y comorbilidades que merman la salud y la calidad de vida de los pacientes, requiriendo a menudo tratamiento a largo plazo, ya sea de forma continua o intermitente. Los datos disponibles sobre el empleo de etanercept como tratamiento de la psoriasis a largo plazo, incluso en dosis altas, demuestran un buen perfil de eficacia y seguridad. La mitad de los pacientes obtienen una mejoría PASI (Psoriasis Area and Severity Index) 75 durante tratamientos prolongados hasta 96 meses. La respuesta PASI 75 es superior en pautas continuas que en pautas intermitentes (con pausas). La mayoría de los pacientes mantienen la respuesta a largo plazo, aunque en algunos se observa una disminución de la eficacia, como ocurre con otros inhibidores del factor de necrosis tumoral. La experiencia acumulada con etanercept en otras enfermedades inflamatorias crónicas también respalda este buen perfil de seguridad (AU)

There are many studies that have shown that etanercept is an effective and safe drug for the short-term treatment of moderate to severe psoriasis. However, psoriasis is a disease with a chronic or recurrent course associated to arthritis and comorbidities that diminish the patient's health and quality of life and that often requires either continuous or intermittent long-term treatment. The data available on the use of etanercept in the long-term treatment of psoriasis, even at high doses, have shown that it has a good efficacy and safety profile. Half of the patients obtained a 75% improvement on the Psoriasis Area and Severity Index (PASI-75 during prolonged treatments of up to 96 months. The PASI 75 response is higher in continuous regimes than in intermittent ones (with pauses). Most of the patients maintain the response at long-term, although a decrease in efficacy is observed in some of them, as occurs with other tumor necrosis factor inhibitors. Accumulated experience with etanercept in other chronic inflammatory diseases also supports this good safety profile (AU)

Calidad de vida, satisfacción y adherencia terapéutica en dermatitis atópica / Quality of life, satisfaction and therapeutic adherence in atopic dermatitis

Obejtivos: Evaluar la Calidad de Vida Relacionada con la Salud (CVRS) de los cuidadores de pacientes pediátricos con dermatitis atópica (DA) mediante el cuestionario Parents Index of Quality of Life in Atopic Dermatitis (PIQOL-AD) y el cuestionario EuroQoL-5D (EQ-5D) y conocer la satisfacción y la adherencia terapçeutica mediante el cuestionario Morisky Green. Métodos: Estudio observacional, multicéntrico y ambispectivo de 9 meses de seguimiento. 372 pacientes menores de 12 años con DA de 78 centros españoles distribuidos en dos grupos; pacientes de 0-23 meses y de 24 meses a 12 años. Se recogieron variables de gravedad (IGA, EASI), de CVRS, pregutnas sobre satisfacción con tratamiento y el cuestionario de adherencia. Resultados: La edad media (DE) de los pacientes fue de 4,2 (3,2) años. Las puntuaciones del PIQoL-AD se relacionaron con la gravedad del paciente (p<0.0001). Mayor preocupación por; "tener cuidado con la ropa que debía llevar el niño" (84,6%) y "por el aspecto del niño" (80,8%). Relación entre gravedad (IGA) y las puntuaciones EQ-5D; a mayor gravedad, mayor porcentaje de cuidadores con problemas en dolor/malestar y ansiedad/depresión. A los 9 meses la puntuación de la EVA de los cuidadores aumentó de forma estadísticamente significativa. El 83% de los cuidadores con pacientes sin casi enfermedad declararon estar muy o bastante satisfechos y el 25.3% una adherencia alta al tratamiento. Conclusiones: La gravedad de la DA es el factor que más condiciona con el tratamiento y en el grado de cumplimiento terapéutico

Objectives: To evaluate the Health-Related Quality of Life (HRQoL) of the pediatric patient´s caregivers with Atopic Dermatitis (AD) measured by Parents Index of Quality of Life in Atopic Dermatitis questionnaire (PIQOL-AD) and EuroQoL-5D questionnaire (EQ-5D) and know the treatment satisfaction and therapeutic compliance using Morisky Green questionnaire. Methods: Observationa, multicentric and ambispective study with a 9 months of prospective phase. 372 patients <= 12 years old with AD from 78 centers of Spain. Patients were allocated in two defferent groups, patients from 0-23 months and patients from 24 months to 2 years old. Patients with AD and whose caregiver may attend all study visits. We collect severity variables (Investigator´s Global Assessment (IGA), EASI), HRQoL (EQ-5D, PIQoL.AD), questions about treatment satisfaction and Morisky Green questionnaire. Results: Mean age (ED) was 4,2 (3,2) years old. PIQoL-AD scores have correlation with patient severity (p<0,001). Patient´s caregivers major concerns were about "be careful with the clothes that the children may wear" (84,6%) and "skin´s childrens aspects" (80.8%). Relationship between severity (IGA) and EQ-5D questionnaire scores. After 9 months of follow up, scores of analogical visual scales (AVS) of EQ-5D increased statistically significant, 83% of the patient´s caregivers with less severity declare to be more or quite satisfied with the treatment. The scores of the adherence questionnaire showed that 25,3% of the patients had a high adherence to the treatment. Conclusions: Results shows that severity of AD is the most conditioning factor in the caregivers day life, in the treatment satisfaction and adherence compliance (AU)

[Vulvar lymphedema: unusual manifestation of metastatic Crohn's disease]. / Linfedema vulvar: una manifestación infrecuente de la enfermedad de Crohn metastásica.

Cutaneous-mucosal lesions constitute one of the most frequent extraintestinal manifestations of Crohn's disease and in some cases may be the first symptom of intestinal disease. We describe the case of a 45-year-old female patient who sought medical help for genital tumefaction of 20 years' evolution. For the previous 15 years, she had been experiencing digestive symptomatology attributed to irritable bowel syndrome. Two months before the consultation, and coinciding with aggravation of the condition, the patient had been diagnosed with colonic Crohn's disease. Skin biopsy of the labia minora revealed sarcoid granulomas. The results of microbiological studies (staining for microorganisms and cultures) were negative. A diagnosis of metastatic vulvar Crohn's disease was made and, treatment with metronidazole was started, which improved the genital edema after 2 months. Genital lymphedema is an exceptionally rare manifestation of metastatic Crohn's disease that may appear several years before intestinal symptomatology develops. Treatment with metronidazole seems to be a good therapeutic option.

Síndrome de Stevens-Johnson por nevirapina

No disponible

Esclerodermatomiositis infantil / Infantile sclerodermatomyositis

La esclerodermatomiositis (EDM) es un síndrome de solapamiento, caracterizado por la presencia de manifestaciones clínicas de esclerosis sistémica y de dermatomiositis, cuyo principal marcador serológico es el anticuerpo anti-PM/Scl. Presentamos el caso clínico de una niña de 10 años diagnosticada de EDM (AU)