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.
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.
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).
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.
Sonidegib is an antagonist of the transmembrane protein Smoothened in the Hedgehog signaling pathway. It is indicated for the treatment of locally advanced basal cell carcinoma (BCC) that is not ...amenable to curative surgery or radiotherapy. Sonidegib’s efficacy and safety were demonstrated in the phase 2 BOLT trial, where 61% (95% CI, 48%–72%) of patients with locally advanced BCC treated with sonidegib 200 mg achieved an objective response to treatment with a mean time to response of 4 months. The median duration of response was 26.1 months and the median progression-free survival was 22.1 months. The most common adverse events were muscle spasms (54.4%), hair loss (49.4%), and loss of taste (44.3%); most events were grade 1 or 2. In this review, we summarize the main findings on the efficacy, safety, and tolerability of sonidegib and discuss the management of locally advanced BCC with this drug.
Sonidegib es un inhibidor del receptor transmembrana Smoothened (SMO) de la vía de señalización de Hedgehog indicado para el tratamiento del carcinoma basocelular localmente avanzado (CBCla) no susceptible a cirugía curativa ni a radioterapia. Sonidegib ha demostrado su eficacia y seguridad en pacientes con CBCla en el ensayo de fase II (BOLT), donde el 61% (IC95%: 48; 72) de los pacientes tratados con 200 mg de sonidegib tuvo una respuesta objetiva al tratamiento, con un tiempo medio hasta la respuesta de 4 meses. La mediana de duración de respuesta fue de 26,1 meses y la mediana de supervivencia libre de progresión fue de 22,1 meses. Los eventos adversos más frecuentes fueron los espasmos musculares (54,4%), alopecia (49,4%) y disgeusia (44,3%), siendo principalmente de grado 1 y 2. Esta revisión proporciona un resumen sobre la eficacia, seguridad y tolerabilidad de sonidegib, así como consideraciones sobre su uso en el manejo de pacientes con CBCla.
The negative impact of psoriasis on patient quality of life can be as important as the physical consequences of the disease. We could assume that clearance of the disease would also lead to an ...improvement in its psychosocial impact. The present study assesses the psychological state of patients with psoriasis receiving systemic treatment in a psoriasis unit, especially those with mild or no disease involvement.
We performed a cross-sectional, observational, noninterventional epidemiological study of 2 cohorts (cases and controls). The patients self-completed demographic data and 4 questionnaires (Rosenberg Self-Esteem Scale, Skindex-29, HADS, and COPE-28 questionnaire) at a single visit.
We recruited 111 patients diagnosed with psoriasis and 109 control patients. In self-esteem, the mean and standard deviation (SD) score was 33.5 (4.8) for the psoriasis group and 33.3 (6.7) for the control group, with no significant differences. In the Skindex-29, the mean score for the psoriasis group was almost 3 times higher than that of the control group (30 vs 11). Significant differences were found in the HADS scores of both groups (12.7 vs 9.0, P<.001). The mean HADS-A scores were 8.0 (4.78) for the psoriasis group compared with 5.7 (3.8) for the control group (P<.001). In the case of HADS-D, the scores were 4.7 (3.9) compared with 3.2 (3.1) (P<.004), respectively.
Our findings indicate that it is necessary to assess the psychological state of patients with psoriasis, because psychological effects persist even in cases where the disease is almost totally controlled.
El impacto negativo que la psoriasis tiene en la calidad de vida del paciente puede ser tan importante como sus consecuencias físicas. Podríamos suponer que el blanqueamiento de la enfermedad conllevaría también una mejoría de su impacto psicosocial. El presente estudio valora el estado psicológico de los pacientes con psoriasis controlados con tratamiento sistémico en una Unidad de Psoriasis, especialmente en aquellos con una afectación leve o nula de la enfermedad.
Estudio epidemiológico observacional y trasversal, sin intervención, con dos cohortes (casos y controles). Los pacientes autocompletaron datos demográficos y 4 cuestionarios (Cuestionario de autoestima de Rosenberg, Skindex-29, HADS y COPE-28) en una única visita.
Se reclutaron 111 pacientes diagnosticados de psoriasis y 109 pacientes control. En autoestima, el promedio y la desviación estándar (DE) del grupo de psoriasis fue de 33,5 (4,8) y de 33,3 (6,7) para el grupo control, sin diferencias significativas. En el Skindex-29, la puntuación media del grupo de pacientes con psoriasis fue casi 3 veces mayor que la media del grupo control (30 vs 11). Se encontraron diferencias significativas en las puntuaciones del HADS de ambos grupos (12,7 vs 9,0; p<0,001). Las puntuaciones promedio del HADS-A fueron de 8,0 (4,78) en el grupo de psoriasis frente a 5,7 (3,8) en el grupo control (p<0,001), mientras que las del HADS-D fueron de 4,7 (3,9) frente a 3,2 (3,1) (p<0,004), respectivamente.
Los resultados obtenidos indican que es necesario medir el estado psicológico de nuestros pacientes con psoriasis, pues incluso con un control casi total de la enfermedad la afectación psicológica permanece.
Several
MC1R
variants are associated with increased risk of malignant melanoma (MM) in a variety of populations. We aim to examine the influence of the
MC1R
variants (RHC: D84E, R151C, R160W; NRHC: ...V60L, R163Q and the synonymous polymorphism T314T) on the MM risk in a population from the Canary Islands. Overall, 1,046 Caucasian individuals were included in the study. A thousand of them were genotyped for
MC1R
variants: 509 were sporadic MM patients and 491 were healthy control subjects from general population. The analysis was adjusted for age, sex, hair colour, eye colour, skin phototype and ancestry. We found that carriers of the R151C and R163Q variants were at an increased risk for melanoma OR 2.76 (1.59–4.78) and OR 5.62 (2.54–12.42), respectively. The risk of carrying RHC variants was 3.04 (1.90–4.86). Current study confirms the increased MM risk for R151C carriers. It also supports the association between R163Q variant and MM risk in the population on the Canary Islands, as opposed to reported on northern populations. These results highlight the importance of the sample population selection in this kind of studies.
Biologic drugs are usually prescribed as second-line treatment for psoriasis, that is, after the patient has first been treated with a conventional psoriasis drug. There are, however, cases where, ...depending on the characteristics of the patient or the judgement of the physician, biologics may be chosen as first-line therapy. No studies to date have analyzed the demographics or clinical characteristics of patients in this setting or the safety profile of the agents used. The main aim of this study was to characterize these aspects of first-line biologic therapy and compare them to those observed for patients receiving biologics as second-line therapy.
We conducted an observational study of 181 patients treated in various centers with a systemic biologic drug as first-line treatment for moderate to severe psoriasis between January 2008 and November 2016. All the patients were registered in the Spanish Registry of Adverse Events Associated with Biologic Drugs in Dermatology.
The characteristics of the first- and second-line groups were very similar, although the patients receiving a biologic as first-line treatment for their psoriasis were older. No differences were observed for disease severity (assessed using the PASI) or time to diagnosis. Hypertension, diabetes, and liver disease were all more common in the first-line group. There were no differences between the groups in terms of reasons for drug withdrawal or occurrence of adverse effects.
No major differences were found between patients with psoriasis receiving biologic drugs as first- or second-line therapy, a finding that provides further evidence of the safety of biologic therapy in patients with psoriasis.
La utilización clínica habitual de los fármacos biológicos en el tratamiento de la psoriasis es en segunda línea, es decir, tras el uso previo de un fármaco clásico. Sin embargo, en casos particulares –particularidades del paciente o criterio médico– se realiza la indicación en primera línea. No existen estudios sobre las características demográficas, clínicas y de seguridad de los pacientes que reciben fármaco biológico en primera línea. Como objetivo primario se pretende determinar dichas características de acuerdo con la iniciación de la terapia biológica en primera o segunda línea.
Se realizó un estudio descriptivo, multicéntrico, de 181 pacientes que iniciaron tratamiento biológico como primer fármaco sistémico para control de su psoriasis moderada-grave, y que forman parte del Registro Español de Acontecimientos Adversos Asociados con Medicamentos Biológicos en Dermatología, entre enero de 2008 y noviembre de 2016.
Los pacientes de ambos grupos son muy similares, si bien se evidencia que el grupo que recibe el biológico en primera línea presenta una edad más avanzada, sin que se justifique por gravedad de la enfermedad (PASI) ni por el tiempo de evolución de esta desde el diagnóstico. En este grupo de pacientes es más frecuente la presencia de hipertensión, diabetes y hepatopatía. No hemos encontrado diferencias en motivos de suspensión ni seguridad entre ambos grupos.
No se han encontrado diferencias relevantes entre los 2 grupos, lo cual refuerza la seguridad de los fármacos biológicos en este contexto.
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Las comunidades autónomas (CC. AA.) españolas deciden sobre las condiciones de prescripción en su ámbito territorial, lo cual puede generar desigualdades en el acceso a nuevos ...fármacos. El objetivo del presente estudio fue evaluar la posible asociación entre el nivel de restricciones para acceder a nuevos fármacos en psoriasis y la probabilidad de alcanzar el control de la enfermedad psoriásica mediante la actividad mínima de la enfermedad (AME). Para ello se utilizaron los datos de dos estudios transversales independientes previos: uno que describió la AME en España, y otro que evaluó la cantidad de restricciones al acceso de fármacos por CC. AA. Tanto en el modelo crudo como en el ajustado se observó que, a mayor número de restricciones, menor fue el porcentaje de pacientes en AME (p=0,013). Los resultados obtenidos son compatibles con una situación de inequidad en salud en España que sería preciso abordar.
Spanish Autonomous Communities (ACs) are entitled to decide on the prescription requirements of their own territories, which can create inequalities in access to new drugs in the management of psoriasis. The objective of this study was to assess whether the level of restrictions in the access to new drugs for the management psoriasis was associated with the probability of achieving disease control measured using the Minimum Disease Activity (MDA) criteria. Therefore, we combined the results of 2 previous independent, cross-sectional studies: one that described the MDA in psoriasis by AC, and another that evaluated the level of restrictions to drug access by AC. We found that the higher the number of restrictions the lower the chances of achieving the MDA criteria (P=.013). Our results suggest that, in Spain, geographical differences in the access to new drugs may be creating health inequalities across the country.
Spanish Autonomous Communities (ACs) are entitled to decide on the prescription requirements of their own territories, which can create inequalities in access to new drugs in the management of ...psoriasis. The objective of this study was to assess whether the level of restrictions in the access to new drugs for the management psoriasis was associated with the probability of achieving disease control measured using the Minimum Disease Activity (MDA) criteria. Therefore, we combined the results of 2 previous independent, cross-sectional studies: one that described the MDA in psoriasis by AC, and another that evaluated the level of restrictions to drug access by AC. We found that the higher the number of restrictions the lower the chances of achieving the MDA criteria (p = 0.013). Our results suggest that, in Spain, geographical differences in the access to new drugs may be creating health inequalities across the country.
ABSTRACT
Background:
The aim of this study was to evaluate the results of sentinel lymph node biopsy (SLNB) in cutaneous melanoma at our institution.
Materials and Methods:
128 patients with primary ...cutaneous melanoma who underwent SLNB between April, 2004, and August, 2010 were studied. Univariate and multivariate analysis was performed to explore the effect of variables on mortality and sentinel node status. Survival analysis was performed using the Kaplan-Meier approach.
Results:
Positive SLNB were detected in 35 (27.3%) of 128 cases. Mean Breslow depths were 3.7 mm for SLNB positive patients and 1.99 mm for SLNB negative patients. False negative rate was 1%. The recurrence rate was 40% for positive patients and 6.5% for negative patients (odds ratio 9.7 confidence interval 95 % 3.3-28.1). 33 patients (29%) had an ulcerated melanoma, 12 (10.5%) in the positive group and 21 (18.5%) in the negative group. The disease recurred in a 48.5% of patients with ulcerated melanoma, but only in a 2.5% of patients with non-ulcerated melanoma. Upon multivariate analysis, only Breslow thickness (P = 0.005) demonstrate statistically significance for SLNB status. Multivariate analysis for clinicopathologic predictors of death demonstrate statistically significance for Breslow thickness (P = 0.020), ulceration (P = 0.030) and sentinel node status (P = 0.020).
Conclusions:
This study confirms that the status of the sentinel node is a strong independent prognostic factor with a higher risk of death and lower survival. Patients with ulcerated melanoma are more likely to develop recurrence, and also higher risk of death than patients with non-ulcerated melanoma.
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