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El Grupo de Psoriasis de la Academia Española de Dermatología y Venereología (GPs) diseño en 2017 la medida Actividad Mínima de Enfermedad en Psoriasis (AME). Se presentan los ...resultados de un estudio observacional, transversal y multicéntrico de la aplicación de esta escala a nivel nacional.
Se realizó un muestreo no aleatorizado, estratificado para alcanzar representación autonómica y provincial, de pacientes consecutivos con psoriasis (Ps) vulgar sin artritis activa. Se incluyeron 830 pacientes: 493 eran varones (59,5%), con una edad media de 51,4 años (DE=14,2), de todas las autonomías del país (excepto Ceuta y Melilla) y 44 (88%) de las 50 provincias. Se obtuvo un cuestionario recogiendo datos demográficos, DLQI, valoración subjetiva en escalas de 0 a 10 de picor, eritema, descamación y visibilidad; y el PASI y el BSA del paciente.
Más de la mitad no cumplían criterio de AME (491; 59,2%), con diferencia significativa entre regiones, por el sexo y por la edad. También había diferencias según el tratamiento realizado (p<0,001). El uso de un medicamento biológico se asoció a un mayor cumplimiento AME frente al uso de otro tipo de medicamentos (59,4 vs. 23,3%). No se observaron diferencias entre los tratamientos biológicos.
El porcentaje global de cumplimiento AME es bajo, con diferencias por la localización geográfica, el sexo, la edad y el fármaco utilizado, si bien ninguno de esos factores por separado las justifica.
In 2017, the Spanish Academy of Dermatology and Venereology Psoriasis Working Group (PWG) designed the Minimal Disease Activity (MDA) criteria to determine the level of disease activity. We hereby present the results of an observational, cross-sectional, multicenter study of the nationwide application of these criteria.
We conducted a non-randomized sampling, stratified to achieve autonomic and provincial representation of consecutive patients with psoriasis (Ps) vulgaris without active arthritis. A total of 830 patients were included: 493 men (59.5%), with a mean age of 51.4 years (SD, 14.2), from all autonomous regions of Spain (except for Ceuta and Melilla) and 44 (88%) out of the 50 provinces. A questionnaire was obtained with demographic data, DLQI, subjective assessment—on a scale from 0 to 10—of itching, erythema, desquamation, visibility, and the patients’ PASI and BSA.
More than 50% failed to meet the MDA criteria (491; 59.2%), with significant differences being reported by region, sex, and age. Additionally, significant differences were reported based on the therapy used (P<.001). The use of biological therapies was associated with higher MDA compliance compared to other therapies (59.4% vs 23.3%). No differences were reported among various biological therapies.
The overall rate of MDA compliance is low, with differences being based on geographic location, sex, age, and drug used, yet none of these factors separately justify them.
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.
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.
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).
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.
BACKGROUND AND OBJECTIVESCurrent psoriasis guidelines do not usually include recommendations about first line classical or biologic treatment. The objectives of this study were: to describe shifts in ...the prescription of the first biological treatment, and to compare treatment withdrawal and rates of adverse events over ten years. MATERIAL AND METHODSBiobadaderm registry was analyzed to describe: first biological prescription in bio-naïve patients, adverse events rate and reasons for drug withdrawal comparing three periods of time (2008-2010, 2011-2014, 2015-2018). RESULTSAnti-TNF drugs were the most prescribed biological drug from 2008 to 2010. Ustekinumab has become the most prescribed first biologic since 2014. The main reasons for drug discontinuation were adverse events, lack of efficacy and remission. In each period any treatment was less likely to be discontinued due to any of these three reasons comparing to the previous period. CONCLUSIONSThe present study identifies trends in prescription of the first biological antipsoriatic drug in clinical practice from 2008 to 2018. It suggests that we have become more comfortable with the safety profile and more exigent with the efficacy of the drugs.
Current psoriasis guidelines do not usually include recommendations about first line classical or biologic treatment. The objectives of this study were: to describe shifts in the prescription of the ...first biological treatment, and to compare treatment withdrawal and rates of adverse events over ten years.
Biobadaderm registry was analyzed to describe: first biological prescription in bio-naïve patients, adverse events rate and reasons for drug withdrawal comparing three periods of time (2008-2010, 2011-2014, 2015-2018).
AntiTNF drugs were the most prescribed biological drug from 2008 to 2010. Ustekinumab has become the most prescribed first biologic since 2014. The main reasons for drug discontinuation were adverse events, lack of efficacy and remission. In each period any treatment was less likely to be discontinued due to any of these three reasons comparing to the previous period.
The present study identifies trends in prescription of the first biological antipsoriatic drug in clinical practice from 2008 to 2018. It suggests that we have become more comfortable with the safety profile and more exigent with the efficacy of the drugs.
Las guías sobre el tratamiento de la psoriasis habitualmente no incluyen las recomendaciones acerca de cuál debe ser la primera línea de tratamiento sistémico o biológico. Los objetivos de este estudio fueron describir las tendencias en la prescripción del primer fármaco biológico y comparar la retirada de los fármacos y las tasas de efectos adversos a lo largo de los 10 años de seguimiento.
Se utilizó el registro Biobadaderm para determinar cuál fue el primer fármaco biológico indicado en pacientes con psoriasis “Naive” para biológicos, así como cuál es la tasa de efectos adversos y los motivos de suspensión de los fármacos. Los resultados obtenidos se compararon en tres periodos distintos de tiempo (2008-2010, 2011-2014, 2015-2018).
Los fármacos anti-TNF fueron los biológicos prescritos con mayor frecuencia entre el año 2008 y el 2010. El Ustekinumab se ha convirtió en el tratamiento biológico más indicado a partir del 2014. El motivo principal de suspensión de los tratamientos fueron los efectos adversos, la falta de eficacia y la remisión de la enfermedad. La probabilidad de suspender los fármacos por uno de estos motivos fue cada vez menor si se compara con el periodo de tiempo previo.
El presente estudio identifica cuáles fueron las tendencias en la prescripción del primer fármaco biológico en la práctica clínica habitual entre el año 2008 al 2018. Sugiere que los dermatólogos estamos cada vez más seguros en cuanto al perfil de seguridad y somos cada vez más exigentes en cuanto a la eficacia de los fármacos.
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.
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.
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.
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/m2). 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.
Risankizumab proved to be a safe and effective therapy for patients with moderate-to-severe psoriasis in the routine clinical practice.
Risankizumab es un anticuerpo monoclonal humanizado que se dirige a la subunidad p19 de IL-23, recientemente aprobado para el tratamiento de la psoriasis en placas moderada a grave. Actualmente faltan datos del mundo real basados en una muestra representativa de pacientes.
Evaluar la eficacia y la seguridad a medio y a largo plazo del risankizumab en pacientes con psoriasis moderada a grave en la práctica clínica habitual.
Estudio retrospectivo y multicéntrico realizado en pacientes consecutivos con psoriasis que recibieron tratamiento con risankizumab desde abril de 2020 hasta noviembre de 2022. El criterio de valoración principal fue la proporción de pacientes que alcanzaron una mejora en el Índice de Área y Severidad de la Psoriasis (Psoriasis Area and Severity Index PASI) del 100% (PASI100) en la semana 52.
Se incluyeron en el estudio un total de 510 pacientes, 198 (38,8%) mujeres y 312 (61,2%) hombres. La edad media fue de 51,7±14,4 años, y 227 (44,5%) sujetos eran obesos (índice de masa corporal IMC>30kg/m2). La puntuación media del PASI basal fue de 11,4±7,2. La proporción de pacientes que alcanzaron PASI100 en la semana 52 fue del 67,0%. A lo largo del seguimiento del estudio, el 21%, el 50,0%, el 59,0% y el 66% de los pacientes alcanzaron un PASI100 en las semanas 4, 16, 24 y 40, respectivamente. La proporción de pacientes que alcanzaron un PASI≤2 fue mayor en el grupo con un IMC≤30kg/m2 en la semana 4 (p=0,04), la semana 16 (p=0,001) y la semana 52 (p=0,002). Una proporción estadísticamente significativa mayor de pacientes alcanzó un PASI100 en el grupo sin tratamiento previo en la semana 16 y a la semana 52 (p=0,001 en cada una, respectivamente). En la semana 16, una proporción significativamente menor de sujetos alcanzó un PASI100 en el grupo con artropatía psoriásica (p=0,04). Entre la muestra total del estudio, 22 (4,3%) pacientes reportaron algún tipo de evento adverso y 20 (3,9%) abandonaron o se retiraron del tratamiento.
Risankizumab fue un tratamiento efectivo y seguro para pacientes con psoriasis moderada a grave en la práctica clínica.
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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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.
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.
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).
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.
La psoriasis suele preceder a la aparición de la artritis psoriásica (APs), por lo que los dermatólogos suelen enfrentarse al reto de identificar precozmente los signos de APs en pacientes con psoriasis. El objetivo fue validar la versión española del cuestionario PURE-4 como herramienta de cribado para la APs, evaluando su rendimiento en términos de sensibilidad, especificidad, viabilidad, fiabilidad y validez de constructo.
Se realizó un estudio transversal, observacional y multicéntrico en pacientes adultos con psoriasis. Inicialmente, los pacientes fueron evaluados por un dermatólogo y completaron dos versiones autoadministradas (en papel y electrónica) del cuestionario PURE-4. Después, el reumatólogo, ciego a los resultados del PURE-4, evaluó la presencia/ausencia de APs, siendo la referencia para determinar el rendimiento del cuestionario PURE-4.
Se incluyeron 268 pacientes (115 42,9% mujeres; edad media, 47,1±12,6 años). Se diagnosticó de APs a 34 pacientes (12,7%) en una media (DE) de 1,4±1,6 semanas. La puntuación PURE-4 media para los pacientes con psoriasis diagnosticados de APs fue de 2,3±1,1, y de 1,3±1,3 para los pacientes sin APs (p<0,001). El punto de corte óptimo con mejor rendimiento para detectar APs fue ≥2 respuestas positivas, con valor predictivo negativo del 95,1% (intervalo de confianza 95%: 90,3-97,6).
El cuestionario PURE-4 demostró un buen rendimiento para el cribado de APs, con un punto de corte óptimo ≥2. Esta sencilla herramienta podría facilitar la derivación temprana de los pacientes al servicio de reumatología.
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La psoriasis suele preceder a la aparición de la artritis psoriásica (APs), por lo que los dermatólogos suelen enfrentarse al reto de identificar precozmente los signos de APs en ...pacientes con psoriasis. El objetivo fue validar la versión española del cuestionario PURE-4 como herramienta de cribado para la APs, evaluando su rendimiento en términos de sensibilidad, especificidad, viabilidad, fiabilidad y validez de constructo.
Se realizó un estudio transversal, observacional y multicéntrico en pacientes adultos con psoriasis. Inicialmente, los pacientes fueron evaluados por un dermatólogo y completaron dos versiones autoadministradas (en papel y electrónica) del cuestionario PURE-4. Después, el reumatólogo, ciego a los resultados del PURE-4, evaluó la presencia/ausencia de APs, siendo la referencia para determinar el rendimiento del cuestionario PURE-4.
Se incluyeron 268 pacientes (115 42,9% mujeres; edad media, 47,1±12,6 años). Se diagnosticó de APs a 34 pacientes (12,7%) en una media (DE) de 1,4±1,6 semanas. La puntuación PURE-4 media para los pacientes con psoriasis diagnosticados de APs fue de 2,3±1,1, y de 1,3±1,3 para los pacientes sin APs (p<0,001). El punto de corte óptimo con mejor rendimiento para detectar APs fue ≥2 respuestas positivas, con valor predictivo negativo del 95,1% (intervalo de confianza 95%: 90,3-97,6).
El cuestionario PURE-4 demostró un buen rendimiento para el cribado de APs, con un punto de corte óptimo ≥2. Esta sencilla herramienta podría facilitar la derivación temprana de los pacientes al servicio de reumatología.
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.
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.
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).
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.
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.BACKGROUND AND OBJECTIVEPsoriasis 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.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.METHODSThis 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.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).RESULTSA 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).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.CONCLUSIONSThe 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.
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