Real-World Treatment Patterns, Resource Use and Costs in Adult Patients With Atopic Dermatitis Receiving Systemic Treatment: Derma-Atopic Study in Spain / Características de los pacientes, patrones de tratamiento, uso de recursos y costes en adultos con dermatitis atópica moderada-grave en la práctica habitual en España: Estudio Derma-Atopic

Background Moderate–severe atopic dermatitis (AD) has a significant impact on patients’ lives, with many requiring systemic treatment to manage symptoms (e.g., pruritus). Several drugs are used off-label to treat AD. This study describes sociodemographic/clinical characteristics, treatment patterns, health resource use (HRU) and costs in adults with AD who initiated systemic treatment or phototherapy in routine practice. Methods This retrospective observational study of electronic medical records in the BIG-PAC database identified adults with prior diagnosis of AD (ICD-9: 691.8 or 692.9) starting oral corticosteroids, immunosuppressants, biologics or phototherapy between 01/01/2012 and 31/12/2016. Patients were followed for 3 years from treatment initiation, up to 31/12/2019. Data on patient characteristics, treatment patterns, HRU and costs were analyzed descriptively. Results Patients (N = 1995) had a mean age of 60 years, 64% were female, with a mean time of 23 years since diagnosis (84% were ≥18 years at AD onset). Main comorbidities were anxiety (38%), arterial hypertension (36%) and dyslipidemia (35%). Most patients used oral corticosteroids as first systemic (84%; median duration 29 days) and immunosuppressants in 13% of patients (median duration 117 days, 5% cyclosporine and 4% methotrexate). Half of patients required a second line systemic and 12% a third line. The use of immunosuppressants and biologics increased with treatment lines. About 13% of patients received systemic treatments continuously over the 3-year follow-up. The average 3-year per patient cost was 3835 euros, with an average annual cost of 1278 euros. Conclusions Results suggest a high comorbidity and economic burden in this real-world adult population with AD, and the need for systemic treatments indicated for use in AD (AU)

Antecedentes La dermatitis atópica (DA) moderada-grave tiene un impacto significativo en la vida de los pacientes, muchos de los cuales requieren tratamiento sistémico para controlar los síntomas (p. ej., prurito). Algunos tratamientos son usados fuera de indicación. Este estudio describió características sociodemográficas y clínicas, patrones de tratamiento, uso de recursos sanitarios (URS) y costes asociados en adultos con DA que iniciaron tratamiento sistémico o fototerapia en la práctica habitual. Métodos Este estudio observacional retrospectivo de historias clínicas electrónicas en la base de datos BIG-PAC identificó adultos con diagnóstico previo de DA (CIE-9: 691.8 o 692.9) que comenzaron con corticosteroides orales, inmunosupresores, biológicos o fototerapia entre el 01/01/2012 y el 31/12/2016. Se siguió a los pacientes durante 3 años desde el inicio del tratamiento, hasta 31/12/2019. Los datos sobre las características clínicas de los pacientes, patrones de tratamiento, URS y costes se analizaron de forma descriptiva. Resultados Los pacientes (N = 1995) tenían una edad media de 60 años, el 64% eran mujeres, con una media de 23 años desde el diagnóstico (84% tenían ≥ 18 años al inicio de la DA). Las principales comorbilidades fueron ansiedad (38%), hipertensión arterial (36%) y dislipidemia (35%). La mayoría de los pacientes utilizaron corticosteroides orales como primer tratamiento sistémico (84%; duración media 29 días) e inmunosupresores en el 13% de los pacientes (duración media 117 días, ciclosporina en el 5% y metotrexato en el 4%). La mitad de los pacientes requirieron una segunda línea de tratamiento sistémico y el 12% una tercera. El uso de inmunosupresores y biológicos aumentó simultáneamente con las líneas de tratamiento. Aproximadamente el 13% de los pacientes recibieron tratamientos sistémicos de forma continua durante los 3 años de seguimiento. El coste medio por paciente a 3 años fue de 3.835 euros, con un coste medio anual de 1.278 euros (AU)

[Artículo traducido] Características de los pacientes, patrones de tratamiento, uso de recursos y costes en adultos con dermatitis atópica moderada-grave en la práctica habitual en España: Estudio Derma-Atopic / Real-World Treatment Patterns, Resource Use and Costs in Adult Patients With Atopic Dermatitis Receiving Systemic Treatment: Derma-Atopic Study in Spain

Antecedentes La dermatitis atópica (DA) moderada-grave tiene un impacto significativo en la vida de los pacientes, muchos de los cuales requieren tratamiento sistémico para controlar los síntomas (p. ej., prurito). Algunos tratamientos son usados fuera de indicación. Este estudio describió características sociodemográficas y clínicas, patrones de tratamiento, uso de recursos sanitarios (URS) y costes asociados en adultos con DA que iniciaron tratamiento sistémico o fototerapia en la práctica habitual. Métodos Este estudio observacional retrospectivo de historias clínicas electrónicas en la base de datos BIG-PAC identificó adultos con diagnóstico previo de DA (CIE-9: 691.8 o 692.9) que comenzaron con corticosteroides orales, inmunosupresores, biológicos o fototerapia entre el 01/01/2012 y el 31/12/2016. Se siguió a los pacientes durante 3 años desde el inicio del tratamiento, hasta 31/12/2019. Los datos sobre las características clínicas de los pacientes, patrones de tratamiento, URS y costes se analizaron de forma descriptiva. Resultados Los pacientes (N = 1995) tenían una edad media de 60 años, el 64% eran mujeres, con una media de 23 años desde el diagnóstico (84% tenían ≥ 18 años al inicio de la DA). Las principales comorbilidades fueron ansiedad (38%), hipertensión arterial (36%) y dislipidemia (35%). La mayoría de los pacientes utilizaron corticosteroides orales como primer tratamiento sistémico (84%; duración media 29 días) e inmunosupresores en el 13% de los pacientes (duración media 117 días, ciclosporina en el 5% y metotrexato en el 4%). La mitad de los pacientes requirieron una segunda línea de tratamiento sistémico y el 12% una tercera. El uso de inmunosupresores y biológicos aumentó simultáneamente con las líneas de tratamiento. Aproximadamente el 13% de los pacientes recibieron tratamientos sistémicos de forma continua durante los 3 años de seguimiento. El coste medio por paciente a 3 años fue de 3.835 euros, con un coste medio anual de 1.278 euros (AU)

Background Moderate–severe atopic dermatitis (AD) has a significant impact on patients’ lives, with many requiring systemic treatment to manage symptoms (e.g., pruritus). Several drugs are used off-label to treat AD. This study describes sociodemographic/clinical characteristics, treatment patterns, health resource use (HRU) and costs in adults with AD who initiated systemic treatment or phototherapy in routine practice. Methods This retrospective observational study of electronic medical records in the BIG-PAC database identified adults with prior diagnosis of AD (ICD-9: 691.8 or 692.9) starting oral corticosteroids, immunosuppressants, biologics or phototherapy between 01/01/2012 and 31/12/2016. Patients were followed for 3 years from treatment initiation, up to 31/12/2019. Data on patient characteristics, treatment patterns, HRU and costs were analyzed descriptively. Results Patients (N = 1995) had a mean age of 60 years, 64% were female, with a mean time of 23 years since diagnosis (84% were ≥18 years at AD onset). Main comorbidities were anxiety (38%), arterial hypertension (36%) and dyslipidemia (35%). Most patients used oral corticosteroids as first systemic (84%; median duration 29 days) and immunosuppressants in 13% of patients (median duration 117 days, 5% cyclosporine and 4% methotrexate). Half of patients required a second line systemic and 12% a third line. The use of immunosuppressants and biologics increased with treatment lines. About 13% of patients received systemic treatments continuously over the 3-year follow-up. The average 3-year per patient cost was 3835 euros, with an average annual cost of 1278 euros. Conclusions Results suggest a high comorbidity and economic burden in this real-world adult population with AD, and the need for systemic treatments indicated for use in AD (AU)

Real-World Treatment Patterns, Resource Use and Costs in Adult Patients With Atopic Dermatitis Receiving Systemic Treatment: Derma-Atopic Study in Spain.

BACKGROUND: Moderate-severe atopic dermatitis (AD) has a significant impact on patients' lives, with many requiring systemic treatment to manage symptoms (e.g., pruritus). Several drugs are used off-label to treat AD. This study describes sociodemographic/clinical characteristics, treatment patterns, health resource use (HRU) and costs in adults with AD who initiated systemic treatment or phototherapy in routine practice. METHODS: This retrospective observational study of electronic medical records in the BIG-PAC database identified adults with prior diagnosis of AD (ICD-9: 691.8 or 692.9) starting oral corticosteroids, immunosuppressants, biologics or phototherapy between 01/01/2012 and 31/12/2016. Patients were followed for 3 years from treatment initiation, up to 31/12/2019. Data on patient characteristics, treatment patterns, HRU and costs were analyzed descriptively. RESULTS: Patients (N=1995) had a mean age of 60 years, 64% were female, with a mean time of 23 years since diagnosis (84% were ≥18 years at AD onset). Main comorbidities were anxiety (38%), arterial hypertension (36%) and dyslipidemia (35%). Most patients used oral corticosteroids as first systemic (84%; median duration 29 days) and immunosuppressants in 13% of patients (median duration 117 days, 5% cyclosporine and 4% methotrexate). Half of patients required a second line systemic and 12% a third line. The use of immunosuppressants and biologics increased with treatment lines. About 13% of patients received systemic treatments continuously over the 3-year follow-up. The average 3-year per patient cost was 3835 euros, with an average annual cost of 1278 euros. CONCLUSIONS: Results suggest a high comorbidity and economic burden in this real-world adult population with AD, and the need for systemic treatments indicated for use in AD.

Real-World Treatment Patterns, Resource Use and Costs in Adult Patients With Atopic Dermatitis Receiving Systemic Treatment: Derma-Atopic Study in Spain. / [Artículo traducido] Características de los pacientes, patrones de tratamiento, uso de recursos y costes en adultos con dermatitis atópica moderada-grave en la práctica habitual en España: Estudio Derma-Atopic.

BACKGROUND: Moderate-severe atopic dermatitis (AD) has a significant impact on patients' lives, with many requiring systemic treatment to manage symptoms (e.g., pruritus). Several drugs are used off-label to treat AD. This study describes sociodemographic/clinical characteristics, treatment patterns, health resource use (HRU) and costs in adults with AD who initiated systemic treatment or phototherapy in routine practice. METHODS: This retrospective observational study of electronic medical records in the BIG-PAC database identified adults with prior diagnosis of AD (ICD-9: 691.8 or 692.9) starting oral corticosteroids, immunosuppressants, biologics or phototherapy between 01/01/2012 and 31/12/2016. Patients were followed for 3 years from treatment initiation, up to 31/12/2019. Data on patient characteristics, treatment patterns, HRU and costs were analyzed descriptively. RESULTS: Patients (N = 1995) had a mean age of 60 years, 64% were female, with a mean time of 23 years since diagnosis (84% were ≥18 years at AD onset). Main comorbidities were anxiety (38%), arterial hypertension (36%) and dyslipidemia (35%). Most patients used oral corticosteroids as first systemic (84%; median duration 29 days) and immunosuppressants in 13% of patients (median duration 117 days, 5% cyclosporine and 4% methotrexate). Half of patients required a second line systemic and 12% a third line. The use of immunosuppressants and biologics increased with treatment lines. About 13% of patients received systemic treatments continuously over the 3-year follow-up. The average 3-year per patient cost was 3835 euros, with an average annual cost of 1278 euros. CONCLUSIONS: Results suggest a high comorbidity and economic burden in this real-world adult population with AD, and the need for systemic treatments indicated for use in AD.

Medidas de los resultados percibidos por el paciente en estudios de vida real en dermatitis atópica en España: revisión sistemática de la literatura / Patient-Reported Outcome Measures in Real-World Atopic Dermatitis Studies in Spain: A Systematic Review

La dermatitis atópica (DA) es una enfermedad cutánea inflamatoria crónica con síntomas tales como el prurito, que pueden causar una carga significativa en la vida del paciente. Los resultados percibidos por los pacientes (PRO) complementan a los resultados clínicos evaluados en la DA por los médicos. Esta revisión sistemática tiene como objetivo identificar y describir las medidas de los resultados percibidos por los pacientes (PROM) utilizadas en estudios observacionales de DA durante la última década en España. Se identificaron 18 PROM para medir 13 PRO diferentes que evalúan múltiples aspectos de la enfermedad, incluyendo los síntomas y la gravedad de la enfermedad, la interferencia con las actividades diarias, el impacto psicosocial y laboral, el empoderamiento del paciente y la calidad de vida relacionada con la salud (CVRS). La CVRS, los síntomas (principalmente el prurito) y la ansiedad/depresión fueron los PRO más evaluados, siendo el Dermatology Life Quality Index, la Escala Visual Analógica del prurito y la Hospital Anxiety and Depression Scale, las PROM más frecuentemente empleadas, respectivamente. El número creciente de estudios observacionales sobre DA que incluyen PROM en España sugiere un aumento de la importancia de los PRO en el manejo de la DA (AU)

Atopic dermatitis (AD) is a chronic inflammatory skin disease with symptoms such as pruritus that can be a major burden for patients. Patient-reported outcomes (PRO) complement clinician-reported outcomes in AD. This systematic review aims to identify and describe patient-reported outcome measures (PROM) used in observational studies of AD over the last decade in Spain. Eighteen PROM were identified to measure 13 different PRO that assess multiple aspects of the disease, including symptoms and disease severity, impact on daily activities and on work productivity/functioning, psychosocial impact, patient empowerment, and health-related quality of life (HRQoL). HRQoL, symptoms (particularly pruritus), and anxiety/depression were the most frequently assessed PRO, and the Dermatology Quality of Life Index, the Visual Analogue Pruritus Scale, and the Hospital Anxiety and Depression Scale were the most frequently used PROM, respectively. The growing number of observational studies on AD including PROM in Spain suggests that PRO are becoming increasingly important in the management of AD (AU)

[Translated article] Patient-Reported Outcome Measures in Real-World Atopic Dermatitis Studies in Spain: A Systematic Review / Medidas de los resultados percibidos por el paciente en estudios de vida real en dermatitis atópica en España: revisión sistemática de la literatura

Atopic dermatitis (AD) is a chronic inflammatory skin disease with symptoms such as pruritus that can be a major burden for patients. Patient-reported outcomes (PRO) complement clinician-reported outcomes in AD. This systematic review aims to identify and describe patient-reported outcome measures (PROM) used in observational studies of AD over the last decade in Spain. Eighteen PROM were identified to measure 13 different PRO that assess multiple aspects of the disease, including symptoms and disease severity, impact on daily activities and on work productivity/functioning, psychosocial impact, patient empowerment, and health-related quality of life (HRQoL). HRQoL, symptoms (particularly pruritus), and anxiety/depression were the most frequently assessed PRO, and the Dermatology Quality of Life Index, the Visual Analogue Pruritus Scale, and the Hospital Anxiety and Depression Scale were the most frequently used PROM, respectively. The growing number of observational studies on AD including PROM in Spain suggests that PRO are becoming increasingly important in the management of AD (AU)

La dermatitis atópica (DA) es una enfermedad cutánea inflamatoria crónica con síntomas tales como el prurito, que pueden causar una carga significativa en la vida del paciente. Los resultados percibidos por los pacientes (PRO) complementan a los resultados clínicos evaluados en la DA por los médicos. Esta revisión sistemática tiene como objetivo identificar y describir las medidas de los resultados percibidos por los pacientes (PROM) utilizadas en estudios observacionales de DA durante la última década en España. Se identificaron 18 PROM para medir 13 PRO diferentes que evalúan múltiples aspectos de la enfermedad, incluyendo los síntomas y la gravedad de la enfermedad, la interferencia con las actividades diarias, el impacto psicosocial y laboral, el empoderamiento del paciente y la calidad de vida relacionada con la salud (CVRS). La CVRS, los síntomas (principalmente el prurito) y la ansiedad/depresión fueron los PRO más evaluados, siendo el Dermatology Life Quality Index, la Escala Visual Analógica del prurito y la Hospital Anxiety and Depression Scale, las PROM más frecuentemente empleadas, respectivamente. El número creciente de estudios observacionales sobre DA que incluyen PROM en España sugiere un aumento de la importancia de los PRO en el manejo de la DA (AU)

Patient-Reported Outcome Measures in Real-World Atopic Dermatitis Studies in Spain: A Systematic Review. / Medidas de los resultados percibidos por el paciente en estudios de vida real en dermatitis atópica en España: revisión sistemática de la literatura.

Atopic dermatitis (AD) is a chronic inflammatory skin disease with symptoms such as pruritus that can be a major burden for patients. Patient-reported outcomes (PRO) complement clinician-reported outcomes in AD. This systematic review aims to identify and describe patient-reported outcome measures (PROM) used in observational studies of AD over the last decade in Spain. Eighteen PROM were identified to measure 13 different PRO that assess multiple aspects of the disease, including symptoms and disease severity, impact on daily activities and on work productivity/functioning, psychosocial impact, patient empowerment, and health-related quality of life (HRQoL). HRQoL, symptoms (particularly pruritus), and anxiety/depression were the most frequently assessed PRO, and the Dermatology Quality of Life Index, the Visual Analogue Pruritus Scale, and the Hospital Anxiety and Depression Scale were the most frequently used PROM, respectively. The growing number of observational studies on AD including PROM in Spain suggests that PRO are becoming increasingly important in the management of AD.

Evaluación de la eficiencia de los tratamientos biológicos en la psoriasis moderada a grave en España: análisis de coste por número necesario a tratar (NNT) / A Cost-per-Number Needed to Treat Analysis Assessing the Efficiency of Biologic Drugs in Moderate to Severe Plaque Psoriasis

Antecedentes y objetivos: La psoriasis es una enfermedad inflamatoria crónica de la piel cuya prevalencia en España se estima en el 2,3% de la población y en la que alrededor del 30% de los pacientes tienen formas moderadas a graves. El tratamiento con agentes biológicos está suponiendo un avance en el manejo de la enfermedad, aunque también representa un reto económico. El objetivo de este estudio es determinar la eficiencia, en términos de coste por número necesario a tratar (NNT), de las terapias biológicas disponibles en España para el tratamiento de la psoriasis en placas moderada a grave. Métodos: Los datos de NNT se obtuvieron de un metaanálisis en red que incluía todos los ensayos clínicos aleatorizados con medicamentos biológicos comercializados en España. Los costes de cada terapia se calcularon según las posologías aprobadas en las fichas técnicas para el primer año de tratamiento. A partir de estos datos se calculó el coste por NNT de los fármacos para los distintos niveles de PASI (75, 90 y 100). Se realizó un análisis de sensibilidad considerando solamente el periodo de medición de la respuesta PASI (de 10 a 16 semanas) según el tratamiento. Resultados: Para la respuesta PASI 75, el orden de terapias de mayor a menor eficiencia es ixekizumab > ustekinumab 45 mg > ustekinumab 90 mg > secukinumab > infliximab > etanercept > adalimumab. Para la respuesta PASI 90, el orden es ixekizumab > secukinumab > ustekinumab 45 mg > ustekinumab 90 mg > infliximab > adalimumab > etanercept. Para la respuesta PASI 100 el orden es ixekizumab > secukinumab > infliximab > ustekinumab 90 mg > ustekinumab 45 mg > adalimumab > etanercept. El análisis de sensibilidad mostró algún cambio en el orden de las secuencias para el periodo de evaluación de la respuesta. Conclusiones: Este análisis muestra una relación entre la eficacia de los tratamientos biológicos disponibles en España para el tratamiento de la psoriasis en placas moderada a grave y su eficiencia, siendo ixekizumab el que mostró un menor coste por NNT en todos los niveles de respuesta PASI alcanzados (75, 90 y 100) para el primer año de tratamiento

Background and objectives: Psoriasis is a chronic inflammatory skin disease with an estimated prevalence in Spain of 2.3% of the population. Approximately 30% of patients have moderate-to-severe forms. Treatment with biologic agents is proving to be a step forward in the management of the disease, although these treatments are very expensive. The objective of this study was to determine the efficiency, in terms of cost per number needed to treat (NNT), of the biologic drugs available in Spain for the treatment of moderate to severe plaque psoriasis. Methods: NNT data were obtained from a network meta-analysis that included all randomized clinical trials of biologic drugs sold in Spain. The cost of each treatment was calculated based on the approved dosage for the first year of treatment, as indicated in the Summary of Product Characteristics. These data were used to calculate the cost per NNT of the drugs for various PASI scores (75, 90, and 100). A sensitivity analysis was performed taking into consideration only the PASI-response measurement time (after 10, 12, or 16 weeks, depending on the drug). Results: The order of efficiency, from most to least efficient, in the case of a PASI 75 response was ixekizumab > ustekinumab 45 mg > ustekinumab 90 mg > secukinumab > infliximab > etanercept > adalimumab. The order for PASI 90 was ixekizumab >secukinumab >ustekinumab 45 mg > ustekinumab 90 mg > infliximab > adalimumab > etanercept. The order for PASI 100 was ixekizumab > secukinumab > infliximab > ustekinumab 90 mg > ustekinumab 45 mg > adalimumab > etanercept. The sensitivity analysis showed some changes in the order, depending on the response-assessment period. Conclusions: The findings show a link between the efficacy of the biologic therapies available in Spain for the treatment of moderate-to-severe plaque psoriasis and their efficiency. Ixekizumab had the lowest cost per NNT for all PASI-response scores (75, 90, and 100) during the first year of treatment

Instrumentos para la valoración de los resultados percibidos por el paciente con psoriasis en España: revisión sistemática de la literatura / Patient-reported outcomes assessment tools for use in psoriasis in Spain: A systematic review

Objetivo: Revisar la bibliografía sobre instrumentos específicos de medida de los resultados percibidos por los pacientes (patient reported outcomes, PRO) validados y utilizados en población española con psoriasis, valorar sus propiedades psicométricas y describir los resultados de su aplicación práctica. Materiales y métodos: Revisión sistemática de la literatura científica en bases de datos internacionales (PubMed/Medline) y nacionales (Medes, Ibecs) referente a estudios que validen o implementen instrumentos específicos de valoración de PRO en población española con psoriasis. Se completó la búsqueda en bases de datos específicas de instrumentos para medir PRO (BiblioPRO, PROQOLID). Se incluyeron los estudios publicados en inglés o español hasta el 01/09/2017. Adicionalmente, se revisaron las listas de referencias bibliográficas de las publicaciones clave identificadas. La valoración de la calidad metodológica de los cuestionarios se efectuó con base en sus propiedades psicométricas (constructo, adaptación transcultural, fiabilidad, validez, factibilidad y sensibilidad al cambio). Resultados: Se seleccionaron 18 publicaciones. Seis artículos describieron la validación al español de 5 instrumentos de PRO: 4 cuestionarios de calidad de vida relacionada con la salud (CVRS) específicos de psoriasis/enfermedades dermatológicas y un cuestionario específico de satisfacción con el tratamiento. La valoración psicométrica muestra variabilidad en los criterios alcanzados por cada instrumento; el cuestionario de CVRS PSO-LIFE resultó el más completo. Los 12 artículos restantes correspondían a estudios observacionales que empleaban los instrumentos validados. Su utilización muestra un elevado impacto de la psoriasis en la CVRS, especialmente en pacientes jóvenes, de género femenino y con enfermedad grave. Conclusiones: Se han identificado 5 instrumentos específicos validados en España para valorar los PRO en pacientes con psoriasis. Dada la variedad de sus propiedades psicométricas, resulta esencial conocer las fortalezas y debilidades de cada uno para seleccionar el instrumento apropiado para cada situación. El empleo de estos cuestionarios pone de manifiesto el elevado impacto de la enfermedad en la CVRS de los pacientes. La evaluación de los PRO en el paciente con psoriasis complementa los resultados clínicos tradicionales y puede contribuir a un manejo más óptimo de la enfermedad

Objectives: To review the literature on validated tools for measuring patient-reported outcomes (PROs) in psoriasis in Spain. To evaluate the psychometric properties of the tools and describe the results of their practical application. Material and methods: Systematic review of studies validating or using instruments for assessing PROs in Spanish patients with psoriasis. Literature searches were performed in international (PubMed/Medline) and Spanish (Medes, Ibecs) databases. We also searched databases of instruments for measuring PROs (BiblioPRO, PROQOLID). The review included studies published in English or Spanish up to January 9, 2017. We also checked the reference lists of the key publications identified. The quality of the questionnaires was evaluated based on their psychometric properties (construct, transcultural adaptation, reliability, validity, feasibility, and sensitivity to change). Results: Eighteen publications were included. Six articles described the validation of Spanish versions of 5 PROs tools: 4 health-related quality of life (HRQoL) questionnaires specific to psoriasis and dermatologic diseases and 1 questionnaire specific to satisfaction with treatment. Our assessment of the HRQoL tools’ psychometric properties showed that the PSO-LIFE questionnaire received the highest scores, although specific properties varied from instrument to instrument. The 12 remaining articles were observational studies that used the validated instruments. In use, these tools detected the high impact of psoriasis on HRQoL, especially in young female patients with severe disease. Conclusions: We identified 5 specific instruments validated in Spain for scoring PROs in patients with psoriasis. The tools' psychometric properties vary, and it is essential to understand their strengths and weaknesses when selecting the right one for each situation. In use, these questionnaires are able to detect the high impact of psoriasis on patients' HRQoL. PROs provide useful information to complement routine clinical findings in psoriasis and may contribute to improving disease management

Patient-reported outcomes assessment tools for use in psoriasis in Spain: A systematic review. / Instrumentos para la valoración de los resultados percibidos por el paciente con psoriasis en España: revisión sistemática de la literatura.

OBJECTIVES: To review the literature on validated tools for measuring patient-reported outcomes (PROs) in psoriasis in Spain. To evaluate the psychometric properties of the tools and describe the results of their practical application. MATERIAL AND METHODS: Systematic review of studies validating or using instruments for assessing PROs in Spanish patients with psoriasis. Literature searches were performed in international (PubMed/Medline) and Spanish (Medes, Ibecs) databases. We also searched databases of instruments for measuring PROs (BiblioPRO, PROQOLID). The review included studies published in English or Spanish up to January 9, 2017. We also checked the reference lists of the key publications identified. The quality of the questionnaires was evaluated based on their psychometric properties (construct, transcultural adaptation, reliability, validity, feasibility, and sensitivity to change). RESULTS: Eighteen publications were included. Six articles described the validation of Spanish versions of 5 PROs tools: 4 health-related quality of life (HRQoL) questionnaires specific to psoriasis and dermatologic diseases and 1 questionnaire specific to satisfaction with treatment. Our assessment of the HRQoL tools' psychometric properties showed that the PSO-LIFE questionnaire received the highest scores, although specific properties varied from instrument to instrument. The 12 remaining articles were observational studies that used the validated instruments. In use, these tools detected the high impact of psoriasis on HRQoL, especially in young female patients with severe disease. CONCLUSIONS: We identified 5 specific instruments validated in Spain for scoring PROs in patients with psoriasis. The tools' psychometric properties vary, and it is essential to understand their strengths and weaknesses when selecting the right one for each situation. In use, these questionnaires are able to detect the high impact of psoriasis on patients' HRQoL. PROs provide useful information to complement routine clinical findings in psoriasis and may contribute to improving disease management.

A Cost-per-Number Needed to Treat Analysis Assessing the Efficiency of Biologic Drugs in Moderate to Severe Plaque Psoriasis. / Evaluación de la eficiencia de los tratamientos biológicos en la psoriasis moderada a grave en España: análisis de coste por número necesario a tratar (NNT).

BACKGROUND AND OBJECTIVES: Psoriasis is a chronic inflammatory skin disease with an estimated prevalence in Spain of 2.3% of the population. Approximately 30% of patients have moderate-to-severe forms. Treatment with biologic agents is proving to be a step forward in the management of the disease, although these treatments are very expensive. The objective of this study was to determine the efficiency, in terms of cost per number needed to treat (NNT), of the biologic drugs available in Spain for the treatment of moderate to severe plaque psoriasis. METHODS: NNT data were obtained from a network meta-analysis that included all randomized clinical trials of biologic drugs sold in Spain. The cost of each treatment was calculated based on the approved dosage for the first year of treatment, as indicated in the Summary of Product Characteristics. These data were used to calculate the cost per NNT of the drugs for various PASI scores (75, 90, and 100). A sensitivity analysis was performed taking into consideration only the PASI-response measurement time (after 10, 12, or 16 weeks, depending on the drug). RESULTS: The order of efficiency, from most to least efficient, in the case of a PASI 75 response was ixekizumab > ustekinumab 45mg > ustekinumab 90mg > secukinumab > infliximab > etanercept > adalimumab. The order for PASI 90 was ixekizumab >secukinumab >ustekinumab 45mg > ustekinumab 90mg > infliximab > adalimumab > etanercept. The order for PASI 100 was ixekizumab > secukinumab > infliximab > ustekinumab 90mg > ustekinumab 45mg > adalimumab > etanercept. The sensitivity analysis showed some changes in the order, depending on the response-assessment period. CONCLUSIONS: The findings show a link between the efficacy of the biologic therapies available in Spain for the treatment of moderate-to-severe plaque psoriasis and their efficiency. Ixekizumab had the lowest cost per NNT for all PASI-response scores (75, 90, and 100) during the first year of treatment.

Prasugrel compared to clopidogrel in patients with acute coronary syndrome undergoing percutenaous coronary intervention: a Spanish model-based cost effectiveness analysis.

OBJECTIVE: To assess the long-term cost-effectiveness of 12 months treatment of prasugrel compared to clopidogrel in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) in the Spanish health care system. METHODS: A Markov state transition model was developed to estimate health outcomes, quality adjusted life years (QALYs), life years (LY), and costs over patients' lifetimes. Clinical inputs were based on an analysis of the TRITON-TIMI 38 clinical trial. Hospital readmissions captured during the trial in a sub-study of patients from eight countries (and subsequent re-hospitalisations modelled to accrue beyond the time horizon of the trial), were assigned to Spanish diagnosis-related group payment schedules to estimate hospitalisation costs. RESULTS: Mean total treatment costs were ?11,427 and ?10,910 for prasugrel and clopidogrel respectively. The mean cost of the study drug was ?538 higher for prasugrel vs. clopidogrel, but rehospitalisation costs at 12 months were ?79 lower for prasugrel due to reduced rates of revascularisation. Hospitalisation costs beyond 12 months were higher with prasugrel by ?55, due to longer life expectancy (+0.071 LY and +0.054 QALYs) associated with the decreased nonfatal myocardial infarction rate in the prasugrel group. The incremental cost per life year and QALY gained with prasugrel was ?7,198, and ?9,489, respectively. CONCLUSION: Considering a willingness-to-pay threshold of ?30,000/QALY gained in the Spanish setting, prasugrel represents a cost-effective option in comparison with clopidogrel among patients with ACS undergoing PCI.

Objetivo: Evaluar a largo plazo el coste-efectividad de 12 meses de tratamiento con prasugrel frente a clopidogrel en pacientes con síndrome coronario agudo (SCA) sometidos a intervención coronaria percutánea (ICP) desde la perspectiva del sistema nacional de salud español. Métodos: Se desarrolló un modelo de Markov de transición entre estados para estimar los resultados en salud, los años de vida ajustados por calidad (AVACs), los años de vida (AV) y los costes a lo largo de la vida de los pacientes. Los datos clínicos fueron obtenidos de un análisis del ensayo clínico TRITON-TIMI 38. Los reingresos hospitalarios registrados durante el ensayo en un subestudio de pacientes provenientes de ocho países, (y las subsiguientes rehospitalizaciones fueron modeladas para acumularse más alla del horizonte temporal del ensayo) fueron asignados a grupos relacionados con el diagnóstico españoles para estimar los costes de hospitalización. Resultados: Los costes medios totales del tratamiento con prasugrel y clopidogrel fueron 11.427 ??y 10.910 ?, respectivamente. El coste medio del fármaco fue 538 ??superior para prasugrel frente a clopidogrel, pero los costes de rehospitalización a los 12 meses fueron 79 ??menores para prasugrel debido a la reducción en las tasas de revascularización. Los costes de hospitalización más allá de los 12 meses fueron 55 ??superiores con prasugrel, debido a la mayor esperanza de vida (+0,071 AV y +0,054 AVACs) asociada a la reducción de la tasa de infartos de miocardio no mortales en el grupo de prasugrel. El coste-efectividad incremental por año de vida y AVAC ganado con prasugrel fue 7.198 ??y 9.489 ?, respectivamente. Conclusión: Considerando el umbral de disponibilidad a pagar de 30.000 ?/ AVAC para España, prasugrel representa una opción coste-efectiva en comparación con clopidogrel en pacientes con SCA sometidos a ICP.

Prasugrel compared to clopidogrel in patients with acute coronary syndrome undergoing percutenous coronary intervention: a Spanish model-based cost-effectiveness analysis

OBJECTIVE: To assess the long-term cost-effectiveness of 12 months treatment of prasugrel compared to clopidogrel in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) in the Spanish health care system. METHODS: A Markov state transition model was developed to estimate health outcomes, quality adjusted life years (QALYs), life years (LY), and costs over patients' lifetimes. Clinical inputs were based on an analysis of the TRITON-TIMI 38 clinical trial. Hospital readmissions captured during the trial in a sub-study of patients from eight countries (and subsequent re-hospitalisations modelled to accrue beyond the time horizon of the trial), were assigned to Spanish diagnosis-related group payment schedules to estimate hospitalisation costs. RESULTS: Mean total treatment costs were €11,427 and €10,910 for prasugrel and clopidogrel respectively. The mean cost of the study drug was €538 higher for prasugrel vs. clopidogrel, but rehospitalisation costs at 12 months were €79 lower for prasugrel due to reduced rates of revascularisation. Hospitalisation costs beyond 12 months were higher with prasugrel by €55, due to longer life expectancy (+0.071 LY and +0.054 QALYs) associated with the decreased nonfatal myocardial infarction rate in the prasugrel group. The incremental cost per life year and QALY gained with prasugrel was €7,198, and €9,489, respectively. CONCLUSION: Considering a willingness-to-pay threshold of €30,000/QALY gained in the Spanish setting, prasugrel represents a cost-effective option in comparison with clopidogrel among patients with ACS undergoing PCI

OBJETIVO: Evaluar a largo plazo el coste-efectividad de 12 meses de tratamiento con prasugrel frente a clopidogrel en pacientes con síndrome coronario agudo (SCA) sometidos a intervención coronaria percutánea (ICP) desde la perspectiva del sistema nacional de salud español. MÉTODOS: Se desarrolló un modelo de Markov de transición entre estados para estimar los resultados en salud, los años de vida ajustados por calidad (AVACs), los años de vida (AV) y los costes a lo largo de la vida de los pacientes. Los datos clínicos fueron obtenidos de un análisis del ensayo clínico TRITON-TIMI 38. Los reingresos hospitalarios registrados durante el ensayo en un subestudio de pacientes provenientes de ocho países, (y las subsiguientes rehospitalizaciones fueron modeladas para acumularse más alla del horizonte temporal del ensayo) fueron asignados a grupos relacionados con el diagnóstico españoles para estimar los costes de hospitalización. RESULTADOS: Los costes medios totales del tratamiento con prasugrel y clopidogrel fueron 11.427 € y 10.910 €, respectivamente. El coste medio del fármaco fue 538 € superior para prasugrel frente a clopidogrel, pero los costes de rehospitalización a los 12 meses fueron 79 € menores para prasugrel debido a la reducción en las tasas de revascularización. Los costes de hospitalización más allá de los 12 meses fueron 55 € superiores con prasugrel, debido a la mayor esperanza de vida (+0,071 AV y +0,054 AVACs) asociada a la reducción de la tasa de infartos de miocardio no mortales en el grupo de prasugrel. El coste-efectividad incremental por año de vida y AVAC ganado con prasugrel fue 7.198 € y 9.489 €, respectivamente. CONCLUSIÓN: Considerando el umbral de disponibilidad a pagar de 30.000 €/ AVAC para España, prasugrel representa una opción coste-efectiva en comparación con clopidogrel en pacientes con SCA sometidos a ICP