Efficacy and Safety of Dupilumab for the Treatment of Severe Atopic Dermatitis in Clinical Practice: A Single Center Experience / Eficacia y seguridad de dupilumab para el tratamiento de la dermatitis atópica grave en la práctica clínica: experiencia en un centro terciario

Background Dupilumab is a new targeted therapy for severe atopic dermatitis (AD) with limited real-world evidence. Objective Explore our experience with dupilumab for AD in clinical practice at a tertiary care center. Material and method Unicentric observational retrospective study including adult and pediatric patients with severe AD receiving dupilumab between December 2017 and December 2021. The Eczema Area and Severity Index (EASI) score, Pruritus Numerical Rating Scale (P-NRS) and Sleep disturbance Numerical Rating Scale (S-NRS) were recovered to assess severity and response. Results Fifty-nine patients received dupilumab: 52, 48, 26 and 13 patients reached 6, 12, 24 and 36 months of treatment, respectively. The EASI-75 response rates were 94.2%, 95.8%, 92.3% and 100% at months 6, 12, 24 and 36. The EASI-90 response rates were 63.5%, 72.9%, 84.6% and 92.3% at months 6, 12, 24 and 36. The EASI <7 response rates were 92.3%, 91.7%, 88.5% and 100% at months 6, 12, 24 and 36. The P-NRS ≥4 reduction rates were 86%, 87.5%, 92.3% and 100% at months 6, 12, 24 and 36. The S-NRS ≥4 reduction rates were 82.7%, 85.4%, 100% and 100% at months 6, 12, 24 and 36. Adverse events were mild and occurred in 20.3% of patients, all of them adults. Conclusion Our findings support dupilumab's favorable efficacy and tolerability profile in clinical practice. Dupilumab offers a rapid and sustained response, regardless of combined therapy. Longer follow-ups are still required to adequately assess its performance (AU)

Antecedentes Dupilumab es una nueva terapia dirigida para la dermatitis atópica (DA) grave con una evidencia en la vida real aún limitada. Objetivo Explorar nuestra experiencia con dupilumab para la DA en práctica clínica en un centro terciario. Material y método Estudio observacional retrospectivo y unicéntrico que incluye pacientes adultos y pediátricos con DA grave en tratamiento con dupilumab entre diciembre de 2017 y diciembre de 2021. La gravedad y la respuesta se evaluaron con las escalas Eczema Area and Severity Index (EASI), Pruritus Numerical Rating Scale y Sleep Disturbance Numerical Rating Scale. Resultado Cincuenta y nueve pacientes recibieron dupilumab: 52, 48, 26 y 13 pacientes alcanzaron los 6, 12, 24 y 36 meses de tratamiento, respectivamente. La tasa de EASI-75 fue del 94,2; 95,8; 92,3 y 100% a los 6, 12, 24 y 36 meses, respectivamente. La tasa de EASI-90 fue del 63,5; 72,9; 84,6 y 92,3% a los 6, 12, 24 y 36 meses, respectivamente. La tasa de EASI <7 fue del 92,3; 91,7; 88,5 y 100% a los 6, 12, 24 y 36 meses, respectivamente. La Pruritus Numerical Rating Scale ≥4 fue del 86; 87,5; 92,3 y 100% a los 6, 12, 24 y 36 meses, respectivamente. La tasa de reducción Sleep Disturbance Numerical Rating Scale ≥4 fue del 82,7; 85,4; 100 y 100% a los 6, 12, 24 y 36 meses, respectivamente. Los eventos adversos fueron leves y ocurrieron en el 20,3% de los pacientes, todos adultos. Conclusión Nuestros hallazgos apoyan el perfil favorable de eficacia y tolerabilidad de dupilumab en práctica clínica real. Dupilumab ofrece una respuesta rápida y mantenida, independientemente del uso de terapia combinada. Se requieren seguimientos más prolongados para evaluar su funcionamiento a largo plazo (AU)

[Artículo traducido]Eficacia y seguridad de dupilumab para el tratamiento de la dermatitis atópica grave en la práctica clínica: experiencia en un centro terciario / Efficacy and Safety of Dupilumab for the Treatment of Severe Atopic Dermatitis in Clinical Practice: A Single Center Experience

Antecedentes Dupilumab es una nueva terapia dirigida para la dermatitis atópica (DA) grave con una evidencia en la vida real aún limitada. Objetivo Explorar nuestra experiencia con dupilumab para la DA en práctica clínica en un centro terciario. Material y método Estudio observacional retrospectivo y unicéntrico que incluye pacientes adultos y pediátricos con DA grave en tratamiento con dupilumab entre diciembre de 2017 y diciembre de 2021. La gravedad y la respuesta se evaluaron con las escalas Eczema Area and Severity Index (EASI), Pruritus Numerical Rating Scale y Sleep Disturbance Numerical Rating Scale. Resultados Cincuenta y nueve pacientes recibieron dupilumab: 52, 48, 26 y 13 pacientes alcanzaron los 6, 12, 24 y 36 meses de tratamiento, respectivamente. La tasa de EASI-75 fue del 94,2; 95,8; 92,3 y 100% a los 6, 12, 24 y 36 meses, respectivamente. La tasa de EASI-90 fue del 63,5; 72,9; 84,6 y 92,3% a los 6, 12, 24 y 36 meses, respectivamente. La tasa de EASI <7 fue del 92,3; 91,7; 88,5 y 100% a los 6, 12, 24 y 36 meses, respectivamente. La Pruritus Numerical Rating Scale ≥4 fue del 86; 87,5; 92,3 y 100% a los 6, 12, 24 y 36 meses, respectivamente. La tasa de reducción Sleep Disturbance Numerical Rating Scale ≥4 fue del 82,7; 85,4; 100 y 100% a los 6, 12, 24 y 36 meses, respectivamente. Los eventos adversos fueron leves y ocurrieron en el 20,3% de los pacientes, todos adultos. Conclusión Nuestros hallazgos apoyan el perfil favorable de eficacia y tolerabilidad de dupilumab en práctica clínica real. Dupilumab ofrece una respuesta rápida y mantenida, independientemente del uso de terapia combinada. Se requieren seguimientos más prolongados para evaluar su funcionamiento a largo plazo (AU)

Background Dupilumab is a new targeted therapy for severe atopic dermatitis (AD) with limited real-world evidence. Objective Explore our experience with dupilumab for AD in clinical practice at a tertiary care center. Material and method Unicentric observational retrospective study including adult and pediatric patients with severe AD receiving dupilumab between December 2017 and December 2021. The Eczema Area and Severity Index (EASI) score, Pruritus Numerical Rating Scale (P-NRS) and Sleep disturbance Numerical Rating Scale (S-NRS) were recovered to assess severity and response. Results Fifty-nine patients received dupilumab: 52, 48, 26 and 13 patients reached 6, 12, 24 and 36 months of treatment, respectively. The EASI-75 response rates were 94.2%, 95.8%, 92.3% and 100% at months 6, 12, 24 and 36. The EASI-90 response rates were 63.5%, 72.9%, 84.6% and 92.3% at months 6, 12, 24 and 36. The EASI <7 response rates were 92.3%, 91.7%, 88.5% and 100% at months 6, 12, 24 and 36. The P-NRS ≥4 reduction rates were 86%, 87.5%, 92.3% and 100% at months 6, 12, 24 and 36. The S-NRS ≥4 reduction rates were 82.7%, 85.4%, 100% and 100% at months 6, 12, 24 and 36. Adverse events were mild and occurred in 20.3% of patients, all of them adults. Conclusion Our findings support dupilumab's favorable efficacy and tolerability profile in clinical practice. Dupilumab offers a rapid and sustained response, regardless of combined therapy. Longer follow-ups are still required to adequately assess its performance (AU)

Efficacy and Safety of Dupilumab for the Treatment of Severe Atopic Dermatitis in Clinical Practice: A Single Center Experience.

BACKGROUND: Dupilumab is a new targeted therapy for severe atopic dermatitis (AD) with limited real-world evidence. OBJECTIVE: Explore our experience with dupilumab for AD in clinical practice at a tertiary care center. MATERIAL AND METHOD: Unicentric observational retrospective study including adult and pediatric patients with severe AD receiving dupilumab between December 2017 and December 2021. The Eczema Area and Severity Index (EASI) score, Pruritus Numerical Rating Scale (P-NRS) and Sleep disturbance Numerical Rating Scale (S-NRS) were recovered to assess severity and response. RESULTS: Fifty-nine patients received dupilumab: 52, 48, 26 and 13 patients reached 6, 12, 24 and 36 months of treatment, respectively. The EASI-75 response rates were 94.2%, 95.8%, 92.3% and 100% at months 6, 12, 24 and 36. The EASI-90 response rates were 63.5%, 72.9%, 84.6% and 92.3% at months 6, 12, 24 and 36. The EASI <7 response rates were 92.3%, 91.7%, 88.5% and 100% at months 6, 12, 24 and 36. The P-NRS ≥4 reduction rates were 86%, 87.5%, 92.3% and 100% at months 6, 12, 24 and 36. The S-NRS ≥4 reduction rates were 82.7%, 85.4%, 100% and 100% at months 6, 12, 24 and 36. Adverse events were mild and occurred in 20.3% of patients, all of them adults. CONCLUSION: Our findings support dupilumab's favorable efficacy and tolerability profile in clinical practice. Dupilumab offers a rapid and sustained response, regardless of combined therapy. Longer follow-ups are still required to adequately assess its performance.

Efficacy and Safety of Dupilumab for the Treatment of Severe Atopic Dermatitis in Clinical Practice: A Single Center Experience. / [Artículo traducido]Eficacia y seguridad de dupilumab para el tratamiento de la dermatitis atópica grave en la práctica clínica: experiencia en un centro terciario.

BACKGROUND: Dupilumab is a new targeted therapy for severe atopic dermatitis (AD) with limited real-world evidence. OBJECTIVE: Explore our experience with dupilumab for AD in clinical practice at a tertiary care center. MATERIAL AND METHOD: Unicentric observational retrospective study including adult and pediatric patients with severe AD receiving dupilumab between December 2017 and December 2021. The Eczema Area and Severity Index (EASI) score, Pruritus Numerical Rating Scale (P-NRS) and Sleep disturbance Numerical Rating Scale (S-NRS) were recovered to assess severity and response. RESULTS: Fifty-nine patients received dupilumab: 52, 48, 26 and 13 patients reached 6, 12, 24 and 36 months of treatment, respectively. The EASI-75 response rates were 94.2%, 95.8%, 92.3% and 100% at months 6, 12, 24 and 36. The EASI-90 response rates were 63.5%, 72.9%, 84.6% and 92.3% at months 6, 12, 24 and 36. The EASI <7 response rates were 92.3%, 91.7%, 88.5% and 100% at months 6, 12, 24 and 36. The P-NRS ≥4 reduction rates were 86%, 87.5%, 92.3% and 100% at months 6, 12, 24 and 36. The S-NRS ≥4 reduction rates were 82.7%, 85.4%, 100% and 100% at months 6, 12, 24 and 36. Adverse events were mild and occurred in 20.3% of patients, all of them adults. CONCLUSION: Our findings support dupilumab's favorable efficacy and tolerability profile in clinical practice. Dupilumab offers a rapid and sustained response, regardless of combined therapy. Longer follow-ups are still required to adequately assess its performance.

Pharmacogenetic biomarkers for secukinumab response in psoriasis patients in real-life clinical practice.

BACKGROUND: Prediction of the response to a biological treatment in psoriasis patients would allow efficient treatment allocation. OBJECTIVE: To identify polymorphisms associated with secukinumab response in psoriasis patients in a daily practice setting. METHODS: We studied 180 SNPs in patients with moderate-to-severe plaque psoriasis recruited from 15 Spanish hospitals. Treatment effectiveness was evaluated by absolute PASI ≤3 and ≤1 at 6 and 12 months. Individuals were genotyped using a custom Taqman array. Multiple logistic regression models were generated. Sensitivity, specificity and area under the curve (AUC) were analysed. RESULTS: A total of 173 patients were studied at 6 months, (67% achieved absolute PASI ≤ 3 and 65% PASI ≤ 1) and 162 at 12 months (75% achieved absolute PASI ≤ 3 and 64% PASI ≤ 1). Multivariable analysis showed the association of different sets of SNPs with the response to secukinumab. The model of absolute PASI≤3 at 6 months showed best values of sensitivity and specificity. Four SNPs were associated with the capability of achieving absolute PASI ≤ 3 at 6 months. rs1801274 (FCGR2A), rs2431697 (miR-146a) and rs10484554 (HLCw6) were identified as risk factors for failure to achieve absolute PASI≤3, while rs1051738 (PDE4A) was protective. AUC including these genotypes, weight of patients and history of biological therapy was 0.88 (95% CI 0.83-0.94), with a sensitivity of 48.6% and specificity of 95.7% to discriminate between both phenotypes. CONCLUSION: We have identified a series of polymorphisms associated with the response to secukinumab capable of predicting the potential response/non-response to this drug in patients with plaque psoriasis.

Modificación de la prevalencia de genotipos del virus del papiloma humano en los condilomas acuminados tras la instauración de la vacuna profiláctica / Changes in the Prevalence of Human Papillomavirus Genotypes in Genital Warts Since the Introduction of Prophylactic Vaccines

Introducción El condiloma acuminado está causado por el virus del papiloma humano (VPH), cuyos genotipos se han descrito tradicionalmente como de bajo y alto riesgo (AR) oncogénico. Clásicamente, los genotipos más frecuentes son el 6, el 11, el 16 y el 18, incluidos en las dos primeras vacunas desarrolladas. Nuestro objetivo es valorar cambios en la prevalencia de estos genotipos tras 10 años desde la instauración de la vacuna profiláctica en nuestro medio. Material y métodos Se trata de un estudio observacional descriptivo retrospectivo realizado en la UITS de un Servicio de Dermatología entre enero de 2016 y junio de 2019, seleccionando posteriormente a los pacientes diagnosticados de condilomas acuminados. Resultados Se han diagnosticado 362 pacientes con condilomas acuminados, realizándose genotipado en 212 pacientes (58,6%). Se han detectado 32 genotipos distintos, siendo los más frecuentes el 6, el 11, el 16 y el 42. En el 93,9% la detección de VPH fue positiva, detectándose hasta 299 genotipos, lo que corresponde a 1,5 por paciente. En el 26,6% de pacientes se detectaron más de un genotipo distinto de VPH. En el 24,1% se detectó al menos un genotipo de AR. No se observó asociación estadísticamente significativa entre la presencia de un genotipo de AR y las variables estudiadas. En el 91,4% de las lesiones se aisló al menos uno de los cuatro genotipos cubiertos por las dos primeras vacunas desarrolladas. Conclusiones La prevalencia de los genotipos de VPH incluidos en las dos primeras vacunas profilácticas desarrolladas ha disminuido. La implicación de al menos uno de los cuatro genotipos más frecuentes se ha mantenido estable con respecto a hace 10 años. Las infecciones por múltiples genotipos y la presencia de al menos un genotipo de AR oncogénico ha aumentado ligeramente (AU)

Background and objective Genital warts are caused by the human papillomavirus (HPV), whose genotypes have traditionally been classified as low risk or high risk (oncogenic). The first 2 prophylactic vaccines included the most common genotypes at the time: HPV-6, HPV-11, HPV-16, and HPV-18. The aim of this study was to evaluate the prevalence of HPV types in our setting 10 years after the introduction of HPV vaccines. Material and methods Descriptive, observational, retrospective study of patients diagnosed with genital warts at the sexually transmitted infection unit of a dermatology department between January 2016 and June 2019. Results In total, 362 patients were diagnosed with genital warts during the study period, and 212 (58.6%) underwent genotyping. Thirty-two distinct HPV types were observed, the most common being HPV-6, HPV-11, HPV-16, and HPV-42. HPV DNA was detected in 93.9% of the samples analyzed, and there were 299 genotypes (mean, 1.5 per patient). Overall, 26.6% of patients had more than a single HPV genotype, while 24.1% had at least 1 high-risk type. No significant associations were found between the presence of high-risk HPV types and any of the study variables. At least 2 of the 4 HPV types targeted in the original vaccines were detected in 94.1% of lesions. Conclusions Compared to 10 years ago, the prevalences of HPV types included in the first 2 prophylactic vaccines have decreased, while the proportion of patients with at least 1 of the 4 most common types has remained unchanged. We also observed a slight increase in infections with multiple HPV types or at least 1 high-risk type (AU)

[Translated article] Changes in the Prevalence of Human Papillomavirus Genotypes in Genital Warts Since the Introduction of Prophylactic Vaccines / Modificación de la prevalencia de genotipos del virus del papiloma humano en los condilomas acuminados tras la instauración de la vacuna profiláctica

Background and objective Genital warts are caused by the human papillomavirus (HPV), whose genotypes have traditionally been classified as low risk or high risk (oncogenic). The first 2 prophylactic vaccines included the most common genotypes at the time: HPV-6, HPV-11, HPV-16, and HPV-18. The aim of this study was to evaluate the prevalence of HPV types in our setting 10 years after the introduction of HPV vaccines. Material and methods Descriptive, observational, retrospective study of patients diagnosed with genital warts at the sexually transmitted infection unit of a dermatology department between January 2016 and June 2019. Results In total, 362 patients were diagnosed with genital warts during the study period, and 212 (58.6%) underwent genotyping. Thirty-two distinct HPV types were observed, the most common being HPV-6, HPV-11, HPV-16, and HPV-42. HPV DNA was detected in 93.9% of the samples analyzed, and there were 299 genotypes (mean, 1.5 per patient). Overall, 26.6% of patients had more than a single HPV genotype, while 24.1% had at least 1 high-risk type. No significant associations were found between the presence of high-risk HPV types and any of the study variables. At least 2 of the 4 HPV types targeted in the original vaccines were detected in 94.1% of lesions. Conclusions Compared to 10 years ago, the prevalences of HPV types included in the first 2 prophylactic vaccines have decreased, while the proportion of patients with at least 1 of the 4 most common types has remained unchanged. We also observed a slight increase in infections with multiple HPV types or at least 1 high-risk type (AU)

Introducción El condiloma acuminado está causado por el virus del papiloma humano (VPH), cuyos genotipos se han descrito tradicionalmente como de bajo y alto riesgo (AR) oncogénico. Clásicamente, los genotipos más frecuentes son el 6, el 11, el 16 y el 18, incluidos en las dos primeras vacunas desarrolladas. Nuestro objetivo es valorar cambios en la prevalencia de estos genotipos tras 10 años desde la instauración de la vacuna profiláctica en nuestro medio. Material y métodos Se trata de un estudio observacional descriptivo retrospectivo realizado en la UITS de un Servicio de Dermatología entre enero de 2016 y junio de 2019, seleccionando posteriormente a los pacientes diagnosticados de condilomas acuminados. Resultados Se han diagnosticado 362 pacientes con condilomas acuminados, realizándose genotipado en 212 pacientes (58,6%). Se han detectado 32 genotipos distintos, siendo los más frecuentes el 6, el 11, el 16 y el 42. En el 93,9% la detección de VPH fue positiva, detectándose hasta 299 genotipos, lo que corresponde a 1,5 por paciente. En el 26,6% de pacientes se detectaron más de un genotipo distinto de VPH. En el 24,1% se detectó al menos un genotipo de AR. No se observó asociación estadísticamente significativa entre la presencia de un genotipo de AR y las variables estudiadas. En el 91,4% de las lesiones se aisló al menos uno de los cuatro genotipos cubiertos por las dos primeras vacunas desarrolladas. Conclusiones La prevalencia de los genotipos de VPH incluidos en las dos primeras vacunas profilácticas desarrolladas ha disminuido. La implicación de al menos uno de los cuatro genotipos más frecuentes se ha mantenido estable con respecto a hace 10 años. Las infecciones por múltiples genotipos y la presencia de al menos un genotipo de AR oncogénico ha aumentado ligeramente (AU)

Performance of Coronary Artery Calcium Testing in Patients With Severe Psoriasis: Risk Assessment and Reclassification Potential in a Low Cardiovascular Risk Population / Realización del examen de calcio en los pacientes con psoriasis severa: evaluación del riesgo y potencial de reclasificación en una población de riesgo cardiovascular bajo

Background Patients with severe psoriasis have an increased cardiovascular (CV) risk and prevalence of subclinical coronary artery disease (CAD). Coronary artery calcium (CAC) testing can detect subclinical CAD and improve cardiovascular risk assessment beyond clinical scores. Objectives Evaluate the presence and magnitude of subclinical CAD determined by CAC score among the different ESC/EAS CV risk categories, as well as the potential for risk reclassification, in patients with severe psoriasis from a low CV risk population. Methods Unicentric cross-sectional study in 111 patients with severe chronic plaque psoriasis from a low CV risk population in the Mediterranean region. Patients were classified into four CV risk categories according to the ESC/EAS guideline recommendations and HeartScore/SCORE calibrated charts. Patients underwent coronary computed tomography to determine their CAC scores. Patients in the moderate-risk category with a CAC score of ≥100 were considered to be reclassified as recommended by the 2019 ESC/EAS guidelines. Reclassification was also considered for patients in the low-risk category with a CAC score>0. Results Presence of subclinical CAD was detected in 46 (41.4%) patients. These accounted for 86.2% of patients in high/very-high-risk categories and 25.6% of patients in non-high-risk categories. Fourteen (17.1%) of the patients in non-high-risk categories were reclassifiable due to their CAC score. This percentage was higher (25%) when considering the moderate-risk category alone and lower (13.8%) in the low-risk category. Age was the only variable associated with presence of subclinical CAD and reclassification. Conclusions Over 40% of patients with severe psoriasis from a low-risk region and up to 25% of those in non-high-risk categories have subclinical CAD (AU)

Antecedentes Los pacientes con psoriasis severa tienen riesgo cardiovascular (CV) incrementado, así como prevalencia de la enfermedad de las arterias coronarias (EAC) subclínica. El examen de calcio en las arterias coronarias (CAC) puede detectar la EAC subclínica y mejorar la evaluación del riesgo CV más allá de las puntuaciones clínicas. Objetivos Evaluar la presencia y magnitud de la EAC subclínica determinadas mediante la puntuación CAC entre las diferentes categorías de riesgo CV de ESC/EAS, así como el potencial de reclasificación del riesgo, en pacientes con psoriasis severa, procedentes de una población de riesgo CV bajo. Métodos Estudio transversal unicéntrico de 111 pacientes con psoriasis crónica en placa procedentes de una población de bajo riesgo CV de la región mediterránea. Los pacientes fueron clasificados en cuatro categorías de riesgo CV conforme a las recomendaciones de la guía ESC/EAS y la tabla de calibración HeartScore/SCORE. Se realizó a los pacientes una tomografía computarizada para determinar sus puntuaciones CAC. Se consideró que los pacientes de la categoría de riesgo moderado con una puntuación CAC≥100 debían ser reclasificados, conforme a las guías ESC/EAS de 2019. También se reconsideró la reclasificación para aquellos pacientes de la categoría de riesgo bajo con una puntuación CAC>0. Resultados La presencia de EAC subclínica fue detectada en 46 pacientes (41,4%), que representaron el 86,2% de los pacientes incluidos en las categorías de riesgo alto/muy alto, y el 25,6% de los pacientes de las categorías de riesgo no alto. Catorce pacientes (17,1%) de las categorías de riesgo no alto no fueron reclasificables debido a su puntuación CAC. Este porcentaje fue más alto (25%) al considerar la categoría de riesgo moderado en solitario, y más bajo (13,8%) en la categoría de riesgo bajo. La edad fue la única variable asociada a la presencia de EAC subclínica y reclasificación (AU)

[Artículo traducido] Realización del examen de calcio en los pacientes con psoriasis severa: evaluación del riesgo y potencial de reclasificación en una población de riesgo cardiovascular bajo / Performance of Coronary Artery Calcium Testing in Patients With Severe Psoriasis: Risk Assessment and Reclassification Potential in a Low Cardiovascular Risk Population

Antecedentes Los pacientes con psoriasis severa tienen riesgo cardiovascular (CV) incrementado, así como prevalencia de la enfermedad de las arterias coronarias (EAC) subclínica. El examen de calcio en las arterias coronarias (CAC) puede detectar la EAC subclínica y mejorar la evaluación del riesgo CV más allá de las puntuaciones clínicas. Objetivos Evaluar la presencia y magnitud de la EAC subclínica determinadas mediante la puntuación CAC entre las diferentes categorías de riesgo CV de ESC/EAS, así como el potencial de reclasificación del riesgo, en pacientes con psoriasis severa, procedentes de una población de riesgo CV bajo. Métodos Estudio transversal unicéntrico de 111 pacientes con psoriasis crónica en placa procedentes de una población de bajo riesgo CV de la región mediterránea. Los pacientes fueron clasificados en cuatro categorías de riesgo CV conforme a las recomendaciones de la guía ESC/EAS y la tabla de calibración HeartScore/SCORE. Se realizó a los pacientes una tomografía computarizada para determinar sus puntuaciones CAC. Se consideró que los pacientes de la categoría de riesgo moderado con una puntuación CAC≥100 debían ser reclasificados, conforme a las guías ESC/EAS de 2019. También se reconsideró la reclasificación para aquellos pacientes de la categoría de riesgo bajo con una puntuación CAC>0. Resultados La presencia de EAC subclínica fue detectada en 46 pacientes (41,4%), que representaron el 86,2% de los pacientes incluidos en las categorías de riesgo alto/muy alto, y el 25,6% de los pacientes de las categorías de riesgo no alto. Catorce pacientes (17,1%) de las categorías de riesgo no alto no fueron reclasificables debido a su puntuación CAC. Este porcentaje fue más alto (25%) al considerar la categoría de riesgo moderado en solitario, y más bajo (13,8%) en la categoría de riesgo bajo. La edad fue la única variable asociada a la presencia de EAC subclínica y reclasificación (AU)

Background Patients with severe psoriasis have an increased cardiovascular (CV) risk and prevalence of subclinical coronary artery disease (CAD). Coronary artery calcium (CAC) testing can detect subclinical CAD and improve cardiovascular risk assessment beyond clinical scores. Objectives Evaluate the presence and magnitude of subclinical CAD determined by CAC score among the different ESC/EAS CV risk categories, as well as the potential for risk reclassification, in patients with severe psoriasis from a low CV risk population. Methods Unicentric cross-sectional study in 111 patients with severe chronic plaque psoriasis from a low CV risk population in the Mediterranean region. Patients were classified into four CV risk categories according to the ESC/EAS guideline recommendations and HeartScore/SCORE calibrated charts. Patients underwent coronary computed tomography to determine their CAC scores. Patients in the moderate-risk category with a CAC score of ≥100 were considered to be reclassified as recommended by the 2019 ESC/EAS guidelines. Reclassification was also considered for patients in the low-risk category with a CAC score>0. Results Presence of subclinical CAD was detected in 46 (41.4%) patients. These accounted for 86.2% of patients in high/very-high-risk categories and 25.6% of patients in non-high-risk categories. Fourteen (17.1%) of the patients in non-high-risk categories were reclassifiable due to their CAC score. This percentage was higher (25%) when considering the moderate-risk category alone and lower (13.8%) in the low-risk category. Age was the only variable associated with presence of subclinical CAD and reclassification. Conclusions Over 40% of patients with severe psoriasis from a low-risk region and up to 25% of those in non-high-risk categories have subclinical CAD (AU)

Changes in the Prevalence of Human Papillomavirus Genotypes in Genital Warts Since the Introduction of Prophylactic Vaccines. / Modificación de la prevalencia de genotipos del virus del papiloma humano en los condilomas acuminados tras la instauración de la vacuna profiláctica.

BACKGROUND AND OBJECTIVE: Genital warts are caused by the human papillomavirus (HPV), whose genotypes have traditionally been classified as low risk or high risk (oncogenic). The first 2 prophylactic vaccines included the most common genotypes at the time: HPV-6, HPV-11, HPV-16, and HPV-18. The aim of this study was to evaluate the prevalence of HPV types in our setting 10 years after the introduction of HPV vaccines. MATERIAL AND METHODS: Descriptive, observational, retrospective study of patients diagnosed with genital warts at the sexually transmitted infection unit of a dermatology department between January 2016 and June 2019. RESULTS: In total, 362 patients were diagnosed with genital warts during the study period, and 212 (58.6%) underwent genotyping. Thirty-two distinct HPV types were observed, the most common being HPV-6, HPV-11, HPV-16, and HPV-42. HPV DNA was detected in 93.9% of the samples analyzed, and there were 299 genotypes (mean, 1.5 per patient). Overall, 26.6% of patients had more than a single HPV genotype, while 24.1% had at least 1 high-risk type. No significant associations were found between the presence of high-risk HPV types and any of the study variables. At least 2 of the 4 HPV types targeted in the original vaccines were detected in 94.1% of lesions. CONCLUSIONS: Compared to 10 years ago, the prevalences of HPV types included in the first 2 prophylactic vaccines have decreased, while the proportion of patients with at least 1 of the 4 most common types has remained unchanged. We also observed a slight increase in infections with multiple HPV types or at least 1 high-risk type.

Performance of Coronary Artery Calcium Testing in Patients With Severe Psoriasis: Risk Assessment and Reclassification Potential in a Low Cardiovascular Risk Population.

BACKGROUND: Patients with severe psoriasis have an increased cardiovascular (CV) risk and prevalence of subclinical coronary artery disease (CAD). Coronary artery calcium (CAC) testing can detect subclinical CAD and improve cardiovascular risk assessment beyond clinical scores. OBJECTIVES: Evaluate the presence and magnitude of subclinical CAD determined by CAC score among the different ESC/EAS CV risk categories, as well as the potential for risk reclassification, in patients with severe psoriasis from a low CV risk population. METHODS: Unicentric cross-sectional study in 111 patients with severe chronic plaque psoriasis from a low CV risk population in the Mediterranean region. Patients were classified into four CV risk categories according to the ESC/EAS guideline recommendations and HeartScore/SCORE calibrated charts. Patients underwent coronary computed tomography to determine their CAC scores. Patients in the moderate-risk category with a CAC score of ≥100 were considered to be reclassified as recommended by the 2019 ESC/EAS guidelines. Reclassification was also considered for patients in the low-risk category with a CAC score>0. RESULTS: Presence of subclinical CAD was detected in 46 (41.4%) patients. These accounted for 86.2% of patients in high/very-high-risk categories and 25.6% of patients in non-high-risk categories. Fourteen (17.1%) of the patients in non-high-risk categories were reclassifiable due to their CAC score. This percentage was higher (25%) when considering the moderate-risk category alone and lower (13.8%) in the low-risk category. Age was the only variable associated with presence of subclinical CAD and reclassification. CONCLUSIONS: Over 40% of patients with severe psoriasis from a low-risk region and up to 25% of those in non-high-risk categories have subclinical CAD. CAC appears to be useful for reclassification purposes in CV risk assessment of patients with severe psoriasis. Further research is required to elucidate how CAC could be implemented in everyday practice at outpatient dermatology clinics dedicated to severe psoriasis.

Definition of minimal disease activity in psoriasis.

OBJECTIVE: To generate an operational definition to adequately reflect the construct 'Minimal Disease Activity (MDA)' in psoriasis. METHODS: A systematic review of domains included in clinical trials of psoriasis was presented to a panel of dermatologists and patients. Further domains were elicited by panel discussions. Domains (and instruments measuring these) were items of two consecutive Delphi rounds targeting dermatologists from the Psoriasis Group of the Spanish Academy of Dermatology and Venereology and patients from the Acción Psoriasis association. The instruments selected were used to generate 388 patient vignettes. The expert group then classified these vignettes as 'No MDA/MDA/Unclassifiable'. The items were further reduced by factorial analysis. Using the classification variable as gold standard, several operational constructions were tested in regression models and ROC curves and accuracy was evaluated with area under the curve (AUC). RESULTS: The following domains were included: itching, scaling, erythema and visibility by 0-10 scales, extension by BSA, impact on quality of life by DLQI, special location and presence of arthritis as yes/no. The definition with the highest AUC and best balance between sensitivity and specificity was the one including no presence of arthritis plus at least three others below the upper limit of the 95% confidence interval (AUC, 0.897; sensitivity, 95.2%, specificity, 84.1%). CONCLUSION: This study provides, for the very first time, the construct of 'Minimal Disease Activity' in psoriasis as agreed by dermatologists and patients. MDA is defined as absence of active arthritis plus 3 out of 6: itching ≤ 1/10; scaling ≤ 2/10; redness ≤ 2/10; visibility ≤ 2/10; BSA ≤ 2; DLQI ≤ 2; and no lesions in special locations. By design, domains are representative of disease impact. This MDA definition may be used as a measure of adequate management and replace other subjective or restrictive tools.

Changing Trends in Drug Prescription and Causes of Treatment Discontinuation of First Biologic Over Ten Years in Psoriasis in the Spanish Biobadaderm Registry. / Cambios en las tendencias de la prescripción y causas de la interrupción en los tratamientos biológicos indicados en la psoriasis durante los primeros 10 años. Datos obtenidos del registro español Biobadaderm.

BACKGROUND AND OBJECTIVES: 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. MATERIAL AND METHODS: 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). RESULTS: Anti-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. CONCLUSIONS: 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.

Validation of an Optical Pencil Method to Estimate the Affected Body Surface Area in Psoriasis. / Validación del método de cuantificación del área corporal afectada por la psoriasis mediante lápiz óptico.

INTRODUCTION: Body surface area (BSA) affected by psoriasis is one of the most often used measures for assessing severity, but this method has shortcomings. OBJECTIVE: To validate a new way to estimate BSA. MATERIAL AND METHOD: Prospective, multicenter study in 56 patients with psoriasis. Each patient was evaluated by 2 dermatologists in 2 visits to the same hospital. Each dermatologist used 2 methods for estimating BSA: the traditional visual estimation in which the area of the palm equals 1% of the total body surface and an optical pencil (OP) method in which the affected area is drawn on a touch screen. Software in the application then calculates the BSA. RESULTS: Overall concordance between the 2 methods was acceptable according to an intraclass correlation coefficient (ICC) of 0.87. However, the limits of agreement were unacceptably large and there was systematic bias: traditional estimates were consistently greater than OP calculations. Concordance between the methods was better (ICC>0.8) on the trunk and lower extremities. Intraobserver reliability was excellent with both methods (ICCs, 0.97 and 0.98 for the traditional and OP estimates, respectively). Interobserver reliability was also high (ICCs, 0.91 and 0.94 for the traditional and OP methods), although the mean BSA differed significantly between observers. The ICCs were much lower for BSA estimates on the head. CONCLUSIONS: This study to validate the OP method for estimating the affected BSA in patients with psoriasis shows good agreement between the OP and traditional approaches. The OP calculations also showed less variance and better interobserver reliability.

Association Between Bullous Pemphigoid and Dipeptidyl Peptidase 4 Inhibitors: A Retrospective Cohort Study. / Asociación entre penfigoide ampolloso e inhibidores de la dipeptidilpeptidasa-4: estudio de cohortes retrospectivo.

BACKGROUND: The association between dipeptidyl peptidase 4 inhibitors (DPP-4i) and bullous pemphigoid (BP) has been demonstrated in several studies. The main aim of this study was to estimate the use of DPP-4i treatment in patients diagnosed with BP in our setting. METHODS: We selected patients histologically diagnosed with BP in our department between October 2015 and October 2018 and performed a retrospective chart review to assess clinical and epidemiological data and direct immunofluorescence (DIF) patterns. RESULTS: Of the 70 patients diagnosed with BP during the study period, 50% were diabetic and 88.57% of these were being treated with a DPP-4i when diagnosed with BP. The most common DPP-4i was linagliptin (used in 18.6% of patients), followed by vildagliptin (17.1%). The median latency period between initiation of DPP-4i treatment and diagnosis of BP was 27.5 months for all treatments, 16 months for linagliptin, and 39 months for vildagliptin (log rank < 0.01). A negative DIF result was significantly more common in patients not being treated with a DPP-4i. The DIF pattern most strongly (and significantly) associated with DPP-4i treatment was linear immunoglobulin G deposits along the dermal-epidermal junction. DPP-4i treatment was withdrawn in 87% of patients and 96% of these achieved a complete response. CONCLUSIONS: DPP-4i treatment is very common in patients with BP in our setting. The latency period between start of treatment and onset of BP seems to be shorter with linagliptin than with other types of gliptins. Patients receiving DPP-4i treatment may show different DIF patterns to those not receiving treatment.

Genital Infection With Herpes Simplex Virus Type 1 and Type 2 in Valencia, Spain: A Retrospective Observational Study. / Infecciones genitales por virus herpes tipo 1 y virus herpes tipo 2 en Valencia, España: estudio observacional retrospectivo.

INTRODUCTION AND OBJECTIVE: The epidemiology of genital herpes has changed in recent years with an increase in the incidence of herpes simplex virus type 1 (HSV-1) infection. The aim of this study was to analyze the clinical and epidemiological characteristics of patients diagnosed with genital herpes. MATERIAL AND METHODS: A retrospective observational study was designed. All patients diagnosed with genital herpes between January 2016 and January 2019 in a Sexually Transmitted Infections Unit (ITS) in Valencia, Spain, were included. RESULTS: We identified 895 STI diagnoses. Of these, 126 (14%) were genital herpes; 68 (54%) of these cases were in women and 58 (46%) in men. Diagnosis was confirmed by molecular detection of HSV DNA in 110 cases (87.3%). Of these, 52 were cases of HSV-1 infection (47.3%) and 58 were HSV-2 infection (52.7%). HSV-2 was more common in men (69.5%), while HSV-1 was more common in women (59.3%). In the subgroup of women, mean age at diagnosis was 26 years for HSV-1 and 34 years for HSV-2 (P=.015). Recurrent genital herpes rates were 13% for HSV-1 and 40% for HSV-2. CONCLUSIONS: There has been an increase in the number of cases of genital herpes caused by HSV-1 in our setting, with young women in particular being affected. This has important prognostic implications because genital herpes caused by HSV-1 is less likely to recur.

Expert consensus on the persistence of biological treatments in moderate-to-severe psoriasis.

BACKGROUND: Treatment persistence is becoming a useful measure to evaluate long-term effectiveness and safety of biological therapies in real-world settings. OBJECTIVE: The main objective of this study was to explore the scientific opinion of a panel of dermatologists and hospital pharmacists to reach a consensus about the impact, causes, and best strategies and interventions that might be associated with improved drug persistence in patients with psoriasis in Spain. METHODS: This research was conducted using a modified Delphi method organized in two rounds and involving a panel of 90 dermatologists and 34 hospital pharmacists. A questionnaire of 70 items was developed. The items proposed to reach a consensus included topics such as definitions and measures in the treatment of psoriasis, analysis of treatment persistence, factors that may influence treatment persistence, impact of treatment persistence and economic cost of treatment. RESULTS: Dermatologists reached a consensus on 77.1% of the items proposed, and hospital pharmacists reached a consensus on 71.4%. Both groups agreed that it is important to use standardized measures in the evaluation of treatment maintenance over time. Dermatologists agreed that treatment survival, persistence and retention are synonymous, but hospital pharmacists considered only treatment persistence as a valid term. In addition, panelists agreed that drug persistence is an indicator of success in the treatment of psoriasis that may be influenced by a drug's effectiveness and safety profile, as well as by patient satisfaction. They agreed that the different causes of treatment discontinuation should be considered in Kaplan-Meier analysis of treatment persistence. Moreover, treatment persistence was agreed to decrease the cost of therapy. CONCLUSION: This Delphi consensus highlights the different perspectives of dermatologists and hospital pharmacists regarding the interpretation of treatment persistence, and the challenge of harmonizing the results obtained.