Metotrexato en psoriasis moderada-grave: revisión de la literatura y recomendaciones de experto / Methotrexate in Moderate to Severe Psoriasis: Review of the Literature and Expert Recommendations

Metotrexato (MTX) es el fármaco sistémico convencional más empleado en el tratamiento de la psoriasis. A pesar de que la experiencia en su uso se remonta a más de 50 años, todavía existen aspectos en el manejo clínico poco estandarizados o conocidos. Bajo esta premisa, un grupo de 15 expertos participó en una conferencia de consenso en la que, a partir de una revisión sistemática y 2 rondas de validación previas, se validaron recomendaciones categorizadas por nivel de evidencia y grado de recomendación sobre el uso de MTX en la psoriasis. La elección de MTX en el tratamiento de la psoriasis moderada grave requiere la evaluación previa de la idoneidad del fármaco, incluyendo estado de vacunación, cribado de tuberculosis y gestación. La dosis recomendada de inicio es de 10-20mg/semana si el paciente no presenta factores de riesgo, con una dosis terapéutica de 15mg/semana para la mayoría de pacientes y máxima de 20mg/semana. La mayor parte de pacientes que respondan al tratamiento mostrarán mejoría antes de las 8 semanas. Es preferible la administración parenteral de MTX cuando exista riesgo de error en la pauta de administración, incumplimiento, intolerancia gastrointestinal o respuesta insuficiente a dosis plenas por vía oral. Los métodos no invasivos son preferibles para la monitorización de la hepatotoxicidad. El tratamiento con MTX representa una buena opción en pacientes con antecedentes oncológicos, mientras que no se recomienda en pacientes portadores crónicos de virus de la hepatitisB o seropositivos para el virus de la inmunodeficiencia humana (VIH+)

Methotrexate (MTX) is the most frequently used conventional systemic drug in the treatment of psoriasis. Despite over 50 years of experience in this setting, certain aspects of the use of this drug in clinical practice are still little standardized and poorly understood. For this reason, a group of 15 experts took part in a consensus development conference to achieve consensus on a series of recommendations on the use of MTX in psoriasis. The guidelines, which were developed on the basis of a systematic review of the literature, were validated by 2 rounds of voting and categorized by level of evidence and grade of recommendation. Before MTX can be used to treat moderate to severe psoriasis, the patient must be evaluated to assess the suitability of the treatment, including consideration of vaccination status and screening for tuberculosis and pregnancy. The recommended starting dose for a patient with no risk factors is 10 to 20mg/wk, the therapeutic dose for most patients is 15mg/wk, and the maximum dose is 20mg/wk. Most patients who respond to treatment will show improvement within 8weeks. Parenteral administration of MTX is desirable when there is a risk of erroroneous dosing, nonadherence, gastrointestinal intolerance, or inadequate response to the therapeutic dose taken orally. Noninvasive methods are preferred for monitoring hepatotoxicity. MTX is a good treatment option for patients with a history of cancer, but is not recommended in patients with chronic hepatitisB infection or individuals who are seropositive for human immunodeficiency virus

Methotrexate in Moderate to Severe Psoriasis: Review of the Literature and Expert Recommendations.

Methotrexate (MTX) is the most frequently used conventional systemic drug in the treatment of psoriasis. Despite over 50years of experience in this setting, certain aspects of the use of this drug in clinical practice are still little standardized and poorly understood. For this reason, a group of 15 experts took part in a consensus development conference to achieve consensus on a series of recommendations on the use of MTX in psoriasis. The guidelines, which were developed on the basis of a systematic review of the literature, were validated by 2 rounds of voting and categorized by level of evidence and grade of recommendation. Before MTX can be used to treat moderate to severe psoriasis, the patient must be evaluated to assess the suitability of the treatment, including consideration of vaccination status and screening for tuberculosis and pregnancy. The recommended starting dose for a patient with no risk factors is 10 to 20mg/wk, the therapeutic dose for most patients is 15mg/wk, and the maximum dose is 20mg/wk. Most patients who respond to treatment will show improvement within 8weeks. Parenteral administration of MTX is desirable when there is a risk of erroroneous dosing, nonadherence, gastrointestinal intolerance, or inadequate response to the therapeutic dose taken orally. Noninvasive methods are preferred for monitoring hepatotoxicity. MTX is a good treatment option for patients with a history of cancer, but is not recommended in patients with chronic hepatitisB infection or individuals who are seropositive for human immunodeficiency virus.

Use of biological treatments in patients with hidradenitis suppurativa.

INTRODUCTION: Hidradenitis suppurativa (HS) is a chronic skin disease which causes a great impact in the quality of life. Multiple therapeutic options have been proposed, and recently the potential use of biological drugs in severe cases has been postulated. MATERIAL AND METHODS: A retrospective study from seven tertiary Spanish centers reviewing the charts of patients with HS treated with biological drugs was performed. Retrieved information included epidemiological data, clinical features, pain intensity, Hurley stage, laboratory data and therapeutic outcomes. RESULTS: Nineteen patients were included in the study; 10 men (52.6%) and 9 women. Eight patients (42%) showed a Hurley severity stage II and 11 a stage III (57.8%). Adalimumab was prescribed as the first biological treatment in nine out of 19 cases (47.3%), whereas infliximab was prescribed in seven cases (36.8%), ustekinumab in two cases (10.5%) and etanercept in one (5.2%). A complete response was observed in three patients (two cases with infliximab and one case with ustekinumab), a partial improvement in 10 patients and in six patients no clinical improvement was noted. One patient referred worsening of the skin symptoms. In 6 cases, a second biological treatment was prescribed. In three of such cases, a partial improvement was noted, whereas in three cases no clinical improvement was observed. In two cases a switch to a third biological drug was indicated, with a partial improvement in one case. DISCUSSION AND CONCLUSIONS: Biological drugs could be a potential and effective therapeutic option for patients with severe HS. Complete and persistent clinical responses are rarely obtained (15%) and partial responses are achieved in approximately 50% of patients. No specific markers for a therapeutic response have been identified. No definitive conclusions regarding the most effective biological drug for HS could be drawn. Higher dosage schedules seem to be associated with higher response rates. The lack of response of one particular drug does not preclude a potential efficacy to another biological treatment.

Safety and effectiveness of ustekinumab and antitumour necrosis factor therapy in patients with psoriasis and chronic viral hepatitis B or C: a retrospective, multicentre study in a clinical setting.

BACKGROUND: Both the safety and efficacy of biologic therapy may be affected in the presence of highly prevalent chronic viral hepatitis. OBJECTIVE: To evaluate the safety and effectiveness of ustekinumab and antitumour necrosis factor therapy in patients with psoriasis and concomitant chronic viral hepatitis. METHODS: This was a retrospective, multicentre study. Twenty-five patients with psoriasis and concurrent hepatitis C virus (HCV) (20 patients) or hepatitis B virus (HBV) (five patients) infection who had received at least one biologic agent (etanercept, 21 treatments; adalimumab, four; ustekinumab, four; infliximab, two) were included. Clinical, imaging and laboratory data were recorded. RESULTS: In the case of HCV infection, the majority of the patients did not exhibit increases in their viral load or serum liver tests. Aspartate aminotransferase, alanine aminotransferase and gamma glutamyl transpeptidase were doubled from the baseline measurement in only one patient treated with etanercept. Two other cases exhibited viral load increases during the follow-up period. In total, 18 of the 26 treatments achieved a 75% improvement in their Psoriasis Area and Severity Index (PASI 75) score during the follow-up period. Two patients treated with etanercept were diagnosed with hepatocellular carcinoma. In the case of HBV infection, all of the patients were being treated with antiviral therapy, and none presented significant variations in viral load or serum liver enzymes. All patients achieved a PASI 75 during follow-up. CONCLUSIONS: Biologic therapy was effective and safe for the majority of our patients with HCV and HBV infection, although there may be a risk of reactivation or aggravation. We describe the first cases to receive ustekinumab. The use of biologics should be limited to those cases in which the risk-benefit ratio is justified.

Manejo práctico de ustekinumab en la psoriasis moderada-grave / Practical management of ustekinumab in moderate-severe psoriasis

Ustekinumab (UST) es hasta la fecha el último fármaco biológico aprobado para el tratamiento de la psoriasis. En su manejo práctico nos son útiles tanto los trabajos con UST como la experiencia previa acumulada con otros agentes. Los estudios previos al tratamiento, así como su monitorización y seguimiento presentan semejanzas entre los diferentes fármacos biológicos. En otros aspectos como el tratamiento combinado o el tránsito entre tratamientos, la todavía corta experiencia con UST nos obliga a tomar decisiones según la práctica seguida con otros agentes biológicos. El objetivo de este artículo es repasar algunos aspectos relacionados con el manejo práctico de UST incidiendo en características diferenciales del fármaco e intentar aprovechar el conocimiento de que disponemos con otras terapias biológicas para optimizar su uso (AU)

Ustekinumab is the latest biologic agent to be approved for the treatment of psoriasis. Experience is therefore limited, but data from studies of ustekinumab can be complemented by experience with other biologic agents. While the guidelines for pretreatment screening and follow-up practices are similar in all of the biologic therapies, no standardized information on combination therapy or treatment switches is yet available for ustekinumab, and dermatologists thus have to base their decisions on experience with other biologic agents. This chapter discusses several aspects related to the use of ustekinumab in clinical practice. We focus on the distinguishing characteristics of this drug and discuss how our knowledge and experience with other biologic agents can be used to help optimize the use of ustekinumab (AU)

[Design and validation of a questionnaire to measure treatment satisfaction in patients with moderate-to-severe psoriasis: the NEODERMA study]. / Diseño y validación de un cuestionario para medir la satisfacción con el tratamiento del paciente con psoriasis moderada y grave: estudio NEODERMA.

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

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

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

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

[Etanercept and chronic infection by HCV and HBV]. / Etanercept e infecci (R)n cr (R)nica por los virus de la hepatitis C y B.

Both psoriasis and chronic infections by HBV and HCV have high prevalence. Thus, it is relatively easy for them to coincide in the same patient. If the psoriasis requires systemic treatment, the dermatologist should consider the hepatic comorbidity when selecting an appropriate treatment. Cyclosporine, in addition to other well-known side effects, is an immunosuppressant that may condition worse evolution of the viral hepatitis. On the other hand, retinoids, psoralens and, above all, methotrexate may worsen the liver function. The anti-TNF-|A biological agents are not hepatotoxic and their theoretical contraindication in this context would be because of their action on the immune response and risk of reactivation of the hepatic infection. However, several studies have demonstrated that neither the viral load nor the hepatic inflammation parameters are generally modified negatively when they are used in hepatitis due to HCV. Their use in this context, with correct monitoring, seems, therefore, very reasonable. On the contrary, in chronic hepatitis B virus, there are cases of worsening, even with fatal outcome in some cases, and the use of these biological agents should be reserved for cases having greater need, and always be associated to antiviral treatment and strict monitoring. The review of the recent literature seems to allow the conclusion that the concomitant use of lamivudine would greatly reduce the risk of viral reactivation and, with this condition, the use of etanercept in some HBV+ patients may also be contemplated.

Etanercept e infección cronica por los virus de la hepatitis C y B / Etanercept and chronic infection by HCV and HBV

Tanto la psoriasis como las infecciones crónicas por los virus de la hepatitis B (VHB) y C (VHC) tienen una alta prevalencia, por tanto la coincidencia en un mismo paciente es relativamente fácil. Si se trata de una psoriasis que requiere tratamiento sistémico el dermatólogo deberá considerar la comorbilidad hepática a la hora de seleccionar un tratamiento adecuado. Ciclosporina, además de otros efectos adversos bien conocidos, es un agente inmunosupresor que puede condicionar una peor evolución de la hepatitis vírica. Por otra parte, los retinoides, psoralenos y, sobre todo, metotrexato pueden empeorar la función hepática. Los agentes biológicos anti-factor de necrosis tumoral alfa (TNF-α) no son hepatotóxicos, y su teórica contraindicación en este contexto vendría dada por su acción sobre la respuesta inmune y el eventual riesgo de reactivación de la infección hepática. Sin embargo, diversos estudios han demostrado que ni la carga viral ni los parámetros de inflamación hepática suelen modificarse negativamente cuando se utilizan en hepatitis por el VHC. Su uso en este contexto, con una correcta monitorización, parece por tanto muy razonable. En cambio, en la hepatitis crónica por el VHB, sí existen casos de agravamiento, incluso con desenlace fatal en alguna ocasión, y el uso de estos agentes biológicos debe reservarse para casos de mayor necesidad, siempre asociados a tratamiento antiviral y monitorización estricta. La revisión de la literatura reciente parece permitir la conclusión de que el uso concomitante de lamivudina reduciría mucho el riesgo de reactivación viral y, con esta condición, puede también contemplarse el uso de etanercept en ciertos pacientes positivos para el VHB (AU)

Both psoriasis and chronic infections by HBV and HCV have high prevalence. Thus, it is relatively easy for them to coincide in the same patient. If the psoriasis requires systemic treatment, the dermatologist should consider the hepatic comorbidity when selecting an appropriate treatment. Cyclosporine, in addition to other well-known side effects, is an immunosuppressant that may condition worse evolution of the viral hepatitis. On the other hand, retinoids, psoralens and, above all, methotrexate may worsen the liver function. The anti- TNF-α biological agents are not hepatotoxic and their theoretical contraindication in this context would be because of their action on the immune response and risk of reactivation of the hepatic infection. However, several studies have demonstrated that neither the viral load nor the hepatic inflammation parameters are generally modified negatively when they are used in hepatitis due to HCV. Their use in this context, with correct monitoring, seems, therefore, very reasonable. On the contrary, in chronic hepatitis B virus, there are cases of worsening, even with fatal outcome in some cases, and the use of these biological agents should be reserved for cases having greater need, and always be associated to antiviral treatment and strict monitoring. The review of the recent literature seems to allow the conclusion that the concomitant use of lamivudine would greatly reduce the risk of viral reactivation and, with this condition, the use of etanercept in some HBV + patients may also be contemplated (AU)

[Adverse reactions during biological therapy for psoriasis: results of a survey of the Spanish Psoriasis Group]. / Efectos adversos observados durante la terapia biológica en la psoriasis. Resultados de una encuesta al Grupo Español de Psoriasis.

BACKGROUND: Biologic therapies have been a major breakthrough in the treatment of psoriasis because they are more selective and have a better short-term and medium-term safety profile. There are reliable data to support both the efficacy and the safety of these drugs. However, it is always useful to report the clinical experience of dermatologists who are experts in the use of biologic agents to treat psoriasis, particularly with regard to their safety. MATERIAL AND METHODS: We present the results of a survey administered to the members of Spanish Psoriasis Group and based on a series of questions referring to the clinical safety of these agents. A total of 988 patients treated with efalizumab, infliximab, etanercept, and adalimumab were reported by 15 members of the group. RESULTS: There was a particularly high proportion of reactions (34%) to infliximab infusions. Blood test abnormalities were detected in 13.25% of patients and infections in 12.24%, with one case of pulmonary tuberculosis. Attention is drawn to the adverse effects profile of efalizumab: de novo arthritis in 5.8% and rebound in 20.9% of patients. CONCLUSION: The safety data provided by our study should be taken into account in view of the large number of patients recruited by dermatologists experienced in the use of this type of therapy.

Efectos adversos observados durante la terapia biológica en la psoriasis. Resultados de una encuesta al Grupo Español de Psoriasis / Adverse reactions during biological therapy for psoriasis: results of a survey of the Spanish Psoriasis Group

Introducción: La terapia biológica ha representado un avance muy importante en el tratamiento de la psoriasis, al tratarse de una generación de fármacos más selectivos y con mejor perfil de seguridad a corto y medio plazo. Existen datos sólidos a favor de la eficacia de cada uno de estos fármacos, así como de su seguridad. A pesar de ello, siempre es útil aportar la experiencia clínica de dermatólogos expertos en el tratamiento de la psoriasis con biológicos, en especial en lo referente a su seguridad. Material y métodos: Se realizó una encuesta a los miembros del Grupo Español de Psoriasis (GEP) basada en una serie de ítems relativos a aspectos referentes a la seguridad clínica de estos fármacos, cuyos resultados se presentan en este artículo. Un total de 988 pacientes tratados con efalizumab, etanercept, infliximab y adalimumab fueron recogidos por parte de 15 miembros del GEP. Resultados: Entre los resultados obtenidos destaca la elevada proporción de reacciones a infliximab (34%). Se observaron alteraciones analíticas en el 13,25% de los pacientes e infecciones en el 12,24%, con un único caso de tuberculosis pulmonar. Es de destacar el perfil de efectos secundarios de efalizumab: artritis de novo en el 5,8% y rebote en el 20,9%. Conclusión: Los datos de seguridad aportados por nuestro trabajo deben tenerse en consideración, habida cuenta del importante número de pacientes reclutados por un grupo de dermatólogos expertos en el manejo de este tipo de fármacos (AU)

Background: Biologic therapies have been a major breakthrough in the treatment of psoriasis because they are more selective and have a better short-term and medium-term safety profile. There are reliable data to support both the efficacy and the safety of these drugs. However, it is always useful to report the clinical experience of dermatologists who are experts in the use of biologic agents to treat psoriasis, particularly with regard to their safety. Material and Methods: We present the results of a survey administered to the members of Spanish Psoriasis Group and based on a series of questions referring to the clinical safety of these agents. A total of 988 patients treated with efalizumab, infliximab, etanercept, and adalimumab were reported by 15 members of the group. Results: There was a particularly high proportion of reactions (34%) to infliximab infusions. Blood test abnormalities were detected in 13.25% of patients and infections in 12.24%, with one case of pulmonary tuberculosis. Attention is drawn to the adverse effects profile of efalizumab: de novo arthritis in 5.8% and rebound in 20.9% of patients. Conclusion: The safety data provided by our study should be taken into account in view of the large number of patients recruited by dermatologists experienced in the use of this type of therapy (AU)

Directrices españolas basadas en la evidencia para el tratamiento de la psoriasis moderada a grave con agentes biológicos / Spanish evidence-based guidelines on the treatment of moderate-to-severe psoriasis with biologic agents

La psoriasis vulgar es una enfermedad cutánea inflamatoria, de curso habitualmente crónico, que afecta a un 1-2 % de la población en los países occidentales industrializados, y produce una reducción marcada de la calidad de vida de los pacientes. Pese a la diversidad de tratamientos disponibles, las encuestas efectuadas antes del advenimiento de los agentes biológicos demuestran un alto grado de insatisfacción con respecto a los tratamientos disponibles. Se ha acumulado abundante evidencia científica con respecto a la eficacia y seguridad de los agentes biológicos, que ha llevado a revisar el papel del tratamiento sistémico en general y ha permitido contemplar nuevos objetivos y estrategias terapéuticas en los pacientes con psoriasis moderada a grave. En este contexto nuevo se hace necesario establecer, de forma consensuada por especialistas expertos y ratificada por los integrantes del Grupo Español de Psoriasis de la Academia Española de Dermatología y Venereología (AEDV), unas directrices para el tratamiento de la psoriasis moderada a grave con agentes biológicos, que incluyan información basada en la evidencia científica disponible acerca de las características farmacológicas, mecanismo de acción, vía y pautas de administración, eficacia, contraindicaciones, efectos adversos y estimaciones del coste de los agentes biológicos aprobados para el tratamiento de la psoriasis moderada a grave en España (AU)

Psoriasis vulgaris is an inflammatory skin disease that is generally chronic and that affects between1 % and 2 % of the population in industrialized Western countries. It is associated with a marked decline in quality of life. A wide range of treatments are currently available, although surveys conducted before the advent of biologic agents reflected a strong degree of dissatisfaction with the treatments then available. Extensive scientific evidence has been gathered on the safety of biologic agents, and this has led to a review of the role of systemic treatment in general and has allowed new therapeutic goals and strategies to be contemplated in patients with moderate-to-severe psoriasis. In this new situation, there is a need for Spanish guidelines on the treatment of moderate-to-severe psoriasis with biologic agents, drafted by consensus among specialists and ratified by the Spanish Psoriasis Group of the Spanish Academy of Dermatology and Venereology (AEDV).These guidelines should be evidence-based with regard to the pharmacologic characteristics, mechanism of action, administration route and regimen, efficacy, contraindications, adverse effects, and cost estimates of biologic agents approved for the treatment of moderate-to severe psoriasis in Spain (AU)

[Spanish evidence-based guidelines on the treatment of moderate-to-severe psoriasis with biologic agents]. / Directrices españolas basadas en la evidencia para el tratamiento de la psoriasis moderada a grave con agentes biológicos.

Psoriasis vulgaris is an inflammatory skin disease that is generally chronic and that affects between 1 % and 2 % of the population in industrialized Western countries. It is associated with a marked decline in quality of life. A wide range of treatments are currently available, although surveys conducted before the advent of biologic agents reflected a strong degree of dissatisfaction with the treatments then available. Extensive scientific evidence has been gathered on the safety of biologic agents, and this has led to a review of the role of systemic treatment in general and has allowed new therapeutic goals and strategies to be contemplated in patients with moderate-to-severe psoriasis. In this new situation, there is a need for Spanish guidelines on the treatment of moderate-to-severe psoriasis with biologic agents, drafted by consensus among specialists and ratified by the Spanish Psoriasis Group of the Spanish Academy of Dermatology and Venereology (AEDV). These guidelines should be evidence-based with regard to the pharmacologic characteristics, mechanism of action, administration route and regimen, efficacy, contraindications, adverse effects, and cost estimates of biologic agents approved for the treatment of moderate-to severe psoriasis in Spain.

[Consensus document on the evaluation and treatment of moderate-to-severe psoriasis. Spanish psoriasis group of the Spanish Academy of Dermatology and Venereology]. / Documento de consenso sobre la evaluación y el tratamiento de la psoriasis moderada/grave del grupo español de psoriasis de la Academia Española de Dermatología y Venereología.

The treatment of psoriasis has been revolutionized by the introduction of biologic agents; these agents achieve skin clearance and long-term improvement without the risk of toxicity that has limited use of the classic systemic treatments. The role of systemic treatment in the management of psoriasis is being reviewed on the basis of a large volume of scientific evidence on the efficacy and safety of biologic agents, and new therapeutic goals and strategies are being devised for patients with moderate-to-severe psoriasis. This has led to the need to establish severity criteria that will provide the rationale for the indication of the different systemic agents currently available for the treatment of moderate-to-severe psoriasis, as well as therapeutic goals, efficacy measures, therapeutic strategies, screening protocols, and choice of treatment based on the risk-benefit ratio of the different agents. These criteria must be established through consensus by experienced dermatologists and based on available scientific evidence. The present document reflects the consensus of the Spanish Psoriasis Group on these different issues in the management of moderate-to-severe psoriasis.

[Update of the topical treatment of psoriasis]. / Revisión actualizada del tratamiento tópico de la psoriasis.

Topical therapy continues to be one of the pillars of psoriasis management. Topical corticosteroids and vitamin D analogs are the drugs of choice during the induction phase, and vitamin D analogs continue to be drugs of choice for maintenance therapy. Tazarotene and dithranol are suitable options in patients with certain, specific characteristics. The calcineurin inhibitors can be considered to be second-line treatment for psoriasis of the face and flexures. The efficacy and safety of the fixed-dose combination of betamethasone and calcipotriol in the induction phase is greater than that of either drug alone. The combination of corticosteroids with salicylic acid achieves better results than corticosteroids in monotherapy. None of the drugs evaluated stands out over the others in all clinical situations, and their use must therefore be individualized in each patient and adjusted according to the course of the disease.

[Reactions to infliximab infusions in dermatologic patients: consensus statement and treatment protocol. Working Group of the Grupo Español de Psoriasis de la Academia Española de Dermatología y Venereología ]. / Reacciones a la infusión de infliximab en pacientes dermatológicos. Grupo de Estudio, Grupo Español de Psoriasis de la Academia Española de Dermatología y Venereología.

Infliximab is a chimeric monoclonal antibody that binds to and blocks tumor necrosis factor alpha and is the most effective biologic agent approved for the treatment of moderate-to-severe psoriasis. It is administered by intravenous infusion, usually in day hospitals on an outpatient basis. The main problem with the administration of infliximab is the possibility of infusion reactions, which may be immediate or delayed; these reactions are related to the immunogenicity of this monoclonal antibody, leading to the production of anti-infliximab antibodies. Infusion reactions to infliximab are not usually anaphylactic (ie, they are not mediated by immunoglobulin E), and re-exposure of the patient using specific protocols to prevent and treat these reactions is therefore possible. The extensive experience in the use of infliximab for the treatment of rheumatic conditions and chronic inflammatory bowel disease has made it possible to develop infusion reaction management protocols; these can be applied to dermatologic patients, who constitute a growing proportion of patients treated with intravenous biological agents. The aim of this review is to draw up a consensus protocol for the treatment of infusion reactions in dermatologic patients treated with infliximab.

Documento de consenso sobre la evaluación y el tratamiento de la psoriasis moderada/grave del Grupo Español de Psoriasis* de la Academia Española de Dermatología y Venereología / Consensus Document on the Evaluation and Treatment of Moderate-to-Severe Psoriasis. Spanish Psoriasis Group of the Spanish Academy of Dermatology and Venereology

El tratamiento de la psoriasis se ha visto revolucionado por la introducción de los agentes biológicos, que permiten obtener blanqueamientos y mejorías a largo plazo sin el riesgo de toxicidad que ha venido limitando el tratamiento de estos pacientes con agentes sistémicos clásicos. Se ha acumulado abundante evidencia científica con respecto a la eficacia y seguridad de los agentes biológicos, que ha llevado a revisar el papel del tratamiento sistémico en general y ha permitido establecer nuevos objetivos y estrategias terapéuticas en los pacientes con psoriasis moderada a grave. En este contexto nuevo se hace necesario establecer, de forma consensuada por especialistas expertos y basada en la evidencia científica disponible, criterios de gravedad que justifiquen la indicación de los diferentes tratamientos sistémicos actualmente disponibles para la psoriasis, así como objetivos terapéuticos y parámetros de eficacia, estrategias de tratamiento, cribaje de los pacientes y selección del tratamiento basada en criterios de beneficio/riesgo. El presente documento recoge el consenso del Grupo Español de Psoriasis en estos diferentes aspectos del manejo de la psoriasis moderada a grave (AU)

The treatment of psoriasis has been revolutionized by the introduction of biologic agents; these agents achieve skin clearance and long-term improvement without the risk of toxicity that has limited use of the classic systemic treatments. The role of systemic treatment in the management of psoriasis is being reviewed on the basis of a large volume of scientific evidence on the efficacy and safety of biologic agents, and new therapeutic goals and strategies are being devised for patients with moderate-to-severe psoriasis. This has led to the need to establish severity criteria that will provide the rationale for the indication of the different systemic agents currently available for the treatment of moderate-to-severe psoriasis, as well as therapeutic goals, efficacy measures, therapeutic strategies, screening protocols, and choice of treatment based on the risk-benefit ratio of the different agents. These criteria must be established through consensus by experienced dermatologists and based on available scientific evidence. The present document reflects the consensus of the Spanish Psoriasis Group on these different issues in the management of moderate-to-severe psoriasis (AU)

Revisión actualizada del tratamiento tópico de la psoriasis / Update of the topical treatment of psoriasis

La terapia tópica sigue representando un pilar fundamental y de actualidad en el manejo de la psoriasis. Los corticoides tópicos y los análogos de la vitamina D son los principios activos de elección durante la fase de inducción, mientras que estos últimos se mantienen como alternativa de elección en el mantenimiento. El tazaroteno y el ditranol resultan alternativas adecuadas en pacientes con determinadas características. Los inhibidores de la calcineurina pueden considerarse tratamientos de segunda línea en la psoriasis de la cara y las flexuras. La eficacia y la seguridad en la fase de inducción de la combinación en dosis fija de betametasona y calcipotriol es superior a la obtenida por ambos principios activos por separado. La combinación de corticoides con ácido salicílico aporta ventajas con respecto a los corticoides en monoterapia. Ninguno de los principios activos evaluados presenta ventajas sobre el resto en todas las situaciones clínicas, por lo que su empleo debe individualizarse para cada paciente y para cada momento evolutivo de la dermatosis (AU)

Topical therapy continues to be one of the pillars of psoriasis management. Topical corticosteroids and vitamin D analogs are the drugs of choice during the induction phase, and vitamin D analogs continue to be drugs of choice for maintenance therapy. Tazarotene and dithranol are suitable options in patients with certain, specific characteristics. The calcineurin inhibitors can be considered to be second-line treatment for psoriasis of the face and flexures. The efficacy and safety of the fixed-dose combination of betamethasone and calcipotriol in the induction phase is greater than that of either drug alone. The combination of corticosteroids with salicylic acid achieves better results than corticosteroids in monotherapy. None of the drugs evaluated stands out over the others in all clinical situations, and their use must therefore be individualized in each patient and adjusted according to the course of the disease (AU)

Reacciones a la infusión de infliximab en pacientes dermatológicos / Reactions to Infliximab Infusions in Dermatologic Patients: Consensus Statement and Treatment Protocol

Infliximab, un anticuerpo monoclonal quimérico que se une y bloquea al factor de necrosis tumoral alfa, constituye el agente biológico más eficaz aprobado para el tratamiento de la psoriasis moderada a grave y se administra mediante infusión intravenosa, generalmente en Hospitales de Día de forma ambulatoria. Las reacciones infusionales, que pueden ser agudas y retardadas, constituyen el principal problema en la administración rutinaria de este fármaco, y están relacionadas con la inmunogenicidad del anticuerpo monoclonal que da lugar a la producción de anticuerpos dirigidos contra el mismo. Las reacciones infusionales a infliximab son en la mayoría de los casos no anafilácticas (mediadas por inmunoglobulina E [IgE]), lo que no excluye el retratamiento de los pacientes empleando protocolos específicos de prevención y tratamiento de las mismas. Existe una amplia experiencia sobre el uso de este fármaco en pacientes con enfermedades reumatológicas y enfermedad inflamatoria idiopática intestinal, lo que ha permitido desarrollar protocolos de tratamiento de las reacciones a la infusión aplicables a los pacientes dermatológicos, que constituyen un grupo cada vez más numeroso de los que son tratados con agentes biológicos por vía intravenosa. El objeto de la presente revisión es desarrollar un protocolo de tratamiento consensuado de las reacciones a la infusión en pacientes dermatológicos tratados con infliximab (AU)

Infliximab is a chimeric monoclonal antibody that binds to and blocks tumor necrosis factor α and is the most effective biologic agent approved for the treatment of moderate-to-severe psoriasis. It is administered by intravenous infusion, usually in day hospitals on an outpatient basis. The main problem with the administration of infliximab is the possibility of infusion reactions, which may be immediate or delayed; these reactions are related to the immunogenicity of this monoclonal antibody, leading to the production of anti-infliximab antibodies. Infusion reactions to infliximab are not usually anaphylactic (ie, they are not mediated by immunoglobulin E), and re-exposure of the patient using specific protocols to prevent and treat these reactions is therefore possible. The extensive experience in the use of infliximab for the treatment of rheumatic conditions and chronic inflammatory bowel disease has made it possible to develop infusion reaction management protocols; these can be applied to dermatologic patients, who constitute a growing proportion of patients treated with intravenous biologic agents. The aim of this review is to draw up a consensus protocol for the treatment of infusion reactions in dermatologic patients treated with infliximab (AU)