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.

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)

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)

[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.

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)