The data in clinical practice regarding the effectiveness and safety of brodalumab in psoriasis are scarce, especially at scalp and palmoplantar locations. The main objective was the percentage of ...patients achieving absolute PASI ≤3/ ≤1/ =0 for plaque psoriasis and the percentage of patients achieving an IGA 0-1/IGA 0 for the special locations at Week 52 of treatment.
Observational retrospective multicentre study in 28 Spanish Hospitals that included adult patients with plaque psoriasis treated with brodalumab, from September 2018 until March 2021.
A total of 200 patients were included. The mean baseline PASI was 10.97 (±6.28) with a mean basal scalp (n = 58) and palmoplantar (n = 40) IGA of 2.10 (±0.97) and 2.15 (±1.26), respectively. At Week 52, 93.98%/75.90%/68.67% of patients reached an absolute PASI ≤3/ ≤1/ =0 in plaque psoriasis (n = 83), with a percentage of patients achieving scalp (n = 27) and palmoplantar (n = 19) IGA 0-1/IGA 0 of 96.3%/88.9% and 100%/88.9%, respectively. Fifteen per cent of patients reported any adverse events with candidiasis being the most reported (6%), but only 6% of the adverse events required the withdrawal.
Brodalumab demonstrated high PASI and IGA responses and was well tolerated in clinical practice in plaque, scalp and palmoplantar psoriasis.
Since its inception, the Psoriasis Group (GPs) of the Spanish Academy of Dermatology and Venereology (AEDV) has worked to continuously update recommendations for the treatment of psoriasis based on ...the best available evidence and incorporating proposals arising from and aimed at clinical practice. An updated GPs consensus document on the treatment of moderate to severe psoriasis was needed because of changes in the treatment paradigm and the approval in recent years of a large number of new biologic agents.
The consensus document was developed using the nominal group technique complemented by a scoping review. First, a designated coordinator selected a group of GPs members for the panel based on their experience and knowledge of psoriasis. The coordinator defined the objectives and key points for the document and, with the help of a documentalist, conducted a scoping review of articles in Medline, Embase, and the Cochrane Library up to January 2021. The review included systematic reviews and meta-analyses as well as clinical trials not included in those studies and high-quality real-world studies. National and international clinical practice guidelines and consensus documents on the management of moderate to severe psoriasis were also reviewed. The coordinator then drew up a set of proposed recommendations, which were discussed and modified in a nominal group meeting. After several review processes, including external review by other GPs members, the final document was drafted.
The present guidelines include updated recommendations on assessing the severity of psoriasis and criteria for the indication of systemic treatment. They also include general principles for the treatment of patients with moderate to severe psoriasis and define treatment goals for these patients as well as criteria for the indication and selection of initial and subsequent therapies Practical issues, such as treatment failure and maintenance of response, are also addressed.
Obesity — A Risk Factor for Psoriasis and COVID-19 Llamas-Velasco, M.; Ovejero-Merino, E.; Salgado-Boquete, L.
Actas dermo-sifiliográficas (English ed.),
June 2021, Letnik:
112, Številka:
6
Journal Article
Recenzirano
Odprti dostop
Obesity is a major health problem whose well-known association with psoriasis has been amply described. The importance of obesity as a risk factor for poor prognosis in the coronavirus disease 2019 ...(COVID-19) caused by severe acute respiratory syndrome coronavirus 2 infection has recently been demonstrated. This review examines a possible relationship between obesity, psoriasis, and COVID-19, analyzing the pathophysiological links and their practical implications. On the one hand, a higher body mass index increases the risk of psoriasis and is also a factor in metabolic syndrome, which is common in patients with psoriasis and has been implicated in reducing the effectiveness of psoriasis treatments. On the other hand, obesity is a risk factor for severe COVID-19 and mortality. Obesity also promotes a proinflammatory state in the lung, where it compromises respiratory mechanics.
La obesidad es un importante problema sanitario y su asociación a la psoriasis es bien conocida y ha sido ampliamente descrita. Recientemente, su relevancia en relación con la COVID-19, enfermedad causada por el betacoronavirus SARS-CoV-2, se ha puesto de manifiesto al demostrarse que es un factor de mal pronóstico para estos pacientes. En este trabajo se analiza la relación que puede existir entre obesidad, psoriasis y COVID-19, analizando los nexos fisiopatológicos comunes entre estas entidades y las implicaciones prácticas de esta asociación. Por un lado, el aumento del índice de masa corporal aumenta el riesgo de padecer psoriasis y, además, la obesidad es un factor implicado tanto en el síndrome metabólico, que también está incrementado en pacientes con psoriasis, como en una menor eficacia de los tratamientos. Por otro lado, la obesidad es un factor de riesgo para gravedad de la COVID-19 y para su mortalidad. Además, a nivel pulmonar promueve un estado proinflamatorio y tiene un efecto mecánico desfavorable.
The advent of biosimilar drugs and their use in routine clinical practice has revolutionized the management of moderate to severe psoriasis and led to changes in the positioning of the existing ...molecules used to control this condition. Evidence from clinical trials complemented by real-world experience has helped to clarify concepts and has significantly changed the use and positioning of biologic agents in this setting. The present document is an update on the position of the Spanish Psoriasis Working Group regarding the use of biosimilar drugs, which takes into account this new situation.
La incorporación de los fármacos biosimilares en el manejo de la psoriasis moderada-grave en nuestra práctica clínica diaria ha supuesto una revolución y un reposicionamiento de las diferentes moléculas que usamos diariamente para su control. La incorporación de evidencia mediante ensayos clínicos y experiencias de real world evidence ha ayudado a clarificar conceptos y modos de utilización que distan de su posicionamiento inicial. Es por ello por lo que se impone una actualización del posicionamiento del Grupo de Trabajo de Psoriasis en la utilización de los fármacos biosimiliares, dada la nueva realidad existente.
Defining quality indicators is a key strategy for ensuring the quality and standardization of health care. The CUDERMA project, an initiative of the Spanish Academy of Dermatology and Venerology ...(AEDV), was undertaken to define quality indicators for the certification of specialized units in dermatology; the first 2 areas selected were psoriasis and dermato-oncology. The aim of this study was to reach a consensus on what should be assessed by the indicators used to certify psoriasis units. The structured process used to do this comprised a literature review to identify potential indicators, the selection of an initial set of indicators to be evaluated by a multidisciplinary group of experts and, finally, a Delphi consensus study. A panel of 39 dermatologists evaluated the selected indicators and classified them as either "essential" or "of excellence". Consensus was finally reached on 67 indicators, which will be standardized and used to develop the certification standard for psoriasis units.
Psoriatic arthritis is a common type of inflammatory arthritis found in up to 40% of patients with psoriasis. Because skin involvement usually precedes joint involvement, dermatologists play a key ...role in early detection. Early diagnosis is important for reducing the risk of irreversible structural damage, attenuating the deterioration of physical function, and improving patients' quality of life. This consensus statement was drafted by a group of 9 dermatologists and 1 rheumatologist to provide simple recommendations to help dermatologists screen for psoriatic arthritis in patients with psoriasis. The experts offer consensus-based guidelines that draw on a review of available scientific evidence and on experience acquired in routine clinical practice.
A new, updated AEDV Psoriasis Group (GPs) consensus document on the treatment of moderate to severe psoriasis was needed owing to the approval, in recent years, of a large number of new drugs and ...changes in the treatment paradigm.
The consensus document was developed using the nominal group technique and a scoping review. First, a designated coordinator selected a group of Psoriasis Group members for the panel. The coordinator defined the objectives and key points for the document and, with the help of a documentalist, conducted a scoping review of articles in Medline, Embase, and the Cochrane Library up to January 2021. The review included systematic reviews and meta-analyses as well as clinical trials not included in those studies and high-quality real-world studies. National and international clinical practice guidelines and consensus documents on the management of moderate to severe psoriasis were also reviewed. Based on these reviews, the coordinator drew up a set of proposed recommendations, which were then discussed and modified in a nominal group meeting. After several review processes, including external review by other GPs members, the final document was drafted.
The present guidelines include general principles for the treatment of patients with moderate to severe psoriasis and also define treatment goals and criteria for the indication of biologic therapy and the selection of initial and subsequent therapies. Practical issues, such as treatment failure and maintenance of response, are also addressed.
BACKGROUND AND OBJECTIVEThe 4-item Psoriatic arthritis UnclutteRed screening Evaluation (PURE-4) questionnaire is a useful tool for identifying patients with suspected psoriatic arthritis before ...referring them to a rheumatology department for confirmation. The original English version has good discriminant validity (sensitivity, 85.7%; specificity, 83.6%). We aimed to produce an adapted Spanish version of the PURE-4 for validation and use in Spain. MATERIAL AND METHODWe applied the method recommended by the International Society for Pharmacoeconomic and Outcome Research for the cultural adaptation of patient-centered measurement tools. The phases in the processes involved forward translation, reconciliation, back translation review, harmonization, cognitive debriefing and review, and proofreading. RESULTSWe obtained the permission of the author of the original questionnaire. Two native-speaking translators translated the questionnaire into Spanish. Small changes, mainly in the way the items were expressed, were then made in order to reconcile the 2 translations. The questionnaire was then back translated to English and revised to achieve a version equivalent to the original. A Spanish translation derived from the revision was tested for understandability in 7 patients, and the final Spanish version was then produced. During the translation phases, the project manager and a scientific committee made up of a dermatologist and a rheumatologist reviewed the different versions. Team members exchanged information throughout the process, providing for harmonization and the quality control that guaranteed conceptual equivalence. CONCLUSIONSThis adaptation of the PURE-4 questionnaire for use in Spain has been the first step toward using it in routine clinical practice. The standardized method we used ensures that the Spanish and the original versions are equivalent.
Since its inception, the Psoriasis Group (GPs) of the Spanish Academy of Dermatology and Venereology (AEDV) has worked to continuously update recommendations for the treatment of psoriasis based on ...the best available evidence and incorporating proposals arising from and aimed at clinical practice. An updated GPs consensus document on the treatment of moderate to severe psoriasis was needed because of changes in the treatment paradigm and the approval in recent years of a large number of new biologic agents.
The consensus document was developed using the nominal group technique complemented by a scoping review. First, a designated coordinator selected a group of GPs members for the panel based on their experience and knowledge of psoriasis. The coordinator defined the objectives and key points for the document and, with the help of a documentalist, conducted a scoping review of articles in Medline, Embase, and the Cochrane Library up to January 2021. The review included systematic reviews and meta-analyses as well as clinical trials not included in those studies and high-quality real-world studies. National and international clinical practice guidelines and consensus documents on the management of moderate to severe psoriasis were also reviewed. The coordinator then drew up a set of proposed recommendations, which were discussed and modified in a nominal group meeting. After several review processes, including external review by other GPs members, the final document was drafted.
The present guidelines include updated recommendations on assessing the severity of psoriasis and criteria for the indication of systemic treatment. They also include general principles for the treatment of patients with moderate to severe psoriasis and define treatment goals for these patients as well as criteria for the indication and selection of initial and subsequent therapies Practical issues, such as treatment failure and maintenance of response, are also addressed.
El desarrollo del actual arsenal terapéutico fundamentado en las terapias biológicas, la experiencia acumulada en ensayos clínicos y en práctica clínica real y los nuevos conocimientos sobre la patogénesis en psoriasis permiten posibilidades de individualización y hacen adecuada una actualización de las recomendaciones en cuanto a la gestión del riesgo en pacientes tratados con estos fármacos.
El Grupo de Psoriasis de la Academia Española de Dermatología y Venereología (GPS) trabaja desde su creación en la actualización continua de las recomendaciones para el tratamiento de la psoriasis, basándose en la mejor evidencia disponible e incorporando propuestas orientadas desde y para la práctica clínica.
Para la elaboración del consenso se siguió la metodología de grupos nominales, con ayuda de una scoping review. Tras designar a un coordinador, se seleccionó un grupo de trabajo constituido por integrantes del GPS con base en su experiencia y conocimiento en psoriasis. El coordinador definió los objetivos y puntos clave del documento y con ayuda de un documentalista se realizó una scoping review incluyendo datos de Medline, Embase y Cochrane Library (hasta enero del 2021). Se seleccionaron revisiones sistemáticas, metaanálisis y ensayos clínicos no incluidos en las mismas, guías de práctica clínica y documentos de consenso nacionales e internacionales, así como estudios de calidad en vida real. El coordinador generó las recomendaciones preliminares que fueron evaluadas y modificadas en una reunión de grupo nominal. Tras varios procesos de revisión, que incluyeron la revisión externa por parte de los miembros del GPS, se redactó el documento definitivo.
Se presentan en este documento recomendaciones prácticas y actualizadas relativas a la toma de decisiones terapéuticas con el uso de las terapias biológicas en pacientes que pertenecen a poblaciones especiales (ancianos, edad pediátrica, mujeres embarazadas o con deseo gestacional) o que presentan comorbilidades (obesidad, artritis psoriásica, enfermedad inflamatoria intestinal, depresión, cáncer, síndrome metabólico, diabetes, hígado graso no alcohólico, enfermedad cardiovascular, insuficiencia cardiaca y enfermedad renal o neurológica). Se aborda también la gestión del riesgo con el uso de terapias biológicas, analizando los riesgos potenciales previos al tratamiento y durante el mismo, así como los acontecimientos adversos más frecuentes, todo ello desde una orientación práctica y adaptada a la práctica clínica habitual.
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