[Biosimilars: Expert consensus of the Latin American Society of Psoriasis (SOLAPSO) in Argentina]. / Biosimilares: Consenso de expertos de la Sociedad Latinoamericana de Psoriasis (SOLAPSO) en Argentina.

With the appearance of biological treatments, therapeutics has changed in many rheumatological, dermatological and oncological diseases. Due to the high cost of these biological medicaments and the expiration of patents, the pharmacological industry develops biosimilars, drugs that are a version (copy) of the substance of the original biological medicine, with the aim of facilitating access to these treatments. These biosimilars are prepared according to the specific requirements of regulatory bodies in terms of quality, efficacy and safety, and must be shown they are comparable to the reference product. This paper reviews the international and national regulatory framework, the controversies surrounding biosimilars, and presents the position of a group of experts regarding the use of biosimilars.

[Analysis of a case series of adult patients with severe atopic dermatitis treated with dupilumab in Argentina]. / Análisis de una serie de casos de pacientes adultos con dermatitis atópica severa tratados con dupilumab en Argentina.

Introduction: Severe atopic dermatitis (AD) treatment is an unmet need, given the limited efficacy and safety of classical systemic treatments (CSTs). Dupilumab is a monoclonal antibody that blocks the signaling of the interleukins that mediate the inflammatory response involved in AD. Methods: the clinical response of a group of patients from Argentina with severe AD and insufficient response and/or toxicity to CSTs who were treated with dupilumab before commercial availability was analyzed. EASI, SCORAD, DLQI scales and analog visual scales of pruritus and sleep were evaluated, during a median follow-up of 189 days. In addition, the incidence of adverse events was analyzed. Results: 20 patients (13 male) were included; median age: 37.5 years; median AD evolution: 20 years; atopic comorbidity: 70%. 100% had received systemic corticosteroids (serious complications: 20%). Main reasons for discontinuation of CSTs were lack of efficacy and occurrence of adverse events. All scores were significantly and steadily reduced, with identifiable clinical response at the second month of treatment. At the end of the follow-up, only 3 patients required concomitant systemic immunosuppressive treatment. Dupilumab was well tolerated, with mild and controllable adverse events. Discussion: Dupilumab is the only biological agent with high efficacy demonstrated in clinical and observational studies. In this case series, its effectiveness was confirmed in difficult-to-treat patients with severe AD and inadequate response to CSTs. The safety profile was favorable and consistent.

Introducción: El tratamiento de la dermatitis atópica (DA) severa es una necesidad insatisfecha, dada la limitada eficacia y seguridad de los tratamientos sistémicos clásicos (TSC). Dupilumab es un anticuerpo monoclonal que bloquea la señalización de las interleuquinas mediadoras de la respuesta inflamatoria involucrada en la DA. Métodos: se analizó la respuesta clínica de un grupo de pacientes de Argentina con DA severa y respuesta insuficiente y/o toxicidad a los TSC que fueron tratados con dupilumab antes de su disponibilidad comercial. Se evaluaron las escalas EASI, SCORAD, DLQI y escalas visuales analógicas de prurito y sueño, durante una mediana de 189 días de seguimiento, así como la incidencia de eventos adversos. Resultados: Se incluyeron 20 pacientes (13 varones); mediana de edad: 37,5 años; mediana de evolución de la DA: 20 años; comorbilidad atópica: 70%. El 100% habían recibido corticoides sistémicos (complicaciones graves: 20%). Los principales motivos de suspensión de los TSC fueron falta de eficacia y aparición de eventos adversos. Los puntajes de todas las escalas se redujeron significativa y sostenidamente, con respuesta clínica evidente al segundo mes de tratamiento. Al final del seguimiento, solo 3 pacientes requerían tratamiento inmunosupresor sistémico concomitante. Dupilumab fue bien tolerado, con eventos adversos leves y controlables. Dsicusión: el dupilumab constituye el único agente biológico con elevada eficacia demostrada en estudios clínicos y observacionales. En esta casuística, se confirmó su efectividad en pacientes con DA severa de difícil tratamiento y respuesta inadecuada a los TSC. El perfil de seguridad resultó favorable y sostenido a mediano plazo.

Latin American Clinical Practice Guidelines on the Systemic Treatment of Psoriasis SOLAPSO - Sociedad Latinoamericana de Psoriasis (Latin American Psoriasis Society).

This Clinical Practice Guideline on the systemic treatment of Psoriasis includes the recommendations elaborated by a panel of experts from the Latin American Psoriasis Society SOLAPSO, who assessed the quality of the available evidence using the GRADE system and the PICO process to guide the literature search. To answer each question, the experts discussed the results of randomized controlled trials, observational studies and metanalysis evaluating the interventions identified (non-biologics, biologics and phototherapy) in different populations of patients with moderate to severe plaque-psoriasis, which was summarized in Tables ad-hoc. The main end-points considered to assess efficacy were PASI 50, 75, 90 and 100, PGA 0-1 and significant improvement of health-related quality of life. Specific adverse events, either severe or leading to treatment interruption, were also evaluated. The 31 recommendations included in this CPG follow the structure proposed by GRADE: direction (for or against) and strength (strong or weak). The goal of this CPG is to improve the management of patients with psoriasis by recommending interventions of proved benefit and providing a reference standard for the treating physician. Adhering to the contents of this CPG does not guarantee therapeutic success. The final decision on the specific treatment is the responsibility of the physician based on the individual circumstances and considering the values, the preferences and the opinions of the patient or caregivers.

Biosimilares: consenso de expertos de la Sociedad Latinoamericana de Psoriasis (SOLAPSO) en Argentina / Biosimilars: Expert consensus of the Latin American Society of Psoriasis (SOLAPSO) in Argentina

Con la aparición de los tratamientos biológicos, se ha modificado la terapéutica de muchas enfermedades, en especial las reumatológicas, dermatológicas y oncológicas. Debido al alto costo de estos productos y el vencimiento de las patentes, la industria farmacológica desarrolla los biosimilares, fármacos que son una versión (copia) de la sustancia de un medicamento biológico original, y que pueden facilitar el acceso a estos tratamientos. Son elaborados de acuerdo a exigencias específicas de organismos reguladores en cuanto a calidad, eficacia y seguridad, y debe demostrarse que son comparables al medicamento de referencia. Este trabajo revisa las normativas regulatorias internacionales y nacionales, las controversias que rodean a los biosimilares y presenta la posición de un grupo de expertos con respecto al uso de biosimilares.

With the appearance of biological treatments, therapeutics has changed in many rheumatological, dermatological and oncological diseases. Due to the high cost of these biological medicaments and the expiration of patents, the pharmacological industry develops biosimilars, drugs that are a version (copy) of the substance of the original biological medicine, with the aim of facilitating access to these treatments. These biosimilars are prepared according to the specific requirements of regulatory bodies in terms of quality, efficacy and safety, and must be shown they are comparable to the reference product. This paper reviews the international and national regulatory framework, the controversies surrounding biosimilars, and presents the position of a group of experts regarding the use of biosimilars.

Estudio del perfil epidemiológico del paciente con psoriasis en diferentes países de latinoamérica 2011 - 2014 / Epidemiological study of patients with psoriasis in different countries of latin america 2011-2014

La psoriasis es una enfermedad inflamatoria crónica, sistémica, que afecta la calidad de vida y sobrevida del paciente. La incidencia a nivel mundial oscila entre el 1,5% - 3%. Objetivo: Mejorar el conocimiento del paciente con psoriasis concerniente a factores clínicos, sociales y tratamientos indicados en Latinoamérica. Material y Métodos: Estudio multicéntrico, colaborativo, longitudinal, descriptivo y cuali-cuantitativo. Encuesta indirecta desarrollada entre 2011 ­ 2014. Resultados: Fueron incorporados 1672 registros. El 47,7% femenino y el 52,3% masculino. 57,3% de Argentina, 19% de Ecuador, 13,1% de Colombia, 4,7% de Cuba, 3,5% de México y con 1% Bolivia, Chile, Honduras, Paraguay, Perú y Uruguay. La psoriasis en placa estuvo presente en el 80,5% y el 95,2%, Guttata entre el 6,5% y 15,2%, y eritrodérmica (2,8%), invertida (2,2%) y pustulosa (1,3%). Comorbilidades: diabetes alrededor del 8%, resaltando Cuba con un valor del 1,3%. México con la mayor prevalencia de dislipemias (45,5%) e Hipertensión Arterial (33,9%). La calidad de vida y su afectación en el 42,3% de los pacientes y un 57,7% la encuentra alterada entre moderada y significativamente. Conclusión: Estudios colaborativos (registros regionales) como el presente son herramientas útiles para determinar características de presentación de la psoriasis en los pacientes de diferentes regiones y países. (AU)

Psoriasis is a systemic, chronic inflammatory disease that affects the quality of life and survival of patients. The worldwide incidence ranges from 1.5% - 3%. Objective: To raise awareness of psoriasis patient concerning clinical, social and treatments indicated in Latin factors. Material and Methods: A multicenter, collaborative, longitudinal, descriptive and qualitative and quantitative study. Indirect survey carried out between 2011 - 2014. Results: They were built 1672 records. 47.7% female and 52.3% male. 57.3% in Argentina, 19% in Ecuador, 13.1% of Colombia, 4.7% of Cuba, 3.,5% and 1% in Mexico and Bolivia, Chile, Honduras, Paraguay, Peru and Uruguay. Plaque psoriasis was present in 80.5% and 95.2%, Guttata between 6.5% and 15.2%, and erythrodermic (2.8%), inverted (2.2%) and pustular (1.3%). Comorbidities: diabetes around 8%, highlighting Cuba with a value of 1.3%. Mexico with the highest prevalence of dyslipidemia (45.5%) and hypertension (33.9%). The quality of life and their involvement in 42.3% of patients and 57.7% find it moderate and significantly altered. Conclusion: Collaborative studies (regional registers) as the present are useful tools for determining characteristics of presentation of psoriasis in patients from different regions and countries. (AU)

Dermatosis paraneoplásicas / Cutaneous paraneoplastic syndromes

Los síntomas paraneoplásicos son patologías marcadoras de procesos malignos internos que afectan órganos y sistemas diferentes del comprometido por el proceso neoplásico. Entre los sistemas y órganos que con mayor frecuencia expresan estas alteraciones se encuentran el sistema nervioso y la piel. La asociación entre neoplasias y dermatosis había sido reconocida desde el siglo III a C. En 1986 Mc Lean estableció los criterios necesarios para definir una dermatosis como paraneoplásica: aparición simultánea o próxima entre la dermatosis y el tumor y que ambos debían tener una evolución paralela. A estas consideraciones debemos agregar como criterios de inclusión, que deben presentar características clínicas e histológicas diferentes entre ambos procesos, que exista alta frecuencia de asociación entre ambas patologías y uniformidad entre el tipo de carcinoma y la expresión cutánea, la cual a su vez debe ser de infrecuente presentación. Aunque la etiopatogenia certera de estos procesos no puede ser demostrada en forma fehaciente, si pueden esbozarse algunas hipótesis que nos permiten agrupar las diferentes manifestaciones cutáneas en cuatro grandes grupos con características etiopatogénicas comunes como la producción o consumo de sustancias biológicamentes activas (enzimas, hormonas, vitaminas), sobre producción y expresión de citocinas, producción de auto-anticuerpos y reducción de la capacidad de defensa del huésped.

Paranoplastic syndromes of malignant diseases that affect internal organs and systems different from the compromised organs by the neoplastic process. The systems and organs that most frequently express these complications are the nervous system and the skin. The association between tumors and skin diseases has been recognized since third century b.C. In 1986 Mc Lean defined the main criteria for a paraneoplastic dermatosis as: co-occurrence or proximity between the dermatosis and the tumor and a parallel evolution. As inclusion criteria to these considerations we must add that a different clinical and histological features of both processes must be present, a high frequency of association between the two conditions and uniformity in the type of skin carcinoma and the skin expression, which must be an unusual presentation. Although accurate pathogenesis of these processes can't be demonstrated some hypotheses can be stated to allow us to combine the various cuateneous manifestations in four groups with common etiopathogenic characteristics such as production or consumption of biologically active substances (enzymes, hormones, vitamins), production and expression of cytokines, production of auto-antibodies and reduced capacity of host defense.