Migraine treatment with biological therapies. The state of the art / Tratamento da enxaqueca com terapias biológicas. O Estado da arte

Migraine is a highly prevalent and debilitating neurological disorder. Most patients do not receive a correct diagnosis and effective treatments. Apart of the few specialists and tertiary centers worldwide, the treatment of migraine is usually symptomatic and prevention, as well as treatments of the underlying mechanisms, are not aimed. It results in frustration and substantial burden. The last few years witnessed the releasing of specific biological therapies, mostly addressing one of the peptides involved in migraine pathophysiology, the calcitonin gene-related peptide (CGRP). Either the small molecules as well as the monoclonal antibodies against CGRP or its canonical receptor have been launched in markets across the globe and represent interesting options for the treatment of migraine. Onabotulinumtoxin A has also been proposed for chronic migraine as well, but not for episodic migraine, based on its unique ability to inhibit the SNARE complex formation and the release of numerous potential mediators of migraine. However, despite the favorable figures on efficacy and tolerability of these compounds, the regulations, and particulars of different countries, regarding the structures and reimbursement of medical care, demonstrated different adhesion profiles of chosen populations to receive these emerging weapons against migraine-imposed suffering. This review addresses the use and characteristics of biological therapies used in migraine treatment.

A enxaqueca é um distúrbio neurológico altamente prevalente e debilitante. A maioria dos pacientes não recebe um diagnóstico correto e tratamentos eficazes. Com exceção dos poucos especialistas e centros terciários em todo o mundo, o tratamento da enxaqueca é geralmente sintomático e a prevenção, bem como o tratamento dos mecanismos subjacentes, não são direcionados. Isso resulta em frustração e fardo substancial. Os últimos anos testemunharam o lançamento de terapias biológicas específicas, abordando principalmente um dos peptídeos envolvidos na fisiopatologia da enxaqueca, o peptídeo relacionado ao gene da calcitonina (CGRP). Tanto as pequenas moléculas como os anticorpos monoclonais contra CGRP ou o seu receptor canônico foram lançados em mercados em todo o mundo e representam opções interessantes para o tratamento da enxaqueca. A onabotulinumtoxina A também foi proposta para enxaqueca crônica, mas não para enxaqueca episódica, com base em sua capacidade única de inibir a formação do complexo SNARE e a liberação de numerosos mediadores potenciais da enxaqueca. No entanto, apesar dos números favoráveis ​​sobre a eficácia e tolerabilidade destes compostos, os regulamentos e particularidades de diferentes países, no que diz respeito às estruturas e reembolso dos cuidados médicos, demonstraram diferentes perfis de adesão das populações escolhidas para receber estas armas emergentes contra o sofrimento imposto pela enxaqueca. Esta revisão aborda o uso e as características das terapias biológicas utilizadas no tratamento da enxaqueca.

Consenso sobre riesgo de complicaciones infecciosas en pacientes usuarios de medicamentos biológicos seleccionados. Parte II: Guía clínica chilena de Prevención de Infecciones Asociadas al Uso de Terapias Biológicas (PREVITEB) / Consensus of infectious complications in patients treated with selected biological therapies. Screening of hepatitis B in high risk Chilean and immigrant pregnant women: Management of mother to child transmission Second part: Chilean Guidelines for Prevention of Infections associated to use of Biological Therapies (PREVITEB)

Resumen La incorporación de terapias biológicas ha significado un gran avance en el manejo de diversas patologías de origen autoinmune, neoplásico u otros. Si bien su uso ha implicado mejoras significativas en el pronóstico de estas enfermedades, no está exento de complicaciones, entre éstas, las infecciosas. El objetivo de este consenso fue evaluar el perfil de seguridad, desde la mirada infectológica, de las terapias biológicas de uso más frecuente y dar recomendaciones para la prevención de infecciones en pacientes tratados con ellas, basándose en la evidencia de mayor calidad disponible para los biológicos seleccionados. El consenso cuenta de dos manuscritos. Esta segunda parte corresponde a la guía clínica que detalla estas recomendaciones mediante estrategias de cribado, terapias profilácticas e indicación de vacunas, según corresponde, para infecciones bacterianas, y por micobacterias en particular, virus, hongos y parásitos, tanto para adultos como para niños.

The use of biological therapies has meant a great improvement in the management of several conditions like autoimmune, neoplastic or others diseases. Although its use has implied significant improvements in the prognosis of these diseases, it is not exempt from complications: infectious diseases as one of them. The objective of this consensus was to evaluate, from an infectious viewpoint, the safeness of the most frequently used biological therapies and give recommendations for the prevention of infections in patients treated with these drugs. These recommendations were based on the highest quality evidence available for the selected biologics. The consensus counts of 2 manuscripts. This second part is a guideline that details these recommendations through screening strategies, prophylactic therapies and vaccines indications for bacterial, mycobacterial, viral, fungal and parasitic infections, both for adults and children.

Cartílago de tiburón: una panacea oncológica más / Shark cartilage: another oncological panacea

Resumen El cáncer es la tercera causa de muerte después de las enfermedades cardiovasculares y diabetes (mellitus); ante tan desolador panorama epidemiológico, es esperable que surjan multitud de terapias "curativas" no convencionales, biológicas y no biológicas. Entre las terapias biológicas se encuentra el cartílago de tiburón, cuyos defensores de su consumo se basan en la falsa premisa de que "los tiburones no tienen cáncer", y cuando son confrontados, alegan teorías conspiranoicas. Aunque se ha demostrado la existencia de un factor inhibidor de angiogénesis en el producto, los ensayos clínicos no han sido concluyentes en cuanto a un efecto benéfico neto en pacientes oncológicos. Pero el mercadeo popular de la sustancia es un negocio de varios millones de dólares anuales. Es prudente que los médicos tengan conocimiento incluso de los posibles efectos colaterales para proporcionar información a los pacientes.

Abstract Cancer is the third cause of death after cardiovascular diseases and diabetes mellitus. In the face of such a devastating epidemiological panorama, it is expected that a multitude of non-conventional, biological and non-biological "curative" therapies will emerge. Among the biological therapies is the shark cartilage, whose defenders of its use are based on the false premise that "sharks do not have cancer", and when confronted, they claim conspiracy theories. Although the presence of an inhibitory factor of angiogenesis in the product has been demonstrated, clinical trials have not been conclusive as to a net beneficial effect in oncological patients. But the popular marketing of the substance is a business of several million dollars a year. It is prudent that doctors have knowledge, including possible side effects, to provide information to patients.

Aproximación de discapacidad en artritis reumatoide. Resultados de un programa de atención integral / Approach to disability in rheumatoid arthritis. Results of a comprehensive care program

Resumen Introducción: Los modelos de atención en artritis reumatoide consideran el abordaje sintomático y la intervención de discapacidad; sin embargo, es importante un modelo que integre los avances en el manejo farmacológico y las estrategias no farmacológicas. Materiales y métodos: Estudio retrospectivo, descriptivo, transversal, en el que incluimos a 640 pacientes con diagnóstico de artritis reumatoide que estaban participando en un programa de atención integral ambulatoria; tomamos las primeras valoraciones realizadas por terapia ocupacional con la evaluación funcional completa que incluían: índice de Barthel, escala Quick DASH y Health Assessment Questionnaire. El nivel de actividad de la enfermedad se calculó a través del DAS28. Resultados: Se evidenciaron puntuaciones más altas del HAQ a medida que el nivel de actividad de la enfermedad aumenta; no se encontraron diferencias significativas en cuanto al nivel de actividad de la enfermedad entre los sujetos que laboran y los que no. Encontramos una baja asociación entre el DAS28 y el Quick DASH en sus 2 módulos de evaluación (r = 0,399 para el instrumental y r = 0,291 para el módulo laboral; p < 0,005). De los 350 sujetos, el 66,7% presentó algún grado de actividad de la enfermedad y el porcentaje de pacientes que calificaron una limitación de moderada a severa en la función de su extremidad superior fue del 66,1% para el módulo laboral y del 84,75% para el módulo instrumental, con mayor limitación funcional a medida que aumenta el nivel de actividad de la enfermedad. Conclusiones: Este estudio ha permitido reevaluar dentro del programa la aplicación de escalas genéricas que abordan de forma general la funcionalidad.

Abstract Introduction: Although rheumatoid arthritis care models consider a symptomatic approach and intervention of disability, it is also important to have a model that integrates advances in the pharmacological management, as well as non-drug treatment strategies. Materials and methods: A descriptive cross-sectional retrospective study was conducted that included 640 patients diagnosed with rheumatoid arthritis and in an outpatient comprehensive care program. The first assessments made by occupational therapy with a full functional evaluation including the Barthel index, Quick DASH scale, and the Health Assessment Questionnaire. The activity of the disease was calculated using DAS28. Results: Higher HAQ scores were observed as the level of disease activity increased. There were no significant differences in the level of activity of the disease among subjects who worked and those who did not. A low correlation was found between the DAS28 and the Quick DASH in 2 evaluation modules (r=.399 for instrumental and r=.291 for the work module) (P<.005). Of the 350 subjects, 66.7% had some degree of disease activity and the percentage of patients shown to have a moderate to severe limitation in the functioning of the upper limb was 66.1% for the work module and 84.75% for the instrumental module, showing a greater functional limitation as the level of disease activity increased. Conclusion: This study has reassessed the applying of generic scales that deal with generally functionality, within the care program.