Medicamentos biocomparables en México: la postura del Colegio Mexicano de Reumatología, 2012 / Biosimilar drugs in Mexico: Position of the Mexican College of Rheumatology, 2012

Los medicamentos biotecnológicos (MBT) son moléculas complejas cuyo proceso de elaboración impide replicar con gran exactitud la sustancia original, por lo que no existe una equivalencia absoluta entre el fármaco original (innovador) y el biocomparable. Los MBT han probado su eficacia en diversas afecciones reumáticas, aunque su alto coste impide su utilización en muchos pacientes. Diversas patentes de medicamentos biotecnológicos han expirado o expirarán próximamente, detonando así el desarrollo de fármacos estructuralmente similares y probablemente con eficacia y seguridad comparable a los medicamentos innovadores, aunque estas características deben ser probadas. La Ley General de Salud Mexicana actual contempla el registro de estos medicamentos para su utilización en nuestro país. Este documento es una reflexión de miembros del Colegio Mexicano de Reumatología, farmacólogos e investigadores en epidemiología, en conjunción con nuestras autoridades sanitarias, sobre los estudios científicos necesarios de los biocomparables previos y posterior a su incursión en el mercado mexicano (AU)

Biotechnological drugs (BTDs) are complex molecules whose manufacturing process precludes the ability to identically reproduce the structure of the original product, and therefore there cannot be an absolute equivalence between the original (innovative) medication and its biosimilar counterpart. BTDs have been proven useful in the treatment of several rheumatic diseases, however their high cost has prevented their use in many patients. Several BTD patents have expired or are close to expire, triggering the development of structurally similar drugs with efficacy and safety profiles comparable to the innovative compound; however, these must be evaluated through evidence based medicine. The Mexican General Health Law contemplates the registry of these biosimilar drugs for their use in our country. This document is a forethought from members of the Mexican College of Rheumatology, pharmacologists, and epidemiologists, in accordance with Mexican health authorities regarding the necessary scientific evidence required to evaluate the efficacy and safety of biosimilar drugs before and after their arrival to the Mexican market (AU)

Biosimilar drugs in Mexico: position of the Mexican College of Rheumatology, 2012.

Biotechnological drugs (BTDs) are complex molecules whose manufacturing process precludes the ability to identically reproduce the structure of the original product, and therefore there cannot be an absolute equivalence between the original (innovative) medication and its biosimilar counterpart. BTDs have been proven useful in the treatment of several rheumatic diseases, however their high cost has prevented their use in many patients. Several BTD patents have expired or are close to expire, triggering the development of structurally similar drugs with efficacy and safety profiles comparable to the innovative compound; however, these must be evaluated through evidence based medicine. The Mexican General Health Law contemplates the registry of these biosimilar drugs for their use in our country. This document is a forethought from members of the Mexican College of Rheumatology, pharmacologists, and epidemiologists, in accordance with Mexican health authorities regarding the necessary scientific evidence required to evaluate the efficacy and safety of biosimilar drugs before and after their arrival to the Mexican market.

[Rituximab: a new therapeutic alternative in Grave's disease]. / Rituximab: una nueva opción terapéutica en la enfermedad de Graves?

Graves' disease is the most frequent cause of hyperthyroidism, affecting mainly young aged women, with an etiology of autoimmune basis. One of its manifestations, Graves' ophthalmopathy whose pathophysiology is unknown, represents one of the greatest therapeutic challenges in these patients, because they require aggressive treatment with steroids and multiple subsequent reconstructive surgeries in certain cases. It also represents a high burden to the health system. Drugs targeting B cells have been very effective for many autoimmune diseases. Rituximab is a murine humanized monoclonal antibody against CD20 + cells currently being studied in various autoimmune diseases including Graves' disease. The objective of this paper is to expose possible mechanisms by which rituximab could act in both hyperthyroidism and ophthalmopathy of Graves' disease, as well as the experience with its use acquired so far. The employment of rituximab in recently diagnosed patients or with mild ophthalmopathy is questionable with the evidence available today however, we think that it may have a role in refractory cases or those who have a contraindication for steroid use.

[Guidelines in RA treatment: concepts on safety and recommendations using anti-TNF-alpha inhibitors. Grupo de Estudio de Nuevas Terapias de Enfermedades reumáticas (GENTE)]. / Recomendaciones para el tratamiento médico de la artritis reumatoide: actualización sobre la seguridad de los antagonistas del factor de necrosis tumoral alfa. Grupo de Estudio de Nuevas Terapias de Enfermedades reumáticas (GENTE).

Recommendations for the use of Disease-Modifying Antirheumatic Drugs (DMARD) with both conventional and biological agents in Rheumatoid Arthritis (RA) must be based on their safety profile, adverse effects, risks, and advantages. With the purpose of presenting the most updated information about the safety of tumor necrosis factor alpha (TNFalpha) antagonists, in this article we summarize the literature published during the last three years about this sort of biological agents in specific clinical situations, such as risk of developing infections, cancer, cardiovascular diseases, and autoimmunity; as well as their administration to patients who will undergo surgical procedures, pregnant and/or breast-feeding women, and patients who need immunizations. Likewise, in this analysis we offer specific recommendations, based on evidence, for the best anti-TNF-alfa management.

[Treatment guidelines for ankylosing spondylitis and its effect on Mexican rheumatology]. / Fundamentos para el tratamiento de la espondilitis anquilosante y su efecto en la reumatología mexicana.

We describe the guidelines for the current treatment of ankylosing spondylitis with an emphasis on the role and outlook of the Mexican rheumatologic community. The topics we analyze include: epidemiological as well as professional, financial, health status, and quality of life aspects. We propose to acknowledge that axial spondyloarthritis is the earliest form of ankylosing spondylitis. Finally we carry out a review of the literature supporting current therapeutic recommendations. Regarding the latter, we approached the ASAS/EULAR recommendations for the treatment of ankylosing spondylitis and their level of agreement with Mexican and other countries' rheumatologists. Finally, we analyzed the recommendations to start tumor necrosis alpha blockers among patients with ankylosing spondylitis.

Fundamentos para el tratamiento de la espondilitis anquilosante y su efecto en la reumatología mexicana / Treatment guidelines for ankylosing spondylitis and its effect on Mexican rheumatology

Esta revisión trata de los fundamentos sobre los que descansa el tratamiento actual de la espondilitis anquilosante, enfatizando la participación y la opinión de la comunidad reumatológica nacional. En la temática se incluye la repercusión de la enfermedad —aspectos epidemiológicos, laborales, económicos, estado de salud y calidad de vida—, propuestas para la identificación de la espondiloartritis axial como la forma más precoz de la espondilitis anquilosante y el análisis de la literatura que dio origen a las recomendaciones terapéuticas actuales. Con relación al último punto, se abordan las recomendaciones ASAS/EULAR para el tratamiento de la espondilitis anquilosante y el nivel de concordancia con la opinión del reumatólogo mexicano y de otros países. Finalmente, se analizan las recomendaciones para iniciar bloqueadores del factor de necrosis tumoral en pacientes con espondilitis anquilosante.

We describe the guidelines for the current treatment of ankylosing spondylitis with an emphasis on the role and outlook of the Mexican rheumatologic community. The topics we analyze include: epidemiological as well as professional, financial, health status, and quality of life aspects. We propose to acknowledge that axial spondyloarthritis is the earliest form of ankylosing spondylitis. Finally we carry out a review of the literature supporting current therapeutic recommendations. Regarding the latter, we approached the ASAS/EULAR recommendations for the treatment of ankylosing spondylitis and their level of agreement with Mexican and other countries' rheumatologists. Finally, we analyzed the recommendations to start tumor necrosis alpha blockers among patients with ankylosing spondylitis.

Class I and class II MHC polymorphisms in Mexican patients with Behçet's disease.

Behçet's disease is a multi-system inflammatory disorder of unknown etiology. The disease is more prevalent in Eastern Mediterranean countries and Japan where there is a linkage to HLA-B51. Mexican Mestizos are suitable subjects for studying the role of ethnicity in the susceptibility to Behçet's disease. High-resolution HLA class I and class II typing was performed by polymerase chain reaction sequence-specific oligonucleotide (PCR-SSO) reverse dot blot and PCR-single-strand polymorphism in 32 patients with Behçet's disease and 99 healthy ethnically-matched controls. A significant increased frequency of HLA-B(*)44 (P = 0.02; OR = 2.78; CI 95% = 1.1-7.7), HLA-B(*)52 (P = 0.02; OR = 5.33; CI 95% = 1.07-29.1), and HLA-B(*)56 (P = 0.003; OR = 4.19; CI 95% = 3.37-5.21) as well as HLA-DRB1(*)01 and HLA-DRB1(*)13 (p = 0.007; OR = 3.36; CI 95% = 1.22-9.27) was found in Mexican patients with Behçet's disease when compared to controls. The low frequency of native markers in Mexican Mestizo patients with Behçet's disease suggests that genetic admixture between Eastern Mediterraneans and Orientals with Amerindians is a recent event that increased the risk of developing Behçet's disease in the Mexican population.

[Challenges and commitments of the general physician in the XXI century]. / Retos y compromisos del medico general en el siglo XXI.

It is urgent that the general practitioner recapture a broad vision of the patient to achieve a better quality of medical care that encompasses prevention and treatment aspects of today's demand. Worldwide accomplishing these goals implies complete renovation of basic principles of preventive medicine, as well as those related with chronic conditions and individual lifestyle modification. Furthermore, it becomes essential to incorporate current knowledge in this plan of action for a better applied and more human restoration of health. The Academia Nacional de Medicina de México takes an additional oath to assure challenges through PRONADAMEG.

Vasculitis primaria del sistema nervioso central / Primary vasculitis of the central nervous system

La vasculitis primaria del sistema nervioso central (VPSNC) es un padecimiento inflamatorio limitado a los vasos de mediano calibre del cerebro, sin otras entidades sistémicas que la expliquen. Las manifestaciones iniciales más frecuentes de este problema son cefalea, convulsiones, hemiparesia y trastornos de la memoria, situación que puede llevar a secuelas neurológicas y frecuentemente a la muerte. Presentamos cuatro pacientes con imágenes radiológicas sugestivas de vasculitis cerebral, con manifestaciones neurológicas difusas como síntomas iniciales y que evolucionaron a lesiones neurológicas multifocales. Ninguno presentó sintomatología sistémica, y todos con exámenes de laboratorio en general normales. En todos ellos se indujo remisión clínica sostenida con esquemas terapéuticos consistentes en ciclofosfamida y prednisona