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The development and marketing of biosimilars opens a new scenario in the treatment of many pathologies, including psoriasis. This article reflects the position of the Mexican Academy of Dermatology (AMD) on the use of biosimilar medicines for the treatment of psoriasis in Mexico. In summary, the AMD estates that there is sufficient evidence to accept comparability of pharmacokinetics and pharmacodynamics of some biosimilar medicines to adalimumab, infliximab and etanercept; this evidence does not sufficiently support interchangeability or indication extrapolation. It is essential to establish a close pharmacovigilance not only to guarantee compliance with the Cofepris rules in Mexico, but also to facilitate the effective monitoring of the adverse effects of biosimilar medicines. Although the goal of biotechnological drugs is to achieve substantial savings for patients and public institutions, no economic criteria should prevail over rigorous scientific criteria that guarantee maximum therapeutic efficacy and optimum safety for patients.
El desarrollo y comercialización de biocomparables abre un nuevo escenario en el tratamiento de muchas patologías, entre ellas la psoriasis. El presente artículo recoge la postura de la Academia Mexicana de Dermatología (AMD) respecto al uso de medicamentos biocomparables para el tratamiento de la psoriasis en México. En resumen, la AMD establece que existe suficiente evidencia para aceptar la comparabilidad farmacocinética y farmacodinámica entre algunos medicamentos biocomparables al adalimumab, el infliximab y el etanercept; esta evidencia no sustenta suficientemente su intercambiabilidad ni la extrapolación de indicaciones; es fundamental establecer una farmacovigilancia estrecha no solo para garantizar el cumplimiento de las reglas de la Comisión Federal para la Protección contra Riesgos Sanitarios en México, sino para facilitar un seguimiento efectivo de los efectos adversos de los medicamentos biocomparables. Si bien la meta de los medicamentos biotecnológicos es lograr un ahorro sustancial para los pacientes y las instituciones públicas, los criterios económicos no deben anteponerse a criterios científicos rigurosos que garanticen la máxima eficacia terapéutica y la óptima seguridad para los pacientes.
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Biosimilares Farmacéuticos/administración & dosificación , Fármacos Dermatológicos/administración & dosificación , Psoriasis/tratamiento farmacológico , Adalimumab/administración & dosificación , Adalimumab/efectos adversos , Biosimilares Farmacéuticos/efectos adversos , Biosimilares Farmacéuticos/uso terapéutico , Fármacos Dermatológicos/efectos adversos , Fármacos Dermatológicos/farmacocinética , Dermatología , Aprobación de Drogas , Etanercept/administración & dosificación , Etanercept/efectos adversos , Humanos , Infliximab/administración & dosificación , Infliximab/efectos adversos , México , FarmacovigilanciaRESUMEN
OBJECTIVE: To develop updated guidelines for the pharmacological management of rheumatoid arthritis (RA). METHODS: A group of experts representative of different geographical regions and various medical services catering to the Mexican population with RA was formed. Questions based on Population, Intervention, Comparison, and Outcome (PICO) were developed, deemed clinically relevant. These questions were answered based on the results of a recent systematic literature review (SLR), and the evidence's validity was assessed using the GRADE system, considered a standard for these purposes. Subsequently, the expert group reached consensus on the direction and strength of recommendations through a multi-stage voting process. RESULTS: The updated guidelines for RA treatment stratify various therapeutic options, including different classes of DMARDs (conventional, biologicals, and JAK inhibitors), as well as NSAIDs, glucocorticoids, and analgesics. By consensus, it establishes the use of these in different subpopulations of interest among RA patients and addresses aspects related to vaccination, COVID-19, surgery, pregnancy and lactation, and others. CONCLUSIONS: This update of the Mexican guidelines for the pharmacological treatment of RA provides reference points for evidence-based decision-making, recommending patient participation in joint decision-making to achieve the greatest benefit for our patients. It also establishes recommendations for managing a variety of relevant conditions affecting our patients.
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Antirreumáticos , Artritis Reumatoide , Artritis Reumatoide/tratamiento farmacológico , Humanos , México , Antirreumáticos/uso terapéutico , Glucocorticoides/uso terapéutico , Femenino , Antiinflamatorios no Esteroideos/uso terapéutico , Embarazo , Analgésicos/uso terapéuticoRESUMEN
BACKGROUND: This article presents evidence and recommendations regarding the efficacy and safety of the approved and available therapies in Mexico to treat severe or established osteoporosis with the aim of developing a position regarding therapeutics in this stage of the disease, according to the descriptive cards of the National Drug Formulary of the National General Health Council of Mexico. METHODS: We performed a systematic and narrative review of the evidence of teriparatide and denosumab, from their pharmacological profile, effectiveness, and safety derived from clinical trials, as well as an analysis of the general recommendations of the national and international clinical practice guidelines. RESULTS: The evidence establishes that teriparatide and denosumab belong to different therapeutic classes, with biologically opposed mechanisms of action and indications of use, which are clearly differentiated in their respective national codes, therefore these drugs cannot be substitutable or interchangeable in severe osteoporosis therapy. Both represent the best options currently available for this stage of the disease; being similar in their efficacy in preventing new vertebral fragility fractures, with an RR of .35 (CI 95%; .22-.55) for teriparatide, and .32 (CI 95%: .26-.41) for denosumab. The absolute risk reduction is higher with teriparatide 9.3% (21 months) compared with denosumab at 4.8% (36 months). CONCLUSIONS: Our results agree with the recommendations available in national and international clinical practice guidelines, with both therapies proposed as a sequential, but not a substitute, treatment.
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There are national and international clinical practice guidelines for systemic lupus erythematosus treatment. Nonetheless, most of them are not designed for the Mexican population or are devoted only to the treatment of certain disease manifestations, like lupus nephritis, or are designed for some physiological state like pregnancy. The Mexican College of Rheumatology aimed to create clinical practice guidelines that included the majority of the manifestations of systemic lupus erythematosus, and also incorporated guidelines in controversial situations like vaccination and the perioperative period. The present document introduces the «Clinical Practice Guidelines for the Treatment of Systemic Lupus Erythematosus¼ proposed by the Mexican College of Rheumatology, which could be useful mostly for non-rheumatologist physicians who need to treat patients with systemic lupus erythematosus without having the appropriate training in the field of rheumatology. In these guidelines, the reader will find recommendations on the management of general, articular, kidney, cardiovascular, pulmonary, neurological, hematologic and gastrointestinal manifestations, and recommendations on vaccination and treatment management during the perioperative period.
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Lupus Eritematoso Sistémico/terapia , Antiinflamatorios/uso terapéutico , Terapia Combinada , Humanos , Inmunosupresores/uso terapéutico , Lupus Eritematoso Sistémico/complicaciones , Lupus Eritematoso Sistémico/diagnóstico , MéxicoRESUMEN
The aim of this paper is to evaluate the relationship of salivary ammonium levels and the presence of bacteria with rheumatoid arthritis (RA) clinical disease activity in a cross-sectional study of Mexican patients. From a periodontal and disease activity standpoint, 132 consecutive RA patients fulfilling clinical criteria were evaluated. Ammonia levels (including peptidyl arginine deiminase activity) were evaluated by colorimetric assay and the presence of Porphyromonas gingivalis, Tannerella forsythia, and Prevotella intermedia was evaluated by polymerase chain reaction (PCR) technique. After a multivariate analysis, adjusting for clinical and serological parameters, a significant association was only observed between severe periodontitis and probing depth with high RA disease activity. Additionally, in contrast to P. gingivalis, the presence of T. forsythia was significantly associated with high disease RA activity even after multivariable adjustment analysis. There was also a significant increase in ammonium levels in the high RA activity group and a significant correlation between salivary ammonia and RA disease activity but not with autoantibody titers. Similarly, we observed a significant increase in the ammonium levels derived from the cultures of P. gingivalis and T. forsythia, with respect to P. intermedia and S. gordonii cultures, or even healthy donors. These results suggest that RA activity is associated with severe periodontitis, high salivary ammonium levels and the presence of T. forsythia.
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OBJECTIVE: To evaluate the association between the clinical activity of RA patients and serum adipocytokines (Leptin, Adiponectin and Resistin) and inflammatory cytokines. METHODS: All RA patients fulfilled ACR 1987 criteria and were treated with DMARDs. Adipocytokine and inflammatory cytokine levels were evaluated using ELISA. RESULTS: 121 patients were included in the study. Stratifying according to DAS28 (low, moderate and high activity), there were significant differences for Leptin, Resistin, IL-6 and IL-17, however, no differences were seen for Adiponectin, TNFα or IL-1ß. Clinical activity positively correlated with Leptin, Resistin, IL-17 and IL-6 levels, but not with Adiponectin, TNFα or IL-1ß. Adiponectin levels negatively correlated with TNFα and positively correlated with IL-1ß. IL-1ß positively correlated with IL-6 and negatively correlated with TNFα and IL-17. CONCLUSION: Circulating Leptin, Resistin, IL-6 and IL-17 levels positively correlate with RA clinical activity in a manner independent of the subject's BMI. Complex relationships between inflammatory cytokines were observed in RA patients suggesting that other metabolic or inflammatory factors could be involved.
Asunto(s)
Adiponectina/sangre , Artritis Reumatoide/diagnóstico , Citocinas/sangre , Leptina/sangre , Resistina/sangre , Adolescente , Adulto , Anciano , Antirreumáticos/uso terapéutico , Artritis Reumatoide/sangre , Artritis Reumatoide/tratamiento farmacológico , Biomarcadores/sangre , Estudios Transversales , Ensayo de Inmunoadsorción Enzimática , Femenino , Humanos , Masculino , México , Persona de Mediana Edad , Índice de Severidad de la Enfermedad , Adulto JovenRESUMEN
Antecedentes: El presente artículo muestra la evidencia y recomendaciones de la eficacia y seguridad de las terapias hasta hoy aprobadas y disponibles en México para el tratamiento de la osteoporosis en su etapa severa o establecida, con la finalidad de establecer una postura terapéutica acerca de la eficacia y seguridad para esta etapa del padecimiento, de acuerdo con las cédulas descriptivas del Cuadro Básico y Catálogo de Medicamentos del Sector Salud en México. Métodos: Se realizó una revisión sistemática y narrativa de la evidencia de teriparatida y denosumab, desde su perfil farmacológico, efectividad y seguridad derivado de ensayos clínicos, además de un análisis de las recomendaciones generales de las principales guías de práctica clínica nacionales e internacionales. Resultados: La evidencia establece que teriparatida y denosumab pertenecen a clases terapéuticas distintas, con mecanismos de acción biológicamente opuestos e indicaciones de uso claramente diferenciadas en sus respectivas cédulas, por lo cual no son sustituibles ni intercambiables en la terapia de osteoporosis severa. Ambas representan la mejor opción disponible hasta el momento para esta etapa del padecimiento. Son similares en su eficacia de prevención de nuevas fracturas vertebrales por fragilidad, con un RR de 0,35 (IC 95%: 0,22-0,55) para teriparatida, y de 0,32 (IC 95%: 0,26-0,41) para denosumab. La reducción absoluta del riesgo es mayor con teriparatida 9,3% (21 meses) que con denosumab 4,8% (36 meses). Conclusiones: Nuestros resultados concuerdan con las recomendaciones disponibles en las principales guías de práctica clínica nacionales e internacionales, por lo que son propuestas ambas terapias como consecutivas y nunca como sustitutivas.(AU)
Background: This article presents evidence and recommendations regarding the efficacy and safety of the approved and available therapies in Mexico to treat severe or established osteoporosis with the aim of developing a position regarding therapeutics in this stage of the disease, according to the descriptive cards of the National Drug Formulary of the National General Health Council of Mexico. Methods: We performed a systematic and narrative review of the evidence of teriparatide and denosumab, from their pharmacological profile, effectiveness, and safety derived from clinical trials, as well as an analysis of the general recommendations of the national and international clinical practice guidelines. Results: The evidence establishes that teriparatide and denosumab belong to different therapeutic classes, with biologically opposed mechanisms of action and indications of use, which are clearly differentiated in their respective national codes, therefore these drugs cannot be substitutable or interchangeable in severe osteoporosis therapy. Both represent the best options currently available for this stage of the disease; being similar in their efficacy in preventing new vertebral fragility fractures, with an RR of .35 (CI 95%; .22-.55) for teriparatide, and .32 (CI 95%: .26-.41) for denosumab. The absolute risk reduction is higher with teriparatide 9.3% (21 months) compared with denosumab at 4.8% (36 months). Conclusions: Our results agree with the recommendations available in national and international clinical practice guidelines, with both therapies proposed as a sequential, but not a substitute, treatment.(AU)
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Humanos , Osteoporosis/tratamiento farmacológico , Denosumab , Fracturas Osteoporóticas , México , Reumatología , Enfermedades ReumáticasRESUMEN
Existen varias guías de práctica clínica tanto nacionales como internacionales para el tratamiento del lupus eritematoso sistémico. No obstante, la mayoría de las guías disponibles no están diseñadas para población mexicana o solamente son para el manejo de manifestaciones específicas como nefritis lúpica o para algún estado fisiológico como el embarazo. El Colegio Mexicano de Reumatología se propuso elaborar unas guías de práctica clínica que conjuntaran la mayor parte de las manifestaciones de la enfermedad y que incluyeran adicionalmente pautas en situaciones controversiales como lo son la vacunación y el periodo perioperatorio. En el presente documento se presenta la «Guía de práctica clínica para el manejo del lupus eritematoso sistémico» propuesta por el Colegio Mexicano de Reumatología, que puede ser de utilidad principalmente a médicos no reumatólogos que se ven en la necesidad de tratar a pacientes con lupus eritematoso sistémico sin tener la formación de especialistas en reumatología. En esta guía se presentan recomendaciones sobre el manejo de manifestaciones generales, articulares, renales, cardiovasculares, pulmonares, neurológicas, hematológicas, gastrointestinales, respecto a la vacunación y al manejo perioperatorio
There are national and international clinical practice guidelines for systemic lupus erythematosus treatment. Nonetheless, most of them are not designed for the Mexican population or are devoted only to the treatment of certain disease manifestations, like lupus nephritis, or are designed for some physiological state like pregnancy. The Mexican College of Rheumatology aimed to create clinical practice guidelines that included the majority of the manifestations of systemic lupus erythematosus, and also incorporated guidelines in controversial situations like vaccination and the perioperative period. The present document introduces the «Clinical Practice Guidelines for the Treatment of Systemic Lupus Erythematosus» proposed by the Mexican College of Rheumatology, which could be useful mostly for non-rheumatologist physicians who need to treat patients with systemic lupus erythematosus without having the appropriate training in the field of rheumatology. In these guidelines, the reader will find recommendations on the management of general, articular, kidney, cardiovascular, pulmonary, neurological, hematologic and gastrointestinal manifestations, and recommendations on vaccination and treatment management during the perioperative period
Asunto(s)
Humanos , Lupus Eritematoso Sistémico/tratamiento farmacológico , Enfermedades Reumáticas/tratamiento farmacológico , Lupus Eritematoso Sistémico/complicaciones , México/epidemiología , Pautas de la Práctica en MedicinaRESUMEN
Objective. To evaluate the association between the clinical activity of RA patients and serum adipocytokines (Leptin, Adiponectin and Resistin) and inflammatory cytokines. Methods. All RA patients fulfilled ACR 1987 criteria and were treated with DMARDs. Adipocytokine and inflammatory cytokine levels were evaluated using ELISA. Results. 121 patients were included in the study. Stratifying according to DAS28 (low, moderate and high activity), there were significant differences for Leptin, Resistin, IL-6 and IL-17, however, no differences were seen for Adiponectin, TNFα or IL-1β. Clinical activity positively correlated with Leptin, Resistin, IL-17 and IL-6 levels, but not with Adiponectin, TNFα or IL-1β. Adiponectin levels negatively correlated with TNFα and positively correlated with IL-1β. IL-1β positively correlated with IL-6 and negatively correlated with TNFα and IL-17. Conclusion. Circulating Leptin, Resistin, IL-6 and IL-17 levels positively correlate with RA clinical activity in a manner independent of the subject's BMI. Complex relationships between inflammatory cytokines were observed in RA patients suggesting that other metabolic or inflammatory factors could be involved (AU)
Objetivo. Evaluar la asociación entre la actividad clínica de pacientes con Artritis reumatoide y adipocitocinas séricas (Leptina, Adiponectina y Resistina), citocinas inflamatorias (TNFα, IL-1β, IL-6, IFNγ e IL-17A). Métodos. Se seleccionaron pacientes con AR (ACR 1987) tratados con FARMEs. Los niveles de adipocitocinas y citocinas inflamatorias fueron evaluados por ELISA. Resultados. 121 pacientes se incluyeron en el estudio. La actividad clínica correlacionó positivamente con Leptina, Resistina, IL-6 e IL-17 pero no para Adiponectina, TNFα o IL-1β. Los niveles de Adiponectina se asociaron negativamente con TNFα y positivamente con IL-1β. Por su parte, IL-1β se asoció de manera positiva con IL-6 y negativamente con TNFα e IL-17. Conclusión. Los niveles circulantes de Leptina, Resistina, IL-6 e IL-17 se asociaron de manera positiva con la actividad clínica de pacientes con AR, independientemente del índice de masa corporal (IMC). Asimismo, en los pacientes con AR se observaron asociaciones complejas entre las adipocitocinas y citocinas, sugiriendo que otros factores tanto metabólicos como inflamatorios pudieran estar involucrados (AU)
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Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Artritis Reumatoide/diagnóstico , Biomarcadores/análisis , Biomarcadores/sangre , Leptina/análisis , Leptina/sangre , Adiponectina/análisis , Adiponectina/sangre , Citocinas/análisis , Citocinas/sangre , Ensayo de Inmunoadsorción Enzimática/instrumentación , Ensayo de Inmunoadsorción Enzimática/métodos , Índice de Masa Corporal , México/epidemiología , Protocolos Clínicos , Análisis de VarianzaRESUMEN
Raynaud's phenomenon is characterized by repeated daily attacks of ischemia followed by reperfusion at the acrallevel. It is a frequent syndrome found in medical practice; and it can be considered as primary or secondary to other conditions, including rheumatic autoimmune diseases. Current classification had clinical and therapeutic implications. Careful clinical evaluation is the most reliable and reproducible method in the diagnosis of Raynaud's phenomenon. Several risk factors had been associated in the genesis of Raynaud's phenomenon; however, its pathogenesis remains elusive although recently, considerable progress in disease mechanism had been described. Such advances are directing new lines of therapy.
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El fenómeno de Raynaud se caracteriza por ataques isquémicos seguidos de vasodilatación de las zonas distales del cuerpo. Es una condición clínica frecuente en la práctica médica diaria; puede ser primario o asociado a diversas enfermedades, como las enfermedades reumáticas autoinmunitarias. Esta clasificación tiene implicaciones clínicas y terapéuticas. La revisión clínica cuidadosa del paciente es la forma más fiable y reproducible para el diagnóstico; otros métodos usados,sin embargo, se encuentran en el área experimental.Diversos factores de riesgo han sido involucrados en el desarrollo del fenómeno de Raynaud; no obstante, su patogenia no se ha dilucidado completamente, aunque es cierto que se ha descrito recientemente avances en su comprensión. Estos mecanismos descritos han impactado directamente en el desarrollo de nuevas terapias para el control de la enfermedad (AU)
Raynauds phenomenon is characterized by repeated daily attacks of ischemia followed by reperfusion at the a crallevel. It is a frequent syndrome found in medical practice;and it can be considered as primary or secondary to other conditions, including rheumatic autoimmune diseases.Current classification had clinical and therapeutic implications. Careful clinical evaluation is the most reliable and reproducible method in the diagnosis of Raynauds phenomenon. Several risk factors had been associated in the genesis of Raynauds phenomenon; however, its pathogenesis remains elusive although recently, considerable progress in disease mechanism had been described. Such advances are directing new lines of therapy (AU)