ABSTRACT
INTRODUCTION: The identification, diagnosis, follow-up, and treatment of patients with secondary progressive multiple sclerosis (SPMS) show significant differences between health care professionals in Argentina. AIM: To provide consensus recommendations on the management of patients with SPMS in Argentina to optimize patient care. DEVELOPMENT: A panel of expert neurologists from Argentina dedicated to the diagnosis and care of multiple sclerosis patients gathered during 2019 and 2020 to carry out a consensus recommendation on the diagnosis and treatment of SPMS patients in Argentina. To achieve consensus, the methodology of 'formal consensus-RAND/UCLA method' was used. Recommendations were established based on published evidence and the expert opinion. Recommendations focused on how to define SPMS and how to follow SPMS patients. CONCLUSION: The recommendations of this consensus guidelines attempt to optimize the care of SPMS patients in Argentina.
TITLE: Consenso sobre la identificación y seguimiento de la esclerosis múltiple secundaria progresiva en Argentina.Introducción. Existen diferencias significativas en el diagnóstico, la identificación y el seguimiento de pacientes con esclerosis múltiple secundaria progresiva (EMSP) entre los profesionales de la salud a cargo de su tratamiento. Objetivo. Proveer recomendaciones sobre el tratamiento de los pacientes con EMSP en Argentina con el fin de optimizar su cuidado. Desarrollo. Un grupo de neurólogos expertos en esclerosis múltiple de Argentina elaboró un consenso para el tratamiento de pacientes con EMSP en la región mediante metodología de ronda de encuestas a distancia y reuniones presenciales. Se establecieron 33 recomendaciones basadas en la evidencia publicada y en el criterio de los expertos que participaron. Las recomendaciones se enfocaron en el diagnóstico y el seguimiento de los pacientes con EMSP. Conclusión. Las recomendaciones establecidas en el presente consenso permitirían optimizar el cuidado y el seguimiento de los pacientes con EMSP en Argentina.
Subject(s)
Multiple Sclerosis, Chronic Progressive/diagnosis , Multiple Sclerosis, Chronic Progressive/therapy , Argentina , Humans , Practice Guidelines as TopicABSTRACT
In order to determine whether Blastoferon®, a biosimilar interferon (IFN)- beta 1a formulation, shares epitopes with other known IFN-beta products, a series of neutralization bioassays were performed with a set of well-characterized anti-IFN- beta monoclonal antibodies and human sera (World Health Organization Reference Reagents). The bioassay was the interferon-induced inhibition of virus cytopathic effect on human cells in culture (EMC virus and A-549 cells). Computer-calculated results were reported as Tenfold Reduction Units (TRU)/ml. To further assess Blastoferon® immunogenicity, in vivo production of anti-IFN beta antibodies was determined in sera of patients included in the pharmacovigilance plan of Blastoferon® by the level of IFN- beta 1a binding antibodies (by enzyme immunoassay -EIA) and neutralizing antibodies (in the Wish-VSV system). The highly characterized neutralizing monoclonal antibodies A1 and A5 that bind to specific regions of the IFN- beta molecule reacted positively with the three beta 1a IFNs: Blastoferon®, Rebif®, and the IFN- beta WHO Second International Standard 00/572. As expected, the non-neutralizing monoclonal antibodies B4 and B7 did not neutralize any of the IFN- beta preparations. The commercially available monoclonal antibody B-02 reacted essentially equally with Rebif® and Blastoferon®. The WHO Reference Reagent human serum anti-IFN- beta polyclonal antibody neutralized all the IFN- beta products, whereas the WHO Reference Reagent human serum anti-IFN-alpha polyclonal antibody G037-501-572 appropriately failed to react with any of the IFN- beta products. On the basis of in vitro reactivity with known, well-characterized monoclonal and polyclonal antibody preparations, Blastoferon® shares immunological determinants with other human interferon- beta products, especially IFN- beta 1a. In vivo antibodies were detected by EIA in 72.9% of 37 chronically treated multiple sclerosis patients, whereas neutralizing antibodies were found in 8.1% of them. Blastoferon® appears to have immunological characteristics comparable to other IFN- beta 1a products.
Subject(s)
Adjuvants, Immunologic , Epitopes , Interferon-beta/immunology , Antibodies, Monoclonal , Antibodies, Neutralizing/blood , Cell Line, Tumor , Cytopathogenic Effect, Viral/drug effects , Encephalomyocarditis virus/drug effects , Encephalomyocarditis virus/pathogenicity , Enzyme-Linked Immunosorbent Assay , Epitope Mapping , Humans , Interferon beta-1a , Interferon beta-1b , Interferon-beta/therapeutic use , Multiple Sclerosis/drug therapy , Multiple Sclerosis/immunology , Neutralization TestsABSTRACT
Switching treatment may be beneficial in patients with relapsing-remitting multiple sclerosis (RRMS) who respond inadequately to first-line immunomodulatory therapy. The objective of this study was to evaluate clinical outcomes after switching treatment in such patients. This prospective longitudinal observational study included 114 patients with RRMS who failed first-line monotherapy and were switched treatments after 3 years. Every 3 months, patients underwent a full neurological examination. Outcome was compared between the 3-year Before Switch and After Switch treatment periods. The primary outcome measure was the annualized relapse rate; secondary outcome measures were the proportion of relapse-free patients and the median change in Expanded Disability Status Scale (EDSS). Patients were switched either from low-dose to high-dose interferon-beta (IFNbeta; n = 31), from IFNbeta to glatiramer acetate (GA; n = 52) or mitoxantrone (n = 13), or from GA to IFNbeta (n = 16). In 3 years after switching, annualized relapse rates fell by 57-78% according to the group. The proportion of relapse-free patients varied from 56% to 81%. Least improved was observed in patients switching between INFbeta preparations. Median EDSS scores remained stable in all groups except the GA to IFNbeta switchers. In conclusion, patients who fail first-line immunomodulatory therapy generally benefit from switching to another class of immunomodulatory therapy.
Subject(s)
Immunologic Factors/therapeutic use , Multiple Sclerosis, Relapsing-Remitting/drug therapy , Multiple Sclerosis, Relapsing-Remitting/immunology , Adult , Argentina/epidemiology , Disability Evaluation , Female , Glatiramer Acetate , Humans , Interferon-beta/therapeutic use , Longitudinal Studies , Male , Middle Aged , Mitoxantrone/therapeutic use , Neurologic Examination , Peptides/therapeutic use , Time Factors , Treatment OutcomeABSTRACT
Este trabajo neuroepidemiológico se llevó a cabo en un grupo de pacientes diagnosticados en forma fehaciente como afecciones vasculares del encéfalo y del circuito Vértebro Basilar Cerebral Posterior. nuestro pacientes nos han permitido construir una visión ampliada del perfil clínico en relación a la topografía lesional y a los mecanismos fisiopatogénicos. Y no nos ajustamos sólo a lo prescripto en 1975 por el comité Ad Hoc. Nuestra propuesta ampliatoria se basa en considerar al circuito posterior sobre un eje que comprenda a las arterias Vertebral - Basilar - Cerebral posterior y bajo el concepto de las manifestaciones clínicas fundadas en las definiciones del Comité Ad Hoc para Stroke y los datos que se agregaron al integrar a la arteria Cerebral Posterior. La estrategia del Meta-análisis nos ha permitido desarrollar la idea de la importancia que poseen signos o síntomas CENTINELAS o de SOSPECHA en un grupo etareo de alto riesgo por ser gerontes y portadores de cardiopatías embolígenas, hipertensión arterial, dislipemias y/o diabetes. Descubrir a sospechosos con datos subclínicos o pausisintomáticos, dentro del perfil de sindromes vasculares agudos o crónicos y enmarcados en una filosofía que priorice el diagnóstico temprano para evitar la lesión estructural incapacitante, redundará en una más alta calidad de vida para el geronte y un mejor control sanitario para la tercera edad
Subject(s)
Humans , Male , Female , Adult , Middle Aged , Vertebrobasilar Insufficiency/diagnosis , Cerebrovascular Disorders/diagnosis , Vertebrobasilar Insufficiency/epidemiology , Cerebral Arterial Diseases/epidemiology , Cerebrovascular Disorders/epidemiologyABSTRACT
Este trabajo neuroepidemiológico se llevó a cabo en un grupo de pacientes diagnosticados en forma fehaciente como afecciones vasculares del encéfalo y del circuito Vértebro Basilar Cerebral Posterior. nuestro pacientes nos han permitido construir una visión ampliada del perfil clínico en relación a la topografía lesional y a los mecanismos fisiopatogénicos. Y no nos ajustamos sólo a lo prescripto en 1975 por el comité Ad Hoc. Nuestra propuesta ampliatoria se basa en considerar al circuito posterior sobre un eje que comprenda a las arterias Vertebral - Basilar - Cerebral posterior y bajo el concepto de las manifestaciones clínicas fundadas en las definiciones del Comité Ad Hoc para Stroke y los datos que se agregaron al integrar a la arteria Cerebral Posterior. La estrategia del Meta-análisis nos ha permitido desarrollar la idea de la importancia que poseen signos o síntomas CENTINELAS o de SOSPECHA en un grupo etareo de alto riesgo por ser gerontes y portadores de cardiopatías embolígenas, hipertensión arterial, dislipemias y/o diabetes. Descubrir a sospechosos con datos subclínicos o pausisintomáticos, dentro del perfil de sindromes vasculares agudos o crónicos y enmarcados en una filosofía que priorice el diagnóstico temprano para evitar la lesión estructural incapacitante, redundará en una más alta calidad de vida para el geronte y un mejor control sanitario para la tercera edad (AU)
