Publication: Comparación de la eficacia de los fármacos inmunomoduladores indicados para el tratamiento de la esclerosis múltiple
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2015-06
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Abstract
Resumen: Introducción y Objetivos: La Esclerosis Múltiple (EM) es una enfermedad desmielinizante progresiva de carácter autoinmune con un alto impacto en la sociedad. Actualmente se trata con medicamentos inmunomoduladores parenterales y terapias orales recientemente instauradas, de las cuales es necesario estudiar su conveniencia para la actualización de los protocolos médicos. Además, hay dos fármacos parenterales usados en la EM muy activa, que son Tysabri y Gilenya. Metodología: El método de obtener las diversas variables a analizar es la lectura de las fichas técnicas, informes públicos de evaluación, y ensayos clínicos pivotales de los fármacos actuales. Se realizan una serie de tablas con el programa Microsoft Excel de cada fármaco individual y una tabla comparativa con las variables más significativas para la eficacia adicionando información complementaria de otros valores clave. Resultados: La tasa anual de recidivas (TAR) de los nuevos fármacos orales presenta una diferencia con placebo de aproximadamente 0,2 puntos, mientras que los parenterales de aproximadamente 0,3 puntos y en torno a 0,5 los indicados para EM muy activa. Algunos estudios de especial importancia serían: el estudio TENERE, que enfrentó Aubagio contra Rebif y cuyo principal objetivo fue el riesgo de fallo de tratamiento, aunque no obtuvo valores estadísticamente significativos; el estudio TRANSFORMS demostró una disminución de TAR de Gilenya(0,33) frente a Rebif (0,16). El estudio CONFIRM enfrentó indirectamente Tecfidera y Copaxone, obteniendo en ambos una disminución similar de 0,4 a 0,22 en el primer caso y 0,4 a 0,28 en el segundo. Los efectos adversos más comunes fueron de tipo infeccioso, y los más graves se consideraron manejables (excepto en Tecfidera que se recomienda control analítico y en Tysabri vigilancia de la aparición de leucopatia multifocal progresiva). Copaxone, Rebif, Betaferon y Avonex (fármacos parenterales) incluyen frecuentemente problemas de administración, y síntomas gripales que suelen mejorar con el uso. El precio del tratamiento con Copaxone, Rebif, Betaferon y Avonex es aproximadamente 500 euros/mes menos que Aubagio y Tecfidera y 1000 euros/mes menos que Tysabri y Gilenya. Discusión y Conclusión: En la mayoría los ensayos comparados se enfrenta el fármaco en estudio frente a placebo; esto supone dos problemas: en primer lugar el problema ético que plantea tratar con placebo habiendo alternativas terapéuticas y en segundo lugar, en los ensayos clínicos estudiados no se enfrentan de manera directa los fármacos, y su validez es cuestionable. Aún así, la diferencia que pudiera haber entre la eficacia de los fármacos orales y los parenterales está salvada por la considerable mejora en la calidad de vida de los pacientes, justificando, en su caso, el cambio de tratamiento.
Introduction and objectives: Multiple Sclerosis (MS) is a progressive autoimmune, inflammatory neurological disease of the central nervous system that causes demyelization. This disease has a high impact in our society. Currently, is treated with parenteral immunomodulatory drugs and recently put in place, oral therapies that make necessary to study their suitability in order to update treatment protocols. Specifically, Tysabri and Gilenya treat active MS Methods: The way to get the variables was reading data sheets, public evaluation reports, and pivotal trials of the drugs. We made tables with Microsoft Excel program of each individual drug and a comparative table with the most significant variables and other key factors Results The annualizes relapse rate (ARR) of the new oral drugs have approximately a difference of 0.2 points against placebo whereas parenteral conventional drugs about 0.3 and about 0.5 the drugs for the activated MS. The primary composite endpoint of the TENERE trail was time to failure of Aubagio against Rebif. No difference was observed between these two drugs. TRANSFORMS trail demonstrated a decrease in the ARR of Gilenya (0.33) against Rebif (0.16). CONFIRM trail indirectly compared tecfidera and copaxone, showing, in both case, a decrease of ARR: from 0.4 to 0.22 and a 0.4 to 0.28 respectively. More common side effects were infections; and the the most damaging were manageable (excluding Tecfidera, in which is recomendated an analytical control and in Tysabri that can cause a multifocal progressive leucopaty). Copaxone, Rebif, Betaferon and Avonex (parenteral drugs) usually cause way administration problems and flu symptoms that usually get better with use. The price is approximately 500€ per month cheaper in Rebif, Betaferon, Copaxone and Avonex than in Aubagio and Tecfidera, and 1000€ per month cheaper than Tysabri and Gilenya. Discussion and conclusion: in most trails compared, the drug is study against placebo; that leads us to two problems: in first place the ethical problem of using placebo to treat any disease having therapeutic alternatives commercialized; and secondly, the drugs are not directly compared, so its validity is questionable. Despite these questions, the difference that may exist between the effectiveness of oral and parenteral drug is saved by the considerable improvement in the quality of life of patients, so the change of treatment could be justified.
Introduction and objectives: Multiple Sclerosis (MS) is a progressive autoimmune, inflammatory neurological disease of the central nervous system that causes demyelization. This disease has a high impact in our society. Currently, is treated with parenteral immunomodulatory drugs and recently put in place, oral therapies that make necessary to study their suitability in order to update treatment protocols. Specifically, Tysabri and Gilenya treat active MS Methods: The way to get the variables was reading data sheets, public evaluation reports, and pivotal trials of the drugs. We made tables with Microsoft Excel program of each individual drug and a comparative table with the most significant variables and other key factors Results The annualizes relapse rate (ARR) of the new oral drugs have approximately a difference of 0.2 points against placebo whereas parenteral conventional drugs about 0.3 and about 0.5 the drugs for the activated MS. The primary composite endpoint of the TENERE trail was time to failure of Aubagio against Rebif. No difference was observed between these two drugs. TRANSFORMS trail demonstrated a decrease in the ARR of Gilenya (0.33) against Rebif (0.16). CONFIRM trail indirectly compared tecfidera and copaxone, showing, in both case, a decrease of ARR: from 0.4 to 0.22 and a 0.4 to 0.28 respectively. More common side effects were infections; and the the most damaging were manageable (excluding Tecfidera, in which is recomendated an analytical control and in Tysabri that can cause a multifocal progressive leucopaty). Copaxone, Rebif, Betaferon and Avonex (parenteral drugs) usually cause way administration problems and flu symptoms that usually get better with use. The price is approximately 500€ per month cheaper in Rebif, Betaferon, Copaxone and Avonex than in Aubagio and Tecfidera, and 1000€ per month cheaper than Tysabri and Gilenya. Discussion and conclusion: in most trails compared, the drug is study against placebo; that leads us to two problems: in first place the ethical problem of using placebo to treat any disease having therapeutic alternatives commercialized; and secondly, the drugs are not directly compared, so its validity is questionable. Despite these questions, the difference that may exist between the effectiveness of oral and parenteral drug is saved by the considerable improvement in the quality of life of patients, so the change of treatment could be justified.