Security of the Combined Treatment of Methotrexate and Leflunomidc in Patients with Rheumatoid Arthritis

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Rheumatoid Arthritis (RA) is a chronic  discase leacling to functional impairrncnt and early mortality. Treatment with diseasernodifying antirheumat.ic drugs have shown to achicvc disease remission and improves its evolution. The use of combined therapy should have a biological efficacy, no increase...

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Autores principales: Nesa, L, Gobbi, Carla Andrea, Alba, Paula, Exeni, Ida Elena, Babini, Alejandra, Albiero, Eduardo Horacio
Formato: Artículo revista
Lenguaje:Español
Publicado: Universidad Nacional Cba. Facultad de Ciencias Médicas. Secretaria de Ciencia y Tecnología 2019
Acceso en línea:https://revistas.unc.edu.ar/index.php/med/article/view/25431
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Revistas de la UNC de Universidad Nacional de Córdoba
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container_title_str Revistas de la UNC
language Español
format Artículo revista
author Nesa, L
Gobbi, Carla Andrea
Alba, Paula
Exeni, Ida Elena
Babini, Alejandra
Albiero, Eduardo Horacio
spellingShingle Nesa, L
Gobbi, Carla Andrea
Alba, Paula
Exeni, Ida Elena
Babini, Alejandra
Albiero, Eduardo Horacio
Security of the Combined Treatment of Methotrexate and Leflunomidc in Patients with Rheumatoid Arthritis
author_facet Nesa, L
Gobbi, Carla Andrea
Alba, Paula
Exeni, Ida Elena
Babini, Alejandra
Albiero, Eduardo Horacio
author_sort Nesa, L
title Security of the Combined Treatment of Methotrexate and Leflunomidc in Patients with Rheumatoid Arthritis
title_short Security of the Combined Treatment of Methotrexate and Leflunomidc in Patients with Rheumatoid Arthritis
title_full Security of the Combined Treatment of Methotrexate and Leflunomidc in Patients with Rheumatoid Arthritis
title_fullStr Security of the Combined Treatment of Methotrexate and Leflunomidc in Patients with Rheumatoid Arthritis
title_full_unstemmed Security of the Combined Treatment of Methotrexate and Leflunomidc in Patients with Rheumatoid Arthritis
title_sort security of the combined treatment of methotrexate and leflunomidc in patients with rheumatoid arthritis
description Rheumatoid Arthritis (RA) is a chronic  discase leacling to functional impairrncnt and early mortality. Treatment with diseasernodifying antirheumat.ic drugs have shown to achicvc disease remission and improves its evolution. The use of combined therapy should have a biological efficacy, no increased toxicity and have an acceptable dose interval. Also, it shoulcl begin its action quickly and he cost-effective. Aims: to assess the security of the combinen treatment withMethotrexate (MTX) and Leflunomide (LF) in patients with Rheurnatoid Arthritis (RA) and to evaluate whethcr the dose and route of MTX administration influence on the toxicity. Patients and Methocls: Patients with RA who fulfihlecl ACR entena and they attencled to the Rheumatology Unit at Córdoba Hospital in the Iast 2 years were assessed. All the patients that received combined treatment with MTX in doses from 7.5 mg to 25 mg weekly orally (PO) orintramuscularly (TM) that started LF treatment in doses of 20 mg/day due to disease activity persistericc were retrospectively assessed.Patients having at least 6 months of combined treatment were inclucled. Data ontreatment and adverse events were collected. They were evaluated at the hegirining, at 6 and 12 months of treatment. The presence of adverse events as well as the stop of combined treatment was evaluated at 6 and 12 months 01treatment. Adverse events in patients with oral and IM MTX treatment and in different doses were compared for the analyses. P<0.05 was considered significant. Results: 62 patients with a mean age of 54 were included. 89% were female and had positive rheumatoid factor and 83% had radiological erosions. Eighty eight percent were in doses of I5mg MTX, 4.9%with lomg and 2flrngattheheginning of LE treatment. Twentv four percent suffered from adverse events and 33% left the medication by 6 months. Among adverse events, 6 patients had cliarrhea, 5 increased hepatic enzymes, 3 alopecia, 3 weight loss, and2 had anemia and leucopenia. Eight patients stopped the medication in 6 months, but only 5 did because of adverse events. There was not significant statistical differcncc in adverse events hetween patients with different dose or routes of administration of MTX. Conclusions: The presence of adverse events in MTX and LF combined treatment was low and it developed dunng the first 6 months of treatment in our patients. The MTX route of administration and doses did not influence on the toxicity of the combined treatment with LF. The combinedtherapy seems to be a sale treatment option in RA patients.
publisher Universidad Nacional Cba. Facultad de Ciencias Médicas. Secretaria de Ciencia y Tecnología
publishDate 2019
url https://revistas.unc.edu.ar/index.php/med/article/view/25431
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spelling I10-R10-article-254312019-09-23T17:51:50Z Security of the Combined Treatment of Methotrexate and Leflunomidc in Patients with Rheumatoid Arthritis Seguridad del tratamiento combinado de metotrexato y leflunomida en pacientes con artritis reumatoidea. Nesa, L Gobbi, Carla Andrea Alba, Paula Exeni, Ida Elena Babini, Alejandra Albiero, Eduardo Horacio Rheumatoid Arthritis (RA) is a chronic  discase leacling to functional impairrncnt and early mortality. Treatment with diseasernodifying antirheumat.ic drugs have shown to achicvc disease remission and improves its evolution. The use of combined therapy should have a biological efficacy, no increased toxicity and have an acceptable dose interval. Also, it shoulcl begin its action quickly and he cost-effective. Aims: to assess the security of the combinen treatment withMethotrexate (MTX) and Leflunomide (LF) in patients with Rheurnatoid Arthritis (RA) and to evaluate whethcr the dose and route of MTX administration influence on the toxicity. Patients and Methocls: Patients with RA who fulfihlecl ACR entena and they attencled to the Rheumatology Unit at Córdoba Hospital in the Iast 2 years were assessed. All the patients that received combined treatment with MTX in doses from 7.5 mg to 25 mg weekly orally (PO) orintramuscularly (TM) that started LF treatment in doses of 20 mg/day due to disease activity persistericc were retrospectively assessed.Patients having at least 6 months of combined treatment were inclucled. Data ontreatment and adverse events were collected. They were evaluated at the hegirining, at 6 and 12 months of treatment. The presence of adverse events as well as the stop of combined treatment was evaluated at 6 and 12 months 01treatment. Adverse events in patients with oral and IM MTX treatment and in different doses were compared for the analyses. P<0.05 was considered significant. Results: 62 patients with a mean age of 54 were included. 89% were female and had positive rheumatoid factor and 83% had radiological erosions. Eighty eight percent were in doses of I5mg MTX, 4.9%with lomg and 2flrngattheheginning of LE treatment. Twentv four percent suffered from adverse events and 33% left the medication by 6 months. Among adverse events, 6 patients had cliarrhea, 5 increased hepatic enzymes, 3 alopecia, 3 weight loss, and2 had anemia and leucopenia. Eight patients stopped the medication in 6 months, but only 5 did because of adverse events. There was not significant statistical differcncc in adverse events hetween patients with different dose or routes of administration of MTX. Conclusions: The presence of adverse events in MTX and LF combined treatment was low and it developed dunng the first 6 months of treatment in our patients. The MTX route of administration and doses did not influence on the toxicity of the combined treatment with LF. The combinedtherapy seems to be a sale treatment option in RA patients. La Artritis Reumatoidea (AR) es una enfermedad crónica que conduce a la incapacidad funcional y mortalidad prematura.El tratamiento con drogas antirreumáticas modificadoras de la enfermedad (DMARD) han demostrado lograr remisión de la enfermedad y modificar su evolución. El uso de terapia combinada debiera lograr eficacia biológica,no aumentar la toxicidad, tener un intervalo de dosis aceptable, comienzo rápido de la acción, y ser costo efectivo.Objetivos: -Evaluar la seguridad del tratamiento combinado de Metotrexato (Mlix)y Leflunomida (LF) en pacientes con AR, y si la dosis y la vía de administración de MTX influencian la toxicidad.Pacientes y Métodos: Se evaluaron retrospectivamente 62 pacientes con diagnóstico de AR según criterios ACR asistidos en la unidad de reumatología del Hospital Córdoba en los dos últimos años que recibieron tratamiento combinado con MTX en dosis de 7.5 mg a 25 mg por semana por vía oral (yO) o intramuscular (IM) que comenzaron el tratamiento con LF a dosis de 20 mg ¡día por persistencia de actividad de la enfermedad.Se incluyeron pacientes que tuvieran al menos 6 meses de tratamiento  combinado.Se recolectaron datos sobre el tratamiento y eventos adversos al comienzo, a los 6 meses y al año del tratamiento. Se evaluó la presencia de eventos  adversos así como la necesidad de suspensión de la droga a los 6 y 12 meses deltratamiento. Para el análisis se comparó la presencia de eventos adversos en los pacientes con MIXVO e IM ya diferentes dosis. Un valor p<0.05 fue considerado significativo. Resultados: La edad promedio fue de 54 años. El 89% eran de sexo femenino ycon factor reumatoide positivo y un 83% presentaban erosiones en las  radiografías de manos y pies. El 88% estaba con dosis de 15 mg MTX, 4.9% con lomg y 25 mg alcomenzar con LF. El 24% presentó eventos adversos y el 33% abandonó la medicación a los 6 meses. Dentro de los eventos adversos: 6 pacientes presentaron diarrea, 5 elevación de enzimas hepáticas, 3 alopecia, 3 pérdida de peso, 2 anemia y leucopenia. 8 pacientes abandonaron la medicación a los 6 meses, pero sólo .5 lo hicieron por eventos adversos.El 16% abandonó la medicación a los 12 meses pero ninguno de éstos fue por eventos adversos. La presencia de eventos adversos o la suspensión de la medicación no fue relacionada a la dosis ni la vía de administración del MTX. Conclusiones: La frecuencia de eventos adversos en el tratamiento combinado con MTX y LF fue baja y se produjo en los primeros 6 meses de tratamiento en nuestros pacientes. La dosis y la vía de administración del MTX no influenciaron la toxicidad en el tratamiento combinado con LF. La terapia combinada deestas drogas ofrece un perfil de seguridad aceptable Universidad Nacional Cba. Facultad de Ciencias Médicas. Secretaria de Ciencia y Tecnología 2019-09-23 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion application/pdf https://revistas.unc.edu.ar/index.php/med/article/view/25431 Revista de la Facultad de Ciencias Médicas de Córdoba.; Vol. 64 No. 4 (2007); 109-114 Revista de la Facultad de Ciencias Médicas de Córdoba; Vol. 64 Núm. 4 (2007); 109-114 Revista da Faculdade de Ciências Médicas de Córdoba; v. 64 n. 4 (2007); 109-114 1853-0605 0014-6722 10.31053/1853.0605.v64.n4 spa https://revistas.unc.edu.ar/index.php/med/article/view/25431/24688 Derechos de autor 2019 Universidad Nacional de Córdoba

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