RESUMO
Introducción: El proyecto BIOBADASAR (Registro argentino deeventos adversos con tratamientos biológicos en reumatología)comenzó en agosto de 2010, para recabar información a largo plazosobre los eventos adversos en tratamientos biológicos en pacientescon enfermedades reumáticas en la práctica clínica cotidiana enArgentina.Pacientes y método: Se registraron datos de cada paciente,tratamientos y acontecimientos adversos relevantes o importantes.Los pacientes debían tener enfermedad diagnosticada y tratadacon un agente biológico. Cada caso se comparó con un control:un paciente con tratamiento no biológico con característicasdemográficas similares. Se analizaron los datos con análisis de lavarianza, con test de t de Student, Mann Whitney, test chi2, o testexacto de Fisher. El análisis de supervivencia de los tratamientoshasta su discontinuación o interrupción se realizó con el método deKaplan-Meier y test log-rank...
Background: BIOBADASAR (Argentine Registry of Adverse Eventsin Biological Treatments in Rheumatology) was started in August2010 to obtain long-term information of patients with rheumatic diseases,treatments and adverse events in everyday clinical practice.Patients and methods: Data on patients demographics,treatments and adverse events were collected. Patients had a diagnosisof a rheumatic disease and were treated with biological agent.To compare information, a control group was included, consisting ofpatients treated with similar demographic characteristics but treatedwith a non-biological agent. Data were analysed with Anova,Student´s t, Mann Whitney, chi2, Fisher´s exact tests, as appropriate.Survival analysis of treatments was performed with Kaplan-Meiercurves and log-rank test...
Assuntos
Tratamento Biológico , Doenças Reumáticas , ReumatologiaRESUMO
Introducción: BIOBADASAR (Registro Argentino de Eventos Adversos con Tratamientos Biológicos en Reumatología) comenzó en agosto de 2010. La importancia de este registro es mostrar datos locales que, probablemente, puedan diferir de otros registros. El objetivo es comunicar los resultados del tercer reporte de BIOBADASAR. Métodos: Todos los pacientes con enfermedades reumáticas que requirieron tratamiento con agentes biológicos y pacientes controles sin estos tratamientos fueron incluidos en la base de datos provenientes de 32 centros participando a lo largo de la Argentina. Tres áreas de datos son analizados: características de los pacientes, tratamientos y eventos adversos...
Introduction: BIOBADASAR (Argentine Registry of Adverse Events with Biological Treatments in Rheumatology) began in August 2010. The importance of this registry is to show local data that may probably differ from other registries. The objective is to communicate the results of the third BIOBADASAR report. Methods: All patients with rheumatic diseases who required treatment with biological agents and control patients without these treatments were included in the database from 32 participating centers throughout Argentina. Three areas of data are analyzed: patient characteristics, treatments and adverse events...
Assuntos
Tratamento Biológico , Doenças Reumáticas , ReumatologiaRESUMO
The objective of this study was to obtain post-marketing information about the use of infliximab in an ambulatory setting. We studied--retrospectively and prospectively--the case records of patients with rheumatoid arthritis (n=37), psoriatic arthritis (n=5), mixed connective tissue disease (n=1), and ankylosing spondylitis (n=2) who received infliximab (3 mg/kg) from August 2000 to January 2003. Descriptive values were given as percentage, mean or median, and standard deviation or interquartile range. Wilcoxon test was used for paired analysis of pre/post doses of corticosteroids, non-steroidal anti-inflammatory drugs, and methotrexate therapy. A p value < or = 0.05 was considered significant. Forty-five patients were included. A total of 207 infusions were administered. In 4 patients the treatment was permanently discontinued due to severe back pain during the infusion (2 cases) and serious anaphylactic reactions (2 cases). Other adverse reactions occurring during infusions were mild and successfully managed with standard treatment. A case of staphylococcal septic arthritis resolved with standard antibiotic treatment. No patient had evidence of active tuberculosis. One patient with rheumatoid arthritis and chronic renal insufficiency, received treatment with infliximab 1.9 mg/kg, every 30 days, with no changes in renal function. Due to improvement of symptoms, 14/39 (35.9%) patients could decrease the doses of corticosteroids, 15/43 (34.8%) decreased the doses of antiinflammatory drugs and 12/34 (35.3%) decreased methotrexate dosage. Although some questions remain to be elucidated, this case series shows the drug safety profile, the possibility to reduce concomitant drug doses, as well as individual approaches for situations where there are not yet guidelines available, so that rheumatologists have to make decisions based on clinical needs.
El objetivo de este estudio fue obtener informacion postmarketing sobre el uso de infliximab en un centro reumatologico de atencion ambulatoria. Se realizo un analisis retrospectivo y prospectivo de las historias clinicas de pacientes con diagnostico de artritis reumatoidea (n=37), artritis psoriasica (n=5),enfermedad mixta del tejido conectivo (n=1) y espondilitis anquilosante (n=2) que recibieron infliximab (3 mg/kg) desde agosto de 2000 a junio de 2003. El analisis descriptivo se realizo con porcentajes, media o medianay desviacion estandar o intervalo intercuartilo. La prueba de Wilcoxon se utilizo para el analisis apareado dedosis de antiinflamatorios no esteroideos y metotrexato, anterior y posterior a la administracion de infliximab. Se consideraron significativos valores de p < o = 0.05. Se incluyeron 45 pacientes a los que se les administraron un total de 207 infusiones. En 2 pacientes el infliximab se discontinuó debido a lumbalgia severa durante la infusion y en otros 2 por anafilaxia intrainfusional. Otras reacciones adversas ocurridas durante las infusiones fueron moderadas y respondieron adecuadamente al tratamiento estandar. Se presento un caso de artritis septica de rodilla por estafilococos. Un caso de artritis reumatoidea con insuficiencia renal compensada recibio infliximab en dosis de 1.9 mg/kg cada 30 dias, sin cambios en la funcion renal. Al momento, ningun paciente ha desarrollado tuberculosis activa. Debido a la mejoria clinica, se redujo la dosis de corticoides en 14/39 (35.9%) pacientes, de antiinflamatorios no esteroideos en 15/43 (34.8%) y de metotrexato en 12/34 (35.3%). En estaserie de casos se muestra el perfil de seguridad de infliximab, la posibilidad de reducir la dosis de drogas concomitantes,asi como algunos enfoques individuales sobre situaciones para las cuales no disponemos de guias basadas en la evidencia medica, y en las que los reumatologos debemos tomar decisiones segun las necesidades clinicas.
Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Antirreumáticos , Anticorpos Monoclonais/uso terapêutico , Artropatias/tratamento farmacológico , Doença Mista do Tecido Conjuntivo/tratamento farmacológico , Assistência Ambulatorial , Antirreumáticos , Anticorpos Monoclonais/efeitos adversos , Estudos Prospectivos , Proteína C-Reativa/análise , Estudos RetrospectivosRESUMO
The objective of this study was to obtain post-marketing information about the use of infliximab in an ambulatory setting. We studied--retrospectively and prospectively--the case records of patients with rheumatoid arthritis (n=37), psoriatic arthritis (n=5), mixed connective tissue disease (n=1), and ankylosing spondylitis (n=2) who received infliximab (3 mg/kg) from August 2000 to January 2003. Descriptive values were given as percentage, mean or median, and standard deviation or interquartile range. Wilcoxon test was used for paired analysis of pre/post doses of corticosteroids, non-steroidal anti-inflammatory drugs, and methotrexate therapy. A p value < or = 0.05 was considered significant. Forty-five patients were included. A total of 207 infusions were administered. In 4 patients the treatment was permanently discontinued due to severe back pain during the infusion (2 cases) and serious anaphylactic reactions (2 cases). Other adverse reactions occurring during infusions were mild and successfully managed with standard treatment. A case of staphylococcal septic arthritis resolved with standard antibiotic treatment. No patient had evidence of active tuberculosis. One patient with rheumatoid arthritis and chronic renal insufficiency, received treatment with infliximab 1.9 mg/kg, every 30 days, with no changes in renal function. Due to improvement of symptoms, 14/39 (35.9%) patients could decrease the doses of corticosteroids, 15/43 (34.8%) decreased the doses of antiinflammatory drugs and 12/34 (35.3%) decreased methotrexate dosage. Although some questions remain to be elucidated, this case series shows the drug safety profile, the possibility to reduce concomitant drug doses, as well as individual approaches for situations where there are not yet guidelines available, so that rheumatologists have to make decisions based on clinical needs.(AU)
El objetivo de este estudio fue obtener informacion postmarketing sobre el uso de infliximab en un centro reumatologico de atencion ambulatoria. Se realizo un analisis retrospectivo y prospectivo de las historias clinicas de pacientes con diagnostico de artritis reumatoidea (n=37), artritis psoriasica (n=5),enfermedad mixta del tejido conectivo (n=1) y espondilitis anquilosante (n=2) que recibieron infliximab (3 mg/kg) desde agosto de 2000 a junio de 2003. El analisis descriptivo se realizo con porcentajes, media o medianay desviacion estandar o intervalo intercuartilo. La prueba de Wilcoxon se utilizo para el analisis apareado dedosis de antiinflamatorios no esteroideos y metotrexato, anterior y posterior a la administracion de infliximab. Se consideraron significativos valores de p < o = 0.05. Se incluyeron 45 pacientes a los que se les administraron un total de 207 infusiones. En 2 pacientes el infliximab se discontinuó debido a lumbalgia severa durante la infusion y en otros 2 por anafilaxia intrainfusional. Otras reacciones adversas ocurridas durante las infusiones fueron moderadas y respondieron adecuadamente al tratamiento estandar. Se presento un caso de artritis septica de rodilla por estafilococos. Un caso de artritis reumatoidea con insuficiencia renal compensada recibio infliximab en dosis de 1.9 mg/kg cada 30 dias, sin cambios en la funcion renal. Al momento, ningun paciente ha desarrollado tuberculosis activa. Debido a la mejoria clinica, se redujo la dosis de corticoides en 14/39 (35.9%) pacientes, de antiinflamatorios no esteroideos en 15/43 (34.8%) y de metotrexato en 12/34 (35.3%). En estaserie de casos se muestra el perfil de seguridad de infliximab, la posibilidad de reducir la dosis de drogas concomitantes,asi como algunos enfoques individuales sobre situaciones para las cuales no disponemos de guias basadas en la evidencia medica, y en las que los reumatologos debemos tomar decisiones segun las necesidades clinicas.(AU)
Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Anticorpos Monoclonais/uso terapêutico , Antirreumáticos/uso terapêutico , Artropatias/tratamento farmacológico , Doença Mista do Tecido Conjuntivo/tratamento farmacológico , Assistência Ambulatorial , Anticorpos Monoclonais/efeitos adversos , Antirreumáticos/efeitos adversos , Proteína C-Reativa/análise , Estudos Prospectivos , Estudos RetrospectivosRESUMO
OBJECTIVE: It has been suggested that genotypic variation in the gene which encodes the matrilin-1 (MATN-1) protein may be involved in the development of hip osteoarthritis (OA). We compared genotype frequencies of the MATN-1 gene (1p35) in patients with OA and controls to determine if there is any association between the MATN-1 genotype and OA. METHODS: 73 OA patients and 53 controls from a rheumatology ambulatory center and a university hospital were studied. They were unrelated subjects. Controls were free of clinical OA. OA was defined according to the American College of Rheumatology criteria. The MATN-1 microsatellite in the 3'untranslated region was amplified by PCR. The size of the amplification products was determined by capilar electrophoresis in a DNA Genetic Analizer Genotypic distribution was compared by the chi2 test. RESULTS: We identified 4 alleles according to their basepair (bp) length: A1 = 110 bp; A2 = 108 bp; A3 = 106 bp and A6 = 104 pb. Six genotypes were found, with an observed heterozygosity of 0.48. The most frequent genotype in OA and controls was A1/A1 (43.8% and 43.4%, respectively). No significant difference in genotype distribution was found between OA - even when discriminating by the affected joint - and controls. CONCLUSION: We did not find any difference in the MATN-1 genotype distribution in OA patients and controls. To our knowledge, this would be the first time a MATN-1 allele of 104 bp (A6) has been identified These results do not support a role of the MATN-1 genotypes in the occurrence of clinical OA.
Assuntos
Proteínas da Matriz Extracelular/genética , Frequência do Gene , Predisposição Genética para Doença , Glicoproteínas/genética , Osteoartrite/genética , Proteína de Matriz Oligomérica de Cartilagem , DNA/análise , Feminino , Genótipo , Humanos , Masculino , Proteínas Matrilinas , Repetições de Microssatélites , Pessoa de Meia-Idade , Reação em Cadeia da PolimeraseRESUMO
We describe a 36-year-old woman with Primary Sjögren's Syndrome (PSS). Purpura, corneal perforation, metabolic acidosis, decreased glomerular filtration, hypokalemia, hyposthenuria, and polyuria were present. Chronic renal insufficiency and renal tubular acidosis type I were diagnosed. Kidney biopsy revealed mesangial glomerulonephritis, interstitial nephritis, and tubular atrophy. Replacement treatment with saliva, tears, and potassium citrate was started. She was given prednisone and cyclophosphamide. This would be the first description of PSS, mesangial glomerulonephritis, and chronic renal insufficiency.
