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1.
Medicine (Baltimore) ; 95(9): e2891, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26945378

RESUMO

The aim of the study was to profile those patients included in the RELESSER registry with histologically proven renal involvement in order to better understand the current state of lupus nephritis (LN) in Spain. RELESSER-TRANS is a multicenter cross-sectional registry with an analytical component. Information was collected from the medical records of patients with systemic lupus erythematosus who were followed at participating rheumatology units. A total of 359 variables including demographic data, clinical manifestations, disease activity, severity, comorbidities, LN outcome, treatments, and mortality were recorded. Only patients with a histological confirmation of LN were included. We performed a descriptive analysis, chi-square or Student's t tests according to the type of variable and its relationship with LN. Odds ratio and confidence intervals were calculated by using simple logistic regression. LN was histologically confirmed in 1092/3575 patients (30.5%). Most patients were female (85.7%), Caucasian (90.2%), and the mean age at LN diagnosis was 28.4 ±â€Š12.7 years. The risk for LN development was higher in men (M/F:47.85/30.91%, P < 0.001), in younger individuals (P < 0.001), and in Hispanics (P = 0.03). Complete response to treatment was achieved in 68.3% of patients; 10.35% developed ESRD, which required a kidney transplant in 45% of such cases. The older the patient, the greater was the likelihood of complete response (P < 0.001). Recurrences were associated with persistent lupus activity at the time of the last visit (P < 0.001) and with ESRD (P < 0.001). Thrombotic microangiopathy was a risk factor for ESRD (P = 0.04), as for the necessity of dialysis (P = 0.01) or renal transplantation (P = 0.03). LN itself was a poor prognostic risk factor of mortality (OR 2.4 [1.81-3.22], P < 0.001). Patients receiving antimalarials had a significantly lower risk of developing LN (P < 0.001) and ESRD (P < 0.001), and responded better to specific treatments for LN (P = 0.014). More than two-thirds of the patients with LN from a wide European cohort achieved a complete response to treatment. The presence of positive anti-Sm antibodies was associated with a higher frequency of LN and a decreased rate of complete response to treatment. The use of antimalarials reduced both the risk of developing renal disease and its severity, and contributed to attaining a complete renal response.


Assuntos
Nefrite Lúpica/epidemiologia , Sistema de Registros , Adolescente , Adulto , Feminino , Humanos , Nefrite Lúpica/terapia , Masculino , Recidiva , Estudos Retrospectivos , Reumatologia , Espanha/epidemiologia , Adulto Jovem
2.
Reumatol Clin ; 7(1): 30-44, 2011 Jan-Feb.
Artigo em Espanhol | MEDLINE | ID: mdl-21794777

RESUMO

INTRODUCTION: Rituximab has been employed successfully for the treatment of Rheumatoid Arthritis (RA). However, its particular mechanism of action, as well as a lack of concrete guidelines for its management have generated doubts on its use. OBJECTIVE: To establish recommendations that facilitates the use of rituximab in common clinical practice. METHODS: In a first Delphi round, 9 expert rheumatologists got together to develop questions on those subjects generating most doubts on the efficacy and safety of the drug. These were adapted to perform a systematic review of the evidence, which was presented in a second meeting. Nominal groups were formed to respond to each question and give a recommendation. These recommendations were presented in a second Delphi round to a larger group of experts in rheumatology. Once again recommendations were discussed, modified and voted upon. Once approved, a vote on the degree of agreement for each recommendation was carried out. RESULTS: 17 recommendations were established, 10 regarding efficacy and 7 safety. All of the efficacy recommendations except 3 presented a good or moderate degree of evidence. Among the safety recommendations, 3 had a good or moderate degree of evidence while in the rest it was indirect, scarce or non-existent and a product of expert recommendation. The degree of agreement between experts was elevated for most of the recommendations. CONCLUSIONS: These recommendations attempt to clear doubts on the use of rituximab and establish guidelines for its use in daily practice. Efficacy recommendations have a high degree of evidence, allowing the clinician to be guided in therapeutic decisions. Safety recommendations have a lower degree of evidence.


Assuntos
Anticorpos Monoclonais Murinos/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Anticorpos Monoclonais Murinos/administração & dosagem , Anticorpos Monoclonais Murinos/efeitos adversos , Antígenos CD20/imunologia , Antirreumáticos/administração & dosagem , Antirreumáticos/efeitos adversos , Artrite Reumatoide/imunologia , Linfócitos B/efeitos dos fármacos , Linfócitos B/imunologia , Ensaios Clínicos como Assunto , Técnica Delfos , Relação Dose-Resposta a Droga , Relação Dose-Resposta Imunológica , Medicina Baseada em Evidências , Insuficiência Cardíaca/etiologia , Hepatite B Crônica/complicações , Humanos , Hospedeiro Imunocomprometido , Imunoglobulina G/biossíntese , Imunoglobulina M/biossíntese , Falência Hepática/etiologia , Doenças Pulmonares Intersticiais/etiologia , Segunda Neoplasia Primária/etiologia , Rituximab , Vacinação
3.
Reumatol. clín. (Barc.) ; 7(1): 30-44, ene.-feb. 2011. tab
Artigo em Espanhol | IBECS | ID: ibc-84610

RESUMO

Introducción. El rituximab se ha empleado con éxito en el tratamiento de la artritis reumatoide (AR). Sin embargo, su particular mecanismo de acción, así como la ausencia de pautas concretas en su manejo, hace que se hayan generado dudas sobre su utilización. Objetivo. Establecer recomendaciones que faciliten el empleo de rituximab en la práctica clínica habitual. Métodos. En una primera ronda Delphi, se reunieron nueve reumatólogos expertos que desarrollaron preguntas sobre los temas con mayor duda sobre eficacia y seguridad del fármaco. Estas se adecuaron para hacer una revisión sistemática de la evidencia, que se presentó en una segunda reunión. Se formaron grupos nominales para dar respuesta a cada pregunta y emitir la recomendación. Estas recomendaciones fueron presentadas en una segunda ronda Delphi a un grupo ampliado de reumatólogos expertos. De nuevo se discutieron, se modificaron y se votaron las recomendaciones. Una vez aprobada cada recomendación, se votó el grado de acuerdo. Resultados. Se establecieron 17 recomendaciones: diez de eficacia y siete de seguridad. Todas las recomendaciones de eficacia, excepto tres, presentaron un nivel de evidencia bueno o moderado. Entre las recomendaciones de seguridad, tres presentaron un nivel de evidencia bueno o moderado, mientras que para el resto la evidencia fue indirecta, escasa o nula y son producto de las recomendaciones de los expertos. El grado de acuerdo entre expertos fue elevado para la mayoría de las recomendaciones. Conclusiones. Estas recomendaciones pretenden aclarar dudas sobre el uso de rituximab y establecer pautas de empleo en la práctica clínica. Las recomendaciones de eficacia tienen un nivel de evidencia alto y permiten guiar al médico en decisiones terapéuticas. Las recomendaciones de seguridad tienen un nivel de evidencia menor (AU)


Introduction. Rituximab has been employed successfully for the treatment of Rheumatoid Arthritis (RA). However, its particular mechanism of action, as well as a lack of concrete guidelines for its management have generated doubts on its use. Objective. To establish recommendations that facilitates the use of rituximab in common clinical practice. Methods. In a first Delphi round, 9 expert rheumatologists got together to develop questions on those subjects generating most doubts on the efficacy and safety of the drug. These were adapted to perform a systematic review of the evidence, which was presented in a second meeting. Nominal groups were formed to respond to each question and give a recommendation. These recommendations were presented in a second Delphi round to a larger group of experts in rheumatology. Once again recommendations were discussed, modified and voted upon. Once approved, a vote on the degree of agreement for each recommendation was carried out. Results. 17 recommendations were established, 10 regarding efficacy and 7 safety. All of the efficacy recommendations except 3 presented a good or moderate degree of evidence. Among the safety recommendations, 3 had a good or moderate degree of evidence while in the rest it was indirect, scarce or non-existent and a product of expert recommendation. The degree of agreement between experts was elevated for most of the recommendations. Conclusions. These recommendations attempt to clear doubts on the use of rituximab and establish guidelines for its use in daily practice. Efficacy recommendations have a high degree of evidence, allowing the clinician to be guided in therapeutic decisions. Safety recommendations have a lower degree of evidence (AU)


Assuntos
Humanos , Masculino , Feminino , Artrite Reumatoide/tratamento farmacológico , Medicina Baseada em Evidências/métodos , Terapia Biológica , Antirreumáticos/uso terapêutico , Metotrexato/uso terapêutico , Medicina Baseada em Evidências/estatística & dados numéricos , Medicina Baseada em Evidências/tendências , Terapia Biológica/métodos , Terapia Biológica/tendências , Avaliação de Eficácia-Efetividade de Intervenções , Enquete Socioeconômica
4.
Reumatol. clín. (Barc.) ; 5(extr.1): 71-76, abr. 2009. ilus
Artigo em Espanhol | IBECS | ID: ibc-78382

RESUMO

Los antagonistas del TNF (tumor necrosis factor ‘factor de necrosis tumoral’) han significado un gran avance en el tratamiento de la artritis reumatoide (AR) desde su introducción a finales de la década de 1990. El desarrollo de producto ha sido similar para los 3 anti-TNF licenciados en la actualidad para el tratamiento de la AR: etanercept, infliximab y adalimumab. Los primeros estudios se centraron en los pacientes con enfermedad activa y refractaria a varios tratamientos modificadores de la enfermedad, por lo que se han obtenido diferencias muy significativas frente a placebo o metotrexato (MTX) en los índices de mejoría del American College of Rheumatology (ACR). Los ensayos en los pacientes no tratados con MTX muestran una diferencia menos notable entre los anti-TNF y el MTX, que se hace más significativa para la combinación de MTX con anti-TNF. En este manuscrito se analizan los resultados de los estudios de registro de los anti-TNF así como otros índices de mejoría, como calidad de vida, reducción del riesgo cardiovascular, efectividad mantenida en el tiempo y progresión de lesiones articulares. También se plantea la posibilidad de tratar con dosis menores a las autorizadas para AR y se analiza la afección de mal pronóstico de los pacientes refractarios a MTX, que actualmente es la indicación para el uso de anti-TNF en AR según el consenso de la Sociedad Española de Reumatología (AU)


Anti-TNF drugs have represented a great advancement in the treatment of rheumatoid arthritis since their introduction in the late 1990s. The development of these products has been very similar for etanercept, infliximab and adalimumab, the 3 approved TNF blockers for the treatment of RA. The first studies centered their attention on patients with active disease and refractory to several disease modifying treatments, finding very significant differences when compared to placebo or methotrexate in the ACR improvement scores. Trials in patients who had not been previously treated with methotrexate show less differences between anti-TNF and methotrexate, but becomes more significant when the two drugs are used combined. In this manuscript we analyze the results of the registry of anti-TNF studies with regard to other improvement indexes such as quality of life, reduction in cardiovascular risk, maintained efficacy through time and progression of joint erosions. We also contemplate the possibility of using lower doses than those authorized for rheumatoid arthritis and analyze factors related to a poor prognosis in patients refractory to methotrexate, which is currently the indication for the use of anti-TNF in RA accordiong to the SER consensus (AU)


Assuntos
Humanos , Anticorpos Monoclonais/farmacocinética , Fatores de Necrose Tumoral/antagonistas & inibidores , Artrite Reumatoide/tratamento farmacológico , Resultado do Tratamento , Metotrexato/uso terapêutico , Antirreumáticos/farmacocinética
5.
Reumatol Clin ; 5 Suppl 1: 71-6, 2009 Apr.
Artigo em Espanhol | MEDLINE | ID: mdl-21794647

RESUMO

Anti-TNF drugs have represented a great advancement in the treatment of rheumatoid arthritis since their introduction in the late 1990s. The development of these products has been very similar for etanercept, infliximab and adalimumab, the 3 approved TNF blockers for the treatment of RA. The first studies centered their attention on patients with active disease and refractory to several disease modifying treatments, finding very significant differences when compared to placebo or methotrexate in the ACR improvement scores. Trials in patients who had not been previously treated with methotrexate show less differences between anti-TNF and methotrexate, but becomes more significant when the two drugs are used combined. In this manuscript we analyze the results of the registry of anti-TNF studies with regard to other improvement indexes such as quality of life, reduction in cardiovascular risk, maintained efficacy through time and progression of joint erosions. We also contemplate the possibility of using lower doses than those authorized for rheumatoid arthritis and analyze factors related to a poor prognosis in patients refractory to methotrexate, which is currently the indication for the use of anti-TNF in RA accordiong to the SER consensus.

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