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Vol. 7. Núm. 1.
Páginas 30-44 (enero - febrero 2011)
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Vol. 7. Núm. 1.
Páginas 30-44 (enero - febrero 2011)
Original article
Acceso a texto completo
Consensus on the use of Rituximab in Rheumatoid Arthritis. A document with evidence based recommendations
Consenso de uso de rituximab en artritis reumatoide. Un documento con recomendaciones basadas en la evidencia
Visitas
6378
Emilio Martín Molaa,
Autor para correspondencia
, Blanca Hernándezb, Miriam García-Ariasa, José María Álvaro-Graciac, Alejandro Balsaa, Juan Gómez-Reinod, José L. Marenco de la Fuentee, Víctor Martínez-Taboadaf, José Andrés Román Ivorrag, Raimon Sanmartíh, Expert Group on Rituximab 1
a Servicio de Reumatología, Hospital Universitario La Paz, Madrid, Spain
b Servicio de Reumatología e i+D+I, Hospital Universitario Virgen Macarena, Sevilla, Spain
c Hospital Universitario de La Princesa, IIS Princesa, Madrid, Spain
d Hospital Clínico Universitario, Universidad de Santiago de Compostela, Santiago de Compostela, A Coruña, Spain
e Unidad de Gestión Clínica de Reumatología, Hospital Universitario de Valme, Sevilla, Spain
f Servicio de Reumatología, Hospital Universitario Marqués de Valdecilla, Facultad de Medicina, Universidad de Cantabria, Santander, Cantabria, Spain
g Servicio de Reumatología, Hospital Universitario La Fe, Valencia, Spain
h Servicio de Reumatología, Hospital Clínic, Barcelona, Spain
Este artículo ha recibido
Información del artículo
Abstract
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 facilitate 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

Seventeen 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.

Keywords:
Rheumatoid arthritis
Rituximab
Biologic therapy
Consensus
Resumen
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..

Palabras clave:
Artritis reumatoide
Rituximab
Terapias biológicas
Consenso
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Annex 1 contains the list of researchers of the Expert Group on Rituximab.

Copyright © 2011. Sociedad Española de Reumatología and Colegio Mexicano de Reumatología
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