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Vol. 12. Issue 6.
Pages 319-322 (November - December 2016)
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Vol. 12. Issue 6.
Pages 319-322 (November - December 2016)
Brief Report
DOI: 10.1016/j.reumae.2015.11.020
VARIAR Study: Assessment of Short-term Efficacy and Safety of Rituximab Compared to an Tumor Necrosis Factor Alpha Antagonists as Second-line Drug Therapy in Patients With Rheumatoid Arthritis Refractory to a First Tumor Necrosis Factor Alpha Antagonist
Estudio VARIAR: VAloración de la eficacia y seguridad a corto plazo en artritis reumatoide del uso de RItuximab comparado con Antagonistas del factor de necrosis tumoral alfa en segunda línea terapéutica en pacientes con artritis reumatoide Refractarios a un primer antagonista del factor de necrosis tumoral alfa
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Vicenç Torrente-Segarraa,
Corresponding author
, Asunción Acosta Pereirab, Rosa Morlac, José Miguel Ruizd, Teresa Clavaguerae, Ramon Figulsa, Hector Corominasa, Carme Gelib, Rosa Rosellóf, Juan José de Agustíng, Cayetano Alegreg, Carolina Pérezh, Angel Garcíai, Arturo Rodríguez de la Sernab
a Hospital General Hospitalet-Moisès Broggi, Sant Joan Despí, Barcelona, Spain
b Hospital Santa Creu i Sant Pau, Barcelona, Spain
c Hospital del Vendrell, El Vendrell, Tarragona, Spain
d Hospital de Viladecans, Viladecans, Barcelona, Spain
e Hospital de Palamós, Palamós, Girona, Spain
f Hospital de San Jorge, Huesca, Spain
g Hospital de la Vall d’Hebron, Barcelona, Spain
h Hospital de Mollet, Mollet del Vallès, Barcelona, Spain
i Hospital de Torrevieja, Torrevieja, Alicante, Spain
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Table 1. Baseline Sociodemographic and Clinical Variables.
Table 2. Changes in the Clinical and Serological Parameters at 6 Months.
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Abstract
Objective

To compare the short-term efficacy and safety of rituximab (RTX) therapy versus anti-TNF in rheumatoid arthritis (RA) patients after discontinuation of a first anti-TNF agent.

Methods

Prospective observational multicenter study in the clinical practice setting, involving patients with severe RA refractory to a first anti-TNF agent, who received either RTX or a second anti-TNF (2TNF), comparing the efficacy endpoints, EULAR response (Good/Moderate) and safety at 6 months.

Results

103 patients enrolled, 82 completed 6-month follow-up, 73.7% women. Baseline data for RTX and 2TNF groups, respectively: TJC, 8.6 and 6.6; SJC, 8.8 and 7.5; DAS28 score, 5.45 (±1.28) and 5.18 (±1.21) (P=.048), ESR, 41 and 38.7mmHg; and HAQ, 1.2 and 1.0. Improvement was observed in all parameters, with no significant differences (except for a more marked reduction in ESR with RTX). There were no serious adverse events.

Conclusions

RTX use as second-line therapy after anti-TNF failure led to improvements in the efficacy and functional variables at 6 months, with no serious adverse events. These results were comparable to those observed in patients who used a second anti-TNF agent in the same clinical scenario.

Keyword:
Rheumatoid arthritis
Rituximab
Anti-TNF-alpha
Resumen
Objetivo

Evaluar la eficacia y la seguridad a corto plazo del tratamiento de pacientes con artritis reumatoide (AR) con rituximab (RTX) comparado con un anti-TNF (2TNF) tras retirada de un primer anti-TNF.

Métodos

Estudio multicéntrico prospectivo, observacional, de práctica clínica de pacientes con AR grave refractaria a anti-TNF que recibieron RTX comparados con los que recibieron un 2TNF. Comparación de las variables de eficacia y respuesta EULAR buena/moderada a los 6 meses.

Resultados

Ciento tres pacientes incluidos; 82 alcanzan seguimiento a 6 meses, 73,7% mujeres. Datos basales grupo RTX y 2TNF, respectivamente: 8,6 y 6,6 NAD, 8,8 y 7,5 NAI, 5,45 ± 1,28 y 5,18 ± 1,21 en DAS28 (p=0,048), 41 y 38,7mmHg de VSG, y 1,2 y 1,0 en HAQ. Mejoría en todos los parámetros en ambos grupos sin diferencias significativas (excepto mayor reducción de VSG con RTX). Ausencia de efectos adversos graves.

Conclusiones

El uso de RTX en segunda línea de terapia biológica tras fallo a un primer anti-TNF en práctica clínica muestra mejoría en las variables de eficacia y funcionalidad a los 6 meses, sin presentar efectos adversos graves. Estos resultados no difieren de los observados tras el uso de un segundo anti-TNF en el mismo escenario clínico.

Palabras clave:
Artritis reumatoide
Rituximab
Anti-TNF-alfa

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