Literature DB >> 25082646

Efficacy and safety of rituximab with and without methotrexate in the treatment of rheumatoid arthritis patients: results from the GISEA register.

Marco Sebastiani1, Maria Grazia Anelli2, Fabiola Atzeni3, Chiara Bazzani4, Ilaria Farina5, Anna Laura Fedele6, Ennio Giulio Favalli7, Irene Fineschi8, Nicolò Cino9, Ilaria Dal Forno10, Stefania Gasparini11, Emanuele Cassarà12, Rita Giardina13, Eleonora Bruschi14, Olga Addimanda15, Giulia Cassone16, Simona Lopriore2, Piercarlo Sarzi-Puttini3, Matteo Filippini4, Federica Pignatti5, Elisa Gremese6, Martina Biggioggero7, Stefania Manganelli8, Giorgio Amato9, Cristian Caimmi10, Fausto Salaffi11, Florenzo Iannone12, Clodoveo Ferri13, Gilda Sandri16, Giovanni Lapadula2, Roberto Gorla4, Marcello Govoni5, Gianfranco Ferraccioli6, Antonio Marchesoni7, Mauro Galeazzi8, Rosario Foti9, Antonio Carletto10, Fabrizio Cantini12, Giovanni Triolo13, Oscar Massimiliano Epis13, Carlo Salvarani14.   

Abstract

INTRODUCTION: Rituximab (RTX) is a monoclonal anti-CD20 antibody approved for the treatment of rheumatoid arthritis (RA) in association with methotrexate (MTX).
OBJECTIVES: To evaluate the efficacy and safety of RTX-MTX combination therapy compared with RTX alone in the treatment of RA.
METHODS: We analyzed data from a prospective cohort study, the Italian biologic register GISEA, to investigate the efficacy and safety of rituximab. Moreover, the adverse events (AE) and the causes of discontinuation therapy were analyzed.
RESULTS: We identified 338 RA patients, 162 treated with RTX and 176 with RTX-MTX. After 52 and 104 weeks of therapy the disease activity score in 28 joints and the Health Assessment Questionnaire Score were available in 168 patients (78 with RTX-MTX and 60 with RTX alone), showing significant reduction without differences among the two groups. AE were reported in 142 patients (42%), for a total of 368 recorded side effects. The majority (90.5%) of AE were mild to moderate in severity. Comparable percentages of severe AE were reported in the 2 groups (9.9% for RTX alone and 9.3% for RTX+MTX). A poor disease control was observed in 14.2% and 13.5% of patients treated with RTX+MTX and RTX, respectively; while 12 patients (4.5% in RTX+MTX, and 2.5% in RTX group) suspended therapy for AE.
CONCLUSIONS: RTX showed a good efficacy and safety profile in the real-life management of RA patients regardless of the association with MTX.
Copyright © 2014 Société française de rhumatologie. Published by Elsevier SAS. All rights reserved.

Entities:  

Keywords:  Anti-CD20; Methotrexate; Rheumatoid arthritis; Rituximab

Mesh:

Substances:

Year:  2014        PMID: 25082646     DOI: 10.1016/j.jbspin.2014.06.011

Source DB:  PubMed          Journal:  Joint Bone Spine        ISSN: 1297-319X            Impact factor:   4.929


  7 in total

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