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

Marco Sebastiani, Maria Grazia Anelli, Fabiola Atzeni, Chiara Bazzani, Ilaria Farina, Anna Laura Fedele, Ennio Giulio Favalli, Irene Fineschi, Nicolò Cino, Ilaria Dal Forno, Stefania Gasparini, Emanuele Cassarà, Rita Giardina, Eleonora Bruschi, Olga Addimanda, Giulia Cassone, Simona Lopriore, Piercarlo Sarzi-Puttini, Matteo Filippini, Federica PignattiElisa Gremese, Martina Biggioggero, Stefania Manganelli, Giorgio Amato, Cristian Caimmi, Fausto Salaffi, Florenzo Iannone, Clodoveo Ferri, Gilda Sandri, Giovanni Lapadula, Roberto Gorla, Marcello Govoni, Gianfranco Ferraccioli, Antonio Marchesoni, Mauro Galeazzi, Rosario Foti, Antonio Carletto, Fabrizio Cantini, Giovanni Triolo, Oscar Massimiliano Epis, Carlo Salvarani

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish
Pages (from-to)508-512
Number of pages5
JournalJoint Bone Spine
Issue number6
Publication statusPublished - 2014


  • Anti-CD20
  • Methotrexate
  • Rheumatoid arthritis
  • Rituximab

ASJC Scopus subject areas

  • Rheumatology
  • Medicine(all)


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