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.

Efficacy and safety of rituximab with and without methotrexate in the treatment of rheumatoid arthritis patients : Results from the GISEA register / M. Sebastiani, M.G. Anelli, F. Atzeni, C. Bazzani, I. Farina, A.L. Fedele, E.G. Favalli, I. Fineschi, N. Cino, I. Dal Forno, S. Gasparini, E. Cassarà, R. Giardina, E. Bruschi, O. Addimanda, G. Cassone, S. Lopriore, P. Sarzi-Puttini, M. Filippini, F. Pignatti, E. Gremese, M. Biggioggero, S. Manganelli, G. Amato, C. Caimmi, F. Salaffi, F. Iannone, C. Ferri, G. Sandri, G. Lapadula, R. Gorla, M. Govoni, G. Ferraccioli, A. Marchesoni, M. Galeazzi, R. Foti, A. Carletto, F. Cantini, G. Triolo, O.M. Epis, C. Salvarani. - In: JOINT BONE SPINE. - ISSN 1297-319X. - 81:6(2014 Dec), pp. 508-512.

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

Favalli, Ennio Giulio;Sarzi-Puttini, Piercarlo;Biggioggero, Martina;
2014-12

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.
Anti-CD20; Methotrexate; Rheumatoid arthritis; Rituximab; Adult; Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Murine-Derived; Antirheumatic Agents; Arthritis, Rheumatoid; Drug Therapy, Combination; Female; Humans; Male; Methotrexate; Middle Aged; Rituximab; Treatment Outcome; Registries; Rheumatology
Settore MED/16 - Reumatologia
JOINT BONE SPINE
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/643171
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