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 journalArticle

13 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)508-512
Number of pages5
JournalJoint Bone Spine
Volume81
Issue number6
DOIs
Publication statusPublished - 2014

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Methotrexate
Rheumatoid Arthritis
Safety
Therapeutics
Rituximab
Group Psychotherapy
Anti-Idiotypic Antibodies
Cohort Studies
Joints
Monoclonal Antibodies

Keywords

  • Anti-CD20
  • Methotrexate
  • Rheumatoid arthritis
  • Rituximab

ASJC Scopus subject areas

  • Rheumatology
  • Medicine(all)

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Efficacy and safety of rituximab with and without methotrexate in the treatment of rheumatoid arthritis patients : Results from the GISEA register. / Sebastiani, Marco; Anelli, Maria Grazia; Atzeni, Fabiola; Bazzani, Chiara; Farina, Ilaria; Fedele, Anna Laura; Favalli, Ennio Giulio; Fineschi, Irene; Cino, Nicolò; Dal Forno, Ilaria; Gasparini, Stefania; Cassarà, Emanuele; Giardina, Rita; Bruschi, Eleonora; Addimanda, Olga; Cassone, Giulia; Lopriore, Simona; Sarzi-Puttini, Piercarlo; Filippini, Matteo; Pignatti, Federica; Gremese, Elisa; Biggioggero, Martina; Manganelli, Stefania; Amato, Giorgio; Caimmi, Cristian; Salaffi, Fausto; Iannone, Florenzo; Ferri, Clodoveo; Sandri, Gilda; Lapadula, Giovanni; Gorla, Roberto; Govoni, Marcello; Ferraccioli, Gianfranco; Marchesoni, Antonio; Galeazzi, Mauro; Foti, Rosario; Carletto, Antonio; Cantini, Fabrizio; Triolo, Giovanni; Epis, Oscar Massimiliano; Salvarani, Carlo.

In: Joint Bone Spine, Vol. 81, No. 6, 2014, p. 508-512.

Research output: Contribution to journalArticle

Sebastiani, M, Anelli, MG, Atzeni, F, Bazzani, C, Farina, I, Fedele, AL, Favalli, EG, Fineschi, I, Cino, N, Dal Forno, I, Gasparini, S, Cassarà, E, Giardina, R, Bruschi, E, Addimanda, O, Cassone, G, Lopriore, S, Sarzi-Puttini, P, Filippini, M, Pignatti, F, Gremese, E, Biggioggero, M, Manganelli, S, Amato, G, Caimmi, C, Salaffi, F, Iannone, F, Ferri, C, Sandri, G, Lapadula, G, Gorla, R, Govoni, M, Ferraccioli, G, Marchesoni, A, Galeazzi, M, Foti, R, Carletto, A, Cantini, F, Triolo, G, Epis, OM & Salvarani, C 2014, 'Efficacy and safety of rituximab with and without methotrexate in the treatment of rheumatoid arthritis patients: Results from the GISEA register', Joint Bone Spine, vol. 81, no. 6, pp. 508-512. https://doi.org/10.1016/j.jbspin.2014.06.011
Sebastiani, Marco ; Anelli, Maria Grazia ; Atzeni, Fabiola ; Bazzani, Chiara ; Farina, Ilaria ; Fedele, Anna Laura ; Favalli, Ennio Giulio ; Fineschi, Irene ; Cino, Nicolò ; Dal Forno, Ilaria ; Gasparini, Stefania ; Cassarà, Emanuele ; Giardina, Rita ; Bruschi, Eleonora ; Addimanda, Olga ; Cassone, Giulia ; Lopriore, Simona ; Sarzi-Puttini, Piercarlo ; Filippini, Matteo ; Pignatti, Federica ; Gremese, Elisa ; Biggioggero, Martina ; Manganelli, Stefania ; Amato, Giorgio ; Caimmi, Cristian ; Salaffi, Fausto ; Iannone, Florenzo ; Ferri, Clodoveo ; Sandri, Gilda ; Lapadula, Giovanni ; Gorla, Roberto ; Govoni, Marcello ; Ferraccioli, Gianfranco ; Marchesoni, Antonio ; Galeazzi, Mauro ; Foti, Rosario ; Carletto, Antonio ; Cantini, Fabrizio ; Triolo, Giovanni ; Epis, Oscar Massimiliano ; Salvarani, Carlo. / Efficacy and safety of rituximab with and without methotrexate in the treatment of rheumatoid arthritis patients : Results from the GISEA register. In: Joint Bone Spine. 2014 ; Vol. 81, No. 6. pp. 508-512.
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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.",
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author = "Marco Sebastiani and Anelli, {Maria Grazia} and Fabiola Atzeni and Chiara Bazzani and Ilaria Farina and Fedele, {Anna Laura} and Favalli, {Ennio Giulio} and Irene Fineschi and Nicol{\`o} Cino and {Dal Forno}, Ilaria and Stefania Gasparini and Emanuele Cassar{\`a} and Rita Giardina and Eleonora Bruschi and Olga Addimanda and Giulia Cassone and Simona Lopriore and Piercarlo Sarzi-Puttini and Matteo Filippini and Federica Pignatti and Elisa Gremese and Martina Biggioggero and Stefania Manganelli and Giorgio Amato and Cristian Caimmi and Fausto Salaffi and Florenzo Iannone and Clodoveo Ferri and Gilda Sandri and Giovanni Lapadula and Roberto Gorla and Marcello Govoni and Gianfranco Ferraccioli and Antonio Marchesoni and Mauro Galeazzi and Rosario Foti and Antonio Carletto and Fabrizio Cantini and Giovanni Triolo and Epis, {Oscar Massimiliano} and Carlo Salvarani",
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T1 - Efficacy and safety of rituximab with and without methotrexate in the treatment of rheumatoid arthritis patients

T2 - Results from the GISEA register

AU - Sebastiani, Marco

AU - Anelli, Maria Grazia

AU - Atzeni, Fabiola

AU - Bazzani, Chiara

AU - Farina, Ilaria

AU - Fedele, Anna Laura

AU - Favalli, Ennio Giulio

AU - Fineschi, Irene

AU - Cino, Nicolò

AU - Dal Forno, Ilaria

AU - Gasparini, Stefania

AU - Cassarà, Emanuele

AU - Giardina, Rita

AU - Bruschi, Eleonora

AU - Addimanda, Olga

AU - Cassone, Giulia

AU - Lopriore, Simona

AU - Sarzi-Puttini, Piercarlo

AU - Filippini, Matteo

AU - Pignatti, Federica

AU - Gremese, Elisa

AU - Biggioggero, Martina

AU - Manganelli, Stefania

AU - Amato, Giorgio

AU - Caimmi, Cristian

AU - Salaffi, Fausto

AU - Iannone, Florenzo

AU - Ferri, Clodoveo

AU - Sandri, Gilda

AU - Lapadula, Giovanni

AU - Gorla, Roberto

AU - Govoni, Marcello

AU - Ferraccioli, Gianfranco

AU - Marchesoni, Antonio

AU - Galeazzi, Mauro

AU - Foti, Rosario

AU - Carletto, Antonio

AU - Cantini, Fabrizio

AU - Triolo, Giovanni

AU - Epis, Oscar Massimiliano

AU - Salvarani, Carlo

PY - 2014

Y1 - 2014

N2 - 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.

AB - 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.

KW - Anti-CD20

KW - Methotrexate

KW - Rheumatoid arthritis

KW - Rituximab

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