title: Efficacy and safety of rituximab with and without methotrexate in the treatment of rheumatoid arthritis patients: results from the GISEA register.
abstract: BACKGROUND
  Rituximab (RTX) is a monoclonal anti-CD20 antibody approved for the treatment of rheumatoid arthritis (RA) in association with methotrexate (MTX).
  
  
  OBJECTIVE
  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.
authors.affiliation: Rheumatology Unit, University of Modena and Reggio Emilia, Modena, Italy. Electronic address: marco.sebastiani@unimore.it.
authors.forename: Marco
authors.initials: M
authors.lastname: Sebastiani
authors.affiliation: Interdisciplinary Department of Medicine, Rheumatology Unit, Bari, Italy.
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Anelli
authors.affiliation: Rheumatology Unit, Ospedale Sacco, Milano, Italy.
authors.forename: Fabiola
authors.initials: F
authors.lastname: Atzeni
authors.affiliation: Rheumatology Unit, Spedali Civili di Brescia, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Bazzani
authors.affiliation: Rheumatology Unit, Dipartimento di Medicina Clinica e Sperimentale, Ferrara, Italy.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Farina
authors.affiliation: Universita Cattolica del Sacro Cuore, Roma, Italy.
authors.forename: Anna Laura
authors.initials: AL
authors.lastname: Fedele
authors.affiliation: Department of Rheumatology, Istituto Ortopedico G. Pini, Milano, Italy.
authors.forename: Ennio Giulio
authors.initials: EG
authors.lastname: Favalli
authors.affiliation: Rheumatology Unit, University of Siena, Siena, Italy.
authors.forename: Irene
authors.initials: I
authors.lastname: Fineschi
authors.affiliation: Rheumatology Unit, A.O.U. Policlinico Vittorio Emanuele, Catania, Italy.
authors.forename: Nicolò
authors.initials: N
authors.lastname: Cino
authors.affiliation: Rheumatology Unit, University of Verona, Verona, Italy.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Dal Forno
authors.affiliation: Clinica Reumatologica, Universita' Politecnica delle Marche, Ancona, Italy.
authors.forename: Stefania
authors.initials: S
authors.lastname: Gasparini
authors.affiliation: Rheumatology Unit, Ospedale di Prato, Italy.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Cassarà
authors.affiliation: Rheumatology Unit, University of Palermo, Palermo, Italy.
authors.forename: Rita
authors.initials: R
authors.lastname: Giardina
authors.affiliation: Rheumatology Unit, Ospedale Niguarda Ca' Grande, Italy.
authors.forename: Eleonora
authors.initials: E
authors.lastname: Bruschi
authors.affiliation: Department of Internal Medicine, Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy.
authors.forename: Olga
authors.initials: O
authors.lastname: Addimanda
authors.affiliation: Rheumatology Unit, University of Modena and Reggio Emilia, Modena, Italy.
authors.forename: Giulia
authors.initials: G
authors.lastname: Cassone
authors.affiliation: Interdisciplinary Department of Medicine, Rheumatology Unit, Bari, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Lopriore
authors.affiliation: Rheumatology Unit, Ospedale Sacco, Milano, Italy.
authors.forename: Piercarlo
authors.initials: P
authors.lastname: Sarzi-Puttini
authors.affiliation: Rheumatology Unit, Spedali Civili di Brescia, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Filippini
authors.affiliation: Rheumatology Unit, Dipartimento di Medicina Clinica e Sperimentale, Ferrara, Italy.
authors.forename: Federica
authors.initials: F
authors.lastname: Pignatti
authors.affiliation: Universita Cattolica del Sacro Cuore, Roma, Italy.
authors.forename: Elisa
authors.initials: E
authors.lastname: Gremese
authors.affiliation: Department of Rheumatology, Istituto Ortopedico G. Pini, Milano, Italy.
authors.forename: Martina
authors.initials: M
authors.lastname: Biggioggero
authors.affiliation: Rheumatology Unit, University of Siena, Siena, Italy.
authors.forename: Stefania
authors.initials: S
authors.lastname: Manganelli
authors.affiliation: Rheumatology Unit, A.O.U. Policlinico Vittorio Emanuele, Catania, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Amato
authors.affiliation: Rheumatology Unit, University of Verona, Verona, Italy.
authors.forename: Cristian
authors.initials: C
authors.lastname: Caimmi
authors.affiliation: Clinica Reumatologica, Universita' Politecnica delle Marche, Ancona, Italy.
authors.forename: Fausto
authors.initials: F
authors.lastname: Salaffi
authors.affiliation: Rheumatology Unit, Ospedale di Prato, Italy.
authors.forename: Florenzo
authors.initials: F
authors.lastname: Iannone
authors.affiliation: Rheumatology Unit, University of Palermo, Palermo, Italy.
authors.forename: Clodoveo
authors.initials: C
authors.lastname: Ferri
authors.affiliation: Rheumatology Unit, University of Modena and Reggio Emilia, Modena, Italy.
authors.forename: Gilda
authors.initials: G
authors.lastname: Sandri
authors.affiliation: Interdisciplinary Department of Medicine, Rheumatology Unit, Bari, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Lapadula
authors.affiliation: Rheumatology Unit, Spedali Civili di Brescia, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Gorla
authors.affiliation: Rheumatology Unit, Dipartimento di Medicina Clinica e Sperimentale, Ferrara, Italy.
authors.forename: Marcello
authors.initials: M
authors.lastname: Govoni
authors.affiliation: Universita Cattolica del Sacro Cuore, Roma, Italy.
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Ferraccioli
authors.affiliation: Department of Rheumatology, Istituto Ortopedico G. Pini, Milano, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Marchesoni
authors.affiliation: Rheumatology Unit, University of Siena, Siena, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Galeazzi
authors.affiliation: Rheumatology Unit, A.O.U. Policlinico Vittorio Emanuele, Catania, Italy.
authors.forename: Rosario
authors.initials: R
authors.lastname: Foti
authors.affiliation: Rheumatology Unit, University of Verona, Verona, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Carletto
authors.affiliation: Rheumatology Unit, Ospedale di Prato, Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Cantini
authors.affiliation: Rheumatology Unit, University of Palermo, Palermo, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Triolo
authors.affiliation: Rheumatology Unit, University of Palermo, Palermo, Italy.
authors.forename: Oscar Massimiliano
authors.initials: OM
authors.lastname: Epis
authors.affiliation: Rheumatology Unit, Ospedale Niguarda Ca' Grande, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Salvarani
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D058846:Antibodies, Monoclonal, Murine-Derived / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D012042:Registries; D000069283:Rituximab; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D018501:Antirheumatic Agents; D000069283:Rituximab; D008727:Methotrexate
keywords: Anti-CD20; Methotrexate; Rheumatoid arthritis; Rituximab