title: Efficacy and safety of off-label use of rituximab in refractory lupus: data from the Italian Multicentre Registry.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of rituximab (RTX) in patients with systemic lupus erythematosus (SLE) refractory to standard therapy in the clinical practice setting.
  
  
  METHODS
  145 SLE patients (ACR criteria) were treated with RTX in 11 Italian Centres: 118 with two infusions (1 g), two weeks apart; 27 with 4 infusions (375 mg/m2), one week apart, followed in 10 cases by two further doses, after 1 and 2 months. Systemic complete response (CR) was defined as European Consensus Lupus Activity Measurement (ECLAM) score ≤1 and partial response (PR) as 1< ECLAM ≤3. Renal CR (RCR) and renal PR (RPR) were defined according to EULAR recommendations for management of lupus nephritis.
  
  
  RESULTS
  Data from 134 (92.4%) patients were available. The mean±SD follow-up was 27.3±18.5 months. After the first course of RTX, CR or PR were observed in 85.8% and CR in 45.5% of cases; RCR or RPR in 94.1% and RCR in 30.9% of patients after 12-month follow-up. Disease flares occurred in 35.1% and renal flares in 31.2% of patients during observational period. Among patients retreated, CR or PR were observed in 84.4% and CR in 57.8% of cases. Adverse events, infections, and infusion reactions occurred after first RTX course in 23.8%, 16.4%, and 3.8% of patients and after retreatment in 33.3%, 22.2% and 11.1%, respectively. No severe infusion reactions or deaths occurred.
  
  
  CONCLUSIONS
  Data from Italian multicentre RTX Registry confirmed the efficacy and safety of RTX in SLE patients refractory to standard treatment in clinical practice setting.
authors.affiliation: Department of Medicine-DIMED, Division of Rheumatology, University of Padova, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Iaccarino
authors.affiliation: Department of Medicine, Rheumatology Unit, University of Perugia, Perugia, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Bartoloni
authors.affiliation: Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy.
authors.forename: Linda
authors.initials: L
authors.lastname: Carli
authors.affiliation: Department of Internal Medicine and Medical Specialities, Rheumatology, La Sapienza University, Roma, Italy.
authors.forename: Fulvia
authors.initials: F
authors.lastname: Ceccarelli
authors.affiliation: Department of Internal Medicine and Medical Specialities, Rheumatology, La Sapienza University, Roma, Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Conti
authors.affiliation: Department of Medical and Biological Sciences, Rheumatology Clinic, University Hospital Santa Maria della Misericordia, Udine, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: De Vita
authors.affiliation: Institute of Rheumatology and Affine Sciences, School of Medicine, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Ferraccioli
authors.affiliation: Research Centre of Systemic Autoimmune and Autoinflammatory Diseases, Rheumatology Unit, Policlinico Le Scotte, University of Siena, Siena, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Galeazzi
authors.affiliation: Department of Medicine-DIMED, Division of Rheumatology, University of Padova, Italy.
authors.forename: Mariele
authors.initials: M
authors.lastname: Gatto
authors.affiliation: Department of Medicine, Rheumatology Unit, University of Perugia, Perugia, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Gerli
authors.affiliation: Department of Medical Sciences, University of Ferrara, Italy.
authors.forename: Marcello
authors.initials: M
authors.lastname: Govoni
authors.affiliation: Institute of Rheumatology and Affine Sciences, School of Medicine, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Elisa
authors.initials: E
authors.lastname: Gremese
authors.affiliation: Research Centre of Systemic Autoimmune and Autoinflammatory Diseases, Rheumatology Unit, Policlinico Le Scotte, University of Siena, Siena, Italy.
authors.forename: Annamaria
authors.initials: A
authors.lastname: Iuliano
authors.affiliation: Department of Medical and Biological Sciences, Rheumatology Clinic, University Hospital Santa Maria della Misericordia, Udine, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Mansutti
authors.affiliation: Division of Nephrology, Fondazione Ca' Granda Ospedale Maggiore IRCCS, Milano, Italy.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Moroni
authors.affiliation: Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy.
authors.forename: Marta
authors.initials: M
authors.lastname: Mosca
authors.affiliation: Rheumatology and Clinical Immunology, Department of Clinical and Experimental Sciences, Spedali Civili and University of Brescia, Italy.
authors.forename: Cecilia
authors.initials: C
authors.lastname: Nalli
authors.affiliation: Department of Rare Disease, Immunology, Haematology and Immunohaematology, Research Centre of Immunopathology of Rare Diseases (CMID), Hospital Torino Nord Emergenza San G. Bosco and University of Torino, Italy.
authors.forename: Carla
authors.initials: C
authors.lastname: Naretto
authors.affiliation: Department of Medical Sciences, University of Ferrara, Italy.
authors.forename: Melissa
authors.initials: M
authors.lastname: Padovan
authors.affiliation: Department of Medicine-DIMED, Division of Rheumatology, University of Padova, Italy.
authors.forename: Lavinia
authors.initials: L
authors.lastname: Palma
authors.affiliation: Division of Nephrology, Fondazione Ca' Granda Ospedale Maggiore IRCCS, Milano, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Raffiotta
authors.affiliation: Department of Rare Disease, Immunology, Haematology and Immunohaematology, Research Centre of Immunopathology of Rare Diseases (CMID), Hospital Torino Nord Emergenza San G. Bosco and University of Torino, Italy.
authors.forename: Dario
authors.initials: D
authors.lastname: Roccatello
authors.affiliation: Rheumatology and Clinical Immunology, Department of Clinical and Experimental Sciences, Spedali Civili and University of Brescia, Italy.
authors.forename: Angela
authors.initials: A
authors.lastname: Tincani
authors.affiliation: Department of Internal Medicine and Medical Specialities, Rheumatology, La Sapienza University, Roma, Italy.
authors.forename: Guido
authors.initials: G
authors.lastname: Valesini
authors.affiliation: Department of Medicine-DIMED, Division of Rheumatology, University of Padova, Italy.
authors.forename: Margherita
authors.initials: M
authors.lastname: Zen
authors.affiliation: Department of Medicine-DIMED, Division of Rheumatology, University of Padova, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Doria
mesh_terms: D000328:Adult; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage*; D018501:Antirheumatic Agents / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D016903:Drug Monitoring / Q000379:methods; D004351:Drug Resistance; D005260:Female; D006801:Humans; D007165:Immunosuppression Therapy / Q000379:methods; D007558:Italy; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D056687:Off-Label Use; D012074:Remission Induction / Q000379:methods; D000069283:Rituximab; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D018501:Antirheumatic Agents; D000069283:Rituximab