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Clin Exp Rheumatol. 2015 Jul-Aug;33(4):449-56. Epub 2015 Jun 8.

Efficacy and safety of off-label use of rituximab in refractory lupus: data from the Italian Multicentre Registry.

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Department of Medicine-DIMED, Division of Rheumatology, University of Padova, Italy.
Department of Medicine, Rheumatology Unit, University of Perugia, Perugia, Italy.
Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy.
Department of Internal Medicine and Medical Specialities, Rheumatology, La Sapienza University, Roma, Italy.
Department of Medical and Biological Sciences, Rheumatology Clinic, University Hospital Santa Maria della Misericordia, Udine, Italy.
Institute of Rheumatology and Affine Sciences, School of Medicine, Catholic University of the Sacred Heart, Rome, Italy.
Research Centre of Systemic Autoimmune and Autoinflammatory Diseases, Rheumatology Unit, Policlinico Le Scotte, University of Siena, Siena, Italy.
Department of Medical Sciences, University of Ferrara, Italy.
Division of Nephrology, Fondazione Ca' Granda Ospedale Maggiore IRCCS, Milano, Italy.
Rheumatology and Clinical Immunology, Department of Clinical and Experimental Sciences, Spedali Civili and University of Brescia, Italy.
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.



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.


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.


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.


Data from Italian multicentre RTX Registry confirmed the efficacy and safety of RTX in SLE patients refractory to standard treatment in clinical practice setting.

[Indexed for MEDLINE]

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