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

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


Objectives: 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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Observational Study

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Murine-Derived / administration & dosage*
  • Antirheumatic Agents / administration & dosage
  • Dose-Response Relationship, Drug
  • Drug Monitoring / methods
  • Drug Resistance
  • Female
  • Humans
  • Immunosuppression Therapy / methods
  • Italy
  • Lupus Erythematosus, Systemic / drug therapy*
  • Lupus Erythematosus, Systemic / immunology
  • Lupus Erythematosus, Systemic / physiopathology
  • Male
  • Middle Aged
  • Off-Label Use
  • Remission Induction / methods
  • Rituximab
  • Severity of Illness Index
  • Treatment Outcome


  • Antibodies, Monoclonal, Murine-Derived
  • Antirheumatic Agents
  • Rituximab