Efficacy and safety of rituximab therapy for systemic lupus erythematosus: a systematic review and meta-analysis

J Zhejiang Univ Sci B. 2012 Sep;13(9):731-44. doi: 10.1631/jzus.B1200057.


Objective: To review the efficacy and safety of rituximab therapy for systemic lupus erythematosus (SLE).

Methods: We searched for randomized controlled trails and observational studies that evaluated the effect of rituximab based on the systemic lupus erythematosus disease activity index (SLEDAI), British Isles lupus assessment group index (BILAG), urine protein levels, and the prednisolone dose, and had adequate data to calculate the mean, standard deviation (SD), and 95% confidence intervals, and to systematically review and meta-analyze observational studies with fixed effects model or random effects model.

Results: We included 2 randomized controlled studies and 19 observational clinical studies. We summarized the data from the 19 observational studies, analyzed the heterogeneity of the literature, and then used fixed effect model or random effect model for statistical analysis. The SLEDAI, BILAG, and urine protein levels and the prednisolone dosage were decreased after rituximab treatment, and the decreases in the BILAG, urine protein levels, and the prednisolone dose were found to be significant (P<0.05), when compared with baseline level. Rituximab's adverse effects generally could be controlled with an effective dosing regimen.

Conclusions: Although there are still controversies about rituximab's treatment on SLE, but our study had showed that rituximab had favorable effects on refractory lupus. The long-term efficacy and safety of rituximab require further study.

Publication types

  • Meta-Analysis
  • Review
  • Systematic Review

MeSH terms

  • Antibodies, Monoclonal, Murine-Derived / administration & dosage
  • Antibodies, Monoclonal, Murine-Derived / adverse effects
  • Antibodies, Monoclonal, Murine-Derived / therapeutic use*
  • Female
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / therapeutic use
  • Lupus Erythematosus, Systemic / immunology
  • Lupus Erythematosus, Systemic / therapy*
  • Male
  • Prednisolone / administration & dosage
  • Proteinuria / therapy
  • Randomized Controlled Trials as Topic
  • Rituximab
  • Severity of Illness Index
  • Treatment Outcome


  • Antibodies, Monoclonal, Murine-Derived
  • Immunosuppressive Agents
  • Rituximab
  • Prednisolone