OBJECTIVE: Conventional treatment of systemic lupus erythematosus (SLE) and 
lupus nephritis (LN) is associated with damage accrual, hence increased 
morbidity rate. Off-label use of rituximab (RTX) has shown significant promise 
in this patient group; however, data are still controversial. We aimed to 
analyze the outcomes of RTX therapy in refractory lupus using a meta-analysis 
approach.
METHODS: Electronic search of the medical literature was conducted using a 
combination of relevant keywords to retrieve studies on the safety and efficacy 
of RTX in SLE and LN patients. Results were screened against our inclusion and 
exclusion criteria and two reviewers independently extracted the data for 
analysis. Comprehensive meta-analysis software was used to pool the data from 
individual studies and provide summary effect estimates.
RESULTS: Thirty-one studies that enrolled 1112 patients were finally eligible 
for the meta-analysis. The overall global, complete, and partial response rates 
to RTX therapy were 72%, 46%, and 32%, respectively. RTX significantly decreased 
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and British Isles 
Lupus Activity Group (BILAG) scores (p<0.001). Prednisone dose was significantly 
reduced after RTX treatment in both SLE and LN groups (p<0.001), and proteinuria 
was lowered in SLE (p<0.001) than in LN patients (p=0.07). Infection and 
infusion-related reactions were the most common side effects.
CONCLUSION: RTX therapy in refractory SLE and LN patients proved clinical 
efficacy and favorable safety outcomes. Larger well-designed randomized clinical 
trials are warranted.