Efficacy and safety of rituximab for systemic lupus erythematosus treatment: a meta-analysis

Background: Given the inconsistency of previous studies and the newly emerging evidence, we decided to conduct a meta-analysis.
Methods: The meta-analysis included 2 randomized controlled trials and 13 observational studies 742 patients in total. Qualified studies were properly searched from databases . Data were analyzed by the RevMan 5.3 software. Results were demonstrated as WMD , SMD and RR with 95% CIs, I² and P value.
Results: we observed that a remarkable increase of complement C3 in the rituximab group than placebo group (WMDfixed=7.67mg/dL, 95%CIs=-0.16~15.50, I2=0%, P=0.05). A significant increase of complement C4 was observed in the rituximab group than placebo group (WMDfixed=3.14mg/dL, 95%CIs=1.06~5.22, I2 =0%, P=0.003). Notably decreased peripheral CD19+B cells in rituximab group than placebo group (WMDfixed=-117.93n/μl, 95%CIs=-172.94~-62.91, I2 =0%, P<0.0001) in RCTs. Patients with severe or refractory SLE got more satisfactory efficacy results after receiving rituximab in observational studies, such as British Isles Lupus Assessment Group index score, SLE Disease Activity Index score, complement C3/C4, anti-dsDNA antibodies, peripheral CD19⁺B cells and so on. Safety profiles were no difference between rituximab and placebo groups.
Conclusion: although the efficacy of rituximab is highly controversial for SLE, our study shows that rituximab presents a satisfying efficacy and safety for SLE.

Keywords
Efficacy; safety; rituximab; systemic lupus erythematosus; meta-analysis.