A Systematic Review For The Treatment Of Lupus Nephritis With Rituximab

Objective:To systematically evaluate the efficacy and safety of rituximab for the treatment in lupus nephritis, and to provide a gist of evidence-based medicine for clinical doctors selecting and using this drug reasonably.Methods:PubMed-EMBASE-Cochrane Central Register of Controlled Trials-Chinese Biomedical Literature Database (CBM)、Chinese Journal Full-text Database (CNKI) and some other databases were electronically searched since the establishment of the database to January 2015. The language was restricted in English or Chinese. We fully collected those relevant controlled clinical trials (randomized or non-randomized controlled trials) of rituximab treatment in lupus nephritis, and assessed the quality of the studies. We chose the clinical remission rate (the sum of complete remission rate and partial remission rate) as primary efficacy measure, the parameters (such as SLEDAI、serum creatinine、serum albumin、complement C3、complement C4、proteinuria) as secondary efficacy measure, and adverse events (such as allergic reaction、 infection、leukopenia、malignant tumor、diarrhea、amenorrhea and death) rate as safety measure. Relevant data were extracted and analyzed with the software Revman5.3.Results:After selected, four studies were included for analysis involving 292 patients. The results of the meta-analysis showed that, (1) the rituximab group had a higher clinical remission rate than conventional therapy group[OR=2.25,95%CI (1.35,3.75),P=0.002], and there was no statistical difference in complete remission rate and partial remission rate between two groups(P>0.1); (2) compared to the conventional therapy group, the rituximab group had a lower SLEDAI[WMD=-3.44,95%CI (-4.20,-2.69), P<0.00001] and a higher serum albumin[SMD=0.60,95%CI (0.27,0.93), P=0.0004], and there was no statistical difference in serum creatinine、complement C3-complement C4 and proteinuria between two groups (P>0.05); (3) the rituximab group and the conventional therapy group had the same adverse events rate, and there was no statistical difference[OR=0.5,95%CI (0.21,1.21), P=0.13].Conclusions:Compared to the conventional therapy, rituximab as an add-on therapy on top of conventional therapy can significantly improve the clinical remission rate, reduce the lupus activity index, improve the serum albumin level, and has the same therapeutic effect in reducing the serum creatinine-. improving the complement C3 and C4 and reducing the proteinuria. Moreover, there is no significant difference in the adverse events rate between the ’add-on-RTX-on-top-of-standard care’and the conventional therapy. However, this study included a small number of trials which had a small size sample and various qualities, and might affect the results of our study. So our results still need to be confirmed by more multi-center, large sample, high-quality randomized controlled trials.