The aim of this study was to assess the efficacy and safety of
tacrolimus for the treatment of
lupus nephritis (LN). A systematic review of clinical trials on
tacrolimus in LN was conducted. Seven studies met the review inclusion criteria. Two studies were case-control studies, and five studies were open-label trials. One randomized controlled trial (RCT) found that
tacrolimus significantly improved
lupus nephritis disease activity index (LNDAI) as compared with a placebo, but no difference was observed between these two groups in terms of treatment-related adverse events. The other case-control study compared
tacrolimus with standard protocols of oral
cyclophosphamide or
azathioprine for the treatment of membranous LN and found that efficacies were similar. All five open-label prospective studies concluded that
tacrolimus is safe and effective as an induction and maintenance
therapy for LN or for the treatment of LN with persistent
proteinuria that failed to respond to
prednisolone and
immunosuppressants. In conclusion, this systematic review shows that
tacrolimus may be effective as an induction and maintenance
therapy for LN or as a treatment for LN with persistent
proteinuria despite gold standard treatment. However, further RCTs are needed to compare
tacrolimus with standard regimens for the treatment of LN.