Efficacy and safety of tacrolimus therapy for lupus nephritis: A systematic review of clinical trials

Lupus, 05/11/2011

Lee YH et al. – 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.


  • Systematic review of clinical trials on tacrolimus in LN was conducted
  • 7 studies met review inclusion criteria
  • 2 studies were case-control studies
  • 5 studies were open-label trials


  • One RCT found that tacrolimus significantly improved lupus nephritis disease activity index (LNDAI) as compared with placebo, but no difference observed between these 2 groups in terms of treatment-related Aes
  • The other case-control study compared tacrolimus with standard protocols of oral cyclophosphamide or azathioprine for treatment of membranous LN and found that efficacies were similar
  • All 5 open-label prospective studies concluded that tacrolimus is safe and effective as an induction and maintenance therapy for LN or for treatment of LN with persistent proteinuria that failed to respond to prednisolone and immunosuppressants

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