Table 1.
Selected trials evaluating calcineurin inhibitors in lupus nephritis
| Trial | Design | N | Outcome Measure | Treatment Arms | Follow-Up Duration | Response Rate |
|---|---|---|---|---|---|---|
| Moroni et al. 2006 (11) | RCT | 75 | Kidney flare | Cyclosporin versus azathioprine | 4 yr | Cyclosporin: 10.6 flares/100 patient yr; azathioprine: 13.4 flares/100 patient yr |
| Bao et al. 2008 (18) | RCT | 40 | Complete remission | Tacrolimus/MMF versus iv cyclophosphamide | 9 mo | Tacrolimus/MMF: 65% complete remission; iv cyclophosphamide: 15% complete remission |
| Zavada et al. 2010 (10) | RCT | 40 | Complete remission, overall response | Cyclosporin versus cyclophosphamide | 18 mo | Cyclosporin: 37% complete remission, 58% response; cyclophosphamide: 14% complete remission, 38% response |
| Yap et al. 2012 (17) | RCT | 16 | Complete remission, partial remission, overall remission | Tacrolimus versus MMF | 24 mo | Tacrolimus: overall 55.6%; MMF: overall 71.4% |
| Li et al. 2012 (13) | RCT | 60 | Complete remission, partial remission, overall remission | Tacrolimus versus cyclophosphamide versus MMF | 24 wk | Cyclophosphamide: 60% overall; MMF: 75% overall; tacrolimus: 75% overall |
| Mok et al. 2013 (22) | Observational | 21 | Kidney response | Tacrolimus/MMF (no control group) | 12 mo | 67% kidney response, 33% no response |
| Liu et al. 2015 (19) | RCT | 362 | Complete remission | Tacrolimus/MMF versus cyclophosphamide | 24 wk | Tacrolimus/MMF: 45.9% complete remission, 83.5% overall; cyclophosphamide: 25.6% complete remission, 63.0% overall |
| Mok et al. 2016 (14) | RCT | 150 | Complete remission at 6 mo | Tacrolimus versus MMF × 6 mo; both azathioprine after | 24 wk for induction phase, 5-yr maintenance | MMF: 59% complete remission; tacrolimus: 62% complete remission after induction; MMF: 38% kidney flare versus tacrolimus: 54% kidney flare during maintenance |
| Zhang et al. 2017 (21) | RCT | 206 | Kidney relapse rate | Tacrolimus/MMF versus azathioprine (maintenance of Liu et al. 2015 [19]) | 18 mo | Tacrolimus/MMF: 5.47% kidney relapse; azathioprine: 7.62% kidney relapse |
| Rovin et al. 2019 (27) | RCT | 265 | Complete remission | High-dose voclosporin + MMF versus low-dose voclosporin + MMF versus MMF | 48 wk | Low-dose voclosporin: 49.4% complete remission; high-dose voclosporin: 39.8% complete remission; MMF: 23.9% complete remission |
RCT, randomized, control trial; MMF, mycophenolate mofetil.