|
CYC [118]
|
Patients randomized to i.v. CYC vs. p.o. CYC, p.o. CYC + AZA, AZA, or prednisone
|
Time to kidney failure
|
n = 107, mainly class III and IV LN
|
7 years
|
Time to ESRD is significantly longer in patients receiving i.v. CYC compared with those receiving steroids alone
|
|
CYC [121]
|
Patients randomized to high-dose (500 to 1,000 mg/m2) monthly i.v. CYC for 6 months vs. low-dose i.v. CYC regimen 500 mg every 2 weeks × six doses
|
Treatment failure (doubling of sCr, absence of primary response or occurrence of a flare)
|
n = 90, class IV LN, 85% Caucasian
|
41 months
|
Induction therapy with low-dose CYC is as effective as high-dose CYC
|
|
MMF [123]
|
Patients randomized to 6 months induction with MMF (2 g/day) or oral CYC (2.5 mg/kg/day) + prednisolone
|
Incidence of complete remission
|
n = 42, class IV LN, 100% Chinese
|
12 months
|
Induction therapy with MMF is as effective as oral CYC
|
|
MMF [124]
|
Patients randomized to monthly i.v. CYC or MMF (3 g/day)
|
Incidence of complete remission at 6 months
|
n = 140, class IV, 56% African American
|
6 months
|
MMF was not inferior to i.v. CYC for induction of remission. In fact, MMF was more effective and better tolerated than i.v. CYC at inducing remission
|
|
MMF [125]
|
Patients randomized to MMF or monthly i.v. CYC for induction
|
Prespecified decrease in urine protein/creatinine ratio and improvement in sCr
|
n = 370, classes III to V LN, 75% Caucasian
|
6 months
|
MMF is not superior to i.v. CYC as induction therapy. No significant differences in response rate between the two groups. Adverse events were similar
|
|
MMF [126]
|
Patients randomized to quarterly i.v. CYC, MMF, or AZA for maintenance after induction with i.v. CYC
|
Incidence of patient and kidney survival
|
n = 59, classes III and IV LN, African American and Hispanic
|
72 months
|
MMF and AZA are both efficacious and safer than i.v. CYC for maintenance therapy
|
|
AZA [126]
|
Patients randomized to quarterly i.v. CYC, MMF, or AZA for maintenance after induction with i.v. CYC
|
Incidence of patient and kidney survival
|
n = 59, classes III and IV LN, African American and Hispanic
|
72 months
|
MMF and AZA are both efficacious and safer than i.v. CYC for maintenance therapy
|
|
AZA, MMF [127]
|
Patients randomized to MMF, or AZA for maintenance after induction with low-dose i.v. CYC
|
Time to renal flares
|
n = 103, classes III and IV LN, European
|
Minimum 3 years
|
No significant difference in renal flares with MMF and AZA as maintenance therapy
|
|
Rituximab (Rovin and colleagues, 2009)
|
Patients randomized to MMF or MMF + rituximab for induction therapy
|
Incidence of complete or partial renal remission
|
n = 144, classes III and IV LN
|
52 weeks
|
Rituximab does not have an additive benefit to MMF for induction therapy
|
