Table 2

Randomized controlled studies in lupus nephritis

Drug and reference

Description

Primary endpoint

Number and type of patients

Follow-up duration

Results


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


AZA, azathioprine; CYC, cyclophosphamide; ESRD, end-stage renal disease; i.v., intravenous; LN, lupus nephritis; MMF, mycophenolate mofetil; p.o., oral; sCr, serum creatinine.

Saxena et al. Arthritis Research & Therapy 2011 13:240   doi:10.1186/ar3378