Abstract :
[en] Recent studies have suggested that mycophenolate mofetil (MMF) may offer
advantages over intravenous cyclophosphamide (IVC) for the treatment of lupus
nephritis, but these therapies have not been compared in an international
randomized, controlled trial. Here, we report the comparison of MMF and IVC as
induction treatment for active lupus nephritis in a multinational, two-phase
(induction and maintenance) study. We randomly assigned 370 patients with classes
III through V lupus nephritis to open-label MMF (target dosage 3 g/d) or IVC (0.5
to 1.0 g/m(2) in monthly pulses) in a 24-wk induction study. Both groups received
prednisone, tapered from a maximum starting dosage of 60 mg/d. The primary end
point was a prespecified decrease in urine protein/creatinine ratio and
stabilization or improvement in serum creatinine. Secondary end points included
complete renal remission, systemic disease activity and damage, and safety.
Overall, we did not detect a significantly different response rate between the
two groups: 104 (56.2%) of 185 patients responded to MMF compared with 98 (53.0%)
of 185 to IVC. Secondary end points were also similar between treatment groups.
There were nine deaths in the MMF group and five in the IVC group. We did not
detect significant differences between the MMF and IVC groups with regard to
rates of adverse events, serious adverse events, or infections. Although most
patients in both treatment groups experienced clinical improvement, the study did
not meet its primary objective of showing that MMF was superior to IVC as
induction treatment for lupus nephritis.
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