Mycophenolate mofetil versus cyclophosphamide for induction treatment of lupus nephritis
Date
2009
Authors
Appel, G. B.
Contreras, G.
Dooley, M. A.
Ginzler, E. M.
Isenberg, D.
Jayne, D.
Li, L-S.
Mysler, E.
Sanchez-Guerrero, J.
Solomons, N.
Journal Title
Journal ISSN
Volume Title
Publisher
Abstract
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/m2 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. Copyright © 2009 by the American Society of Nephrology.
Description
Keywords
creatinine, cyclophosphamide, mycophenolic acid 2 morpholinoethyl ester, prednisone, drug derivative, immunosuppressive agent, mycophenolic acid, abdominal pain, adolescent, adult, aged, alopecia, anemia, arthralgia, article, backache, child, clinical trial, controlled clinical trial, controlled study, coughing, creatinine blood level, creatinine urine level, diarrhea, drug dose reduction, drug dose titration, drug efficacy, drug eruption, drug induced headache, drug safety, drug withdrawal, female, human, hypertension, lupus erythematosus nephritis, major clinical study, male, multicenter study, muscle spasm, nausea, peripheral edema, priority journal, randomized controlled trial, remission, rhinopharyngitis, school child, treatment response, urinary tract infection, vomiting, ethnic group, glomerulus filtration rate, intravenous drug administration, mortality, pathology, race, treatment outcome, Continental Population Groups, Cyclophosphamide, Ethnic Groups, Female, Glomerular Filtration Rate, Humans, Immunosuppressive Agents, Injections, Intravenous, Lupus Nephritis, Male, Mycophenolic Acid, Treatment Outcome
Citation
Journal of the American Society of Nephrology
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