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Mycophenolate Mofetil versus Cyclophosphamide for Induction Treatment of Lupus Nephritis

Gerald B. Appel^*, Gabriel Contreras, Mary Anne Dooley, Ellen M. Ginzler, David Isenberg^||, David Jayne^¶, Lei-Shi Li^**, Eduardo Mysler, Jorge Sánchez-Guerrero, Neil Solomons, David Wofsy^|||| the Aspreva Lupus Management Study Group

^* Department of Nephrology, Columbia University, New York, New York; University of Miami, Miller School of Medicine, Miami, Florida; Department of Medicine, University of North Carolina, Chapel Hill, Chapel Hill, North Carolina; Department of Medicine, SUNY-Downstate Medical Center, New York, New York; ^|| Centre for Rheumatology, Department of Medicine, University College London, London, United Kingdom; ^¶ Renal Unit, Addenbrooke's Hospital, Cambridge, United Kingdom; ^** Research Institute of Nephrology, Nanjing, China; Organización Médica de Investigación, Buenos Aires, Argentina; Instituto Nacional de Ciencias Médicas y Nutrición, Salvador Zubirán, México; Aspreva Pharmaceuticals Corporation, Victoria, British Columbia, Canada; and ^|| Department of Medicine, University of California, San Francisco, California

Correspondence: Dr. Neil Solomons, Aspreva Pharmaceuticals Corporation, #1203, 4464 Markham Street, Victoria, BC V8Z7X8, Canada. Phone: 250-708-4287; Fax: 254-744-2498; E-mail: nsolomons{at}aspreva.com

Received for publication October 1, 2008. Accepted for publication December 5, 2008.

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.

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Copyright © 2009 by the American Society of Nephrology. Online ISSN: 1533-3450 Print ISSN: 1046-6673