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, Carlos Abud, Sharon Adler, Graciela Alarcón, Elisa Albuquerque, Fernando Almeida, Alejandro Alvarellos, Gerald Appel, Hilario Avila, Cornelia BlumeIoannis Boletis, Alain Bonnardeaux, Alan Braun, Jill Buyon, Ricard Cervera, Nan Chen, Shunle Chen, António Gomes Da Costa, Razeen Davids, David D'Cruz, Enrique De Ramón, Atul Deodhar, Andrea Doria, Bertrand Dussol, Paul Emery, Justus Fiechtner, Jürgen Floege, Hilda Fragoso-Loyo, Richard Furie, Rozina Ghazalli, Cybele Ghossein, Gary Gilkeson, Ellen Ginzler, Caroline Gordon, Jennifer Grossman, Jieruo Gu, Loïc Guillevin, Pierre Yves Hatron, Gisela Herrera, Falk Hiepe, Frederic Houssiau, Osvaldo Hübscher, Claudia Hura, Joshua Kaplan, Gianna Kirsztajn, Emese Kiss, Ghazali Ahmad Kutty, Maurice Laville, Maria Lazaro, Oliver Lenz, Leishi Li, Liz Lightstone, Sam Lim, Michel Malaise, Susan Manzi, Juan Marcos, Olivier Meyer, Pablo Monge, Saraladev Naicker, Nathaniel Neal, Michael Neuwelt, Kathy Nicholls, Nancy Olsen, Jose Ordi-Ros, Barbara Ostrov, Manuel Pestana, Michelle Petri, Gyula Pokorny, Jacques Pourrat, Jiaqi Qian, Jai Radhakrishnan, Brad Rovin, Julio Sanchez Roman, Joseph Shanahan, William Shergy, Fotini Skopouli, Alberto Spindler, Christopher Striebich, Robert Sundel, Charles Swanepoel, Yen Tan Si, Guillermo Tate, Vladimír Tesaŕ, Mohamed Tikly, Haiyan Wang, Rosnawati Yahya, Xueqing Yu, Fengchun Zhang, Diana Zoruba

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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.

Original languageEnglish (US)
Pages (from-to)1103-1112
Number of pages10
JournalJournal of the American Society of Nephrology
Volume20
Issue number5
DOIs
StatePublished - May 2009

ASJC Scopus subject areas

  • Nephrology

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    Appel, G. B., Contreras, G., Dooley, M. A., Ginzler, E. M., Isenberg, D., Jayne, D., Li, L. S., Mysler, E., Sánchez-Guerrero, J., Solomons, N., Wofsy, D., Abud, C., Adler, S., Alarcón, G., Albuquerque, E., Almeida, F., Alvarellos, A., Appel, G., Avila, H., ... Zoruba, D. (2009). Mycophenolate mofetil versus cyclophosphamide for induction treatment of lupus nephritis. Journal of the American Society of Nephrology, 20(5), 1103-1112. https://doi.org/10.1681/ASN.2008101028