Details
| Originalsprache | Englisch |
|---|---|
| Seiten (von - bis) | 1103-1112 |
| Seitenumfang | 10 |
| Fachzeitschrift | Journal of the American Society of Nephrology |
| Jahrgang | 20 |
| Ausgabenummer | 5 |
| Frühes Online-Datum | 30 Apr. 2009 |
| Publikationsstatus | Veröffentlicht - Mai 2009 |
| Extern publiziert | Ja |
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.
ASJC Scopus Sachgebiete
- Medizin (insg.)
- Nephrologie
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in: Journal of the American Society of Nephrology, Jahrgang 20, Nr. 5, 05.2009, S. 1103-1112.
Publikation: Beitrag in Fachzeitschrift › Artikel › Forschung › Peer-Review
}
TY - JOUR
T1 - Mycophenolate mofetil versus cyclophosphamide for induction treatment of lupus nephritis
AU - Appel, Gerald B.
AU - Contreras, Gabriel
AU - Dooley, Mary Anne
AU - Ginzler, Ellen M.
AU - Isenberg, David
AU - Jayne, David
AU - Li, Lei Shi
AU - Mysler, Eduardo
AU - Sánchez-Guerrero, Jorge
AU - Solomons, Neil
AU - Wofsy, David
AU - Abud, Carlos
AU - Adler, Sharon
AU - Alarcón, Graciela
AU - Albuquerque, Elisa
AU - Almeida, Fernando
AU - Alvarellos, Alejandro
AU - Appel, Gerald
AU - Avila, Hilario
AU - Blume, Cornelia
AU - Boletis, Ioannis
AU - Bonnardeaux, Alain
AU - Braun, Alan
AU - Buyon, Jill
AU - Cervera, Ricard
AU - Chen, Nan
AU - Chen, Shunle
AU - Da Costa, António Gomes
AU - Davids, Razeen
AU - D'Cruz, David
AU - De Ramón, Enrique
AU - Deodhar, Atul
AU - Doria, Andrea
AU - Dussol, Bertrand
AU - Emery, Paul
AU - Fiechtner, Justus
AU - Floege, Jürgen
AU - Fragoso-Loyo, Hilda
AU - Furie, Richard
AU - Ghazalli, Rozina
AU - Ghossein, Cybele
AU - Gilkeson, Gary
AU - Ginzler, Ellen
AU - Gordon, Caroline
AU - Grossman, Jennifer
AU - Gu, Jieruo
AU - Guillevin, Loïc
AU - Hatron, Pierre Yves
AU - Herrera, Gisela
AU - Hiepe, Falk
AU - Houssiau, Frederic
AU - Hübscher, Osvaldo
AU - Hura, Claudia
AU - Kaplan, Joshua
AU - Kirsztajn, Gianna
AU - Kiss, Emese
AU - Kutty, Ghazali Ahmad
AU - Laville, Maurice
AU - Lazaro, Maria
AU - Lenz, Oliver
AU - Li, Leishi
AU - Lightstone, Liz
AU - Lim, Sam
AU - Malaise, Michel
AU - Manzi, Susan
AU - Marcos, Juan
AU - Meyer, Olivier
AU - Monge, Pablo
AU - Naicker, Saraladev
AU - Neal, Nathaniel
AU - Neuwelt, Michael
AU - Nicholls, Kathy
AU - Olsen, Nancy
AU - Ordi-Ros, Jose
AU - Ostrov, Barbara
AU - Pestana, Manuel
AU - Petri, Michelle
AU - Pokorny, Gyula
AU - Pourrat, Jacques
AU - Qian, Jiaqi
AU - Radhakrishnan, Jai
AU - Rovin, Brad
AU - Roman, Julio Sanchez
AU - Shanahan, Joseph
AU - Shergy, William
AU - Skopouli, Fotini
AU - Spindler, Alberto
AU - Striebich, Christopher
AU - Sundel, Robert
AU - Swanepoel, Charles
AU - Si, Yen Tan
AU - Tate, Guillermo
AU - Tesaŕ, Vladimír
AU - Tikly, Mohamed
AU - Wang, Haiyan
AU - Yahya, Rosnawati
AU - Yu, Xueqing
AU - Zhang, Fengchun
AU - Zoruba, Diana
PY - 2009/5
Y1 - 2009/5
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=65649140169&partnerID=8YFLogxK
U2 - 10.1681/ASN.2008101028
DO - 10.1681/ASN.2008101028
M3 - Article
C2 - 19369404
AN - SCOPUS:65649140169
VL - 20
SP - 1103
EP - 1112
JO - Journal of the American Society of Nephrology
JF - Journal of the American Society of Nephrology
SN - 1046-6673
IS - 5
ER -