RT Journal Article
T1 The STARMEN trial indicates that alternating treatment with corticosteroids and cyclophosphamide is superior to sequential treatment with tacrolimus and rituximab in primary membranous nephropathy.
A1 Fernández-Juárez, Gema
A1 Rojas-Rivera, Jorge
A1 Logt, Anne-Els van de
A1 Justino, Joana
A1 Sevillano, Angel
A1 Caravaca-Fontán, Fernando
A1 Ávila, Ana
A1 Rabasco, Cristina
A1 Cabello, Virginia
A1 Varela, Alfonso
A1 Díez, Montserrat
A1 Martín-Reyes, Guillermo
A1 Diezhandino, Marian Goicoechea
A1 Quintana, Luis F
A1 Agraz, Irene
A1 Gómez-Martino, Juan Ramón
A1 Cao, Mercedes
A1 Rodríguez-Moreno, Antolina
A1 Rivas, Begoña
A1 Galeano, Cristina
A1 Bonet, Jose
A1 Romera, Ana
A1 Shabaka, Amir
A1 Plaisier, Emmanuelle
A1 Espinosa, Mario
A1 Egido, Jesus
A1 Segarra, Alfonso
A1 Lambeau, Gérard
A1 Ronco, Pierre
A1 Wetzels, Jack
A1 Praga, Manuel
A1 STARMEN Investigators, 
K1 corticosteroids
K1 cyclophosphamide
K1 primary membranous nephropathy
K1 rituximab
K1 tacrolimus
AB A cyclical corticosteroid-cyclophosphamide regimen is recommended for patients with primary membranous nephropathy at high risk of progression. We hypothesized that sequential therapy with tacrolimus and rituximab is superior to cyclical alternating treatment with corticosteroids and cyclophosphamide in inducing persistent remission in these patients. This was tested in a randomized, open-label controlled trial of 86 patients with primary membranous nephropathy and persistent nephrotic syndrome after six-months observation and assigned 43 each to receive six-month cyclical treatment with corticosteroid and cyclophosphamide or sequential treatment with tacrolimus (full-dose for six months and tapering for another three months) and rituximab (one gram at month six). The primary outcome was complete or partial remission of nephrotic syndrome at 24 months. This composite outcome occurred in 36 patients (83.7%) in the corticosteroid-cyclophosphamide group and in 25 patients (58.1%) in the tacrolimus-rituximab group (relative risk 1.44; 95% confidence interval 1.08 to 1.92). Complete remission at 24 months occurred in 26 patients (60%) in the corticosteroid-cyclophosphamide group and in 11 patients (26%) in the tacrolimus-rituximab group (2.36; 1.34 to 4.16). Anti-PLA2R titers showed a significant decrease in both groups but the proportion of anti-PLA2R-positive patients who achieved immunological response (depletion of anti-PLA2R antibodies) was significantly higher at three and six months in the corticosteroid-cyclophosphamide group (77% and 92%, respectively), as compared to the tacrolimus-rituximab group (45% and 70%, respectively). Relapses occurred in one patient in the corticosteroid-cyclophosphamide group, and three patients in the tacrolimus-rituximab group. Serious adverse events were similar in both groups. Thus, treatment with corticosteroid-cyclophosphamide induced remission in a significantly greater number of patients with primary membranous nephropathy than tacrolimus-rituximab.
YR 2020
FD 2020-11-07
LK https://hdl.handle.net/10668/25927
UL https://hdl.handle.net/10668/25927
LA en
DS RISalud
RD Apr 17, 2025