The STARMEN trial indicates that alternating treatment with corticosteroids and cyclophosphamide is superior to sequential treatment with tacrolimus and rituximab in primary membranous nephropathy - CNRS - Centre national de la recherche scientifique Accéder directement au contenu
Article Dans Une Revue Kidney International Année : 2021

The STARMEN trial indicates that alternating treatment with corticosteroids and cyclophosphamide is superior to sequential treatment with tacrolimus and rituximab in primary membranous nephropathy

1 Nephrology Division, Hospital Universitario Fundación Alcorcón, Madrid, Spain
2 Nephrology Division, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain
3 Radboud Institute for Health Sciences
4 IPMC - Institut de pharmacologie moléculaire et cellulaire
5 Hospital Universitario 12 de Octubre [Madrid]
6 Dr Peset University Hospital
7 Hospital Reina Sofia, Cordoba
8 Hospital Universitario Virgen del Rocío [Sevilla]
9 Hospital Universitario Virgen de la Victoria = Virgen de la Victoria University Hospital
10 Institut Investigacions Biomèdiques (IBB) Sant Pau [Barcelona, Spain]
11 Hospital Regional Universitario de Málaga = Regional University Hospital of Malaga [Spain]
12 Hospital General Universitario "Gregorio Marañón" [Madrid]
13 Department of Nephrology, Hospital Clinic, Barcelona, Spain.
14 Vall d'Hebron University Hospital [Barcelona]
15 San Pedro de Alcantara Hospital [Cáceres, Espagne]
16 Instituto de Investigación Biomédica de A Coruña (INIBIC), Complexo Hospitalario Universitario de A Coruña (CHUAC), Universidade da Coruña (UDC), Spain
17 Hospital Clinico San Carlos
18 Hospital Universitario La Paz [Madrid, Espagne]
19 Hospital Universitario Ramón y Cajal [Madrid]
20 Germans Trias i Pujol Hospital
21 HGUCR - Hospital General Universitario de Ciudad Real [Ciudad Real, Spain]
22 CoRaKID - Maladies rénales fréquentes et rares : des mécanismes moléculaires à la médecine personnalisée
23 Radboud Institute for Health Sciences [Nijmegen, the Netherlands]
24 Hospital Universitario Fundación Alcorcón
25 Hospital Universitario Fundación Jiménez Díaz [Madrid, Spain]
26 CRESIB - Barcelona Centre for International Health Research, Hospital Clinic
27 Hospital Universitario, A Coruña
28 Fundació Puigvert [Barcelona, Spain]
29 GTPUH - Germans Trias i Pujol University Hospital [Badalona, Barcelona, Spain]
30 Hospital Universitario Puerta de Hierro-Majadahonda [Madrid, Spain]
31 Getafe University Hospital = Hospital Universitario de Getafe
32 Severo Ochoa Hospital
33 Hospital Universitario Infanta Leonor [Madrid]
34 Del Henares Hospital
35 Hospital Universitario Infanta Sofía
36 Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, The Netherlan ds
Ana Vigil
  • Fonction : Auteur

Résumé

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.

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Gema Fernández-Juárez, Jorge Rojas-Rivera, Anne-Els van De Logt, Joana Justino, Angel Sevillano, et al.. The STARMEN trial indicates that alternating treatment with corticosteroids and cyclophosphamide is superior to sequential treatment with tacrolimus and rituximab in primary membranous nephropathy. Kidney International, 2021, 99 (4), pp.986-998. ⟨10.1016/j.kint.2020.10.014⟩. ⟨hal-03418112⟩
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