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Abstract: FR-OR53

Sequential Treatment with Tacrolimus and Rituximab vs. Alternating Corticosteroids and Cyclophosphamide in Primary Membranous Nephropathy (PMN)

Session Information

Category: Glomerular Diseases

  • 1203 Glomerular Diseases: Clinical, Outcomes, and Trials

Authors

  • Fernandez Juarez, Gema, Hospital Univesitario Fundacion Alcorcón, Madrid, Madrid, Spain
  • Rojas-Rivera, Jorge Enrique, Fundacion Jimenez Diaz, Madrid, Spain
  • van de Logt, Anne-Els, 3 Radboud University Medical Center, Nijmegen,, Netherlands
  • Justino, Joana, Institut de Pharmacologie Moleculaire et Cellulaire, Valbonne, Provence-Alpes-Côte d'Azu, France
  • Sevillano, Angel M., Hospital Universitario 12Octubre, Madrid, Spain
  • Caravaca-Fontan, Fernando, Hospital Universitario 12Octubre, Madrid, Spain
  • Avila, Ana, Hospital Dr. Peset, Valencia, Spain
  • Rabasco, Cristina, Hospital Reina Sofia, Córdoba, Spain
  • Cabello, Virginia, Hospital Virgen del Rocio, Sevilla, Sevilla, Spain
  • Goicoechea, Marian, Hospital Universitario Gregorio Marañón, Madrid, Spain
  • Quintana, Luis F., Hospital Clnic, Barcelona, Spain
  • Agraz, Irene, Vall d'Hebron Hospital Universitari, Barcelona, Catalunya, Spain
  • Romera segorbe, Ana Maria, Hospital General Ciudad Real, Ciudad Real, Spain
  • Shabaka, Amir, Hospital Univesitario Fundacion Alcorcón, Madrid, Madrid, Spain
  • Espinosa, Mario, Hospital Reina Sofia, Córdoba, Spain
  • Egido, Jesus, Fundacion Jimenez Diaz, Madrid, Spain
  • Lambeau, Gerard J., Institut de Pharmacologie Moleculaire et Cellulaire, Valbonne, Provence-Alpes-Côte d'Azu, France
  • Ronco, Pierre M., Tenon Hospital, Paris, Spain
  • Praga, Manuel, Hospital Universitario 12Octubre, Madrid, Spain
Background

A cyclical corticosteroid-cyclophosphamide regimen is recommended for patients with PMN at high risk of progression. RTX monotherapy and calcineurin inhibitors have shown efficacy in inducing remission, but relapses are very common after discontinuation of calcineurin inhibitors.

Methods

In a randomized and open-label controlled trial, 86 patients (pts) with PMN and persistent nephrotic syndrome after a 6m observation period were assigned to receive a 6-m cyclical treatment with corticosteroid and cyclophosphamide (n=43) or sequential treatment with tacrolimus (full-dose for 6m and tapering for another 3m) and RTX (1 g at 6thm) (n=43). Primary outcome was complete or partial remission of nephrotic syndrome at 24m.

Results

The primary outcome occurred in 36 pts (84%) in the Ct-cyclophosphamide group and in 25 pts (58%) in the tacrolimus-RTX group (RR 1.44 95%CI 1.08-1.92). Complete remission at 24m occurred in 26pts (60%) in the corticosteroid-cyclophosphamide group and in 11pts (26%) in the tacrolimus-RTX group (RR 2.36 95%CI 1.34-4.16). Immunological response was faster in the corticosteroid-cyclophosphamide group and associated with remission at 24 m. Relapses occurred in 1 pt (2.7%) in the corticosteroid-cyclophosphamide group, and 3 pts (12%) in the tacrolimus-RTX group. The rate of serious adverse events was similar in both groups.

Conclusion

Treatment with corticosteroid-cyclophosphamide induced remission in a significantly greater number of patients with PMN than tacrolimus-rituximab. ( NCT01955187).

Funding

  • Government Support - Non-U.S.