Kidney Week

Abstract: FR-OR53

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

Session Information

• High-Impact Clinical Trials
  October 23, 2020 | Location: Live-Streamed
  Abstract Time: 11:00 AM - 11:15 AM

Category: Glomerular Diseases

• 1203 Glomerular Diseases: Clinical, Outcomes, and Trials

Authors

• Fernandez Juarez, Gema, Hospital Univesitario Fundacion Alcorcón, Madrid, Madrid, Spain

Gema Fernandez Juarez, MD, PhD

• Rojas-Rivera, Jorge Enrique, Fundacion Jimenez Diaz, Madrid, Spain

Jorge Enrique Rojas-Rivera,

• van de Logt, Anne-Els, 3 Radboud University Medical Center, Nijmegen,, Netherlands

Anne-Els van de Logt,

• Justino, Joana, Institut de Pharmacologie Moleculaire et Cellulaire, Valbonne, Provence-Alpes-Côte d'Azu, France

Joana Justino,

• Sevillano, Angel M., Hospital Universitario 12Octubre, Madrid, Spain

Angel M. Sevillano,

• Caravaca-Fontan, Fernando, Hospital Universitario 12Octubre, Madrid, Spain

Fernando Caravaca-Fontan,

• Avila, Ana, Hospital Dr. Peset, Valencia, Spain

Ana Avila,

• Rabasco, Cristina, Hospital Reina Sofia, Córdoba, Spain

Cristina Rabasco,

• Cabello, Virginia, Hospital Virgen del Rocio, Sevilla, Sevilla, Spain

Virginia Cabello,

• Goicoechea, Marian, Hospital Universitario Gregorio Marañón, Madrid, Spain

Marian Goicoechea,

• Quintana, Luis F., Hospital Clnic, Barcelona, Spain

Luis F. Quintana,

• Agraz, Irene, Vall d'Hebron Hospital Universitari, Barcelona, Catalunya, Spain

Irene Agraz,

• Romera segorbe, Ana Maria, Hospital General Ciudad Real, Ciudad Real, Spain

Ana Maria Romera segorbe,

• Shabaka, Amir, Hospital Univesitario Fundacion Alcorcón, Madrid, Madrid, Spain

Amir Shabaka,

• Espinosa, Mario, Hospital Reina Sofia, Córdoba, Spain

Mario Espinosa,

• Egido, Jesus, Fundacion Jimenez Diaz, Madrid, Spain

Jesus Egido,

• Lambeau, Gerard J., Institut de Pharmacologie Moleculaire et Cellulaire, Valbonne, Provence-Alpes-Côte d'Azu, France

Gerard J. Lambeau,

• Ronco, Pierre M., Tenon Hospital, Paris, Spain

Pierre M. Ronco,

• Praga, Manuel, Hospital Universitario 12Octubre, Madrid, Spain

Manuel Praga,

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 6^thm) (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.