Rituximab or Cyclophosphamide in the Treatment of Membranous Nephropathy: The RI-CYCLO Randomized Trial.

Scolari, Francesco; Delbarba, Elisa; Domenico, Santoro; Gesualdo, Loreto; Pani, Antonello; Dallera, Nadia; Mani, Laila-Yasmin; Santostefano, Marisa; Feriozzi, Sandro; Quaglia, Marco; Boscutti, Giuliano; Ferrantelli, Angelo; Marcantoni, Carmelita; Passerini, Patrizia; Magistroni, Riccardo; Alberici, Federico; Ghiggeri, Gian Marco; Ponticelli, Claudio; Ravani, Pietro (2021). Rituximab or Cyclophosphamide in the Treatment of Membranous Nephropathy: The RI-CYCLO Randomized Trial. (In Press). Journal of the American Society of Nephrology : JASN American Society of Nephrology 10.1681/ASN.2020071091

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Background: A cyclic corticosteroid-cyclophosphamide regimen is the first-line therapy for membranous nephropathy. Compared with this regimen, rituximab therapy might have a more favorable safety profile, but a head-to-head comparison is lacking.

Methods: We randomly assigned 74 adults with membranous nephropathy and proteinuria >3.5 g/d to rituximab (1 g) on days 1 and 15, or a 6-month cyclic regimen with corticosteroids alternated with cyclophosphamide every other month. The primary outcome was complete remission of proteinuria at 12 months. Other outcomes included determination of complete or partial remission at 24 months and occurrence of adverse events.

Results: At 12 months, six of 37 patients (16%) randomized to rituximab and 12 of 37 patients (32%) randomized to the cyclic regimen experienced complete remission (odds ratio [OR], 0.4; 95% CI, 0.13 to 1.23); 23 of 37 (62%) receiving rituximab and 27 of 37 (73%) receiving the cyclic regimen had complete or partial remission (OR, 0.61; 95% CI, 0.23 to 1.63). At 24 months, the probabilities of complete and of complete or partial remission with rituximab were 0.42 (95% CI, 0.26 to 0.62) and 0.83 (95% CI, 0.65 to 0.95), respectively, and 0.43 (95% CI, 0.28 to 0.61) and 0.82 (95% CI, 0.68 to 0.93), respectively, with the cyclic regimen. Serious adverse events occurred in 19% of patients receiving rituximab and in 14% receiving the cyclic regimen.

Conclusions: This pilot trial found no signal of more benefit or less harm associated with rituximab versus a cyclic corticosteroid-cyclophosphamide regimen in the treatment of membranous nephropathy. A head-to-head, pragmatic comparison of the cyclic regimen versus rituximab may require a global noninferiority trial.

Clinical trial registry name and registration number: Rituximab versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy (RI-CYCLO), NCT03018535.

Keywords: glomerulonephritis; membranous nephropathy; nephrotic syndrome.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Dermatology, Urology, Rheumatology, Nephrology, Osteoporosis (DURN) > Clinic of Nephrology and Hypertension

UniBE Contributor:

Mani, Laila-Yasmin

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1533-3450

Publisher:

American Society of Nephrology

Funders:

[UNSPECIFIED] Wissenschaftlicher Fonds der Universitätsklinik für Nephrologie und Hypertonie

Language:

English

Submitter:

Laila-Yasmin Mani

Date Deposited:

16 Mar 2021 09:07

Last Modified:

17 Mar 2021 01:34

Publisher DOI:

10.1681/ASN.2020071091

PubMed ID:

33649098

URI:

https://boris.unibe.ch/id/eprint/153035

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