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See 1 citation in J Am Soc Nephrol 2017:

J Am Soc Nephrol. 2017 Jan;28(1):348-358. doi: 10.1681/ASN.2016040449. Epub 2016 Jun 27.

Rituximab for Severe Membranous Nephropathy: A 6-Month Trial with Extended Follow-Up.

Author information

1
Department of Nephrology and Dialysis, Assistance Publique Hôpitaux de Paris, Hôpital Tenon, Paris, France; karine.dahan@aphp.fr pierre.ronco@upmc.fr.
2
Sorbonne Universités, Université Pierre et Marie Curie Paris 06, Paris, France.
3
Institut National de la Santé et de la Recherche Médicale, Unité Mixte de Recherche 1155, Paris, France.
4
Department of Nephrology and Dialysis, Assistance Publique Hôpitaux de Paris, Hôpital Tenon, Paris, France.
5
Department of Clinical Pharmacology and Unité de Recherche Clinique, Assistance Publique Hôpitaux de Paris, Hôpital Saint Antoine, Paris, France.
6
Department of Nephrology and Transplantation, Assistance Publique-Hôpitaux de Marseille, Hôpital de la Timone, Marseille, France.
7
Department of Nephrology and Transplantation, Assistance Publique Hôpitaux de Paris, Hôpital Henri Mondor, Creteil, France; and.
8
Department of Nephrology and Transplantation, Centre Hospitalier Universitaire, Dijon, France.

Abstract

Randomized trials of rituximab in primary membranous nephropathy (PMN) have not been conducted. We undertook a multicenter, randomized, controlled trial at 31 French hospitals (NCT01508468). Patients with biopsy-proven PMN and nephrotic syndrome after 6 months of nonimmunosuppressive antiproteinuric treatment (NIAT) were randomly assigned to 6-month therapy with NIAT and 375 mg/m2 intravenous rituximab on days 1 and 8 (n=37) or NIAT alone (n=38). Median times to last follow-up were 17.0 (interquartile range, 12.5-24.0) months and 17.0 (interquartile range, 13.0-23.0) months in NIAT-rituximab and NIAT groups, respectively. Primary outcome was a combined end point of complete or partial remission of proteinuria at 6 months. At month 6, 13 (35.1%; 95% confidence interval [95% CI], 19.7 to 50.5) patients in the NIAT-rituximab group and eight (21.1%; 95% CI, 8.1 to 34.0) patients in the NIAT group achieved remission (P=0.21). Rates of antiphospholipase A2 receptor antibody (anti-PLA2R-Ab) depletion in NIAT-rituximab and NIAT groups were 14 of 25 (56%) and one of 23 (4.3%) patients at month 3 (P<0.001) and 13 of 26 (50%) and three of 25 (12%) patients at month 6 (P=0.004), respectively. Eight serious adverse events occurred in each group. During the observational phase, remission rates before change of assigned treatment were 24 of 37 (64.9%) and 13 of 38 (34.2%) patients in NIAT-rituximab and NIAT groups, respectively (P<0.01). Positive effect of rituximab on proteinuria remission occurred after 6 months. These data suggest that PLA2R-Ab levels are early markers of rituximab effect and that addition of rituximab to NIAT does not affect safety.

KEYWORDS:

anti-PLA2R antibody; anti-THSD7A antibody; idiopathic membranous nephropathy; randomized controlled trial; rituximab; severe adverse event

PMID:
27352623
PMCID:
PMC5198292
DOI:
10.1681/ASN.2016040449
[Indexed for MEDLINE]
Free PMC Article

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