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Rituximab or Cyclosporine in the Treatment of Membranous Nephropathy.
Fervenza, Fernando C; Appel, Gerald B; Barbour, Sean J; Rovin, Brad H; Lafayette, Richard A; Aslam, Nabeel; Jefferson, Jonathan A; Gipson, Patrick E; Rizk, Dana V; Sedor, John R; Simon, James F; McCarthy, Ellen T; Brenchley, Paul; Sethi, Sanjeev; Avila-Casado, Carmen; Beanlands, Heather; Lieske, John C; Philibert, David; Li, Tingting; Thomas, Lesley F; Green, Dolly F; Juncos, Luis A; Beara-Lasic, Lada; Blumenthal, Samuel S; Sussman, Amy N; Erickson, Stephen B; Hladunewich, Michelle; Canetta, Pietro A; Hebert, Lee A; Leung, Nelson; Radhakrishnan, Jay; Reich, Heather N; Parikh, Samir V; Gipson, Debbie S; Lee, Dominic K; da Costa, Bruno R; Jüni, Peter; Cattran, Daniel C.
Afiliação
  • Fervenza FC; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Appel GB; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Barbour SJ; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Rovin BH; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Lafayette RA; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Aslam N; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Jefferson JA; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Gipson PE; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Rizk DV; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Sedor JR; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Simon JF; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • McCarthy ET; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Brenchley P; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Sethi S; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Avila-Casado C; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Beanlands H; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Lieske JC; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Philibert D; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Li T; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Thomas LF; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Green DF; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Juncos LA; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Beara-Lasic L; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Blumenthal SS; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Sussman AN; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Erickson SB; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Hladunewich M; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Canetta PA; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Hebert LA; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Leung N; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Radhakrishnan J; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Reich HN; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Parikh SV; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Gipson DS; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Lee DK; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • da Costa BR; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Jüni P; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
  • Cattran DC; From the Mayo Clinic, Rochester, MN (F.C.F., S.S., J.C.L., S.B.E., N.L.); Columbia University (G.B.A., P.A.C., J.R.) and the New York University Medical Center (L.B.-L.) - both in New York; the University of British Columbia, Division of Nephrology, Vancouver (S.J.B.), the University Health Network,
N Engl J Med ; 381(1): 36-46, 2019 07 04.
Article em En | MEDLINE | ID: mdl-31269364
ABSTRACT

BACKGROUND:

B-cell anomalies play a role in the pathogenesis of membranous nephropathy. B-cell depletion with rituximab may therefore be noninferior to treatment with cyclosporine for inducing and maintaining a complete or partial remission of proteinuria in patients with this condition.

METHODS:

We randomly assigned patients who had membranous nephropathy, proteinuria of at least 5 g per 24 hours, and a quantified creatinine clearance of at least 40 ml per minute per 1.73 m2 of body-surface area and had been receiving angiotensin-system blockade for at least 3 months to receive intravenous rituximab (two infusions, 1000 mg each, administered 14 days apart; repeated at 6 months in case of partial response) or oral cyclosporine (starting at a dose of 3.5 mg per kilogram of body weight per day for 12 months). Patients were followed for 24 months. The primary outcome was a composite of complete or partial remission of proteinuria at 24 months. Laboratory variables and safety were also assessed.

RESULTS:

A total of 130 patients underwent randomization. At 12 months, 39 of 65 patients (60%) in the rituximab group and 34 of 65 (52%) in the cyclosporine group had a complete or partial remission (risk difference, 8 percentage points; 95% confidence interval [CI], -9 to 25; P = 0.004 for noninferiority). At 24 months, 39 patients (60%) in the rituximab group and 13 (20%) in the cyclosporine group had a complete or partial remission (risk difference, 40 percentage points; 95% CI, 25 to 55; P<0.001 for both noninferiority and superiority). Among patients in remission who tested positive for anti-phospholipase A2 receptor (PLA2R) antibodies, the decline in autoantibodies to anti-PLA2R was faster and of greater magnitude and duration in the rituximab group than in the cyclosporine group. Serious adverse events occurred in 11 patients (17%) in the rituximab group and in 20 (31%) in the cyclosporine group (P = 0.06).

CONCLUSIONS:

Rituximab was noninferior to cyclosporine in inducing complete or partial remission of proteinuria at 12 months and was superior in maintaining proteinuria remission up to 24 months. (Funded by Genentech and the Fulk Family Foundation; MENTOR ClinicalTrials.gov number, NCT01180036.).
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Glomerulonefrite Membranosa / Ciclosporina / Rituximab / Imunossupressores Tipo de estudo: Clinical_trials Limite: Adolescent / Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: N Engl J Med Ano de publicação: 2019 Tipo de documento: Article
Texto completo
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XML
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Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Glomerulonefrite Membranosa / Ciclosporina / Rituximab / Imunossupressores Tipo de estudo: Clinical_trials Limite: Adolescent / Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: N Engl J Med Ano de publicação: 2019 Tipo de documento: Article