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Plasma Exchange and Glucocorticoids in Severe ANCA-Associated Vasculitis.
Walsh, Michael; Merkel, Peter A; Peh, Chen-Au; Szpirt, Wladimir M; Puéchal, Xavier; Fujimoto, Shouichi; Hawley, Carmel M; Khalidi, Nader; Floßmann, Oliver; Wald, Ron; Girard, Louis P; Levin, Adeera; Gregorini, Gina; Harper, Lorraine; Clark, William F; Pagnoux, Christian; Specks, Ulrich; Smyth, Lucy; Tesar, Vladimir; Ito-Ihara, Toshiko; de Zoysa, Janak Rashme; Szczeklik, Wojciech; Flores-Suárez, Luis Felipe; Carette, Simon; Guillevin, Loïc; Pusey, Charles D; Casian, Alina L; Brezina, Biljana; Mazzetti, Andrea; McAlear, Carol A; Broadhurst, Elizabeth; Reidlinger, Donna; Mehta, Samir; Ives, Natalie; Jayne, David R W.
  • Walsh M; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Merkel PA; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Peh CA; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Szpirt WM; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Puéchal X; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Fujimoto S; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Hawley CM; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Khalidi N; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Floßmann O; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Wald R; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Girard LP; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Levin A; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Gregorini G; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Harper L; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Clark WF; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Pagnoux C; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Specks U; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Smyth L; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Tesar V; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Ito-Ihara T; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • de Zoysa JR; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Szczeklik W; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Flores-Suárez LF; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Carette S; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Guillevin L; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Pusey CD; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Casian AL; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Brezina B; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Mazzetti A; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • McAlear CA; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Broadhurst E; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Reidlinger D; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Mehta S; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Ives N; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
  • Jayne DRW; From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division o
N Engl J Med ; 382(7): 622-631, 2020 02 13.
Article en En | MEDLINE | ID: mdl-32053298
ABSTRACT

BACKGROUND:

More effective and safer treatments are needed for antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.

METHODS:

We conducted a randomized trial with a 2-by-2 factorial design to evaluate the use of plasma exchange and two regimens of oral glucocorticoids in patients with severe ANCA-associated vasculitis (defined by an estimated glomerular filtration rate of <50 ml per minute per 1.73 m2 of body-surface area or diffuse pulmonary hemorrhage). Patients were randomly assigned to undergo plasma exchange (seven plasma exchanges within 14 days after randomization) or no plasma exchange (control group). Patients were also randomly assigned to follow either a standard-dose regimen or a reduced-dose regimen of oral glucocorticoids. Patients were followed for up to 7 years for the primary composite outcome of death from any cause or end-stage kidney disease (ESKD).

RESULTS:

Death from any cause or ESKD occurred in 100 of 352 patients (28.4%) in the plasma-exchange group and in 109 of 352 patients (31.0%) in the control group (hazard ratio, 0.86; 95% confidence interval [CI], 0.65 to 1.13; P = 0.27). The results were similar in subgroup analyses and in analyses of secondary outcomes. We also assessed the noninferiority of a reduced-dose regimen of glucocorticoids to a standard-dose regimen, using a noninferiority margin of 11 percentage points. Death from any cause or ESKD occurred in 92 of 330 patients (27.9%) in the reduced-dose group and in 83 of 325 patients (25.5%) in the standard-dose group (absolute risk difference, 2.3 percentage points; 90% CI, -3.4 to 8.0), which met the criterion for noninferiority. Serious infections at 1 year were less common in the reduced-dose group than in the standard-dose group (incidence rate ratio, 0.69; 95% CI, 0.52 to 0.93), but other secondary outcomes were similar in the two groups.

CONCLUSIONS:

Among patients with severe ANCA-associated vasculitis, the use of plasma exchange did not reduce the incidence of death or ESKD. A reduced-dose regimen of glucocorticoids was noninferior to a standard-dose regimen with respect to death or ESKD. (Funded by the U.K. National Institute for Health Research and others; PEXIVAS Current Controlled Trials number, ISRCTN07757494; ClinicalTrials.gov number, NCT00987389.).
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Intercambio Plasmático / Vasculitis Asociada a Anticuerpos Citoplasmáticos Antineutrófilos / Glucocorticoides / Fallo Renal Crónico Tipo de estudio: Clinical_trials / Etiology_studies / Incidence_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Año: 2020 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Search on Google

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Intercambio Plasmático / Vasculitis Asociada a Anticuerpos Citoplasmáticos Antineutrófilos / Glucocorticoides / Fallo Renal Crónico Tipo de estudio: Clinical_trials / Etiology_studies / Incidence_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Año: 2020 Tipo del documento: Article