Forskning
Udskriv Udskriv
Switch language
Region Hovedstaden - en del af Københavns Universitetshospital
Udgivet

Plasma Exchange and Glucocorticoids in Severe ANCA-Associated Vasculitis

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

  1. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Remdesivir for the Treatment of Covid-19 - Final Report

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Dapagliflozin in Patients with Chronic Kidney Disease

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  4. Ofatumumab versus Teriflunomide in Multiple Sclerosis

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  5. Serum Urate Lowering with Allopurinol and Kidney Function in Type 1 Diabetes

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  1. Developments in the Histopathological Classification of ANCA-Associated Glomerulonephritis

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Arteriel Hypertension: Medicin. Lærebog i medicin

    Publikation: Bidrag til bog/antologi/rapportBidrag til bog/antologiFormidling

  3. Medicin

    Publikation: Bog/antologi/afhandling/rapportBogUndervisningpeer review

  • Michael Walsh
  • Peter A Merkel
  • Chen-Au Peh
  • Wladimir M Szpirt
  • Xavier Puéchal
  • Shouichi Fujimoto
  • Carmel M Hawley
  • Nader Khalidi
  • Oliver Floßmann
  • Ron Wald
  • Louis P Girard
  • Adeera Levin
  • Gina Gregorini
  • Lorraine Harper
  • William F Clark
  • Christian Pagnoux
  • Ulrich Specks
  • Lucy Smyth
  • Vladimir Tesar
  • Toshiko Ito-Ihara
  • Janak Rashme de Zoysa
  • Wojciech Szczeklik
  • Luis Felipe Flores-Suárez
  • Simon Carette
  • Loïc Guillevin
  • Charles D Pusey
  • Alina L Casian
  • Biljana Brezina
  • Andrea Mazzetti
  • Carol A McAlear
  • Elizabeth Broadhurst
  • Donna Reidlinger
  • Samir Mehta
  • Natalie Ives
  • David R W Jayne
  • PEXIVAS Investigators
  • Martin Egfjord (Medlem af forfattergruppering)
Vis graf over relationer

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.).

OriginalsprogEngelsk
TidsskriftThe New England journal of medicine
Vol/bind382
Udgave nummer7
Sider (fra-til)622-631
Antal sider10
ISSN0028-4793
DOI
StatusUdgivet - 13 feb. 2020

Bibliografisk note

Copyright © 2020 Massachusetts Medical Society.

ID: 61259912