Please use this identifier to cite or link to this item: https://hdl.handle.net/2440/124181
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Type: Journal article
Title: Plasma exchange and glucocorticoids in severe ANCA-associated vasculitis
Author: Walsh, M.
Merkel, P.
Peh, C.
Szpirt, W.
Puechal, X.
Fujimoto, S.
Hawley, C.
Khalidi, N.
Flosmann, O.
Wald, R.
Girard, L.
Levin, A.
Gregorini, G.
Harper, L.
Clark, W.
Pagnoux, C.
Specks, U.
Smyth, L.
Tesar, V.
Ito-Ihara, T.
et al.
Citation: New England Journal of Medicine, 2020; 382(7):622-631
Publisher: Massachusetts Medical Society
Issue Date: 2020
ISSN: 0028-4793
1533-4406
Statement of
Responsibility: 
Michael Walsh, Peter A. Merkel, Chen-Au Peh, Wladimir M. Szpirt, Xavier Puéchal, Shouichi Fujimoto ... et al.
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. opens in new tab; ClinicalTrials.gov number, NCT00987389. opens in new tab.)
Keywords: PEXIVAS Investigators
Humans
Kidney Diseases
Kidney Failure, Chronic
Cyclophosphamide
Immunosuppressive Agents
Glucocorticoids
Plasma Exchange
Combined Modality Therapy
Administration, Oral
Incidence
Dose-Response Relationship, Drug
Adult
Aged
Middle Aged
Female
Male
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Induction Chemotherapy
Rituximab
Rights: Copyright © 2020, Massachusetts Medical Society
DOI: 10.1056/NEJMoa1803537
Grant ID: http://purl.org/au-research/grants/nhmrc/626939
http://purl.org/au-research/grants/nhmrc/1086192
http://purl.org/au-research/grants/nhmrc/631731
http://purl.org/au-research/grants/nhmrc/1092957
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