Study link: https://pubmed.ncbi.nlm.nih.gov/32053298/
Question: Do plasma exchange and reduced-dose
regimens of oral glucocorticoids effective treatment options for patients with
severe antineutrophil cytoplasmic antibody (ANCA) associated vasculitis?
Trial design and population: In this, an
open-label trial, n= 352 were
randomized to plasma exchange and reduced-dose regimen of glucocorticoids or no
plasma exchange and reduced-dose regimen of glucocorticoids.
Primary outcome: The use of plasma exchange was
not effective in reducing the incidence of death or end stage kidney disease
among patients with severe ANCA-associated vasculitis (HR0.86, 95% CI, 0.65 to
1.13; P=0.27).
Secondary outcome: A reduced-dose regimen of glucocorticoids was noninferior to a
standard-dose regimen concerning death or end stage kidney disease (ARR 2.3%,
90% CI 3.4-8.0).
Exclusion criteria: Key exclusion criteria included patients below age 15
years, a diagnosis of vasculitis other than granulomatosis with polyangiitis
(Wegener’s) or microscopic polyangiitis, plasma exchange in 3 months prior to
randomization, a positive serum test for anti-glomerular basement membrane or a
renal biopsy showing linear glomerular immunoglobulin deposition, treatment
with >1 IV dose of cyclophosphamide and/or >14 days of oral
cyclophosphamide and/or >14 days of prednisone/prednisolone (>30 mg/day)
and/or treatment with >1 dose of rituximab within the last 28 days, receipt of
dialysis for greater than 21 days immediately prior to randomization or prior
renal transplant, a comorbidity or condition that, in the opinion of the
investigator, precludes the use of cyclophosphamide/rituximab, glucocorticoids,
or plasma exchange or absolutely mandates the use of plasma exchange.
