SUMMARIZATION

 

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.