Plasma exchange and glucocorticoids in severe ANCA-associated vasculitis
Research output: Contribution to journal › Article › peer-review
Colleges, School and Institutes
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).
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.
|Number of pages||10|
|Journal||The New England Journal of Medicine|
|Publication status||Published - 13 Feb 2020|
- Administration, Oral, Adult, Aged, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis/complications, Combined Modality Therapy, Cyclophosphamide/therapeutic use, Dose-Response Relationship, Drug, Female, Glucocorticoids/administration & dosage, Humans, Immunosuppressive Agents/therapeutic use, Incidence, Induction Chemotherapy, Kidney Diseases/complications, Kidney Failure, Chronic/epidemiology, Male, Middle Aged, Plasma Exchange/adverse effects, Rituximab/therapeutic use