PEXIVAS (plasmapheresis)
Trial question
What is the role of plasma exchange in patients with severe ANCA-associated vasculitis?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 704
704 patients (307 female, 397 male).
Inclusion criteria: patients with severe ANCA-associated vasculitis.
Key exclusion criteria: age < 15 years; plasma exchange within 3 months' diagnosis of vasculitis; pregnancy.
Interventions
N=352 plasma exchange (seven plasma exchanges within 14 days after randomization).
N=352 no plasma exchange (no exchange of plasma).
Primary outcome
Composite outcome of death from any cause or end-stage kidney disease
28.4%
31%
31.0 %
23.3 %
15.5 %
7.8 %
0.0 %
Plasma
exchange
No plasma
exchange
No significant
difference ↔
No significant difference in composite outcome of death from any cause or end-stage kidney disease (28.4% vs. 31%; HR 0.86, 95% CI 0.65 to 1.13).
Safety outcomes
No significant differences in serious adverse events, serious infections at 1 year.
Conclusion
In patients with severe ANCA-associated vasculitis, plasma exchange was not superior to no plasma exchange with respect to the composite outcome of death from any cause or end-stage kidney disease.
Reference
Michael Walsh, Peter A Merkel, Chen-Au Peh et al. Plasma Exchange and Glucocorticoids in Severe ANCA-Associated Vasculitis. N Engl J Med. 2020 Feb 13;382(7):622-631.
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