PEXIVAS (corticosteroids)
Trial question
Is a reduced-dose regimen noninferior to a standard-dose regimen of oral corticosteroids 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; treatment with > 30 mg/day of prednisone/prednisolone for > 14 days; diagnosis of vasculitis other than granulomatosis with polyangiitis or microscopic polyangiitis; pregnancy.
Interventions
N=353 a reduced-dose corticosteroid regimen (dose reduction by approximately 50% of the standard regimen).
N=351 a standard-dose corticosteroid regimen (no dose reduction).
Primary outcome
Composite outcome of death from any cause or end-stage kidney disease
27.9%
25.5%
27.9 %
20.9 %
13.9 %
7.0 %
0.0 %
A reduced-dose corticosteroid
regimen
A standard-dose corticosteroid
regimen
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in composite outcome of death from any cause or end-stage kidney disease (27.9% vs. 25.5%; AD 2.3%, 95% CI -4.5 to 9.1).
Safety outcomes
No significant difference in serious adverse events.
Significant difference in serious infections at 1 year (27.2% vs. 33.0%).
Conclusion
In patients with severe ANCA-associated vasculitis, a reduced-dose corticosteroid regimen were noninferior to a standard-dose corticosteroid regimen 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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