6/29/23, 1:37 AM PEXIVAS (corticosteroids) Pathway Feedback Search Clinical Topics Home Studies PEXIVAS (corticosteroids) PEXIVAS (corticosteroids) DiseaseEosinophilic granulomatosis wit DiseaseGranulomatosis with polyangiitis DiseaseMicroscop 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 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) https://web.pathway.md/studies/recv6w0U8UAHRCD85 1/2 6/29/23, 1:37 AM PEXIVAS (corticosteroids) Pathway Primary outcome Composite outcome of death from any cause or end-stage kidney disease 27.9 % 27.9 25.5 20.9 % 13.9 % 7.0 % 0.0 % A reduced-dose corticosteroid regimen A standard-dose corticosteroid regimen Difference not exceeding nonferiority 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 was 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. Open reference URL https://web.pathway.md/studies/recv6w0U8UAHRCD85 2/2