6/28/23, 11:16 PM MEPEX Pathway Feedback Search Clinical Topics Home Studies MEPEX MEPEX Disease Disease Disease Eosinophilic granulomatosis wit Granulomatosis with polyangiitis Microscop Trial question What is the role of plasma exchange in patients with newly diagnosed autoantibodies to neutrophil cytoplasmic antigens-associated systemic vasculitis presenting with renal failure? Study design Multi-center Open label RCT Population Characteristics of study participants 39.0% female N = 137 61.0% male 137 patients (53 female, 84 male) Inclusion criteria: patients with a new diagnosis of ANCA-associated systemic vasculitis confirmed by renal biopsy and serum creatinine > 500 micromol/L Key exclusion criteria: age < 18 or > 80 yr; pregnancy; previous malignancy; hepatitis B antigenemia, anti-HCV, or anti-HIV antibody; other multisystem autoimmune disease; or life- threatening nonrenal manifestations of vasculitis Interventions N=70 plasma exchange (total of seven plasma exchanges within 14 days of study entry plus oral cyclophosphamide and oral prednisolone) https://web.pathway.md/studies/recX2HyglA9TrgdOe 1/2 6/28/23, 11:16 PM MEPEX Pathway N=67 methylprednisolone (intravenous 1,000 mg/d for 3 consecutive months plus oral cyclophosphamide and oral prednisolone) Primary outcome Dialysis independence at 3 months 69.0 % 69 51.8 % 49 34.5 % Significant increase 17.3 % NNH = 5 0.0 % Plasma exchange Methylprednisolone Significant increase in dialysis independence at 3 months (69% vs. 49%; RR 1.41, 95% CI 18 to 35) Secondary outcomes Significant decrease in progression to ESRD at 12 months (19% vs. 43%; HR 0.47, 95% CI 0.24 to 0.91) Safety outcomes No significant differences in severe adverse events (50% vs. 48%, p=0.68) and survival at 1 year (73% vs. 76%, p=0.80). Conclusion In patients with a new diagnosis of ANCA-associated systemic vasculitis confirmed by renal biopsy and serum creatinine > 500 micromol/L, plasma exchange was superior to methylprednisolone with respect to dialysis independence at 3 months. Reference Jayne DR, Gaskin G, Rasmussen N et al. Randomized trial of plasma exchange or high-dosage methylprednisolone as adjunctive therapy for severe renal vasculitis. J Am Soc Nephrol. 2007 Jul;18(7):2180-8. Open reference URL https://web.pathway.md/studies/recX2HyglA9TrgdOe 2/2