MEPEX
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
61.0% male
N = 137
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).
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%
49%
69.0 %
51.8 %
34.5 %
17.3 %
0.0 %
Plasma
exchange
Methylprednisolone
Significant
increase ▲
NNH = 5
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.
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