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Randomized Trial of Plasma Exchange or High-Dosage Methylprednisolone as Adjunctive Therapy for Severe Renal Vasculitis

David R.W. Jayne^*, Gill Gaskin, Niels Rasmussen, Daniel Abramowicz, Franco Ferrario^||, Loic Guillevin^¶, Eduardo Mirapeix^**, Caroline O.S. Savage, Renato A. Sinico^||, Coen A. Stegeman, Kerstin W. Westman, Fokko J. van der Woude^||||, Robert A.F. de Lind van Wijngaarden^¶¶, Charles D. Pusey on behalf of the European Vasculitis Study Group

^* Department of Medicine, Addenbrooke's, Hospital, Cambridge, United Kingdom; Renal Section, Division of Medicine, Imperial College, London, United Kingdom; Department of Otolaryngology, Rigshospitalet, Copenhagen, Denmark; Department of Immunology, Free University of Brussels, Brussels, Belgium; ^|| Renal Immunopathology Centre, Ospedale San Carlo Borromeo, Milan, Italy; ^¶ Hôpital Cochin, Paris, France; ^** Hospital Clinic i Provincial, Barcelona, Spain; Department of Nephrology, University of Birmingham, Birmingham, United Kingdom; Department of Nephrology, University Medical Center Groningen and University of Groningen, Groningen, Netherlands; Department of Nephrology and Transplantation, University Hospital of Malmö, Malmö, Sweden; ^|||| Department of Nephrology, University of Mannheim, Mannheim, Germany; and ^¶¶ Department of Pathology, Leiden University Medical Centre, Leiden, Netherlands

Correspondence: Dr. David Jayne, Box 118, Addenbrooke's Hospital, Cambridge CB2 2QQ, UK. Phone: +44-1223-217259; Fax: +44-1223-586506; dj106{at}cam.ac.uk

Received for publication January 23, 2007. Accepted for publication April 25, 2007.

Systemic vasculitis associated with autoantibodies to neutrophil cytoplasmic antigens (ANCA) is the most frequent cause of rapidly progressive glomerulonephritis. Renal failure at presentation carries an increased risk for ESRD and death despite immunosuppressive therapy. This study investigated whether the addition of plasma exchange was more effective than intravenous methylprednisolone in the achievement of renal recovery in those who presented with a serum creatinine >500 µmol/L (5.8 mg/dl). A total of 137 patients with a new diagnosis of ANCA-associated systemic vasculitis confirmed by renal biopsy and serum creatinine >500 µmol/L (5.8 mg/dl) were randomly assigned to receive seven plasma exchanges (n = 70) or 3000 mg of intravenous methylprednisolone (n = 67). Both groups received oral cyclophosphamide and oral prednisolone. The primary end point was dialysis independence at 3 mo. Secondary end points included renal and patient survival at 1 yr and severe adverse event rates. At 3 mo, 33 (49%) of 67 after intravenous methylprednisolone compared with 48 (69%) or 70 after plasma exchange were alive and independent of dialysis (95% confidence interval for the difference 18 to 35%; P = 0.02). As compared with intravenous methylprednisolone, plasma exchange was associated with a reduction in risk for progression to ESRD of 24% (95% confidence interval 6.1 to 41%), from 43 to 19%, at 12 mo. Patient survival and severe adverse event rates at 1 yr were 51 (76%) of 67 and 32 of 67 (48%) in the intravenous methylprednisolone group and 51 (73%) of 70 and 35 of (50%) 70 in the plasma exchange group, respectively. Plasma exchange increased the rate of renal recovery in ANCA-associated systemic vasculitis that presented with renal failure when compared with intravenous methylprednisolone. Patient survival and severe adverse event rates were similar in both groups.

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