Article Figures & Data
Figures
- Figure 1.
Enrollment, patient survival, and renal outcome during the trial.
- Figure 2.
(A) Proportion of patients in each group without progression to ESRD. ESRD required at least 6 wk of dialysis dependence (intravenous methylprednisolone group [MP] versus plasma exchange group [PE] P = 0.008). (B) Proportion of patients in each group who survived during the trial (MP versus plasma exchange group P = 0.68). (C) For patients who were alive at 6 wk (119 of 137), the proportion of patients who subsequently survived according to whether they had recovered renal function or had reached end-stage renal failure at 6 wk (P = 0.005).
- Figure 3.
Sequential serum creatinine (μmol/L) for those who recovered renal function (mean; 95% confidence interval [CI]).
- Figure 4.
Sequential Birmingham Vasculitis Activity Score for new/worse disease (mean; 95% CI).
- Figure 5.
Sequential Vasculitis Damage Index scores (mean; 95% CI).
Tables
- Table 1.
Baseline clinical and serologic characteristics of the patients with ANCA-associated systemic vasculitis and renal failurea
Clinical and Laboratory Features at Entry Intravenous Methylprednisolone (n = 67) Plasma Exchange(n = 70) Total(n = 137) P Age (yr; median [range]) 66 (27 to 81) 67 (28 to 79) 66 (27 to 81) 0.93 Female gender (n [%]) 24 (36) 29 (41) 53 (38.7) 0.50 Wegener's granulomatosis/microscopic polyangiitis (n [%]) 24/43 (35.8/64.2 8) 18/52 (25.7/74.3) 42/95 (30.7/69.3) 0.20 Nonoliguric/dialysis requiring (n [%]) 19/48 (28.4/71.6) 23/47 (32.9/67.1) 42/95 (30.7/69.3) 0.57 PR3-ANCA (n [%]) 31 (46.3) 26 (37.1) 57 (42.6) 0.35 MPO-ANCA (n [%]) 31 (46.3) 40 (57.1) 71 (51.9) ANCA negative (n [%]) 3 (4.5) 4 (5.7) 7 (5.3) BVAS 21 (12 to 41) 21 (12 to 39) 21 (12 to 41) 0.69 Vasculitis Damage Index (median [range]) 0 (0 to 4) 0 (0 to 7) 0 (0 to 7) 0.86 Creatinine (μmol/L; median [range]) 718 (498 to 1566) 754 (500 to 1669) 735 (498 to 1669) 0.96 C-reactive protein (mg/L; median [range]) 108 (2 to 264) 76 (7 to 281) 93 (2 to 281) 0.23 Erythrocyte sedimentation rate (mm/h; median [range]) 84 (2 to 150) 94 (20 to 140) 89 (2 to 150) 0.34 ↵a ANCA, autoantibodies to neutrophil cytoplasmic antigens; BVAS, Birmingham Vasculitis Activity Score; MPO, myeloperoxidase; PR3, proteinase 3.
Histologic Lesion Intravenous Methylprednisolone (n = 49) Plasma Exchange(n = 51) Total Group(n = 100) Glomerular % normal glomeruli 13.6 ± 18.2 12.1 ± 12.1 12.8 ± 15.3 % fibrinoid necrosis 28.9 ± 25.3 22.2 ± 24.9 25.5 ± 25.2 % crescents 59.2 ± 28.6 53.0 ± 28.9 56.0 ± 28.8 segmental 23.1 ± 23.4 28.9 ± 31.3 25.9 ± 27.3 circumferential 76.9 ± 44.3 71.1 ± 54.3 74.1 ± 49.5 cellular 90.4 ± 49.1 90.8 ± 57.2 90.6 ± 53.0 fibrous 9.6 ± 12.6 9.2 ± 18.0 9.4 ± 15.3 % global sclerosis 24.6 ± 26.9 28.2 ± 24.6 26.4 ± 25.7 Tubulointerstitial and vascular interstitial edema (0/1) 0.5 ± 0.5 0.5 ± 0.5 0.5 ± 0.5 interstitial infiltrates (0/1/2/3) 1.8 ± 0.7 1.8 ± 0.6 1.8 ± 0.7 neutrophilic (0/1/2) 0.7 ± 0.4 0.7 ± 0.5 0.7 ± 0.5 mononuclear cell (0/1/2) 1.8 ± 0.4 1.8 ± 0.4 1.8 ± 0.4 eosinophilic (0/1/2) 0.4 ± 0.5 0.3 ± 0.5 0.4 ± 0.5 interstitial fibrosis (0/1/2) 1.2 ± 0.6 1.3 ± 0.6 1.2 ± 0.6 tubular casts (0/1) 0.9 ± 0.3 0.9 ± 0.3 0.9 ± 0.3 tubular necrosis (0/1) 0.8 ± 0.4 0.8 ± 0.4 0.8 ± 0.4 tubular atrophy (0/1/2) 1.1 ± 0.5 1.2 ± 0.6 1.1 ± 0.6 intraepithelial infiltrates (0/1) 0.8 ± 0.4 0.8 ± 0.4 0.8 ± 0.4 arteriosclerosis (0/1) 0.8 ± 0.4 0.7 ± 0.4 0.8 ± 0.4 ↵a The average distribution of the most characteristic glomerular, tubulointerstitial, and vascular lesions from 100 renal biopsies are described according to treatment group. This represents 75% of the 137 patients who were randomly assigned in this study. Glomerular lesions are expressed as a mean percentage ± SD of the total number of glomeruli per patient. All crescents were scored as either segmental or circumferential and as either cellular or fibrous, expressed as a percentage ± SD of the total number of crescents. Tubulointerstitial and vascular lesions were scored either in a dichotomous or in a semiquantitative manner. The numbers after every lesion indicate the possible scoring values.
- Table 3.
Adverse events according to type, severity (mild/moderate or severe/life threatening), and treatment group
Adverse Event Study Groups Total Intravenous Methylprednisolone Plasma Exchange Mild/Moderate Severe/Life Threatening Mild/Moderate Severe/Life Threatening Leukopenia (at least 1 episode) 35 7 35 8 85 Recurrent leukopenia (>1 episode) 13 2 11 4 30 Infection 13 17 11 20 61 Thrombocytopenia 2 0 3 5 10 Allergy 4 0 6 0 10 Cardiovascular 2 3 1 3 9 Diabetes 3 2 2 1 8 Gastrointestinal 0 1 3 2 6 Bone fracture 0 2 1 2 5 Thrombosis 1 0 1 3 5 Hemorrhage 0 1 1 1 3 Alopecia 0 0 2 0 2 Vascular access complication 0 1 0 1 2 Other 1 3 2 2 8 Totals 74 39 79 52 244 No.(%) of patients with ≥1 event 59 (87) 32 (48) 63 (91) 35 (50) 122 (89)
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Randomized Trial of Plasma Exchange or High-Dosage Methylprednisolone as Adjunctive Therapy for Severe Renal Vasculitis
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