Baseline characteristics of the patients at trial entry
Variable | Mycophenolate mofetil group | Cyclophosphamide group |
(n=70) | (n=70) | |
Age (years), median (IQR) | 60 (48–70) | 61 (53–68) |
Paediatric <18 years (%) | 4 (6) | 4 (6) |
Male sex, n (%) | 41 (59) | 33 (47) |
Diagnosis, n (%) | ||
GPA | 47 (67) | 44 (63) |
MPA | 23 (33) | 26 (37) |
ANCA, n (%) | ||
PR3 or cANCA | 41 (59) | 42 (60) |
MPO or pANCA | 28 (40) | 26(37) |
Negative | 1 (1) | 2 (3) |
ANCA ELISA, n (%) | ||
PR3-ANCA | 40 (57) | 42 (60) |
MPO-ANCA | 27 (39) | 26 (37) |
Negative | 3 (4) | 2 (3) |
eGFR at entry (mL/min/m2), median (IQR) | ||
All patients | 51 (29–92) | 51 (31–79) |
Patients with renal disease | 47 (27–70) | 46 (29–74) |
Organs involvement*, n (%) | ||
Renal | 57 (81) | 57 (81) |
Lung | 30 (43) | 35 (50) |
ENT | 41 (59) | 38 (54) |
BVAS†, median (IQR) | 19 (13–25) | 18 (14–23) |
CRP (mg/L), median (IQR) | 22 (7.5–52) | 19 (5–83) |
ESR (mm/hour), median (IQR) | 54 (31–98) | 59 (33–90) |
Cyclophosphamide prerandomisation | ||
Patients, n (%) | 17 (24) | 22 (31) |
Total dose (g), median (IQR) | 1 (0.55–1.1) | 1 (0.6–1.07) |
Intravenous methylprednisolone prerandomisation | ||
Patients, n (%) | 41 (59) | 35 (50) |
Total dose (g), median (IQR) | 1.5 (1.5–3) | 1.5 (1.5–2) |
Plasma exchange prerandomisation | ||
Patients, n (%) | 8 (11) | 4 (6) |
Total exchanges, median (IQR) | 5 (5–7) | 7 (6–7) |
*Renal involvement is defined as one or more renal BVAS items present at entry excluding hypertension alone. Lung and ENT require one or more lung or ENT BVAS items present at entry respectively.
†Baseline BVAS data were missing in one subject in the mycophenolate mofetil (MMF) group.
ANCA, antineutrophil cytoplasmic antibody; BVAS, Birmingham Vasculitis Activity Score; CRP, C-reactive protein; ENT, ear, nose, throat; ESR, erythrocyte sedimentation rate; GPA, granulomatosis with polyangiitis; MPA, microscopic polyangiitis; MPO, myeloperoxidase; eGFR, estimated glomerular filtration rate.