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Table 3 Comparison of trial design and preliminary data from the RITUXVAS and RAVE studies

From: Progress in treatment of ANCA-associated vasculitis

  RITUXVAS trial [42] RAVE trial [43]
Patients (n) 44 - 33 RTX, 11 CYC 197 - 99 RTX, 98 CYC
New diagnosis (%) 100 49
Wegner's granulomatosis:microscopic polyangiitis 1:1 3:1
PR3:myeloperoxidase (%) 58:42 67:33
Median age (years), RTX:CYC 68:67 54:51.5
Mean Birmingham Vasculitis Activity Score at entry, RTX:CYC 19:18 8.5:8.2
Renal function at entry, RTX:CYC 20:12 (GFR) 54:69 (creatinine clearance)
Rituximab dose 375 mg/m2×4 + two i.v. CYC pulses 375mg/m2×4
CYC dose 15 mg/kg i.v., six to 10 cycles 2 mg/kg/day per orally
Plasma exchange Yes No
Steroid dose 1 g i.v. methylprednisolone 1 to 3 g i.v. methylprednisolone
  1 mg/kg/day prednisolone per orally 1 mg/kg/day prednisolone per orally
  Decrease to 5 mg/day by 6/12 Decrease to 40 mg/day by 1/12
   Stop prednisolone by 6/12
Maintenance therapy CYC → AZA at 3 to 6 months CYC → AZA at 3 to 6 months
  RTX → none RTX → none
Primary endpoints 12 months 6 months
Remission (%), RTX:CYC 76:82 64:53 (no prednisolone)
   71:62 (<10 mg prednisolone)
Median time to remission (days), RTX:CYC 90:94 NR
Serious adverse events (%), RTX:CYC 42:36 22:33
Deaths, RTX:CYC 6:1 1:2
GFR at end of study, RTX:CYC 39:27 NR
  1. CYC, cyclophosphamide; GFR, glomerular filtration rate; i.v., intravenous; NR, not recorded; RTX, rituximab.