Table 3.
Comparison of trial design and preliminary data from the RITUXVAS and RAVE studies
| 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 |
CYC, cyclophosphamide; GFR, glomerular filtration rate; i.v., intravenous; NR, not recorded; RTX, rituximab.