Progress in treatment of ANCA-associated vasculitis

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.

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