Table 1.
RTX | CYC/AZA | ALL | |
---|---|---|---|
N=23 | N=21 | N=44 | |
Male | 12 (52%) | 9 (43%) | 21 (48%) |
PR3-ANCA positive | 18 (78%) | 18 (86%) | 36 (82%) |
GPA | 20 (87%) | 20 (95%) | 40 (91%) |
Relapsing disease at study entry | 15 (65%) | 13 (62%) | 28 (64%) |
Mean time to first non-severe relapse (range, months)* | 7.7 (1.8–15.1) | 7.3 (2.4–16.9) | 7.5 (1.8–16.9) |
Reached remission before relapse | 20 (87%) | 20 (95%) | 40 (91%) |
BVAS/WG at relapse | 1.8 | 1.6 | 1.7 |
Off prednisone at relapse | 14 (61%) | 14 (67%) | 28 (64%) |
Median prednisone dose at relapse if dose > 0 mg/day (range) | 5.0 (2.5–20) | 5.0 (2.5–15) | 5.0 (2.5–20) |
Organ involvement | |||
Constitutional features† | 18 (78%) | 11 (52%) | 29 (66%) |
Cutaneous involvement | 2 (9%) | 1 (5%) | 3 (7%) |
Mucous membranes and eyes | 2 (9%) | 5 (24%) | 7 (16%) |
Mouth ulcers | 1 (4%) | 0 (0%) | 1 (2%) |
Conjunctivitis/episcleritis | 0 (0%) | 5 (24%) | 5 (11%) |
Other | 1 (4%) | 0 (0%) | 1 (2%) |
Ear, nose and throat | 7 (30%) | 4 (19%) | 11 (25%) |
Bloody nasal discharge | 3 (13%) | 2 (10%) | 5 (11%) |
Sinus involvement | 2 (9%) | 2 (10%) | 4 (9%) |
Other | 2 (9%) | 1 (5%) | 3 (7%) |
Pulmonary involvement | 5 (22%) | 3 (14%) | 8 (18%) |
Nodules/cavities | 2 (9%) | 1 (5%) | 3 (7%) |
Endobronchial involvement | 0 (0%) | 2 (10%) | 2 (5%) |
Other | 3 (13%) | 1 (5%) | 4 (9%) |
Renal involvement - hematuria | 1 (4%) | 3 (14%) | 4 (9%) |
Other minor items | 2 (9%) | 0 (0%) | 2 (5%) |
Of the four patients who flared before reaching remission, those flares occurred at 1.8, 2.4 and 3.9 months (in two patients) after study entry.
fevers, arthritis/arthralgias