Table 1.
Efficacy Outcomes.*
| Efficacy Measure | Rituximab (N = 99) |
Cyclophosphamide– Azathioprine (N = 98) |
Difference | P Value |
|---|---|---|---|---|
| number (percent) | percentage points (95% CI) | |||
|
| ||||
| Complete remission | ||||
|
| ||||
| 6 mo | 63 (64) | 52 (53) | 11 (−3 to 24) | 0.13 |
|
| ||||
| 12 mo | 47 (47) | 38 (39) | 9 (−5 to 22) | 0.22 |
|
| ||||
| 18 mo | 39 (39) | 32 (33) | 7 (−7 to 20) | 0.32 |
|
| ||||
| Remission and <10 mg/day of prednisone | ||||
|
| ||||
| 6 mo | 70 (71) | 60 (61) | 10 (−4 to 23) | 0.16 |
|
| ||||
| 12 mo | 59 (60) | 60 (61) | −2 (−15 to 12) | 0.82 |
|
| ||||
| 18 mo | 54 (55) | 52 (53) | 2 (−12 to 15) | 0.84 |
|
| ||||
| Complete remission at any time† | 76 (77) | 70 (71) | 0.15 | |
|
| ||||
| Remission and <10 mg/day of prednisone at any time‡ | 82 (83) | 84 (86) | 0.91 | |
|
| ||||
| Remission at any time‡ | 89 (90) | 89 (91) | 0.50 | |
|
| ||||
| Complete remission in patients with relapsing disease at baseline† | ||||
|
| ||||
| 6 mo | 34/51 (67) | 21/50 (42) | 25 (6 to 44) | 0.01 |
|
| ||||
| 12 mo | 25/51 (49) | 12/50 (24) | 25 (7 to 43) | 0.009 |
|
| ||||
| 18 mo | 19/51 (37) | 10/50 (20) | 17 (0 to 34) | 0.06 |
|
| ||||
| milliliters per minute | ||||
|
| ||||
| Estimated creatinine clearance | ||||
|
| ||||
| Total cohort | ||||
|
| ||||
| Baseline | 76.83±3.77 | 91.56±3.75 | −14.74 | 0.01 |
|
| ||||
| 6 mo | 78.59±3.75 | 93.14±3.73 | −14.55 | 0.01 |
|
| ||||
| 12 mo | 80.36±3.87 | 94.72±3.86 | −14.37 | 0.01 |
|
| ||||
| 18 mo§ | 82.12±4.12 | 96.30±4.12 | −14.18 | 0.02 |
|
| ||||
| Patients with major renal disease¶ | ||||
|
| ||||
| Baseline | 53.54±4.63 | 70.52±4.64 | −16.97 | 0.01 |
|
| ||||
| 6 mo | 57.06±4.59 | 73.71±4.60 | −16.65 | 0.01 |
|
| ||||
| 12 mo | 60.57±4.80 | 76.91±4.80 | −16.34 | 0.02 |
|
| ||||
| 18 mo§ | 64.08±5.21 | 80.10±5.10 | −16.02 | 0.03 |
Plus–minus values are means ±SE.
Complete remission was defined as a score of 0 on the Birmingham Vasculitis Activity Scores for Wegener’s Granulomatosis (BVAS/WG; with scores ranging from 0 to 63, and higher scores indicating more active disease), no prednisone therapy, and no other reason to be considered as having had treatment failure. Data were analyzed according to the intention-to-treat principle with worst-case imputation. Only patients who had a complete remission at 6 months were included in the 12-month analysis, and only those who maintained the complete remission at 12 months were included in the 18-month analysis.
Remission was defined as a score of 0 on the BVAS/WG.
The two groups did not differ significantly with respect to improvement in estimated creatinine clearance levels between baseline and 18 months (P = 0.90 for the total cohort and P = 0.80 for the subgroup of patients with major renal disease).
A total of 51 patients in each of the groups had major renal disease, which was defined as the presence of at least one factor designated as a major abnormality in the renal category of the BVAS/WG (urinary red-cell casts, biopsy-proven glomerulonephritis, or an increase of >30% in baseline serum creatinine concentration).