Table 2.
History of positive ANCA test | Baseline BVAS | Baseline VDI score | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Yes | No | BVAS = 0 | BVAS > 0 | VDI < 5 | VDI ≥ 5 | |||||||
PBO | Mepo | PBO | Mepo | PBO | Mepo | PBO | Mepo | PBO | Mepo | PBO | Mepo | |
(n = 13) | (n = 13) | (n = 55) | (n = 55) | (n = 20) | (n = 31) | (n = 48) | (n = 37) | (n = 36) | (n = 38) | (n = 32) | (n = 30) | |
Accrued duration of remission a , b (wk), n (%) | ||||||||||||
0 | 10 (77) | 4 (31) | 45 (82) | 28 (51) | 16 (80) | 10 (32) | 39 (81) | 22 (59) | 27 (75) | 17 (45) | 28 (88) | 15 (50) |
>0 to <12 | 2 (15) | 0 | 6 (11) | 8 (15) | 2 (10) | 3 (10) | 6 (13) | 5 (14) | 5 (14) | 6 (16) | 3 (9) | 2 (7) |
12 to <24 | 0 | 4 (31) | 3 (5) | 5 (9) | 0 | 8 (26) | 3 (6) | 1 (3) | 2 (6) | 6 (16) | 1 (3) | 3 (10) |
24 to <36 | 0 | 2 (15) | 0 | 8 (15) | 0 | 3 (10) | 0 | 7 (19) | 0 | 4 (11) | 0 | 6 (20) |
≥36 | 1 (8) | 3 (23) | 1 (2) | 6 (11) | 2 (10) | 7 (23) | 0 | 2 (5) | 2 (6) | 5 (13) | 0 | 4 (13) |
OR (95% CI) c | 21.06 (2.65, 167.18) | 4.91 (2.04, 11.81) | 6.76 (1.66, 27.60) | 3.88 (1.44, 10.51) | 4.03 (1.49, 10.87) | 24.12 (4.91, 118.50) | ||||||
Proportion of patients in remission b at Weeks 36 and 48, n (%) | 0 | 7 (54) | 2 (4) | 15 (27) | 1 (5) | 14 (45) | 1 (2) | 8 (22) | 2 (6) | 11 (29) | 0 | 11 (37) |
OR (95% CI) c | NA | 9.01 (1.87, 43.43) | 13.40 (1.46, 122.82) | 15.28 (1.71, 136.57) | 5.58 (1.05, 29.61) | NA |
Abbreviations: ANCA, antineutrophil cytoplasmic antibody; BVAS, Birmingham Vasculitis Activity Score; CI, confidence interval; Mepo, mepolizumab; NA, not applicable—estimate could not be calculated owing to lack of patients in the placebo group achieving remission at Weeks 36 and 48; OR, odds ratio; PBO, placebo; VDI, Vasculitis Damage Index.
Accrued number of weeks of remission over the 52‐week study period categorized in weeks (0, >0 to <12, 12 to <24, 24 to <36, and ≥36 weeks).
Remission was defined as BVAS = 0 and oral glucocorticoid dose ≤4 mg/day of a prednisone equivalent.
Mepolizumab versus placebo.