Table 2.
Other efficacy endpoints (FAS, NRI)
| Endpoint, n (%)a | Week 8 | Week 32 | Week 52 | ||||
|---|---|---|---|---|---|---|---|
| Placebo (N = 96) | ADA 80/40 mg (N = 87) | ADA 160/80 mg (N = 90) | Placebo (N = 96) | ADA 40 mg EOW (N = 177) | Placebo (N = 96) | ADA 40 mg EOW (N = 177) | |
| Rectal bleeding subscore ≤1 | 65 (67.7) | 70 (80.5)* | 64 (71.1) | 27 (28.1) | 74 (41.8) | 22 (22.9) | 59 (33.3) |
| PGA subscore ≤1 | 43 (44.8) | 41 (47.1) | 55 (61.1)* | 27 (28.1) | 66 (37.3) | 19 (19.8) | 57 (32.2)* |
| Stool frequency subscore ≤1 | 31 (32.3) | 30 (34.5) | 36 (40.0) | 20 (20.8) | 57 (32.2)* | 13 (13.5) | 51 (28.8)* |
| IBDQ responseb | 38 (39.6) | 42 (48.3) | 38 (42.2) | 21 (21.9) | 55 (31.1) | 12 (12.5) | 45 (25.4)† |
| Steroid-freec | ND | ND | ND | 12 (20.7) | 35 (29.2) | 12 (20.7) | 39 (32.5) |
| Steroid-free remissionc | ND | ND | ND | 5 (8.6) | 12 (10.0) | 4 (6.9) | 17 (14.2) |
ADA adalimumab, EOW every other week, FAS full analysis set, IBDQ Inflammatory Bowel Disease Questionnaire, ND not determined, NRI nonresponder imputation, PGA physician’s global assessment, UC ulcerative colitis
aUnless otherwise noted
bResponse was defined as an increase in IBDQ score of ≥16 points from baseline
cPercentages calculated based on the number of patients taking steroids at baseline (placebo, N = 58; ADA 40 mg EOW, N = 120)
* P ≤ 0.05, † P ≤ 0.01