Table 1.
Patient demographics and baseline characteristics (FAS)
| Characteristic | Placebo (N = 96) | ADA 80/40 mg (N = 87) | ADA 160/80 mg (N = 90) |
|---|---|---|---|
| Male, n (%) | 70 (72.9) | 50 (57.5) | 61 (67.8) |
| Age, mean ± SD (years) | 41.3 ± 13.6 | 44.4 ± 15.0 | 42.5 ± 14.6 |
| Weight, mean ± SD (kg) | 60.8 ± 14.1 | 58.7 ± 11.1 | 60.1 ± 12.3 |
| Tobacco, nonsmoker, n (%) | 55 (57.3) | 53 (60.9) | 50 (55.6) |
| Alcohol, nondrinker, n (%) | 36 (37.5) | 45 (51.7) | 43 (47.8) |
| Duration of UC (years) | |||
| Mean ± SD | 7.8 ± 6.6 | 8.3 ± 7.7 | 7.8 ± 7.1 |
| Range | 0.6–26.6 | 0.8–37.8 | 0.4–32.5 |
| Site of UC, n (%) | |||
| Pancolitis | 59 (61.5) | 54 (62.1) | 63 (70.0) |
| Descending colon | 35 (36.5) | 32 (36.8) | 27 (30.0) |
| Othera | 2 (2.1) | 1 (1.1) | 0 |
| Mayo score, mean ± SD | 8.5 ± 1.6 | 8.5 ± 1.4 | 8.6 ± 1.4 |
| Partial Mayo score, mean ± SD | 6.1 ± 1.3 | 6.0 ± 1.3 | 6.2 ± 1.4 |
| IBDQ score, mean ± SDb | 148.2 ± 28.9 | 144.9 ± 28.7 | 146.0 ± 31.7 |
| C-reactive protein, median (range) (mg/dL) | 0.34 (0.05–8.72) | 0.31 (0.05–10.77) | 0.22 (0.05–6.28) |
| Baseline UC medication, n (%) | |||
| 5-ASAs | 89 (92.7) | 84 (96.6) | 83 (92.2) |
| Immunomodulators (AZA, 6-MP) | 52 (54.2) | 38 (43.7) | 41 (45.6) |
| Systemic corticosteroids | 58 (60.4) | 63 (72.4) | 57 (63.3) |
Baseline is the last measurement time point before the first dose of study medication in the induction period
ADA adalimumab, 5-ASA 5-aminosalicylic acid, AZA azathioprine, FAS full analysis set, IBDQ Inflammatory Bowel Disease Questionnaire, 6-MP 6-mercaptopurine, SD standard deviation, UC ulcerative colitis
aTwo patients (distal colitis and appendix/ascending colon/rectal colon/transverse colon) in the placebo arm and one patient (rectal to sigmoidal colon) in the 80/40 mg arm
bPlacebo, n = 96; 80/40 arm, n = 85; 160/80 arm, n = 88