Table 1.
Patient demographics and baseline characteristics (ITT).
| Placebo N = 103 |
Adalimumab N = 102 | Total N = 205 |
p value | |
|---|---|---|---|---|
| Men, n (%) | 73 (71) | 67 (66) | 140 (68) | 0.425 |
| Age, mean (SD), y | 32.6 (9.5) | 33.2 (10.2) | 32.9 (9.9) | 0.672 |
| Weight, mean (SD), kg | 53.0 (9.9) | 53.3 (9.1) | 53.2 (9.5) | 0.861 |
| FC, mean (SD), µg/g | 1435 (766) | 1482 (809) | 1458 (786) | 0.682 |
| hs-CRP, mean (SD), mg/L | 27.1 (31.5) | 23.9 (24.6) | 25.5 (28.3) | 0.422 |
| Corticosteroid use, n (%) | 32 (31) | 31 (30) | 63 (31) | 0.916 |
| IMM use, n (%) | 65 (63) | 61 (60) | 126 (62) | 0.627 |
| Azathioprine | 59 (57) | 60 (59) | 119 (58) | |
| Mercaptopurine | 2 (2) | 0 | 2 (1) | |
| Methotrexate | 4 (4) | 1 (1) | 5 (2) | |
| CDAI, mean (SD) | 274.7 (49.1) | 272.1 (48.1) | 273.4 (48.5) | 0.695 |
| Disease duration, mean (SD), y | 2.3 (2.7) | 3.1 (3.2) | 2.7 (3.0) | 0.040 |
| Disease location, n (%)* | ||||
| Colonic | 24 (23) | 19 (19) | 43 (21) | |
| Ileal | 19 (18) | 22 (22) | 41 (20) | |
| Ileal-colonic | 60 (58) | 60 (59) | 120 (59) | |
| Upper disease | 10 (10) | 9 (9) | 19 (9) | |
| CD surgical history, n (%) | ||||
| Any surgery before baseline | 26 (25) | 24 (24) | 50 (24) | |
| Surgery within 2 y of baseline | 8 (8) | 11 (11) | 19 (9) | |
CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; FC, fecal calprotectin; hs-CRP, high-sensitivity C-reactive protein; IMM, immunosuppressant medication; ITT, intent-to-treat population consisting of all randomized patients.
*
Patients could have multiple CD locations. Patients with both colonic and ileal CD were categorized as ileal-colonic. The locations of colonic, ileal, and ileal-colonic did not overlap.