Table 1.
Patient Demographics and Baseline Characteristics
| Characteristic | Safety analysis population (n = 1,523) |
|---|---|
| Male sex | 878 (57.6) |
| Age (yr) | 41.8 ± 16.1 |
| Body weight (kg)a | 57.4 ± 11.8 |
| BMI (kg/m2) | |
| < 18.5 | 306 (20.1) |
| ≥ 18.5 to < 25.0 | 939 (61.7) |
| ≥ 25.0 to < 30.0 | 148 (9.7) |
| ≥ 30.0 | 29 (1.9) |
| Unknown | 101 (6.6) |
| Disease duration (yr)b | 7.9 ± 7.6 |
| History of allergy, yes | 331 (21.7) |
| History of smoking, no | 1,029 (67.6) |
| Comorbidities | 650 (42.7) |
| Prior use of biologics, yes | 408 (26.8) |
| Infliximab | 390 (25.6) |
| Other biologics | 23 (1.5) |
| Concomitant medications, yes | 1,499 (98.4) |
| 5-ASA | 1,310 (86.0) |
| Corticosteroid | 709 (46.6) |
| Azathioprine and 6-mercaptopurine | 664 (43.6) |
| Tacrolimus and cyclosporine | 72 (4.7) |
| Antibiotics | 111 (7.3) |
| Other | 1,187 (77.9) |
| Montreal classification | |
| Proctitis | 37 (2.4) |
| Left-sided colitis | 465 (30.5) |
| Extensive colitis | 1,018 (66.8) |
| Unknown/not provided | 3 (0.2) |
| Partial Mayo score | 5.0 ± 2.1 |
| 0 to < 3 | 198 (13.0) |
| 3 to < 6 | 570 (37.4) |
| 6 to < 9 | 696 (45.7) |
| Unknown/not provided | 59 (3.9) |
| CRP (mg/dL)c | 1.2 ± 2.4 |
Values are presented as number (%) or mean±standard deviation.
a
n=1,437 evaluable patients.
b
n=1,403 evaluable patients.
c
n=1,347 evaluable patients.
BMI, body mass index; ASA, aminosalicylic acid; CRP, C-reactive protein.