Table 1.
Patient Demographics and Baseline Disease Characteristics
| Characteristic | Safety analysis population (n = 389) |
|---|---|
| Age (yr) | 34.0 ± 11.8 |
| Male sex | 283 (72.8) |
| Weight (kg) | 55.1 ± 10.4 |
| Duration of CD (yr) | 9.0 ± 9.4 |
| < 2 | 115 (29.6) |
| 2 to < 5 | 48 (12.3) |
| 5 to < 10 | 55 (14.1) |
| ≥ 10 | 142 (36.5) |
| Unknown | 29 (7.5) |
| History of smoking, never smoked | 243 (62.5) |
| Comorbidities | |
| Liver disorders | 17 (4.4) |
| Renal disorders | 5 (1.3) |
| Blood disorders | 44 (11.3) |
| Respiratory disorders | 11 (2.8) |
| Others | 71 (18.3) |
| CD-related pretreatment drugs | |
| Anti-TNF-α agent | 140 (36.0) |
| Aminosalicylates | 351 (90.2) |
| Corticosteroids | 62 (15.9) |
| Immunomodulators | 80 (20.6) |
| Antibiotics | 46 (11.8) |
| CD-related concomitant drugs | |
| Aminosalicylates | 336 (86.4) |
| Corticosteroids | 59 (15.2) |
| Immunomodulators | 125 (32.1) |
| Antibiotics | 49 (12.6) |
| Others | 286 (73.5) |
| Disease locationa | |
| Ileal | 104 (26.7) |
| Colonic | 57 (14.7) |
| Ileocolonic | 220 (56.6) |
| Isolated upper disease | 53 (13.6) |
| CD-related intestinal complications | 167 (42.9) |
| CD-related extraintestinal manifestations | 113 (29.0) |
| Self-administration of adalimumab | 342 (87.9) |
| Work status | |
| Employed ≥ 35 hr/wk | 192 (49.4) |
| Employed < 35 hr/wk | 32 (8.2) |
| Unemployed, but can perform normal daily activitiesa | 113 (29.0) |
| No normal daily activities (due to hospitalization, etc.) | 49 (12.6) |
| Unknown | 3 (0.8) |
| CDAI scorec | 193.9 ± 102.2 |
| < 150 | 101 (26.0) |
| 150 to < 220 | 65 (16.7) |
| 220 to < 450 | 98 (25.2) |
| ≥ 450 | 5 (1.3) |
| Unknown | 120 (30.8) |
| CRP levels (mg/dL)d | 0.72 (0.19-2.14) |
Values are presented as mean±standard deviation, number (%), or median (interquartile range).
a
According to Montreal classification.
b
Daily activity includes working around the house, shopping, childcare, exercising, and studying.
c
(n=269).
d
(n=364).
CD, Crohn’s disease; TNF-α, tumor necrosis factor alpha; CDAI, Crohn’s Disease Activity Index; CRP, C-reactive protein.