Baseline characteristics and values: groups I and II combined
| Characteristic | Placebo (n = 43) | Fontolizumab 4 mg/kg (n = 45) | Fontolizumab 10 mg/kg (n = 45) |
|---|---|---|---|
| CD, Crohn’s disease; CDAI, Crohn’s disease activity index; GI, gastrointestinal tract. | |||
| Female (%) | 63 | 64 | 51 |
| Age (y) (median (range)) | 39 (20–72) | 43 (19–65) | 39 (21–68) |
| CD mean duration (y) | 6.7 | 6.4 | 7.4 |
| Fistulae present (%) | 16 | 13 | 9 |
| Smokers (%) | 30 | 27 | 18 |
| CDAI (mean (range)) | 303 (228–401) | 300 (241–457) | 303 (241–456) |
| CDAI ⩾350 (%) | 16 | 7 | 13 |
| Ileum only (%) | 19 | 22 | 9 |
| Colon only (%) | 35 | 40 | 38 |
| Ileum and colon (%) | 46 | 36 | 49 |
| Lower and upper GI (%) | 0 | 2 | 4 |
| C-reactive protein >4 mg/l (%) | 47 | 56 | 53 |
| Use of medications for treatment of CD (%) | |||
| Prior infliximab use | 19 | 22 | 22 |
| 5-aminosalicylic acid | 54 | 49 | 40 |
| Corticosteroids | 33 | 36 | 38 |
| Azathioprine | 40 | 27 | 36 |
| Methotrexate | 7 | 2 | 4 |