Baseline demographics and disease characteristics
| BMS-936557 n=55 | Placebo n=54 | Total N=109 | |
|---|---|---|---|
| Mean age (SD) | 44.7 (12.8) | 41.8 (14.2) | 43.2 (13.5) |
| Mean weight, kg (SD) | 81.9 (16.1) | 74.5 (18.1) | 78.2 (17.4) |
| Male, n (%) | 37 (67.3) | 31 (57.4) | 68 (62.4) |
| Race, % Caucasian | 53 (96.4) | 54 (100) | 107 (98.2) |
| Country of enrolment, n (%) | NA | NA | |
| Czech Republic | 8 (7.3) | ||
| Hungary | 24 (22.0) | ||
| Latvia | 18 (16.5) | ||
| Romania | 11 (10.1) | ||
| Ukraine | 28 (25.7) | ||
| Russia | 9 (8.3) | ||
| North America | 11 (10.1) | ||
| Mean duration of UC, years (SD) | 6.7 (7.8) | 5.5 (4.4) | 6.1 (6.4) |
| Extent of disease, n (%) | |||
| Proctosigmoiditis | 15 (27.3) | 13 (24.1) | 28 (25.7) |
| Left-sided | 24 (43.6) | 22 (40.7) | 46 (42.2) |
| Extensive | 16 (29.1) | 19 (35.2) | 35 (32.1) |
| Mean Mayo score (SD) | 7.9 (1.3) | 7.9 (1.1) | NA |
| Mean CRP, mg/dl (SD) | 1.3 (2.0) | 1.2 (1.4) | 1.3 (1.7) |
| Prior inadequate response/intolerance, n (%) | |||
| Immunosuppressants | 10 (5.5) | 4 (7.4) | 14 (12.8) |
| Anti-TNF | 3 (5.5) | 3 (5.6) | 6 (5.5) |
| Concomitant immunomodulator*, n (%) | 6 (10.9) | 10 (18.5) | 16 (14.7) |
| Concomitant corticosteroids†, n (%) | 30 (54.5) | 27 (50.0) | 57 (52.3) |
*Azathioprine or 6-mercaptopurine.
†Mean prednisolone equivalent dose=17.2 mg/day.
CRP, C-reactive protein; NA, not available; TNF, tumour necrosis factor; UC, ulcerative colitis.