Table 1.
Baseline demographic and clinical characteristics
| Infliximab group (n=135) | Ciclosporin group (n=135) | ||
|---|---|---|---|
| Age at randomisation (years) | 35 (27–50) | 36 (27–50) | |
| Sex | |||
| Female | 46/135 (34%) | 54/135 (40%) | |
| Male | 89/135 (66%) | 81/135 (60%) | |
| Ethnic origin | |||
| White | 126/134 (94%) | 124/133 (93%) | |
| Asian or Asian British | 5/134 (4%) | 7/133 (5%) | |
| Black or Black British | 2/134 (1%) | 1/133 (<1%) | |
| Other | 1/134 (<1%) | 1/133 (<1%) | |
| Weight (kg) | 72·9 (64·4–82·5) | 70·9 (64·6–84·2)* | |
| Smoking status | |||
| Never or history unknown | 58/130 (45%) | 75/134 (56%) | |
| Current or ex-smoker | 72/130 (55%) | 59/134 (44%) | |
| Family history | |||
| Yes (any one of mother, father, sibling, or child) | 28/132 (21%) | 19/135 (14%) | |
| No | 104/132 (79%) | 116/135 (86%) | |
| Condition severity (Truelove and Witts' criteria) | |||
| Severe | 97/133 (73%) | 95/131 (73%) | |
| Not severe | 36/133 (27%) | 36/131 (27%) | |
| Mayo score | |||
| 0 | 2/131 (2%) | 1/128 (<1%) | |
| 1 | 2/131 (2%) | 2/128 (2%) | |
| 2 | 35/131 (27%) | 35/128 (27%) | |
| 3 | 92/131 (70%) | 90/128 (70%) | |
| Montreal score | |||
| E1 | 7/124 (6%) | 10/126 (8%) | |
| E2 | 64/124 (52%) | 54/126 (43%) | |
| E3 | 53/124 (43%) | 62/126 (49%) | |
| Haemoglobin (g/dL) | 12·7 (11·1–14·0)* | 12·6 (10·7–13·5)* | |
| C-reactive protein (mg/dL) | 62·0 (21·5–128·5)† | 54·0 (22·8–106·1)* | |
| Albumin (g/L) | 33 (29–37)‡ | 33 (28–38)‡ | |
| Receiving azathioprine, 6-mercaptopurine, or methotrexate at baseline | |||
| At least one | 16/135 (12%) | 26/135 (19%) | |
| None | 119/135 (88%) | 109/135 (81%) | |
| Duration of symptoms for current episode (days) | 21 (14–42)§ | 28 (14–42)¶ | |
| Duration of intravenous hydrocortisone (days) | 5·0 (3·3–6·0)‖ | 5·0 (4·0–6·0)** | |
| Mean EQ-5D | 0·519 (SD 0·296)†† | 0·496 (SD 0·314)† | |
| Mean CUCQ | 0·366 (SD 0·133)* | 0·357 (SD 0·133)† | |
Data are median (IQR), n (%), or n/N (%), unless otherwise indicated.
*
n=134.
†
n=133.
‡
n=130.
§
n=135.
¶
n=131.
‖
n=108.
**
n=110.
††
n=132.