Table 3 Demographic data on 60 patients included in the two week efficacy analysis of tacrolimus (FK506) for treatment of ulcerative colitis (UC).
| Variable | High trough group | Low trough group | Placebo group | p Value |
|---|---|---|---|---|
| No of patients | 19 | 21 | 20 | |
| Sex (M/F) | 9/10 | 11/10 | 9/11 | 0.890* |
| Age (y) (mean (SD)) | 33.3 (10.3) | 31.2 (10.8) | 30.0 (6.4) | 0.645† |
| Weight (kg) (mean (SD)) | 53.0 (12.9) | 50.9 (8.2) | 53.6 (9.3) | 0.758† |
| Disease duration (y) (mean (SD)) | 7.0 (6.3) | 4.8 (3.5) | 6.0 (3.5) | 0.470† |
| Extent of disease | ||||
| Pancolitis | 12 | 14 | 10 | 0.522* |
| Left sided | 7 | 7 | 10 | |
| DAI total score | ||||
| 6 | 0 | 2 | 1 | |
| 7–9 | 13 | 9 | 8 | |
| 10–12 | 6 | 10 | 11 | |
| Mean (SD) | 9.2 (1.2) | 9.2 (1.8) | 9.4 (1.5) | 0.845† |
| Steroid resistant/dependent | ||||
| Resistant* | 5 | 5 | 5 | 0.983* |
| Dependent | 14 | 16 | 15 | |
| Previous treatment (within 6 months) | ||||
| Azathioprine | 5 | 1 | 2 | 0.150* |
| Cytapheresis | 4 | 4 | 7 | 0.445* |
| Concomitant medication | ||||
| Prednisolone (⩾10 mg/day) | 19 | 21 | 20 | – |
| 5‐Aminosalicylates | 19 | 21 | 18 | 0.126* |
| Immunosuppressants | 0 | 0 | 0 | – |
| Cytapheresis | 0 | 0 | 0 | – |
*Steroid resistance was defined as unresponsiveness to oral or intravenous corticosteroid therapy (equivalent to a daily dose of more than 30 mg of prednisolone) over at least 2 weeks.
*χ2 test.
†Kruskal‐Wallis test.