Table 1.
Characteristics of patients in the open label induction period and the randomized maintenance period*.
| Induction | Maintenance | |||||
|---|---|---|---|---|---|---|
| Open label MTX (n=179) | Placebo (n=40) | MTX (n=44) | ||||
| Age (years, mean, range) | 42 | (19–74) | 45.1 | (21–69) | 42.1 | (25–66) |
| Sex (m: n ;%) | 110 | (61%) | 24 | (60%) | 22 | (50%) |
| Duration of disease (median, IQR) | 6 | (3–11) | 6.0 | (2–13.5) | 7.5 | (4–14) |
| Smoking history | ||||||
| Current | 8 | (4%) | 1 | (2%) | 3 | (7%) |
| Former | 59 | (33%) | 13 | (33%) | 16 | (36%) |
| Never | 112 | (63%) | 26 | (65%) | 25 | (57%) |
| Site of disease | ||||||
| Left colon (n/%) | 86 | (48%) | 17 | (43%) | 25 | (57%) |
| Pancolitis (n/%) | 93 | (52%) | 23 | (57%) | 19 | (43%) |
| Failed drugs before inclusion (n;%) | ||||||
| Mesalamine | 65 | (36%) | 16 | (40%) | 14 | (32%) |
| Azathioprine/6-MP | 33 | (18%) | 11 | (28%) | 7 | (16%) |
| Anti-TNF | 20 | (11%) | 4 | (10%) | 7 | (16%) |
| Anti-TNF and azathioprine/6-MP | 61 | (35%) | 9 | (23%) | 16 | (36%) |
| Vedolizumab | 8 | (4%) | 1 | (3%) | 1 | (2%) |
| Steroid dependency at baseline (week 0) | 66 | (37%) | 17 | (43%) | 13 | (30%) |
| Mayo endoscopy score week 0 (score 2/3; n;%) | 106/73 | (59%/41%) | 26/14 | (65%/35%) | 24/20 | (55%/45%) |
| Steroid taper (20/40mg; n;%) | 95/84 | (53%/47%) | 18/22 | (45%/55%) | 24/20 | (55%/45%) |
| Clinical Mayo score week 0 / 16 (median, IQR) | 6 | (5–7) | 2 | (0–3) | 1 | (0–3) |
| Calprotectin week 0 /16 (median, IQR) | 657 | (252–825) | 163 | (30–593) | 344 | (84–767) |
| CRP week 0/16 (median, IQR) | 0.3 | (0.1–0.7) | 0.2 | (0.2–0.7) | 0.3 | (0.1–0.8) |
| Hemoglobin week 0/16 (median, IQR) | 13.8 | (12.7–14.7) | 13.1 | (12.2–14.5) | 13.0 | (12.0–13.9) |
*
There were no significant differences between groups in the maintenance period. TNF denotes tumor necrosis factor, 6-MP denotes 6-mercaptopurine.