Table 1A. Baseline demographic and disease characteristics of randomized patients in the maintenance triala, at week 0 of the induction study.
| Total patients | Maintenance group (N=308) | Study extension group (N=203) | |
|---|---|---|---|
| Gender—male | n (%) | 166 (54) | 114 (56) |
| Extensive disease | n (%) | 135 (44) | 87 (43) |
| Age, years | Mean±s.d. | 40.2±13.51 | 40.0±13.13 |
| Median (IQR) | 39.0 (29.0; 50.5) | 39.0 (29.0; 49.0) | |
| Weight, kg | Mean±s.d. | 73.3±17.39 | 73.3±18.09 |
| Median (IQR) | 72.1 (60.0; 84.0) | 72.0 (59.5; 84.0) | |
| UC disease duration, years | Mean±s.d. | 7.0±6.97 | 7.1±6.58 |
| Median (IQR) | 4.6 (2.4; 9.6) | 5.3 (2.7; 10.0) | |
| Hemoglobin, g/dl | Mean±s.d. | 12.9±1.92 | 13.1±1.92 |
| Median (IQR) | 13.2 (11.9; 14.2) | 13.3 (11.9; 14.4) | |
| Albumin, g/dl | Mean±s.d. | 4.2±0.40 | 4.3±0.39 |
| Median (IQR) | 4.3 (4.0; 4.5) | 4.3 (4.1; 4.5) | |
| Fecal calprotectin (mg/kg) | n | 275 | 186 |
| Mean±s.d. | 1719.5±2,813.58 | 1561.8±2,661.22 | |
| Median (IQR) | 760.0 (283.0; 1,683.0) | 689.5 (259.0; 1,514.0) | |
| Mayo scoreb (0–12) | n | 308 | 203 |
| Mean±s.d. | 8.3±1.37 | 8.2±1.37 | |
| Median (IQR) | 8.0 (7.0; 9.0) | 8.0 (7.0; 9.0) | |
| IBDQc | n | 305 | 200 |
| Mean±s.d. | 129.2±32.98 | 131.2±33.50 | |
| Median (IQR) | 129.0 (105.0; 152.0) | 130.0 (109.0; 154.0) | |
| C-reactive protein (mg/l) | n | 301 | 197 |
| Mean±s.d. | 8.7±13.78 | 6.9±10.43 | |
| Median (IQR) | 4.0 (1.3; 10.1) | 3.6 (1.3; 9.0) | |
| Any UC medication | n (%) | 287 (93.2) | 188 (92.6) |
| Corticosteroids (excluding budesonide) | n (%) | 156 (50.6) | 99 (48.8) |
| ≥20 mg/day P.Eq | n (%) | 107 (34.7) | 70 (34.5) |
| <20 mg/day P.Eq | n (%) | 49 (15.9) | 29 (14.3) |
| Budesonide | n (%) | 10 (3.2) | 6 (3.0) |
| Immunomodulatory drugs | n (%) | 95 (30.8) | 58 (28.6) |
| 6-MP/AZA | n (%) | 93 (30.2) | 58 (28.6) |
| Methotrexate | n (%) | 2 (0.6) | 0 |
| Aminosalicylates | n (%) | 247 (80.2) | 165 (81.3) |
6-MP, 6-mercaptopurine; AZA, azathioprine, IBDQ, inflammatory bowel disease questionnaire; IQR, interquartile range; P.Eq, prednisone equivalent; UC, ulcerative colitis.
Golimumab induction responders who received golimumab on entry into maintenance.
Mayo scores range from 0–12, with higher scores indicating more severe disease.
IBDQ score ranges from 32 to 224, with higher scores indicating better quality of life.