Baseline demographics and clinical characteristics
| All patients (N=155) | Placebo (N=53) | MLN02 (N=102) | |
|---|---|---|---|
| Age | 41.7±14.1 | 39.8±13.1 | 42.8±14.6* |
| Male sex, n (%) | 87 (56.1) | 29 (54.7) | 58 (56.9) |
| Months since diagnosis | 77.9±82.6 | 80.6±82.2 | 76.5±83.2 |
| Current smoker, n (%) | 8 (5.2) | 4 (7.5) | 4 (3.9) |
| UC clinical score† | 6.9±1.5 | 6.6±1.6 | 7.0±1.4 |
| Stool frequency | 2.2±0.8 | 2.2±0.9 | 2.3±0.8 |
| Rectal bleeding | 1.5±0.8 | 1.4±0.9 | 1.6±0.8 |
| Assessment by the patient | 1.3±0.7 | 1.3±0.8 | 1.3±0.7 |
| Assessment by the physician | 1.9±0.3 | 1.8±0.4 | 1.9±0.3 |
| Rectal bleeding+stool frequency (MCS) | 3.7±1.1 | 3.6±1.1 | 3.8±1.1 |
| Modified Baron score | 2.7±0.7 | 2.7±0.8 | 2.7±0.7 |
| Modified Riley histopathological index | 5.9±1.3 | 5.6±1.6 | 6.1±1.0 |
| Mesalamine use, n (%) | 124 (80.0) | 41 (77.4) | 83 (81.4) |
| Haemoglobin concentration | 13.4±1.7 | 13.2±1.7 | 13.5±1.7 |
| White cell count | 8.4±2.6 | 8.4±2.1 | 8.5±2.8 |
*Plus–minus values are means±SD.
†The UC Clinical Score, a modification of the Mayo Clinic Score (MCS), consists of four items—rectal bleeding, stool frequency, functional assessment by the patient and global assessment by the physician. Items are scored on a scale from 0 (normal) to 3 (severe disease). The composite score ranges from 0 (inactive disease) to 12 (severe disease activity).16