Table 1. Patient Demographics and Clinical Characteristics of the Overall Study Population and Japanese Subpopulation: Induction Studies and Maintenance Study.
| Characteristics | UNITI-1 | UNITI-2 | IM-UNITI | |||
|---|---|---|---|---|---|---|
| Japan (n=56) | All (n=741) | Japan (n=26) | All (n=628) | Japan (n=21) | All (n=397) | |
| Demographic characteristic | ||||||
| Female (%) | 37.5 | 57.2 | 23.1 | 53.3 | 33.3 | 56.4 |
| Age, median, yr | 30.0 | 36.0 | 37.0 | 37.0 | 35.0 | 36.0 |
| Weight, median, kg | 55.6 | 67.0 | 61.1 | 70.8 | 57.0 | 69.0a |
| CD characteristic | ||||||
| Median disease duration (yr) | 6.2 | 10.1b | 7.4 | 6.4 | 6.7 | 7.6 |
| Median CDAI | 305.0 | 317.0 | 279.5 | 292.5 | 297.0 | 311.0 |
| Median CRP (mg/dL) | 14.8 | 9.9 | 10.3 | 8.1 | 18.7 | 9.3 |
| Abnormal CRP >3.0 mg/dL (%) | 82.1 | 78.3 | 92.3 | 76.8 | 85.7 | 76.8c |
| Fecal calprotectin >250 mg/g (%) | 71.4 | 63.4 | 73.1 | 62.9 | 85.7 | 68.8c |
| Any extra-intestinal manifestations (%) | 21.4 | 50.8b | 26.9 | 55.6 | 23.8 | 51.9 |
| Current fistula (%) | 44.6 | 19.3 | 34.6 | 15.6 | 38.1 | 14.9 |
| Baseline concomitant medications for CD (%) | ||||||
| Corticosteroidd | 32.1 | 45.9 | 11.5 | 39.3 | 19.0 | 45.6 |
| Immunomodulator (6-MP/AZA, MTX) | 60.7 | 31.4 | 38.5 | 34.9 | 66.7 | 36.0 |
| CD-related medication history (%) | ||||||
| Previously treated with and failed full/adequate course of: | ||||||
| Corticosteroid | 44.6 | 70.3 | 65.4 | 80.9 | 66.7 | 77.7 |
| Immunomodulator | 41.1 | 78.9 | 46.2 | 67.5 | 53.3 | 76.9 |
| Corticosteroid or immunomodulator | 60.7 | 89.3 | 96.2 | 99.4 | 71.4 | 94.7 |
| Inadequate initial response, loss of response, or intolerance to ≥1 TNF-antagonists | 100.0 | 99.2 | 0 | NA | 61.9 | 44.6 |
| TNF-antagonist naïve | 0 | NA | 42.3 | 68.6 | 19.0 | 39.5 |
| Previously received but not failed a TNF-antagonists | 0 | NA | 57.7 | 31.4 | 19.0 | 15.6 |
an=389.
bn=740.
cn=388.
dIncluding budesonide.
6-MP, 6-mercaptopurine; AZA, azathioprine; MTX, methotrexate; NA, not applicable; TNF, tumor necrosis factor.