TABLE 1.
Disease Characteristics at Baseline (Week 0 of Induction; Phase 3 Studies Only)
| Ulcerative Colitis | Crohn’s Disease | Inflammatory Bowel Disease | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Ustekinumab | Ustekinumab | Ustekinumab | ||||||||
| Placebo | 130 mg | 6 mg/kg | Combined | Placebo | 130 mg | 6 mg/kg | Combined | Placebo | ||
| Patients randomized | 319 | 320 | 322 | 642 | 470 | 467 | 472 | 939 | 789 | 1581 |
| Age (years) | ||||||||||
| Median | 40.0 | 42.0 | 41.0 | 41.5 | 37.0 | 37.0 | 36.0 | 39.0 | 39.0 | 38.0 |
| IQ range | (30.0; 51.0) | (31.0; 51.0) | (30.0; 52.0) | (30.0; 51.0) | (29.0; 47.0) | (28.0; 47.0) | (27.0; 46.0) | (27.0; 47.0) | (29.0; 49.0) | (29.0; 49.0) |
| Male | 197 (61.8) | 190 (59.4) | 195 (60.6) | 385 (60.0) | 222 (47.2) | 207 (44.3) | 198 (41.9) | 405 (43.1) | 419 (53.1) | 790 (50.0) |
| White | 248 (77.7) | 239 (74.7) | 243 (75.5) | 482 (75.1) | 399 (84.9) | 393 (84.2) | 399 (84.5) | 792 (84.3) | 647 (82.0) | 1274 (80.6) |
| Weight (kg) Mean (SD) | 72.9 (16.8) | 73.7 (16.8) | 73.0 (19.3) | 73.3 (18.1) | 72.7 (18.7) | 71.2 (19.5) | 70.4 (19.3) | 70.8 (19.4) | 72.8 (18.5) | 71.8 (18.9) |
| Current smokers | 20 (6.3) | 12 (3.8) | 15 (5.0) | 28 (4.4) | 117 (24.9)c | 119 (25.5) | 99 (21.0) | 218 (23.2) | 137 (17.4)c | 246 (15.6) |
| IBD disease duration (years) | ||||||||||
| N | 319 | 320 | 322 | 642 | 469 | 467 | 472 | 939 | 788 | 1581 |
| Mean (SD) | 8.0 (7.2) | 8.1 (7.2) | 8.2 (7.8) | 8.2 (7.5) | 11.4 (9.2) | 10.5 (8.5) | 10.9 (9.4) | 10.7 (9.0) | 10.0 (8.6) | 9.66 (8.5) |
| Median | 6.0 | 5.9 | 6.0 | 6.0 | 9.0 | 8.7 | 8.5 | 8.5 | 7.8 | 7.4 |
| IQ range | (2.7; 11.3) | (2.8; 11.4) | (2.7; 11.1) | (2.8; 11.2) | (4.4; 15.6) | (3.9; 14.8) | (3.8; 15.1) | (3.8; 14.8) | (3.5; 13.7) | (3.2; 13.5) |
| Extent of UC disease | ||||||||||
| N | 316 | 318 | 320 | 638 | 0 | 0 | 0 | 0 | 316 | 638 |
| Limited to left side of colon N (%) | 167 (52.8) | 183 (57.5) | 168 (52.5) | 351 (55.0) | - | - | - | - | 167 (52.8) | 351 (55.0) |
| Extensive | 149 (47.2) | 135 (42.5) | 152 (47.5) | 287 (45.0) | - | - | - | - | 149 (47.2) | 287 (45.0) |
| Involved GI areas | ||||||||||
| N | 0 | 0 | 0 | 0 | 468 | 466 | 472 | 938 | 468 | 938 |
| Ileum only N (%) | - | - | - | - | 75 (16.0) | 94 (20.2) | 87 (18.4) | 181 (19.3) | 75 (16.0) | 181 (19.3) |
| Colon only N (%) | - | - | - | - | 87 (18.6) | 82 (17.6) | 85 (18.0) | 167 (17.8) | 87 (18.6) | 167 (17.8) |
| Ileum and colon N (%) | - | - | - | - | 302 (64.5) | 288 (61.8) | 299 (63.3) | 587 (62.6) | 302 (64.5) | 587 (62.6) |
| Mayo score (0–12)a | ||||||||||
| N | 319 | 320 | 321 | 641 | 0 | 0 | 0 | 0 | 319 | 641 |
| Mean (SD) | 8.9 (1.6) | 8.9 (1.6) | 8.9 (1.5) | 8.9 (1.5) | - | - | - | - | 8.9 (1.6) | 8.9 (1.5) |
| Median | 9.0 | 9.0 | 9.0 | 9.0 | - | - | - | - | 9.0 | 9.0 |
| IQ range | (8.0; 10.0) | (8.0; 10.0) | (8.0; 10.0) | (8.0; 10.0) | - | - | - | - | (8.0; 10.0) | (8.0; 10.0) |
| CDAI scoreb | ||||||||||
| N | 0 | 0 | 0 | 0 | 470 | 467 | 472 | 939 | 470 | 939 |
| Mean (SD) | - | - | - | - | 311.7 (61.2) | 313.4 (62.0) | 315.6 (62.1) | 314.5 (62.0) | 311.7 (61.2) | 314.5 (62.0) |
| Median | - | - | - | - | 301.0 | 306.0 | 308.5 | 307.0 | 301.0 | 307.0 |
| IQ range | - | - | - | - | (261.0; 351.0) | (264.0; 352.0) | (267.0; 359.0) | (265.0; 354.0) | (261.0; 351.0) | (265.0; 354.0) |
Abbreviations: CDAI, Crohn’s Disease Activity Index; GI, gastrointestinal; IBD, inflammatory bowel disease; IQ, interquartile; SD, standard deviation; UC, ulcerative colitis.
Data presented as N (%) unless otherwise noted.
aMayo score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and Physician’s Global Assessment, each scored from 0–3. Moderate-to-severe UC is defined as total score of 6–12 on Mayo score (range 0–12).
bCDAI has a possible range of 0 to 600 (with higher scores indicating more severe disease studies.). CDAI <150 is used as a marker of remission, >450 is a marker of severe disease.
cMissing data for one patient.