Table 1.
Baseline characteristics of induction studies.
| Patient characteristics | OCTAVE 1 (N = 614) |
OCTAVE 2 (N = 547) |
PURSUIT-IV (N = 291) |
PURSUIT-SC (N = 1065) |
ACT 1 (N = 364) |
ACT 2 (N = 364) |
GEMINI 1 (N = 895) |
ULTRA 1 (N = 576) |
ULTRA 2 (N = 518) |
|---|---|---|---|---|---|---|---|---|---|
| Tofacitinib | Tofacitinib | Golimumab | Golimumab | Infliximab | Infliximab | Vedolizumab | Adalimumab | Adalimumab | |
| Sex, n (%) | |||||||||
| Male | 363 (59.1) | 317 (58.0) | 174 (59.8) | 596 (56.0) | 222 (61.0) | 215 (59.1) | 525 (58.7) | 356 (61.8) | 305 (58.9) |
| Female | 251 (40.9) | 230 (42.1) | 117 (40.2) | 469 (44.0) | 142 (39.0) | 149 (40.9) | 370 (41.3) | 220 (38.2) | 213 (41.1) |
| Randomization | |||||||||
| Treatment | 492 (80.1) | 435 (79.5) | 214 (73.5) | 734 (68.9) | 243 (66.8) | 241 (66.2) | 746 (83.35) | 353 (61.3) | 258 (49.8) |
| Placebo | 122 (19.9) | 112 (20.5) | 77 (26.5) | 331 (31.1) | 121 (33.2) | 123 (33.8) | 149 (16.65) | 223 (38.7) | 260 (50.2) |
| Disease extent, n (%) | |||||||||
| Left-sided colitis | 286 (46.7) | 274 (50.3) | 161 (55.3) | 615 (57.8) | 196 (54.4) | 215 (60.1) | 455 (50.8) | 202 (35.1) | 200 (38.6) |
| Extensive colitis | 74 (12.1) | 54 (9.9) | 130 (44.7) | 449 (42.2) | 164 (45.6) | 143 (39.9) | 109 (12.2) | 316 (54.9) | 250 (48.3) |
| Pancolitis | 253 (41.3) | 216 (39.6) | 331 (37.0) | 58 (10.1) | 68 (13.1) | ||||
| Other | 1 (0.2) | ||||||||
| Age (years), mean (SD) | 41.4 (14.3) | 40.8 (13.4) | 41.0 (13.7) | 40.0 (13.4) | 40.3 (13.1) | 39.7 (13.2) | 40.63 (12.8) | ||
| Disease duration, n (%) mean | |||||||||
| <6 years | 291 (47.4) | 271 (49.5) | 270 (93.8) | 991 (93.1) | 179 (49.2) | 184 (50.7) | 517 (57.9) | 286 (49.7) | 258 (49.8) |
| ≥6 years | 323 (52.6) | 276 (50.5) | 18 (6.3) | 74 (6.9) | 185 (50.8) | 179 (49.3) | 376 (42.1) | 290 (50.3) | 260 (50.2) |
| Ethnicity | |||||||||
| Hispanic | 31 (5.2) | 14 (2.7) | 31 (3.5) | 26 (4.5) | 13 (2.5) | ||||
| Not Hispanic | 570 (94.8) | 510 (97.3) | 481 (53.7) | 550 (95.5) | 505 (97.5) | ||||
| Race, n (%) | |||||||||
| White | 505 (84.0) | 424 (80.9) | 239 (82.1) | 874 (82.1) | 340 (93.4) | 344 (94.5) | 734 (82.0) | 528 (91.7) | 494 (95.4) |
| Black | 6 (1.0) | 4 (0.8) | 4 (1.4) | 26 (2.4) | 6 (1.7) | 8 (2.2) | 12 (1.3) | 19 (3.3) | 11 (2.1) |
| Asian | 71 (11.8) | 74 (14.1) | 44 (15.1) | 126 (11.8) | 4 (1.1) | 5 (1.37) | 135 (15.1) | 22 (3.8) | 5 (1.0) |
| Other | 19 (3.2) | 22 (4.2) | 4 (1.4) | 39 (3.7) | 14 (3.9) | 7 (1.9) | 14 (1.6) | 7 (1.2) | 8 (1.5) |
| Smoking status | |||||||||
| Ex-smoker | 197 (32.1) | 164 (30.0) | 161 (44.2) | 153 (42.0) | 285 (31.8) | 173 (30.2) | 200 (38.5) | ||
| Never smoked | 389 (63.4) | 353 (64.5) | 191 (52.5) | 191 (52.5) | 555 (62.0) | 360 (62.5) | 281 (54.1) | ||
| Smoker | 28 (4.6) | 30 (5.5) | 12 (3.3) | 20 (5.5) | 55 (6.2) | 39 (6.8) | 38 (7.3) | ||
| Baseline BMI kg/mg2, mean (SD) | 24.7 (5.0) | 25.1 (5.0) | 25.1 (5.6) | 25.5 (5.2) | 25.5 (5.5) | ||||
| Prior steroid treatment, n (%) | 558 (90.9) | 493 (90.1) | 199 (68.4) | 613 (57.6) | 96 (26.4) | 90 (24.7) | 347 (38.8) | ||
| Prior immunosuppressant treatment, n (%) | 467 (76.1) | 392 (71.7) | 127 (43.6) | 489 (45.9) | 50 (13.7) | 26 (7.14) | 376 (42.1) | ||
| Prior anti-TNF treatment, n (%) | 327 (53.3) | 303 (55.4) | 0 (0.00)a | 0 (0.00)a | 431 (48.2) | 0 (0.00)c | 0 (0.00)b | ||
| Concomitant steroid treatment, n (%) | 280 (45.6) | 257 (47.0) | 134 (36.8) | 126 (34.6) | 481 (53.7) | ||||
| Concomitant immunosuppressantd treatment, n (%) | 154 (42.3) | 125 (34.3) | 308 (34.4) |
a
Participants with previous exposure to biologic anti-tumor necrosis factor (TNF) agents were excluded from the study.
b
Participants with any prior exposure to Tysabri® (natalizumab), or Orencia® (abatacept) or any other biological therapy [other than Kineret® (anakinra) and anti-TNF agents] were excluded.
c
Participants who received infliximab or any other anti-TNF agent or any biological therapy in the past were excluded.
d
Immunosuppressants include azathioprine, mercaptopurine or methotrexate.