Table 1 Baseline characteristics of the meta-analyzed study cohort, stratified by trial
Drug Class Trial Alias | Anti-Il-12/23 | Anti-Integrin | Anti-TNF | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
CERTIFI | UNITI1 | UNITI2 | ENACT | GEMINI2 | GEMINI3 | ACCENT | CLASSIC | EXTEND | PRECISE1 | PRECISE2 | SONIC | ||||
Trial NCT identifier | NCT00771667 | NCT01369329 | NCT01369342 | NCT00032786 | NCT00783692 | NCT01224171 | NCT00207662 | NCT00055523 NCT00055497 | NCT00348283 | NCT00291668 | NCT00552058 | NCT02499783 | NCT00152490 | NCT00152490 | NCT00152425 |
Year | 2008 | 2011 | 2011 | 2001 | 2008 | 2010 | 1999 | 2002 | 2006 | 2006 | 2008 | 2015 | 2003 | 2003 | 2005 |
Included cohort size | 252 | 502 | 416 | 875 | 1050 | 407 | 190 | 73 | 64 | 60 | 409 | 102 | 593 | 559 | 151 |
Treatment Group | |||||||||||||||
Active | 126 (50%) | 252 (50%) | 209 (50%) | 698 (80%) | 915 (87%) | 205 (50%) | 190 (100%) | 73 (100%) | 64 (100%) | 30 (50%) | 210 (51%) | 102 (100%) | 298 (50%) | 559 (10%) | 151 (100%) |
Placebo | 126 (50%) | 250 (50%) | 207 (50%) | 177 (20%) | 135 (13%) | 202 (50%) | .. | .. | .. | 30 (50%) | 199 (49%) | .. | 295 (50%) | .. | .. |
Age | 39 ( ± 13) | 37 ( ± 12) | 39 ( ± 13) | 38 ( ± 13) | 36 ( ± 12) | 38 ( ± 13) | 37 ( ± 12) | 38 ( ± 11) | 37 ( ± 11) | 33 ( ± 12) | 37 ( ± 12) | 33 ( ± 10) | 37 ( ± 12) | 39 ( ± 13) | 36 ( ± 13) |
Female Sex | 107 (42%) | 224 (45%) | 189 (45%) | 372 (43%) | 492 (47%) | 176 (43%) | 79 (42%) | 35 (48%) | 24 (38%) | 47 (78%) | 181 (44%) | 67 (66%) | 259 (44%) | 271 (48%) | 77 (51%) |
BMI | 26 ( ± 7.3) | 22 ( ± 0.58) | 25 ( ± 6.2) | 25 ( ± 5.6) | 24 ( ± 6.0) | 24 ( ± 5.7) | 24 ( ± 4.7) | 26 ( ± 6.0) | 25 ( ± 4.6) | 20 ( ± 2.7) | 24 ( ± 4.9) | 19 ( ± 2.7) | 24 ( ± 5.3) | 24 ( ± 5.1) | 25 ( ± 5.5) |
Baseline CDAI | 320 ( ± 67) | 320 ( ± 60) | 300 ( ± 56) | 300 ( ± 61) | 320 ( ± 69) | 310 ( ± 53) | 310 ( ± 54) | 290 ( ± 52) | 320 ( ± 69) | 290 ( ± 58) | 290 ( ± 60) | 270 ( ± 48) | 300 ( ± 61) | 300 ( ± 59) | 290 ( ± 62) |
CRP (mg/L) | 21 ( ± 28) | 18 ( ± 23) | 16 ( ± 20) | 19 ( ± 25) | 21 ( ± 26) | 18 ( ± 22) | 20 ( ± 23) | 13 ( ± 18) | 20 ( ± 21) | 31 ( ± 21) | 19 ( ± 26) | 24 ( ± 25) | 18 ( ± 25) | 20 ( ± 28) | 25 ( ± 28) |
History of Anti-TNF Use | 252 (100%) | 479 (95%) | 135 (32%) | 348 (40%) | 649 (62%) | 306 (75%) | 0 (0%) | 2 (3%) | 31 (48%) | 1 (2%) | 0 (0%) | 0 (0%) | 161 (27%) | 156 (28%) | 0 (0%) |
Steroid Use | 134 (53%) | 232 (46%) | 172 (41%) | 356 (41%) | 532 (51%) | 213 (52%) | 94 (49%) | 21 (29%) | 6 (9%) | 14 (23%) | 179 (44%) | 31 (30%) | 235 (40%) | 205 (37%) | 58 (38%) |
Imm. use | 64 (25%) | 166 (33%) | 143 (34%) | 330 (38%) | 341 (32%) | 137 (34%) | 44 (23%) | 19 (26%) | 26 (41%) | 17 (28%) | 139 (34%) | 61 (60%) | 235 (40%) | 230 (41%) | 0 (0%) |
Ileal Disease | 182 (72%) | 407 (81%) | 335 (81%) | 675 (77%) | 752 (72%) | 310 (76%) | 155 (82%) | 47 (64%) | 48 (75%) | 42 (70%) | 286 (70%) | 82 (80%) | 425 (72%) | 378 (68%) | 104 (69%) |