Table 1 Characterization of baseline covariates of included studies and simulated head-to-head trial. Placebo arms from the CLASSIC, EXTEND, and NCT02499783 studies were not included due to the absence of an 8-week parallel arm placebo group (see Fig. 2). CRP = c-reactive protein, TNFi = tumor necrosis factor inhibitor
Drug | Certolizumab- Pegol (CZP) | Natalizumab (NTZ) | Ustekinumab (UST) | Adalimumab (ADA) | Simulated Head-to-Head | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
Trial Alias | PRECISE1 | ENACT | ENCORE | CERTIFI | UNITI1 | UNITI2 | CLASSICI/II | EXTEND | NCT02499783 | Observed Ustekinumab (UST) | Simulated Adalimumab (ADA) |
NCT | NCT00152490 | NCT00032786 | NCT00078611 | NCT00771667 | NCT01369329 | NCT01369342 | NCT00055523 | NCT00348283 | NCT02499783 | ||
NCT00055497 | |||||||||||
Year | 2003 | 2001 | 2004 | 2008 | 2011 | 2011 | 2002 | 2006 | 2015 | ||
Sample size | N = 603 | N = 879 | N = 480 | N = 252 | N = 523 | N = 416 | N = 73 | N = 64 | N = 102 | N = 149 | N = 135 |
Treatment Group | |||||||||||
Active | 304 (50%) | 701 (80%) | 243 (51%) | 126 (50%) | 260 (50%) | 209 (50%) | 73 (100%) | 64 (100%) | 102 (100%) | 149 (100%) | 135 (100%) |
Placebo | 299 (50%) | 178 (20%) | 237 (49%) | 126 (50%) | 263 (50%) | 207 (50%) | - | - | - | - | - |
Age—Mean (SD) | 37 (± 12) | 38 (± 13) | 38 (± 13) | 39 (± 13) | 38 (± 12) | 39 (± 13) | 38 (± 11) | 37 (± 11) | 33 (± 10) | 39 (± 14) | 39 (± 12) |
Sex: Female—N (%) | 337 (56%) | 502 (57%) | 284 (59%) | 145 (58%) | 288 (55%) | 227 (55%) | 38 (52%) | 40 (62%) | 35 (34%) | 82 (55%) | 71 (53%) |
BMI—Mean (SD) | 24 (± 5·3) | 25 (± 5·6) | 25 (± 6·4) | 26 (± 7·3) | 22 (± 0·58) | 23 (± 0·68) | 26 (± 6·0) | 25 (± 4·6) | 19 (± 2·7) | 23 (± 0·73) | 22 (± 0·50) |
Baseline CDAI—Mean (SD) | 300 (± 61) | 300 (± 60) | 300 (± 61) | 320 (± 67) | 320 (± 60) | 300 (± 56) | 290 (± 52) | 320 (± 69) | 270 (± 48) | 290 (± 54) | 290 (± 53) |
CRP (mg/L)—Mean (SD) | 18 (± 25) | 20 (± 29) | 22 (± 23) | 21 (± 28) | 17 (± 23) | 16 (± 20) | 13 (± 17) | 20 (± 21) | 24 (± 25) | 18 (± 24) | 14 (± 15) |
History of TNFi Use—N (%) | 163 (27%) | 351 (40%) | 223 (46%) | 252 (100%) | 520 (99%) | 135 (32%) | 2 (3%) | 31 (48%) | 0 (0%) | 0 (0%) | 0 (0%) |
Steroid Use—N (%) | 235 (39%) | 348 (40%) | 190 (40%) | 134 (53%) | 253 (48%) | 172 (41%) | 21 (29%) | 6 (9%) | 31 (30%) | 68 (46%) | 45 (33%) |
Immunomodulator Use—N (%) | 238 (39%) | 302 (34%) | 180 (38%) | 66 (26%) | 172 (33%) | 155 (37%) | 20 (27%) | 26 (41%) | 61 (60%) | 60 (40%) | 57 (42%) |
Ileal Disease—N (%) | 432 (72%) | 678 (77%) | 355 (74%) | 182 (72%) | 420 (80%) | 335 (81%) | 47 (64%) | 48 (75%) | 82 (80%) | 120 (81%) | 112 (83%) |
CDAI Reduction—Mean (SD) | 67 (± 93) | 99 (± 101) | 92 (± 98) | 65 (± 100) | 51 (± 97) | 94 (± 101) | 114 (± 104) | 136 (± 100) | 123 (± 82) | 110 (± 100) | 140 (± 100) |