Table 1.
Demographics and baseline characteristics in GEMINI 1, GEMINI 2, and GEMINI LTS trials.
| Characteristic | GEMINI 1: UC | GEMINI 2: CD | Pooled GEMINI 1 and 2 | GEMINI LTSa | |||||
|---|---|---|---|---|---|---|---|---|---|
| Vedolizumab n= 620 |
Placebo n= 149 |
Vedolizumab n= 814 |
Placebo n= 148 |
Vedolizumab n= 1434 |
Placebo n= 297 |
UC n = 894 | CD n = 1349 | Total n= 2243 |
|
| Age, mean [SD] yearsb | 40.1 [13.1] | 41.2 [12.5] | 35.5 [11.9] | 38.6 [13.2] | 37.5 [12.6] | 39.9 [12.9] | 41.2 [13.6] | 37.8 [12.7] | 39.1 [13.2] |
| Female sex, n [%] | 256 [41.3] | 57 [38.3] | 435 [53.4] | 79 [53.4] | 691 [48.2] | 136 [45.8] | 372 [41.6] | 743 [55.1] | 1115 [49.7] |
| White, n [%] | 518 [83.5] | 115 [77.2] | 731 [89.8] | 124 [83.8] | 1249 [87.1] | 239 [80.5] | 762 [85.2] | 1219 [90.4] | 1981 [88] |
| Body weight, mean [SD] kg | 73.4 [18.3] | 72.4 [17.7] | 70.1 [19.8] | 68.7 [18.9] | 71.5 [19.2] | 70.6 [18.3] | 75.2 [18.1] | 71.8 [19.3] | 73.2 [18.9] |
| Current smoker, n [%] | 36 [5.8] | 11 [7.4] | 216 [26.5] | 34 [23.0] | 252 [17.6] | 45 [15.2] | 43 [5.0]c | 363 [27.1]d | 406 [18.4] |
| Former smoker, n [%] | 204 [32.9] | 50 [33.6] | 190 [23.3] | 29 [19.6] | 394 [27.5] | 79 [26.6] | 272 [31.4]c | 319 [23.8]d | 591 [26.8] |
| Duration of disease, mean [SD] yearse | 6.7 [6.0] | 7.1 [7.3] | 9.1 [7.5] | 8.2 [7.8] | 8.0 [7.0] | 7.7 [7.5] | 8.0 [6.9] | 10.1 [8.3] | 9.3 [7.9] |
| Disease duration ≥7 years, n [%] | 214 [34.5] | 53 [35.6] | 419 [51.5] | 64 [43.2] | 633 [44.1] | 117 [39.4] | 372 [41.6] | 755 [56.0] | 1127 [50.2] |
| Baseline disease activity, mean [SD] complete Mayo score | 8.6 [1.8] | 8.6 [1.7] | − | − | − | − | − | − | − |
| Baseline disease activity, mean [SD] partial Mayo score | 6.0 [1.6] | 6.1 [1.5] | − | 7 | − | − | 5.8 [1.8] | − | − |
| Baseline disease activity, mean [SD] HBI score | – | – | 11.2 [3.8] | 10.9 [3.7] | − | – | − | 10.9 [3.6] | 10.9 [3.6] |
| Baseline disease activity, mean [SD] CDAI scoref | – | – | 323.1 [68.5] | 324.6 [78.1] | – | – | − | 314.0 [63.2] | 314.0 [63.2] |
| Baseline disease activity score, mean [SD] common indexg | − | − | − | − | 5.8 [1.70] | 5.8 [1.70] | − | − | − |
| In-study surgery, n [%] | 49 [7.9] | 15 [10.1] | 126 [15.5] | 13 [8.8] | 175 [12.2] | 28 [9.4] | − | − | − |
| History of fistulising disease, n [%] | – | – | 297 [36.5] | 56 [37.8] | – | – | – | 500 [37.1] | – |
| Previous TNF antagonist use, n [%] | 311 [50.2] | 73 [49.0] | 535 [65.7] | 72 [48.6] | 846 [59.0] | 145 [48.8] | 415 [46.4] | 898 [66.6] | 1313 [58.5] |
| Any previous TNF antagonist failure, n [%] | 266 [42.9] | 63 [42.3] | 497 [61.1] | 70 [47.3] | 763 [53.2] | 133 [44.8] | 380 [42.5] | 848 [62.9] | 1228 [54.7] |
| Concomitant immunomodulators, n [%] | 213 [34.4] | 44 [29.5] | 270 [33.2] | 51 [34.5] | 483 [33.7] | 95 [32.0] | 237 [26.5] | 381 [28.2] | 618 [27.6] |
| Concomitant corticosteroids, n [%] | 325 [52.4] | 84 [56.4] | 417 [51.2] | 71 [48.0] | 742 [51.7] | 155 [52.2] | 452 [50.6] | 681 [50.5] | 1133 [50.5] |
| Concomitant narcotics, n [%] | 123 [19.8] | 25 [16.8] | 276 [33.9] | 39 [26.4] | 399 [27.8] | 64 [21.5] | 247 [27.6] | 530 [39.3] | 777 [34.6] |
Previous lung disease was not a specific exclusion criterion. For GEMINI 1 and GEMINI 2, the baseline was Week 0 of each study. Unless otherwise stated, for the GEMINI LTS trial the baseline was the baseline of the previous study for rollover patients and the start of the GEMINI LTS trial for de novo patients.
CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; HBI, Harvey–Bradshaw Index; LTS, long-term safety; SD, standard deviation; TNF, tumour necrosis factor; UC, ulcerative colitis.
aInterim data cut-off: May 19, 2015.
bFor the GEMINI LTS trial, age was defined as [1 + first dose date in the GEMINI LTS trial−birth date]/365.25.
c n = 865.
d n = 1341.
eFor the GEMINI LTS study data, disease duration defined as [1 + first dose date in the GEMINI LTS trial−diagnosis date]/365.25.
fCDAI was not collected for de novo patients.
gBaseline disease activity scores based on partial Mayo Score for GEMINI 1 [UC], HBI score for GEMINI 2 [CD], and common index for pooled GEMINI 1 and 2. Common index ranged from 0 to 9 to allow the combination of baseline partial Mayo and HBI scores in the pooled analysis.