Table 5.
Characteristics in the Non-Asian Countries Subgroup of GEMINI 2 Patients: Maintenance Phase
| Parameter | ITT |
Non-ITT |
Placebo combined | Vedolizumab combined | ||||
|---|---|---|---|---|---|---|---|---|
| Placebo | Vedolizumab q8w | Vedolizumab q4w | Placeboa | Vedolizumab q4wa | ||||
| No. | 146 | 143 | 142 | 131 | 478 | 277 | 763 | |
| Male sex | 69 (47) | 62 (43) | 74 (52) | 62 (47) | 210 (44) | 131 (47) | 346 (45) | |
| Age (yr) | 37.4 ± 12.2 | 34.8 ± 12.2 | 35.6 ± 12.4 | 39.4 ± 13.5 | 36.1 ± 11.8 | 38.3 ± 12.8 | 35.7 ± 12.0 | |
| Body weight (kg) | 70.1 ± 17.7 | 69.9 ± 18.4 | 73.0 ± 18.2 | 70.7 ± 18.4 | 71.4 ± 20.3 | 70.4 ± 18.0 | 71.4 ± 19.6 | |
| Duration of CD (yr) | 7.4 (0.3–43.6) | 6.5 (0.3–34.7) | 6.8 (0.2–42.5) | 6.6 (0.3–42.0) | 8.5 (0.3–42.8) | 6.9 (0.3–43.6) | 7.6 (0.2–42.8) | |
| Concomitant medications for CD | ||||||||
| Only glucocorticoids | 55 (38) | 57 (40) | 56 (39) | 43 (33) | 157 (33) | 98 (35) | 270 (35) | |
| Only immunomodulators | 22 (15) | 24 (17) | 26 (18) | 23 (18) | 70 (15) | 45 (16) | 120 (16) | |
| Glucocorticoids and immunomodulators | 24 (16) | 20 (14) | 19 (13) | 20 (15) | 87 (18) | 44 (16) | 126 (17) | |
| No glucocorticoids or immunomodulators | 45 (31) | 42 (29) | 41 (29) | 45 (34) | 164 (34) | 90 (32) | 247 (32) | |
| Patients with prior anti-TNF use | 82 (56) | 86 (60) | 81 (57) | 68 (52) | 357 (75) | 150 (54) | 524 (69) | |
| Patients with prior anti-TNF failure | 78 (53) | 81 (57) | 76 (54) | 66 (50) | 331 (69) | 144 (52) | 488 (64) | |
| CDAI score | 325 ± 65 | 326 ± 68 | 318 ± 63 | 322 ± 77 | 323 ± 69 | 323 ± 71 | 322 ± 67 | |
Values are presented as number (%), mean±standard deviation, or median (range).
Intent-to-treat (ITT)=patients who showed response to vedolizumab at 6 weeks and were randomized as part of the double-blind maintenance phase (maintenance ITT population); Non-ITT placebo=patients that were randomized to placebo during the induction phase and continued to received double-blind placebo during maintenance phase (maintenance safety population only); Non-ITT vedolizumab q4w=patients that did not show response to vedolizumab at 6 weeks and received open-label vedolizumab during the maintenance phase (maintenance safety population only); Placebo combined=all patients that received placebo during the maintenance phase; Vedolizumab combined=all patients that received vedolizumab during the maintenance phase.
Patient numbers do not exactly match those shown in disposition (Fig. 1) because those patients who were discontinued from the study during the induction phase continued to be included in the safety population and have been counted within these groups.
q4w, every 4 weeks; q8w, every 8 weeks; CD, Crohn’s disease; TNF, tumor necrosis factor; CDAI, Crohn’s Disease Activity Index.