TABLE 1.
GEMINI 2 and GEMINI 3 Baseline Demographics and Disease Characteristics of Placebo and Vedolizumab Treatment Arms Stratified by Corticosteroid Use
| GEMINI 2 | GEMINI 3 | |||||||
|---|---|---|---|---|---|---|---|---|
| Placebo (n = 148) | Vedolizumab (n = 220) | Placebo (n = 207) | Vedolizumab (n = 209) | |||||
| Corticosteroid (n = 65) | No CS (n = 81) | Corticosteroid (n = 100) | No CS (n = 119) | Corticosteroid (n = 108) | No CS (n = 97) | Corticosteroid (n = 111) | No CS (n = 97) | |
| Baseline characteristics | ||||||||
| Male sex, n (%) | 30 (46) | 38 (47) | 52 (52) | 52 (44) | 51 (47) | 37 (38) | 51 (46) | 39 (40) |
| Mean age, years (SD) | 39.9 (13.8) | 37.7 (12.6) | 35.9 (11.2) | 36.6 (11.9) | 37.7 (13.8) | 36.6 (12.5) | 38.2 (12.1) | 39.0 (12.3) |
| Mean BMI, kg/m2 (SD) | 23.7 (4.9) | 23.8 (6.5) | 23.3 (6.4) | 22.9 (4.9) | 24.8 (6.6) | 24.4 (5.6) | 23.8 (5.0) | 24.3 (5.4) |
| Mean disease duration, years (SD) | 8.6 (8.1) | 8.1 (7.6) | 9.0 (8.3) | 9.3 (8.2) | 8.9 (7.4) | 11.1 (8.5) | 10.0 (7.9) | 11.3 (9.7) |
| Mean CDAI score (SD) | 308.0 (64.7) | 339.4 (85.8) | 327.0 (69.6) | 327.1 (72.0) | 308.6 (58.5) | 293.8 (50.3) | 312.7 (54.6) | 315.3 (52.0) |
| Prior therapy | ||||||||
| Any prior therapy, n (%) | 65 (100) | 81 (100) | 100 (100) | 119 (100) | 108 (100) | 97 (100) | 111 (100) | 97 (100) |
| Any systemic corticosteroid, n (%) | 64 (98) | 75 (93) | 94 (94) | 105 (88) | 102 (94) | 84 (87) | 107 (96) | 82 (85) |
| Any IM, n (%) | 47 (72) | 64 (79) | 78 (78) | 95 (80) | 100 (93) | 91 (94) | 95 (86) | 80 (82) |
| Any anti-TNFα, n (%) | 33 (51) | 41 (51) | 52 (52) | 64 (54) | 83 (77) | 74 (76) | 86 (77) | 69 (71) |
| Baseline treatment | ||||||||
| Concomitant aminosalicylic acid use, n (%) | 27 (42) | 39 (48) | 53 (53) | 48 (40) | 33 (31) | 27 (28) | 38 (34) | 30 (31) |
| Anti-TNFα-naïve, n (%)a | 33 (51) | 42 (52) | 50 (50) | 59 (50) | 24 (22) | 25 (26) | 24 (22) | 27 (28) |
| Anti-TNFα-failure, n (%)a | 29 (45) | 40 (49) | 47 (47) | 57 (48) | 82 (76) | 73 (75) | 86 (77) | 68 (70) |
| Concomitant corticosteroid only, n (%) | 42 (65) | 3 (4)b | 64 (64) | 3 (3)b | 70 (65) | 0 (0) | 71 (64) | 1 (1)b |
| Concomitant corticosteroid and IM, n (%) | 22 (34) | 3 (4)b | 35 (35) | 3 (3)b | 35 (32) | 1 (1)b | 37 (33) | 0 (0) |
Note: further details in Supplementary Table 1.
aDiscrepancies in patient numbers compared with the overall group occurred because some patients had previously received anti-TNFα therapy and did not fail and due to double counting (anti-TNFα history was recorded during screening and enrollment by the patient [IVRS] and based on CRF [by the physician] at study baseline).
bDiscrepancies in reporting of concomitant corticosteroid use (subgroups of patients “corticosteroid” and “no-corticosteroid” are based on actual data, whereas row summaries that refer to corticosteroid usage are based on an IVRS).
BMI, body mass index; CS, corticosteroid; IM, immunomodulator; SD, standard deviation; TNFα, necrosis factor alpha.