Table 1. Patient demographics and baseline characteristics (Induction phase).
| Cohort 1 | Cohort 2 | ||
|---|---|---|---|
| Vedolizumab (n = 164) |
Placebo (n = 82) |
Vedolizumab (n = 46) |
|
| Age, y, mean (SD) | 42.3 (14.4) | 44.0 (16.0) | 42.4 (15.6) |
| Male sex, n (%) | 99 (60.4) | 55 (67.1) | 26 (56.5) |
| BMI, kg/m2, mean (SD) | 21.7 (3.4) | 21.8 (3.7) | 21.1 (2.7) |
| Duration of UC, y, mean (SD) | 7.2 (6.2) | 8.6 (8.0) | 9.2 (7.7) |
| Range | 0.6–32.7 | 0.5–53.5 | 0.7–29.8 |
| Full Mayo score, mean (SD) | 8.3 (1.5) | 8.1 (1.5) | 8.3 (1.7) |
| Mayo endoscopic subscore = 2, n (%)a | 110 (67.1) | 54 (65.9) | – |
| In patients with prior use of TNFα antagonistb | 47 of 85 (55.3) | 27 of 41 (65.9) | |
| Mayo endoscopic subscore = 3, n (%)a | 54 (32.9) | 28 (34.1) | – |
| In patients with prior use of TNFα antagonistb | 38 of 85 (44.7) | 14 of 41 (34.1) | |
| Site of disease, n (%) | |||
| Total colitis | 101 (61.6) | 51 (62.2) | 32 (69.6) |
| Left-sided colitis | 63 (38.4) | 31 (37.8) | 14 (30.4) |
| Concomitant medication for UC, n (%) | |||
| 5-ASA | 145 (88.4) | 75 (91.5) | 39 (84.4) |
| OC only | 31 (18.9) | 11 (13.4) | 13 (28.3) |
| Immunomodulators only | 59 (36.0) | 29 (35.4) | 17 (37.0) |
| OC and immunomodulators | 21 (12.8) | 14 (17.1) | 6 (13.0) |
| No OC or immunomodulators | 53 (32.2) | 28 (34.1) | 10 (21.7) |
| Prior TNFα antagonist therapy, n (%) | 85 (51.8) | 41 (50.0) | 24 (52.2) |
| Prior failure of TNFα antagonist, n (%) | 84 (51.2) | 41 (50.0) | 23 (50.0) |
| Inadequate responsec | 50 of 84 (59.5) | 22 of 41 (53.7) | 10 of 23 (43.5) |
| Loss of responsec | 32 of 84 (38.1) | 18 of 41 (43.9) | 12 of 23 (52.2) |
| Intolerancec | 2 of 84 (2.4) | 1 of 41 (2.4) | 1 of 23 (4.3) |
| Prior failure of corticosteroid therapy, n (%) | 109 (66.5) | 57 (69.5) | 34 (73.9) |
| Prior failure of immunomodulator therapy, n (%) | 99 (60.4) | 52 (63.4) | 31 (67.4) |
| Extraintestinal manifestations, n (%) | 53 (32.3) | 16 (19.5) | 14 (30.4) |
| C-reactive protein level <3 mg/L, n (%) | 76 (46.3) | 50 (61.0) | – |
| In patients with prior use of TNFα antagonistb | 33 of 85 (38.8) | 25 of 41 (61.0) | |
| C-reactive protein level ≥3 mg/L, n (%) | 88 (53.7) | 32 (39.0) | – |
| In patients with prior use of TNFα antagonistb | 52 of 85 (61.2) | 16 of 41 (39.0) | |
aMayo endoscopic subscore 2 = moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = severe disease (spontaneous bleeding, ulceration).
bPercentage calculated based on patients with prior use of TNFα antagonist: n = 85 for vedolizumab and n = 41 for placebo
cPercentage calculated based on patients with prior failure of TNFα antagonist: n = 84 for vedolizumab (cohort 1), n = 41 for placebo, and n = 23 for vedolizumab (cohort 2).
5-ASA, 5-aminosalicylic acid; BMI, body mass index; OC, oral corticosteroids; SD, standard deviation; TNFα, tumor necrosis factor alpha; UC, ulcerative colitis.