Demographic and baseline characteristics (n=78)
| Placebo (n=38) | Anti-NKG2D (n=40) | Total (n=78) | |
|---|---|---|---|
| Age, years | 34.1 (11.6) | 36.5 (14.0) | 35.3 (12.8) |
| Female, n (%) | 22 (57.9) | 20 (50.0) | 42 (53.8) |
| White, n (%) | 37 (97.4) | 38 (95.0) | 75 (96.2) |
| BMI, kg/m2 | 22.6 (4.4) | 23.0 (5.1) | 22.8 (4.8) |
| Smokers, n (%) | 13 (34.2) | 13 (32.5) | 26 (33.3) |
| CDAI score | 325.7 (64.0) | 335.1 (66.5) | 330.5 (65.1) |
| Calprotectin, μg/g | 462.1 (307.0) | 536.8 (379.5) | 500.0 (345.4) |
| Strata | |||
| CDAI <330 | 20 (52.6) | 21 (52.5) | 41 (52.6) |
| CDAI ≥330 | 18 (47.4) | 19 (47.5) | 37 (47.4) |
| Failure to biologic therapy, n (%) | 11 (28.9) | 12 (30.0) | 23 (29.5) |
| Non-failure to biologic therapy, n (%) | 27 (71.1) | 28 (70.0) | 55 (70.5) |
| Calprotectin ≤250 μg/g | 14 (36.8) | 13 (32.5) | 27 (34.6) |
| Calprotectin >250 μg/g | 24 (63.2) | 27 (67.5) | 51 (65.4) |
| HBI score | 10.1 (2.6) | 10.2 (3.0) | 10.1 (2.8) |
| IBDQ score | 121 (30) | 119 (29) | 120 (29) |
| CRP, mg/L (geometric mean (CV)) | 10.6 (210) | 15.1 (184) | 12.7 (198) |
| Screening CRP<10 mg/L, n (%) | 7 (18.4) | 10 (25.0) | 17 (21.8) |
| Screening CRP ≥10 mg/L, n (%) | 31 (81.6) | 30 (75.0) | 61 (78.2) |
| Disease location, n (%)* | |||
| Ileal | 6 (15.8) | 10 (25.0) | 16 (20.5) |
| Colonic | 12 (31.6) | 13 (32.5) | 25 (32.1) |
| Ileocolonic | 18 (47.4) | 17 (42.5) | 35 (44.9) |
| Medication, n (%) | |||
| 5-Aminosalicylic acid | 27 (71.1) | 25 (62.5) | 52 (66.7) |
| Thiopurines or methotrexate | 20 (52.6) | 19 (47.5) | 39 (50.0) |
| Corticosteroids | 12 (31.6) | 14 (35.0) | 26 (33.3) |
Mean (SD) unless otherwise stated.
*Data were missing for two patients in the placebo group at screening.
BMI, body mass index; CRP, C-reactive protein; CV, coefficient of variation; HBI, Harvey–Bradshaw Index; IBDQ, IBD Questionnaire.