Table 1.
Demographic and Clinical Characteristics of the Overall Study Population
| Demographics | All Patients | Combination Therapy (Active) | Monotherapy (Placebo) | P value | |||
|---|---|---|---|---|---|---|---|
| n | % or SD | n | % or SD | n | % or SD | ||
| Total Number of patients | 297 | 100% | 156 | 53% | 141 | 47% | |
| Female (N, %) | 104 | 35% | 53 | 33% | 51 | 36% | 0.72 |
| Mean age (SD) | 13.9 | 2.6 | 13.8 | 2.5 | 14.0 | 2.8 | 0.49 |
| Race (n, %) | |||||||
| Asian | 4 | 1% | 2 | 1% | 2 | 1% | 1.0 |
| Black / African American | 32 | 11% | 13 | 8% | 19 | 13% | 0.15 |
| White | 244 | 82% | 131 | 84% | 113 | 80% | 0.45 |
| Multi-race or Other | 13 | 4% | 8 | 5% | 5 | 4% | 0.51 |
| Ethnicity (n, %) | |||||||
| Hispanic or Latino | 8 | 3% | 5 | 3% | 3 | 2% | 0.73 |
| Not Hispanic or Latino | 285 | 97% | 150 | 97% | 138 | 98% | |
| Clinical Characteristics | |||||||
| Mean Height, z-score (SD) | −0.24 | 1.07 | −0.21 | 1.08 | −0.28 | 1.07 | 0.61 |
| Mean Weight, z-score (SD) | −0.25 | 1.12 | −0.27 | 1.14 | −0.23 | 1.10 | 0.74 |
| Mean BMI, z-score (SD) | −0.20 | 1.17 | −0.25 | 1.21 | −0.14 | 1.14 | 0.44 |
| Mean time from diagnosis in months (SD) | 8.9 | 15.6 | 8.1 | 16.0 | 9.7 | 19.2 | 0.46 |
| Disease Location – Lower GI (n, %) | |||||||
| None | 5 | 2% | 5 | 3% | 0 | 0% | |
| Ileum Only | 67 | 24% | 32 | 22% | 35 | 26% | 0.03 |
| Colon Only | 48 | 17% | 19 | 13% | 29 | 21% | |
| Ileocolonic | 161 | 57% | 88 | 61% | 73 | 53% | |
| Upper GI – Proximal (n, %) | 140 | 52% | 74 | 53% | 66 | 51% | 0.72 |
| Upper GI – Distal (n, %) | 70 | 28% | 36 | 28% | 34 | 28% | 0.99 |
| Perianal disease at enrollment (n, %) | 31 | 21% | 17 | 22% | 14 | 21% | 0.86 |
| History of perianal disease (n, %) | 85 | 29% | 43 | 28% | 42 | 30% | 0.72 |
| Mean sPCDAI score at randomization | 17.0 | 15.6 | 17.2 | 16.4 | 16.9 | 14.6 | 0.86 |
| Physician Global Assessment at randomization | |||||||
| Quiescent | 69 | 23% | 37 | 24% | 32 | 23% | 0.53 |
| Mild | 100 | 34% | 48 | 31% | 52 | 37% | |
| Moderate | 80 | 27% | 41 | 26% | 39 | 28% | |
| Severe | 8 | 3% | 6 | 4% | 2 | 1% | |
| Mean Baseline PROMIS Fatigue Score (SD) | 47.6 | 15.2 | 47.4 | 15.5 | 47.8 | 14.9 | 0.83 |
| Mean Baseline PROMIS Pain Score (SD) | 46.9 | 14.3 | 46.5 | 14.5 | 47.4 | 14.1 | 0.60 |
| Prior Treatment | |||||||
| Prior azathioprine or mercaptopurine therapy (n, %) | 36 | 12% | 18 | 12% | 18 | 13% | 0.75 |
| Prior methotrexate (n, %) | 47 | 16% | 26 | 17% | 21 | 15% | 0.70 |
| Current Treatment | |||||||
| Any Steroid at Randomization (n, %) | 120 | 41% | 64 | 41% | 56 | 40% | 0.90 |
| Anti-TNF (n, %) | |||||||
| Infliximab | 212 | 71% | 110 | 71% | 102 | 72% | 0.73 |
| Adalimumab | 85 | 29% | 46 | 29% | 39 | 28% | |
| Baseline Labs | |||||||
| Mean Sed rate (ESR) highest within 42 days of randomization (SD) | 18.6 | 18.4 | 20.4 | 19.3 | 16.6 | 17.3 | 0.11 |
| Mean Alb worst within 42 days of randomization (SD) | 3.8 | 0.6 | 3.8 | 0.5 | 3.9 | 0.6 | 0.40 |
| Mean Hemoglobin (Hgb) lowest within 42 days of randomization (SD) | 12.1 | 2.2 | 11.8 | 1.8 | 12.4 | 2.7 | 0.06 |
| CRP at randomization greater than 2x upper limit of normal (n, %) | 47 | 19% | 27 | 21% | 20 | 16% | 0.34 |