Table 2.
Patient Demographics and Baseline Characteristics
| Total Patient Population (n = 1096) | ||||
|---|---|---|---|---|
| Continuous Covariates for the Patients in the Population PK Data Set at Baseline | ||||
| Covariate | Mean (SD) | Median | Range | Missing n (%) |
| Age, y | 41.3 (13.8) | 40 | 18‐80 | 0 |
| Body weight, kg | 73.6 (16.6) | 72 | 37‐154.5 | 0 |
| Height, cm | 171.5 (9.6) | 171.6 | 145.5‐199.0 | 0 |
| BMI, kg/m 2 | 25.0 (5.0) | 24.2 | 15.4‐54.6 | 0 |
| BCCL, mL/min a | 112.3 (30.3) | 108.7 | 40.8‐255.2 | 1 (0.1) |
| Serum creatinine, mg/dL | 0.9 (0.2) | 0.9 | 0.4‐1.6 | 1 (0.1) |
| CRP, mg/dL | 11.5 (18.7) | 4.7 | 0.1‐208.4 | 16 (1.5) |
| Albumin, g/dL | 4.2 (0.4) | 4.2 | 2.1‐5.4 | 1 (0.1) |
| AP, U/L | 71.4 (25.7) | 67.0 | 12.0‐393.0 | 1 (0.1) |
| ALT, U/L | 18.8 (13.2) | 15.5 | 5.0‐227.0 | 2 (0.2) |
| AST, U/L | 18.2 (8.5) | 17.0 | 7.0‐125.0 | 3 (0.3) |
| Mayo score b | 8.9 (1.5) | 9.0 | 3.0‐12.0 | 2 (0.2) |
| Categorical Covariates for the Patients in the Population PK Data Set at Baseline | ||
|---|---|---|
| Covariate | n | Ratio (%) |
| Sex | ||
| Male | 641 | 58.5 |
| Female | 455 | 41.5 |
| Race | ||
| White | 891 | 81.3 |
| Black | 11 | 1.0 |
| Asian | 119 | 10.9 |
| Other | 46 | 4.2 |
| Ethnicity | ||
| Hispanic | 37 | 3.4 |
| Non‐Hispanic | 887 | 80.9 |
| Smoking status | ||
| Never smoked | 694 | 63.3 |
| Current smoker | 62 | 5.7 |
| Ex‐smoker | 340 | 31.0 |
| History of alcohol use | 332 | 30.3 |
| TNFi‐naïve | 558 | 50.9 |
| Prior TNFi failure | 511 | 46.6 |
| Concomitant medications | ||
| 5‐ASA | 852 | 77.7 |
| Oral corticosteroids | 469 | 42.8 |
| Extent of disease | ||
| Proctosigmoiditis | 138 | 12.6 |
| Left‐sided colitis | 327 | 29.8 |
| Extensive colitis | 108 | 9.9 |
| Pancolitis | 376 | 34.3 |
| Proctitis | 1 | 0.1 |
Abbreviations: 5‐ASA, 5‐aminosalicylic acid; ALT, alanine transaminase; AP, alkaline phosphatase; AST, aspartate transaminase; BCCL, baseline creatinine clearance; BMI, body mass index; CRP, C‐reactive protein; PK, pharmacokinetics; SD, standard deviation; TNFi, tumor necrosis factor inhibitor.
a
Creatinine clearance <40 mL/min at induction was an exclusion criterion for the studies included in this analysis.
b
Considered a continuous variable for this analysis.