Table 1.
Patient demographics and disease characteristics at the time of XAP-PK sub-study enrolment.
| CD [n = 88] | UC [n = 79] | Total [n = 167] | |
|---|---|---|---|
| Age, mean [SD], years | 41.5 [11.5] | 48.1 [11.8] | 44.6 [12.1] |
| Sex, male, n [%] | 48 [54.5] | 45 [57.0] | 93 [55.7] |
| Time since diagnosis, mean [SD], years | 13.8 [6.3] | 13.9 [7.3] | 13.9 [6.8] |
| Time since start of vedolizumab therapy in previous studies, mean [SD], years | 6.2 [1.0] | 6.6 [1.5] | 6.4 [1.3] |
| Previous anti-TNF exposure, n [%] | |||
| Naïve | 56 [63.6] | 59 [74.7] | 115 [68.9] |
| Experienced | 32 [36.4] | 20 [25.3] | 52 [31.1] |
| Concomitant medication use at enrolment, n [%] | |||
| CS only | 6 [6.8] | 5 [6.3] | 11 [6.6] |
| IMM only | 23 [26.1] | 17 [21.5] | 40 [24.0] |
| CS + IMM | 1 [1.1] | 1 [1.3] | 2 [1.2] |
| No concomitant CS/IMM | 58 [65.9] | 56 [70.9] | 114 [68.3] |
| Clinical remission at enrolment, n [%] | 73 [83.0] | 74 [93.7] | 147 [88.0] |
| CS-free clinical remission at enrolment, n [%] | 68 [77.3] | 70 [88.6] | 138 [82.6] |
| Baseline CRP, n [%] | |||
| Normal [≤5.0 mg/L] | 57 [64.8] | 69 [87.3] | 126 [75.4] |
| High [>5.0 mg/L] | 27 [30.7] | 6 [7.6] | 33 [19.8] |
| Missing | 4 [4.5] | 4 [5.1] | 8 [4.8] |
| Baseline HBI score, mean [SD] | 2.1 [3.2] | — | — |
| Baseline partial Mayo score, mean [SD] | — | 0.5 [1.0] | — |
CD, Crohn’s disease; CRP, C-reactive protein; CS, corticosteroid; HBI, Harvey-Bradshaw Index; IMM, immunomodulator; PK, pharmacokinetics; SD, standard deviation; TNF, tumour necrosis factor; UC, ulcerative colitis; XAP, Extended Access Program.