Table 1.
Baseline demographics and clinical characteristics of patients with fistulae at IMAgINE 1 baseline.
| LD adalimumab 20/10 mg [n = 21] |
HD adalimumab 40/20 mg [n = 15] |
All patients [n = 36] |
|
|---|---|---|---|
| Male, n [%] | 17 [81.0] | 7 [46.7] | 24 [66.7] |
| Mean age ± SD, years | 14.3 ± 2.1 | 14.5 ± 2.3 | 14.4 ± 2.2 |
| ≥13 years, n [%] | 14 [66.7] | 11 [73.3] | 25 [69.4] |
| Caucasian, n [%] | 18 [85.7] | 14 [93.3] | 32 [88.9] |
| Mean weight ± SD, kg | 46.1 ± 9.8 | 45.7 ± 12.1 | 45.9 ± 10.6 |
| ≥40 kg, n [%] | 15 [71.4] | 11 [73.3] | 26 [72.2] |
| Fistulae per patient [all perianal], n | |||
| 1 | 14 | 9 | 23 |
| 2 | 3 | 5 | 8 |
| 3 | 2 | 0 | 2 |
| ≥4 | 2 | 1 | 3 |
| Baseline median CRP [range], mg/dLa | 2.04 [0–7.8] | 1.33 [0.2–6.8] | 1.95 [0–7.8] |
| ≥1 mg/dL, n [%] | 11 [55.0] | 9 [60.0] | 20 [57.1] |
| Baseline median PCDAI [range] | 42.5 [30.0–60.0] | 45.0 [32.5–62.5] | 42.5 [30.0–62.5] |
| Median disease duration [range], years | 2.1 [0.3–9.2] | 2.8 [0.3–7.0] | 2.5 [0.3–9.2] |
| Baseline medication use, n [%] | |||
| Systemic corticosteroids | 10 [47.6] | 3 [20.0] | 13 [36.1] |
| IMMs | 13 [61.9] | 12 [80.0] | 25 [69.4] |
| Thiopurinesb | 10 [47.6] | 9 [60.0] | 19 [52.8] |
| Methotrexate | 3 [14.3] | 3 [20.0] | 6 [16.7] |
| Antibioticsc | 6 [28.6] | 0 | 6 [16.7] |
| Metronidazole | 4 [19.1] | 0 | 4 [11.1] |
| Ciprofloxacin | 2 [9.5] | 0 | 2 [5.6] |
| Prior infliximab use, n [%] | 7 [33.3] | 6 [40.0] | 13 [36.1] |
CRP, C-reactive protein; HD, high dose; IMM, immunomodulator; LD, low dose; PCDAI, Paediatric Crohn’s Disease Activity Index; SD, standard deviation.
aOne CRP measurement missing from the LD adalimumab group. bAzathioprine, 6-mercaptopurine.
Comparisons between LD and HD subgroups were calculated by using Fisher’s exact test. cMore patients in the HD group were receiving antibiotics compared with the LD group [P = 0.03], otherwise P > 0.05.