Table 1.
Open in new tab

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, years14.3 ± 2.114.5 ± 2.314.4 ± 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, kg46.1 ± 9.845.7 ± 12.145.9 ± 10.6
 ≥40 kg, n [%]15 [71.4]11 [73.3]26 [72.2]
Fistulae per patient [all perianal], n
 114923
 2358
 3202
 ≥4213
Baseline median CRP [range], mg/dLa2.04 [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], years2.1 [0.3–9.2]2.8 [0.3–7.0]2.5 [0.3–9.2]
Baseline medication use, n [%]
Systemic corticosteroids10 [47.6]3 [20.0]13 [36.1]
IMMs13 [61.9]12 [80.0]25 [69.4]
 Thiopurinesb10 [47.6]9 [60.0]19 [52.8]
 Methotrexate3 [14.3]3 [20.0]6 [16.7]
Antibioticsc6 [28.6]06 [16.7]
 Metronidazole4 [19.1]04 [11.1]
 Ciprofloxacin2 [9.5]02 [5.6]
Prior infliximab use, n [%]7 [33.3]6 [40.0]13 [36.1]
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, years14.3 ± 2.114.5 ± 2.314.4 ± 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, kg46.1 ± 9.845.7 ± 12.145.9 ± 10.6
 ≥40 kg, n [%]15 [71.4]11 [73.3]26 [72.2]
Fistulae per patient [all perianal], n
 114923
 2358
 3202
 ≥4213
Baseline median CRP [range], mg/dLa2.04 [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], years2.1 [0.3–9.2]2.8 [0.3–7.0]2.5 [0.3–9.2]
Baseline medication use, n [%]
Systemic corticosteroids10 [47.6]3 [20.0]13 [36.1]
IMMs13 [61.9]12 [80.0]25 [69.4]
 Thiopurinesb10 [47.6]9 [60.0]19 [52.8]
 Methotrexate3 [14.3]3 [20.0]6 [16.7]
Antibioticsc6 [28.6]06 [16.7]
 Metronidazole4 [19.1]04 [11.1]
 Ciprofloxacin2 [9.5]02 [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.

Table 1.
Open in new tab

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, years14.3 ± 2.114.5 ± 2.314.4 ± 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, kg46.1 ± 9.845.7 ± 12.145.9 ± 10.6
 ≥40 kg, n [%]15 [71.4]11 [73.3]26 [72.2]
Fistulae per patient [all perianal], n
 114923
 2358
 3202
 ≥4213
Baseline median CRP [range], mg/dLa2.04 [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], years2.1 [0.3–9.2]2.8 [0.3–7.0]2.5 [0.3–9.2]
Baseline medication use, n [%]
Systemic corticosteroids10 [47.6]3 [20.0]13 [36.1]
IMMs13 [61.9]12 [80.0]25 [69.4]
 Thiopurinesb10 [47.6]9 [60.0]19 [52.8]
 Methotrexate3 [14.3]3 [20.0]6 [16.7]
Antibioticsc6 [28.6]06 [16.7]
 Metronidazole4 [19.1]04 [11.1]
 Ciprofloxacin2 [9.5]02 [5.6]
Prior infliximab use, n [%]7 [33.3]6 [40.0]13 [36.1]
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, years14.3 ± 2.114.5 ± 2.314.4 ± 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, kg46.1 ± 9.845.7 ± 12.145.9 ± 10.6
 ≥40 kg, n [%]15 [71.4]11 [73.3]26 [72.2]
Fistulae per patient [all perianal], n
 114923
 2358
 3202
 ≥4213
Baseline median CRP [range], mg/dLa2.04 [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], years2.1 [0.3–9.2]2.8 [0.3–7.0]2.5 [0.3–9.2]
Baseline medication use, n [%]
Systemic corticosteroids10 [47.6]3 [20.0]13 [36.1]
IMMs13 [61.9]12 [80.0]25 [69.4]
 Thiopurinesb10 [47.6]9 [60.0]19 [52.8]
 Methotrexate3 [14.3]3 [20.0]6 [16.7]
Antibioticsc6 [28.6]06 [16.7]
 Metronidazole4 [19.1]04 [11.1]
 Ciprofloxacin2 [9.5]02 [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.

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