Table 1.
Characteristics | Early anti-TNF therapy [n = 135; 59%] |
No early anti-TNF therapy [n = 196; 41%] |
Total [n = 331] |
p-value |
---|---|---|---|---|
Age in years, median [IQR] | 13.9 [12.2–15.3] | 13.2 [10.8–15.1] | 13.7 [11.4–15.2] | 0.03 |
Male sex, n [%] | 88 [65] | 116 [59] | 204 [62] | 0.32 |
First-degree relative with IBD, n [%] | 23 [17] | 42 [21] | 65 [20] | 0.40 |
Ethnicity, n [%] | 0.73 | |||
White | 87 [73] | 120 [67] | 207 [70] | |
Asian | 15 [13] | 23 [13] | 38 [13] | |
Black | 3 [3] | 5 [3] | 8 [3] | |
Hispanic/Latino | 1 [1] | 1 [1] | 2 [1] | |
Mixed/other | 13 [11] | 29 [16] | 42 [14] | |
Time to diagnosis in days, median [IQR] | 141 [76–365] | 159 [83–250] | 153 [79–285] | 0.85 |
BMI Z-score, mean [SD] | -1.21 [1.48] | -0.79 [1.50] | -0.96 [1.51] | 0.013 |
Disease location,an [%] | <0.001 | |||
L1 isolated ileal | 21 [15] | 61 [32] | 82 [25] | |
L2 isolated colonic | 16 [12] | 40 [21] | 56 [17] | |
L3 ileocolonic | 95 [71] | 85 [45] | 180 [56] | |
L4 isolated upper disease | 2 [2] | 3 [2] | 5 [2] | |
Upper gastrointestinal tract involvementa, n [%] | 0.33 | |||
L4a | 61 [45] | 84 [44] | 145 [45] | |
L4b | 12 [9] | 10 [5] | 22 [7] | |
L4ab | 0 [0] | 3 [2] | 3 [1] | |
No upper disease | 62 [46] | 92 [49] | 154 [48] | |
Perianal disease,an [%] | 46 [34] | 19 [10] | 65 [20] | <0.001 |
Disease behaviour,an [%] | 0.21 | |||
B1 | 112 [83] | 174 [89] | 286 [87] | |
B2 | 12 [9] | 15 [8] | 27 [8] | |
B3 | 9 [7] | 5 [3] | 14 [4] | |
B2B3 | 2 [2] | 1 [1] | 3 [1] | |
Disease activity, n [%] | 0.006 | |||
None/inactive | 4 [3] | 11 [6] | 15 [5] | |
Mild | 27 [20] | 67 [35] | 94 [29] | |
Moderate | 51 [38] | 66 [34] | 117 [36] | |
Severe | 52 [39] | 48 [25] | 100 [31] | |
Moderate-to-severe disease activity, n [%] | 103 [77] | 114 [59] | 217 [67] | 0.002 |
wPCDAI, mean [SD] | 51 [22] | 44 [21] | 47 [21] | 0.005 |
Endoscopic severity,bn [%] | 0.13 | |||
Mucosal healing | 3 [3] | 8 [6] | 11 [5] | |
Mild endoscopic inflammation | 15 [17] | 38 [27] | 53 [23] | |
Moderate-to-severe endoscopic inflammation | 73 [80] | 897 [68] | 170 [73] | |
SES-CD score, median [IQR] | 12 [7–18] | 15 [11–22] | 13 [8–19] | 0.009 |
Induction therapy, n [%] | <0.001 | |||
Exclusive Enteral Nutrition | 47 [35] | 136 [69] | 183 [55] | |
Corticosteroids | 19 [14] | 41 [21] | 60 [18] | |
5-aminosalicylates | 1 [1] | 9 [5] | 10 [3] | |
Upfront anti-TNFc | 64 [47] | n/a | 64 [19] | |
None/otherd | 4 [3] | 10 [5] | 14 [4] | |
Steroid use within first 3 months, n [%] | 35 [26] | 74 [38] | 109 [33] | 0.024 |
IMM use within first 3 months, n [%] | 110 [82] | 128 [65] | 238 [72] | <0.001 |
Missing values for each variable: age in years 0; male sex 0; first-degree relative with IBD 0; ethnicity 34; days to diagnosis 12; BMI Z-score 12; disease location 8; upper gastrointestinal tract involvement 7; perianal disease 10; disease behaviour 1; disease activity 5; wPCDAI 77; endoscopic severity 97; SES-CD score 97; induction therapy 0; steroid use within first 3 months 1; IMM use within first 3 months 1.
SES-CD, Simple Endoscopic Score for Crohn’s disease; anti-TNF: anti-tumour necrosis factor alpha; IMM: immunomodulator [methotrexate, azathioprine, 6-mercaptopurine, thioguanine]; IQR: interquartile range; SD: standard deviation; wPCDAI: weighted paediatric Crohn's disease activity index.
aAs per Paris classification.
bBased on SES-CD reference values according to MINI-index paper.
cMost [n = 41] of these patients had one or more clear indications to start upfront anti-TNF, including active perianal disease [n = 19], B2/B3 disease at diagnosis [n = 18], inclusion in the TISKids trial [n = 7], active EIMs [n = 8]. Patients with upfront anti-TNF could also have one or multiple predictors of poor outcome, such as growth delay [n = 13], extensive disease [n = 30], deep colonic ulcer [n = 22]. Three patients did not have any predictor of poor outcome or other clear indication for upfront anti-TNF.
dFive dietary therapy [Crohn’s disease exclusion diet with partial enteral nutrition], three antibiotics, three monotherapy with an immunomodulator, two no therapy, one unknown.