TABLE 1.
Baseline characteristics of patients with moderate–severe disease a (count [%], mean ± SD or median [IQR] are presented as appropriate)
| Crohn's disease | Ulcerative colitis | |||||
|---|---|---|---|---|---|---|
| Ineligible (n = 71) | Eligible (n = 41) | p | Ineligible (n = 31) | Eligible (n = 21) | p | |
| Gender (male) | 32 (45%) | 23 (56%) | 0.4 | 8 (26%) | 7 (33%) | 0.8 |
| Age at diagnosis (years) | 11.9 ± 3.8 | 9.08 ± 4.2 | 0.001 | 12.1 ± 3.7 | 11.0 ± 4.32 | 0.4 |
| Disease duration prior to receiving biologic (months) | 5.8 (2.0–24.2) | 5.6 (2.0–17.7) | 0.5 | 6.5 (1.9–28.6) | 6.4 (1.7–16.3) | 0.6 |
| Biologic type | ||||||
| Infliximab | 24 (34%) | 6 (15%) | 12 (39%) | 8 (38%) | ||
| Adalimumab | 25 (35%) | 3 (7%) | — | 5 (16%) | 1 (5%) | — |
| Vedolizumab | 15 (21%) | 9 (22%) | 14 (45%) | 12 (57%) | ||
| Ustekinumab | 7 (10%) | 23 (56%) | 0 (0%) | 0 (0%) | ||
| Height (Z score) | −0.447 ± 1.52 | −0.915 ± 1.61 | 0.1 | −0.093 ± 0.99 | −0.411 ± 0.78 | 0.2 |
| Growth delay b | 14 (20%) | 14 (34%) | 0.1 | 0 (0%) | 1 (5%) | 0.8 |
| Weight (Z score) | −0.941 ± 1.76 | −0.896 ± 1.8 | 0.9 | −0.173 ± 1.1 | −0.273 ± 0.927 | 0.7 |
| BMI (Z score) | −0.886 ± 1.92 | −0.301 ± 1.57 | 0.1 | −0.032 ± 1.12 | −0.11 ± 1.04 | 0.8 |
| Family history of IBD | 12 (17%) | 2 (5%) | 0.04 | 4 (13%) | 1 (5%) | 0.4 |
| Extra intestinal manifestation | 10 (14%) | 14 (34%) | 0.02 | 2 (6%) | 3 (14%) | 0.6 |
| Concomitant treatment with CS | 13 (18%) | 12 (29%) | 0.1 | 10 (32%) | 5 (24%) | 0.6 |
| wPCDAI/PUCAI c | 55 (45–72.5) | 57.5 (47.5–63.1) | 0.9 | 55 (45–62.5) | 52.5 (41.3–63.8) | 0.6 |
| Moderate d | 47 (66%) | 26 (63%) | 0.9 | 25 (81%) | 16 (76%) | 0.9 |
| Severe d | 24 (34%) | 15 (37%) | 6 (19%) | 5 (24%) | ||
| Location b | L1: 3 (4%) | 5 (12%) | E1: 0 (0%) | 2 (10%) | 0.4 | |
| L2: 53 (75%) | 19 (46%) | E2: 5 (16%) | 3 (14%) | |||
| L3: 14 (20%) | 17 (41%) | E3: 4 (13%) | 1 (5%) | |||
| L4a: 4 (6%) | 12 (29%) | E4: 19 (61%) | 12 (57%) | |||
| L4b: 3 (4%) | 2 (5%) | |||||
| Behaviour b | ||||||
| B1 | 49 (69%) | 28 (68%) | 0.7 | |||
| B2 | 13 (18%) | 5 (12%) | ||||
| B3 | 5 (7%) | 4 (10%) | ||||
| P | 14 (20%) | 11 (27%) | ||||
| Blood tests | ||||||
| Haemoglobin (g/dl) | 11.8 (10.6–12.4) | 11.5 (10.9–12.8) | 0.9 | 11.5 (9.8–12.7) | 12.0 (10.8–12.7) | 0.4 |
| Anaemia (<10 g/dl) | 6 (8%) | 3 (7%) | 0.9 | 6 (19%) | 2 (10%) | 0.4 |
| Platelets (103/L) | 392 (305–480) | 430 (369–547) | 0.1 | 423 (370–499) | 396 (304–475) | 0.2 |
| Thrombocytosis (>450,000/L) | 15 (21%) | 14 (34%) | 0.4 | 9 (29%) | 5 (24%) | 0.6 |
| CRP (mg/L) | 3.1 (1.6–6.8) | 1.5 (0.8–2.9) | 0.03 | 0.40 (0.16–0.5) | 0.44 (0.1–1.1) | 0.9 |
| ESR (mm/h) | 33.5 [16.3, 59.0] | 29.0 (17–44.8) | 0.5 | 20.5 (12.0–30.3) | 28.5 (8.8–46.0) | 0.3 |
| Elevated inflammatory marker e | 42 (59%) | 28 (68%) | 0.9 | 9 (29%) | 10 (48%) | 0.5 |
| Albumin (g/dl) | 3.7 (3.3–4.0) | 3.7 (3.4–4.0) | 0.9 | 4.0 (3.5–4.1) | 4.2 (3.5–4.6) | 0.2 |
| Hypoalbuminemia (<3.5 g/dL) | 20 (28%) | 8 (20%) | 0.3 | 5 (16%) | 3 (14%) | 0.9 |
Abbreviations: BMI, body mass index; CRP, C‐reactive protein; CS, corticosteroids; ESR, erythrocyte sedimentation rate; IBD, inflammatory bowel disease; PUCAI, paediatric ulcerative colitis activity index; wPCDAI, weighted paediatric Crohn's disease activity index.
Disease extent was missed in six UC patients; disease behaviour was missed in eight CD patients; Baseline blood tests were missing in 28 CD and 14 UC patients.
Determined as the most severe state within 3 months of starting biologic.
As per Paris classification. 18
Defined by wPCDAI/PUCAI or physician global assessment.
C‐reactive protein (CRP) >0.5 mg/L or erythrocyte sedimentation rate (ESR) > 25 mm/h.