Ustekinumab: “Real-world” outcomes and potential predictors of nonresponse in treatment-refractory Crohn’s disease

Table 2 Baseline characteristics

Variable	n = 57
Male, n (%)	30 (52.6)
Age at start of treatment (yr), median (range)	43.0 (21-68)
Montreal classification of CD:
Age, n (A1:A2:A3)	4:40:13
Location, n (L1:L2:L3:L4)	18:9:30:4
Behaviour, n (B1:B2:B3), n = 56	17:16:23
Prior CD-related intestinal resection, n (%)	36 (63.2)
First degree relative(s) with IBD, n (%), n = 49	8 (14.0)
Disease duration at baseline (yr), median (range)	43 (21-68)
Presence of at least one extraintestinal manifestation, n (%)	30 (52.6)
Active cigarette smoking, n (%)	17 (29.8)
BMI (kg/m²), mean ± SD (range), n = 56	24.7 ± 5.1 (17.9-40.7)
History of anti-TNF-α treatment, n (%)	54 (94.7)
History of anti-integrin treatment, n (%)	16 (28.1)
History of immunomodulator treatment, n (%)	47 (82.5)
History of total hospitalisations within 12 months from baseline, n (%)	14 (24.6)
History of CD-related hospitalisations within 12 mo from baseline, n (%)	12 (21.1)
HBI, mean ± SD (range), n = 51	6.6 ± 5.1 (0-24)
Prior exposure to
0 biologics, n (%)	3 (5.3)
1 biologic, n (%)	14 (24.6)
2 biologics, n (%)	27 (47.4)
3 biologics, n (%)	13 (22.8)
Endoscopic, MRI and ultrasound findings at 0-12 weeks to baseline
Ulcers in colonoscopy, n (%), n = 25	21 (84.0)
Inflammation in MRI, n (%), n = 21	20 (95.2)
Ultrasound wall thickening > 3 mm, n (%), n = 22	19 (79.2)
Reason for starting ustekinumab therapy
Clinical disease activity, n (%)	34 (59.6)
Imaging (MRI, ultrasound, endoscopy results), n (%)	17 (29.8)
High FC concentration, n (%)	2 (3.5)
Loss of effect of prior therapy, n (%)	2 (3.5)
Intolerance of prior therapy, n (%)	2 (3.5)
Concomitant medications at baseline
Steroids (including budesonide), n (%)	20 (35.1)
Immunomodulators, n (%)	3 (5.3)
NOD2 genotyping
NOD2 rs2066844, n (CC:TT:CT), n = 42	34:0:8
NOD2 rs2066845, n (CC:GG:CG), n = 42	1:34:7
NOD2 rs2066847, n (--:CC:C-), n = 42	35:0:7
Biochemical parameters at baseline
Plasma CRP concentration (mg/L), median (range), n = 56	8.0 (1.0-82.4)
WCC, (/nL), median (range), n = 56	9.2 (4.0-19.1)
Haemoglobin concentration (g/dL), mean ± SD (range), n = 56	13.33 ± 1.6 (8.8-16.5)
PLT count (/nL), mean ± SD (range), n = 56	329.8 ± 132.3 (146-845)
Plasma albumin concentration (g/L), mean ± SD (range), n = 54	43.1 ± 3.5 (33.2-49.0)
Plasma ferritin concentration (µg/L), median (range), n = 40	83.0 (4-591)
Transferrin saturation (%), mean ± SD (range), n = 36	18.2 ± 13.2 (2-58)
FC concentration (µg/g), median (range), n = 24	351.2 (30-1800)

BMI: Body mass index; CD: Crohn’s disease; CRP: C-reactive protein; FC: Faecal calprotectin; HBI: Harvey-Bradshaw-Index; MRI: Magnetic resonance imaging; NOD2: Nucleotide oligodimerisation domain 2; PLT: Platelet; SD: Standard deviation; TNF-α: Tumour necrosis factor alpha; WCC: White blood cell count.