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

Table 3 Comparison of baseline characteristics between the subgroups of patients with steroid-free clinical response versus non-responders to ustekinumab therapy

Parameter	Steroid-free clinical remission/response	Nonresponse	P value
n = 57 (%)	26 (45.6)	31 (54.4)
Male, n (%)	10 (38.5)	20 (64.5)	0.051
Age at baseline (yr), median (range)	41.5 (22–68)	44 (21–68)	0.812
Montreal classification of CD
Age, n (A1:A2:A3)	2:17:7	2:23:6	0.761
Location, n (L1:L2:L3)	8:4:14	10:5:16	0.991
Location L4, n (%)	1 (3.8)	3 (9.7)	0.621
Behaviour, n (B1:B2:B3), n = 56	8:6:11	9:10:12	0.791
Prior CD-related intestinal resections, n (%)	17 (65.4)	19 (61.3)	0.751
First degree relative(s) with IBD, n (%), n = 49	4 (15.4)	4 (17.4)	1.001
Disease duration at baseline (yr), median (range)	10 (1-32)	14 (0-40)	0.432
Presence of at least one extraintestinal manifestation, n (%)	9 (34.6)	21 (67.7)	0.011
Active cigarette smoking, n (%)	8 (30.1)	9 (29.0)	0.891
BMI (kg/m²), mean ± SD (range), n = 56	25.1 ± 5.3 (18.0–40.7) (n = 26)	24.3 ± 5.0 (17.9–39.7) (n = 30)	0.442
History of anti-TNF-α treatment, n (%)	25 (94.7)	29 (93.5)	0.661
History of anti-integrin treatment, n (%)	7 (26.9)	9 (29.0)	0.861
History of immunomodulator treatment, n (%)	22 (84.6)	25 (80.6)	0.691
History of total hospitalisations within 12 months from baseline, n (%)	4 (15.4)	10 (32.3)	0.221
History of CD-related hospitalisations within 12 mo from baseline, n (%)	3 (11.5)	9 (29.0)	0.191
HBI at baseline, mean ± SD (range), n = 51	4.7 ± 4.3 (0-14) (n = 23)	8.1 ± 5.3 (1-24) (n = 28)	0.012
Prior exposure to			0.961
0 biologics, n (%)	1 (3.8)	2 (6.5)
1 biologic, n (%)	6 (23.1)	8 (25.8)
2 biologics, n (%)	13 (50.0)	14 (45.2)
3 biologics, n (%)	6 (23.1)	7 (22.6)
Concomitant medication at baseline
Steroids (including budesonide), n (%)	4 (15.4)	16 (51.6)	0.0041
Immunomodulators, n (%)	2 (7.7)	1 (3.2)	0.451
NOD2 genotyping
NOD2 rs2066844; n = 42 (CC:TT:CT)	15:0:4	19:0:4	0.761
NOD2 rs2066845, n = 42 (CC:GG:CG)	1:16:2	0:18:5	0.361
NOD2 rs2066847, n = 42 (--:CC:C-)	17:0:2	18:0:5	0.331
Biochemical parameters at baseline
Plasma CRP concentration (mg/L), median (range), n=56	7.8 (1.0-57.1) n = 26	8.9 (1.0-82.4) n = 30	0.642
WCC (/nL), median (range), n = 56	9.0 (4.0-15.8) n = 26	9.2 (4.9-19.1) n = 30	0.342
Haemoglobin concentration (g/dL), mean ± SD (range), n = 56	13.3 ± 1.8 (8.8-16.5) n = 26	13.4 ± 1.5 (10.5-16.1) n = 30	0.892
PLT count (/nL), mean ± SD (range), n = 56	322 ± 65.0 (208-431) n = 26	337 ± 171.6 (146-845) n = 30	0.262
Plasma albumin concentration (g/L), mean ± SD (range), n = 54	42.8 ± 3.7 (33.2-49.0) n = 25	43.3 ± 3.4 (36.2-49.0) n = 29	0.522
Plasma ferritin concentration (µg/L), median (range), n = 40	69.5 (4.0-428.0) n = 18	134.5 (9.0-591.0) n = 22	0.142
Transferrin saturation (%), mean ± SD (range), n = 36	15.4 ± 12.4 (2.0-45.0) n = 16	20.4 ± 13.7 (6.0-58.0) n = 20	0.192
FC concentration (µg/g), median (range), n = 24	451 (30-1800) n = 8	302 (74-1800) n = 16	0.882

¹Chi-squared test;

²Mann-Whitney-test. BMI: Body mass index; CRP: C-reactive protein; FC: Faecal calprotectin; HBI: Harvey-Bradshaw-Index; NOD2: Nucleotide oligodimerisation domain 2; PLT: Platelet; SD: Standard deviation; TNF-α: Tumour necrosis factor alpha; WCC: White blood cell count.