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 |
1
Chi-squared test;
2
Mann-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.