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

Table 5 Comparison between parameters determined at 24 ± 6 wk from start of ustekinumab therapy between steroid-free clinical responders and non-responders

	Steroid-free clinical remission or response	Nonresponse	P value
n = 48 (%)	26 (45.6)	22 (38.6)
HBI, mean ± SD (range). n = 44	1.5 ± 1.8 (0-7) n = 24	7.1 ± 3.6 (0-15) n = 20	< 0.012
BMI (kg/m²), mean ± SD (range), n = 45	25.2 ± 5.3 (16.5-40.7) (n = 25)	25.6 ± 5.5 (18.2-38.4) (n = 20)	0.852
Presence of at least one extraintestinal manifestation n (%), n = 45 (%)	1 (4.2) n = 24	6 (28.6) n = 21	0.021
Ustekinumab dosing interval 8 wk, n = 46 (%)	13 (52.0)	11 (52.4)	0.981
Endoscopic, MRI and ultrasound findings at 24 ± 6 wk
Colonoscopy, n = 5	0	5
Mucosal healing, n (%)		0 (0)
MRI, n = 7	1	6
No inflammation or improvement of inflammation, n (%)	1 (100)	3 (50)	0.231
Ultrasound, n = 13	8	5
Wall thickening > 3 mm, n (%)	3 (37.5)	3 (60.0)	0.431
Endoscopic, MRI and ultrasound findings at 24 to 48 ± 6 wk
Colonoscopy, n = 17	8	9
Mucosal healing, n (%)	5 (62.5)	2 (22.2)	0.091
MRI, n = 12	6	6
No inflammation or improvement of inflammation, n (%)	4 (66.7)	3 (50)	0.561
Ultrasound, n = 26	13	13
Wall thickening > 3 mm, n (%)	6 (46.2)	5 (38.5)	0.691
Biochemical parameters
Plasma CRP concentration (mg/L), median (range), n = 44	3.6 (0.6-35.3) n = 23	3.4 (1-58.9) n = 21	0.582
WCC (/nL), median (range), n = 45	8.0 (3.7-13.5) n = 23	9.4 (5.4-14.6) n = 22	0.082
Haemoglobin concentration (g/dL), mean ± SD (range), n = 45	13.9 ± 1.2 (11.0-16.2) n = 23	13.4 ± 1.8 (8.5-15.9) n = 22	0.362
PLT count (/nL), mean ± SD (range), n = 45	314 ± 63.9 (215-442) n = 23	302 ± 111.7 (155-573) n = 22	0.312
Plasma albumin concentration (g/L), mean ± SD (range), n = 39	44.5 ± 2.5 (39.4-50.0) n = 21	42.4 ± 5.7 (22.90-48.9) n = 18	0.242
Plasma ferritin concentration (µg/L), median (range), n = 33	70.0 (9.0-296.0) n = 19	63.0 (6.0-884.0) n = 14	0.962
Transferrin saturation (%), mean ± SD (range), n = 31	19.2 ± 6.8 (9.0-34.0) n = 19	16.8 ± 7.1 (4.0-25.0) n = 12	0.612
FC concentration (µg/g), median (range), n = 27	104 (30-1254) n = 16	254 (45-1261) n = 11	0.432

¹Chi-squared test;

²Mann-Whitney-test. BMI: Body mass index; CRP: C-reactive protein; FC: Faecal calprotectin; HBI: Harvey-Bradshaw-Index; MRI: Magnetic resonance imaging; PLT: Platelet; WCC: White blood cell.