Risankizumab is effective following ustekinumab failure in Crohn’s disease: A real-world study from a tertiary center

Table 1 Baseline demographics of the study population

Characteristics	n (%)
Sex
Male	27 (52.9)
Female	24 (47.1)
Montreal disease classification
Age at diagnosis
A1	7 (13.7)
A2	25 (49)
A3	19 (37.3)
Location
L1-ileal	19 (37.3)
L2-colonic	10 (19.6)
L3-ileocolonic	21 (41.2)
L4-isolated upper gi disease	1 (1.9)
Behaviour
B1-non-stricturing	22 (43.1)
B2-stricturing	18 (35.3)
B2/3-stricturing and penetrating	5 (9.8)
B3-penetrating	6 (11.7)
Perianal disease	7 (13.7)
Number of previous advanced therapies
1	7 (13.7)
2	32 (62.8)
3	9 (17.6)
4	3 (5.9)

Table 2 Summary of changes from baseline at 3 months, 6 months and 9 months in all patients

Marker	3 months				6 months				9 months
	n	Mean change	95%CI	P value	n	Mean change	95%CI	P value	n	Mean change	95%CI	P value
Albumin (g/L)	51	+0.92	0.04-1.81	0.042	37	+1.13	0.13-2.12	0.026	22	+2.13	0.92-3.34	< 0.001
CRP (mg/L)	51	-1.75	-9.06-5.56	0.639	37	+1.5	-6.52-9.52	0.714	22	-6.85	-16.46-2.76	0.163
FCP (μg/g)	33	-253.3	-541.48-34.95	0.085	22	-141.3	-468.65-186.08	0.398	12	-193.5	-601.82-214.86	0.353
HBI	48	-2.5	-3.32 to -1.76	< 0.001	32	-3.0	-3.87 to -2.08	< 0.001	19	-4.36	-5.51 to -3.20	< 0.001

CRP: C-reactive protein; FCP: Faecal calprotectin; HBI: Harvey-Bradshaw Index; CI: Confidence interval.

Table 3 Breakdown of Harvey-Bradshaw Index scores at each data point classified based upon severity of disease, n (%)

	Baseline	3 months	6 months	9 months
Remission (< 5)	20 (39.2)	33 (70.2)	25 (78.1)	18 (94.7)
Mild disease (5-7)	14 (27.5)	9 (19.2)	6 (18.8)	1 (5.3)
Moderate disease (8-16)	12 (23.5)	3 (6.4)	1 (3.1)	0
Severe disease (> 16)	4 (7.8)	3 (6.4)	0	0

Table 4 Summary of changes from baseline at 3 months, 6 months and 9 months for patients with secondary loss of response

Marker	3 months				6 months				9 months
	n	Mean change	95%CI	P value	n	Mean change	95%CI	P value	n	Mean change	95%CI	P value
Albumin (g/L)	41	+1.44	36.79-39.13	0.004	37	+1.31	36.69-39.36	0.019	22	+2.08	38.00-41.18	0.003
CRP (mg/L)	41	-5.1	-12.2-1.99	0.158	37	2.03	-5.88-9.95	0.606	22	-7.56	-17.1-1.97	0.115
FCP (μg/g)	28	-291	-688.5-91.0	0.133	19	-291	-686.9-104.1	0.149	8	-376	-757.3 to -5.7	0.054
HBI	37	-0.55	1.91-3.49	0.221	32	-1.09	1.44-3.31	0.031	18	-2.62	0.68-2.16	< 0.001

CRP: C-reactive protein; FCP: Faecal calprotectin; HBI: Harvey-Bradshaw Index; CI: Confidence interval.