Real-world effectiveness and safety of risankizumab in multirefractory Crohn’s disease: A multicenter AIRIS-Crohn registry analysis

Table 1 Baseline characteristics and disease features, n (%)

Baseline characteristic	Patients (n = 205)
Mean (years), median (interquartile range)	49.2 (38-61)
Sex
Female	107 (52.2)
Male	98 (47.8)
Smoking status
Active	49 (23.9)
Former	56 (27.3)
Never	100 (48.8)
Disease location
Ileal	100 (48.8)
Colonic	16 (7.8)
Ileocolonic	88 (42.9)
Upper gastrointestinal	14 (6.9)
Extraintestinal manifestations	125 (61.0)
Perianal disease	36 (17.6)
Prior intestinal resection	80 (39.4)
Previous biologics failed
Infliximab	125 (61.0)
Adalimumab	145 (70.7)
Vedolizumab	47 (22.9)
Ustekinumab	167 (81.5)
Certolizumab	7 (3.4)
Upadacitinib	21 (10.2)
Concomitant corticosteroids	57 (28.4)
Concomitant immunomodulators	5 (2.5)
Herpes zoster vaccination	87 (44.2)

Table 2 Clinical and biochemical remission, median (interquartile range)/n (%)

Outcome	Baseline	12 weeks	6 months	12 months	P value
HBI	8 (5-11)	4 (3-8) (< 0.001)1	5 (3-8) (0.003)1	4 (3-8) (< 0.001)1	< 0.001
CRP (mg/L)	4.8 (2.9-12.1)	4.0 (2.0-8.2)	4.0 (2-10)	3.9 (1.6-7.4)	0.268
FC (μg/g)	1113.5 (437-2200)	807.5 (274.0-1500.3)	840.0 (336.5-1488.0)	1063.5 (341.3-2200.0)	0.103
Clinical remission	41 (20.2)	89 (48.6) (< 0.001)2	56 (46.3) (< 0.001)2	22 (48.9) (0.016)2
Clinical-biochemical remission	9 (4.4)	16 (8.7)	8 (6.6)	3 (6.7)
Steroid-free remission		75 (41.0)	53 (43.8)	19 (42.2)

¹Pairwise comparisons of the Friedman test.

²McNemar test for related samples.

HBI: Harvey-Bradshaw index; CRP: C-reactive protein; FC: Fecal calprotectin.

Table 3 Clinical remission by line of therapy, n (%)

Line of therapy1	Baseline	6 months	12 months	P value
First line (n = 30)	7 (24.1)	9 (81.8)	5 (83.3)	0.021 at 6 months
Second line (n = 72)	19 (26.4)	23 (54.8)	9 (56.3)
Third line (n = 96)	15 (15.6)	26 (39.4)	9 (42.9)

¹Clinical remission rates at baseline, 6 and 12 months, stratified by line of therapy.

Table 4 Steroid-free remission by prior biologic failure, median (interquartile range)/n (%)

Prior biologic failed1	Number of prior therapies	Steroid-free remission 6 months	Steroid-free remission 12 months
Vedolizumab	4 (3-4)	10 (30.3)	4 (30.8)
Ustekinumab	3 (2-3)	43 (41.5)	14 (36.8)
Upadacitinib	4 (3-5)	4 (26.7)	1 (16.7)

¹Steroid-free remission rates according to prior biologic therapy exposure.