|
Age at study entry (years)
|
|
Median (n)
|
39 (525)
|
39 (150)
|
39 (375)
|
|
Min–max
|
18–80
|
19–74
|
18–80
|
|
Age at study entry by category, n (%)1
|
|
18–39
|
274 (52.2%)
|
78 (52.0%)
|
196 (52.3%)
|
|
40–64
|
199 (37.9%)
|
53 (35.3%)
|
146 (38.9%)
|
|
≥ 65
|
52 (9.9%)
|
19 (12.7%)
|
33 (8.8%)
|
|
Age at diagnosis (years)
|
|
Median (n)
|
26 (494)
|
32 (144)
|
24 (350)
|
|
Min–max
|
1–71
|
1–71
|
6–66
|
|
Age at diagnosis by category, n (%)
|
|
< 18
|
106 (20.2%)
|
18 (12.0%)
|
88 (23.5%)
|
|
18–39
|
272 (51.8%)
|
75 (50.0%)
|
197 (52.5%)
|
|
40–49
|
56 (10.7%)
|
22 (14.7%)
|
34 (9.1%)
|
|
50–64
|
52 (9.9%)
|
23 (15.3%)
|
29 (7.7%)
|
|
≥ 65
|
8 (1.5%)
|
6 (4.0%)
|
2 (0.5%)
|
|
Not reported
|
31 (5.9%)
|
6 (4.0%)
|
25 (6.7%)
|
|
Sex, n (%)
|
|
Female
|
306 (58.3%)
|
83 (55.3%)
|
223 (59.5%)
|
|
Male
|
219 (41.7%)
|
67 (44.7%)
|
152 (40.5%)
|
|
Race, n (%)
|
|
White
|
450 (85.7%)
|
128 (85.3%)
|
322 (85.9%)
|
|
Black or African American
|
36 (6.9%)
|
9 (6.0%)
|
27 (7.2%)
|
|
Native Hawaiian or Other Pacific Islander
|
2 (0.4%)
|
1 (0.7%)
|
1 (0.3%)
|
|
Asian
|
6 (1.1%)
|
1 (0.7%)
|
5 (1.3%)
|
|
Other
|
12 (2.3%)
|
4 (2.7%)
|
8 (2.1%)
|
|
Not reported
|
19 (3.6%)
|
7 (4.7%)
|
12 (3.2%)
|
|
Ethnicity, n (%)
|
|
Hispanic or Latino
|
20 (3.8%)
|
4 (2.7%)
|
16 (4.3%)
|
|
Not Hispanic or Latino
|
478 (91.0%)
|
134 (89.3%)
|
344 (91.7%)
|
|
Other
|
2 (0.4%)
|
1 (0.7%)
|
1 (0.3%)
|
|
Not reported
|
25 (4.8%)
|
11 (7.3%)
|
14 (3.7%)
|
|
Insurance type at enrollment
|
525 (100.0%)
|
150 (100.0%)
|
375 (100.0%)
|
|
Private
|
428 (81.5%)
|
122 (81.3%)
|
306 (81.6%)
|
|
Medicare
|
59 (11.2%)
|
19 (12.7%)
|
40 (10.7%)
|
|
Medicaid
|
42 (8.0%)
|
14 (9.3%)
|
28 (7.5%)
|
|
Supplemental
|
17 (3.2%)
|
5 (3.3%)
|
12 (3.2%)
|
|
Other
|
8 (1.5%)
|
2 (1.3%)
|
6 (1.6%)
|
|
Unknown
|
7 (1.3%)
|
1 (0.7%)
|
6 (1.6%)
|
|
Site type, n (%)
|
|
Academic
|
387 (73.7%)
|
101 (67.3%)
|
286 (76.3%)
|
|
Community
|
138 (26.3%)
|
49 (32.7%)
|
89 (23.7%)
|
|
Crohn's disease location, n (%)
|
|
n
|
375
|
–
|
375
|
|
Colon
|
52 (13.9%)
| |
52 (13.9%)
|
|
Ileocolon
|
226 (60.3%)
| |
226 (60.3%)
|
|
Ileum
|
92 (24.5%)
| |
92 (24.5%)
|
|
Not reported
|
5 (1.3%)
| |
5 (1.3%)
|
|
Upper GI tract involvement, n (%)1
|
|
n
|
375
|
–
|
375
|
|
No
|
167 (44.5%)
| |
167 (44.5%)
|
|
Yes
|
79 (21.1%)
| |
79 (21.1%)
|
|
Not reported
|
129 (34.4%)
| |
129 (34.4%)
|
|
Crohn's disease behavior, n (%)
|
|
n
|
375
|
–
|
375
|
|
Inflammatory (B1)
|
133 (35.5%)
| |
133 (35.5%)
|
|
Stricturing (B2)
|
112 (29.9%)
| |
112 (29.9%)
|
|
Penetrating/fistulizing (B3)
|
130 (34.7%)
| |
130 (34.7%)
|
|
Perianal disease, n (%)
|
|
n
|
375
|
–
|
375
|
|
No
|
156 (41.6%)
| |
156 (41.6%)
|
|
Yes
|
115 (30.7%)
| |
115 (30.7%)
|
|
Not reported
|
104 (27.7%)
| |
104 (27.7%)
|
|
Ulcerative colitis extent, n (%)
|
|
n
|
150
|
150
|
–
|
|
Extensive
|
100 (66.7%)
|
100 (66.7%)
| |
|
Left-sided
|
40 (26.7%)
|
40 (26.7%)
| |
|
Proctitis
|
2 (1.3%)
|
2 (1.3%)
| |
|
Not reported
|
8 (5.3%)
|
8 (5.3%)
| |
|
Previous biologic use, n (%)1
|
|
No
|
295 (56.2%)
|
116 (77.3%)
|
179 (47.7%)
|
|
Yes
|
230 (43.8%)
|
34 (22.7%)
|
196 (52.3%)
|
|
Biologic, n (%)
|
|
Adalimumab
|
230 (43.8%)
|
69 (46.0%)
|
161 (42.9%)
|
|
Certolizumab
|
34 (6.5%)
|
2 (1.3%)
|
32 (8.5%)
|
|
Etanercept
|
1 (0.2%)
|
0 (0.0%)
|
1 (0.3%)
|
|
Golimumab
|
3 (0.6%)
|
1 (0.7%)
|
2 (0.5%)
|
|
Infliximab
|
160 (30.5%)
|
52 (34.7%)
|
108 (28.8%)
|
|
Ustekinumab
|
24 (4.6%)
|
0 (0.0%)
|
24 (6.4%)
|
|
Vedolizumab
|
73 (13.9%)
|
26 (17.3%)
|
47 (12.5%)
|
|
Objective assessment or TDM, n (%)
|
|
No assessment prior to treatment change
|
143 (27.2%)
|
41 (27.3%)
|
102 (27.2%)
|
|
Objective assessment only
|
245 (46.7%)
|
65 (43.3%)
|
180 (48.0%)
|
|
TDM only
|
32 (6.1%)
|
11 (7.3%)
|
21 (5.6%)
|
|
Objective assessment and TDM
|
105 (20.0%)
|
33 (22.0%)
|
72 (19.2%)
|
