Table 1.
Baseline demographics, disease characteristics, medication history and utilization of study population
| Variable | All participants (N = 525) | Participant type | |
|---|---|---|---|
| Ulcerative colitis (N = 150) | Crohn's disease (N = 375) | ||
| 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%) |
1Includes biologic use prior to the initiation of the biologic for which there was a dose change or discontinuation due to lack of effect