Table 4.
Baseline demographics, disease characteristics, treatment details, and TARGET-IBD activity for the year-one study cohort
| All (N = 997) | UC (n = 388) | CD (n = 599) | IBDU (n = 10) | P (CD vs UC) | |
|---|---|---|---|---|---|
| Age at study entry (years) | |||||
| Median (n) | 45 (992) | 47 (385) | 44 (597) | 37 (10) | 0.0137 |
| Q1–Q3 (IQR) | 32–59 (27) | 34–61 (27) | 30–59 (29) | 31–47 (16) | |
| Female sex, n (%) | 545 (54.7) | 203 (52.3) | 339 (56.6) | 3 (30) | 0.1876 |
| Race, n (%) | 0.0946 | ||||
| White | 832 (86.6) | 325 (87.4) | 499 (86.2) | 8 (80.0) | |
| Black | 86 (8.9) | 26 (7.0) | 59 (10.2) | 1 (10.0) | |
| Other | 43 (4.5) | 21 (5.6) | 21 (3.6) | 1 (10.0) | |
| Not available | 36 | 16 | 20 | 0 | |
| BMI (kg/m2) | |||||
| Median (n) | 26 (954) | 27 (376) | 26 (569) | 33 (9) | 0.0051 |
| Q1–Q3 (IQR) | 23–31 (8) | 24–32 (8) | 22–30 (8) | 25–42 (17) | |
| Current smoker, n (%) | 82 (8.6) | 14 (3.8) | 67 (11.6) | 1 (10.0) | <0.0001 |
| Not available | 43 | 20 | 23 | 0 | |
| Site type, n (%) | |||||
| Academic | 494 (49.5) | 154 (39.7) | 333 (55.6) | 7 (70.0) | <0.0001 |
| Community | 503 (50.5) | 234 (60.3) | 266 (44.4) | 3 (30.0) | |
| Disease duration (years) | |||||
| Median (n) | 10 (877) | 8 (342) | 11 (525) | 8 (10) | <0.0001 |
| Q1–Q3 (IQR) | 4–18 (14) | 3–14 (11) | 5–22 (17) | 3–16 (13) | |
| CD location, n (%) | 599 | 0 | 599 | 0 | — |
| Colon | 114 (19.8) | NA | 114 (19.8) | NA | |
| Ileocolonic | 336 (58.4) | NA | 336 (58.4) | NA | |
| Ileum | 125 (21.7) | NA | 125 (21.7) | NA | |
| Not available | 24 | NA | 24 | NA | |
| Perianal disease, n (%) | 154 (30.6) | 0 (NA) | 154 (30.6) | 0 (NA) | — |
| Not available | 95 | NA | 95 | NA | |
| CD behavior, n (%) | 544 | 0 | 544 | 0 | — |
| Inflammatory | 241 (44.3) | NA | 241 (44.3) | NA | |
| Stricturing | 149 (27.4) | NA | 149 (27.4) | NA | |
| Penetrating | 154 (28.3) | NA | 154 (28.3) | NA | |
| Not available | 55 | NA | 55 | NA | |
| UC extent, n (%) | 361 | 361 | 0 | 0 | — |
| Extensive | 176 (48.8) | 176 (48.8) | NA | NA | |
| Left-sided | 139 (38.5) | 139 (38.5) | NA | NA | |
| Proctitis | 46 (12.7) | 46 (12.7) | NA | NA | |
| Not available | 27 | 27 | NA | NA | |
| Prior biologics, n (%) | |||||
| Anti-TNF | 235 (23.6) | 29 (7.5) | 204 (34.1) | 2 (20) | <0.0001 |
| Anti-integrin* | 16 (1.6) | 4 (1.0) | 12 (2.0) | 0 (0.0) | 0.2376 |
| Ustekinumab | 4 (0.4) | 1 (0.3) | 3 (0.5) | 0 (0.0) | 0.5573 |
| Medications during study, n (%)† | |||||
| 5-ASA | 551 (55.3) | 339 (87.4) | 206 (34.4) | 6 (60.0) | <0.0001 |
| IM‡ | 406 (40.7) | 128 (33.0) | 275 (45.9) | 3 (30.0) | <0.0001 |
| Steroids§ | 568 (57.0) | 243 (62.6) | 315 (52.6) | 10 (100.0) | 0.0019 |
| Anti-TNF | 539 (54.1) | 156 (40.2) | 380 (63.4) | 3 (30.0) | <0.0001 |
| Vedolizumab | 155 (15.5) | 69 (17.8) | 85 (14.2) | 1 (10.0) | 0.1288 |
| Ustekinumab | 61 (6.1) | 2 (0.5) | 59 (9.8) | 0 (0.0) | <0.0001 |
| Tofacitinib | 1 (0.1) | 1 (0.3) | 0 (0.0) | 0 (0.0) | 0.2141 |
| Healthcare encounter count during study, n† | |||||
| Endoscopy | 2146 | 758 | 1361 | 27 | |
| Imaging | 994 | 144 | 841 | 9 | |
| IBD surgery during study, n (%)† | 260 (26.1) | 11 (2.8) | 249 (41.6) | 0 (0.0) | <0.0001 |
| At least 1 PRO completed, n (%) | 562 (56.4) | 208 (53.6) | 351 (58.6) | 3 (30.0) | 0.1226 |
| Participation ongoing, n (%) | 981 (98.4) | 376 (96.9) | 595 (99.3) | 10 (100.0) | 0.0032 |
*Anti-integrin data include natalizumab and vedolizumab.
†Includes both the 3-year retrospective period as well as prospective data collection.
‡Includes azathioprine, mercaptopurine, or methotrexate.
§Includes prednisone, hydrocortisone, methylprednisolone, and budesonide.
5-ASA, 5-aminosalicylate; BMI, body mass index; IBDU, inflammatory bowel disease undefined; IM, immunomodulator; IQR, interquartile range; TNFa, tumor necrosis factor alpha.