Table 1. Patient Characteristics Assessed During the 12 Months Prior to Enrollment.
| Characteristic | No. (%) of patients with Crohn disease (n = 1734 [57.9%]) | SMD | No. (%) of patients with ulcerative colitis (n = 1263 [42.1%]) | SMD | ||
|---|---|---|---|---|---|---|
| New anti-TNF users (n = 875) | Prolonged CS users (n = 859) | New anti-TNF users (n = 286) | Prolonged CS users (n = 977) | |||
| Age, y | ||||||
| 19-35 | 323 (36.9) | 179 (20.8) | 0.27 | 98 (34.3) | 216 (22.1) | 0.23 |
| 36-50 | 223 (25.5) | 150 (17.5) | 62 (21.7) | 190 (19.4) | ||
| 51-65 | 202 (23.1) | 280 (32.6) | 63 (22.0) | 296 (30.3) | ||
| 66-70 | 77 (8.8) | 102 (11.9) | 32 (11.2) | 103 (10.5) | ||
| 71-79 | 25 (2.9) | 60 (7.0) | 17 (5.9) | 67 (6.9) | ||
| 81-85 | 16 (1.8) | 38 (4.4) | 9 (3.1) | 46 (4.7) | ||
| >85 | 5 (0.6) | 34 (4.0) | 3 (1.0) | 41 (4.2) | ||
| Age, mean (SD), y | 44.4 (16.0) | 53.35 (17.2) | 47.09 (17.42) | 52.81 (17.5) | ||
| White race | 673 (76.9) | 662 (77.1) | 0.18 | 227 (79.4) | 745 (76.3) | |
| Calendar year at entry | ||||||
| 2007 | 35 (4.0) | 116 (13.5) | 0.01 | 8 (2.8) | 100 (10.2) | 0.12 |
| 2008 | 57 (6.5) | 123 (14.3) | 8 (2.8) | 106 (10.8) | ||
| 2009 | 80 (9.1) | 100 (11.6) | 15 (5.2) | 113 (11.6) | ||
| 2010 | 84 (9.6) | 110 (12.8) | 23 (8.0) | 138 (14.1) | ||
| 2011 | 112 (12.8) | 93 (10.8) | 29 (10.1) | 120 (12.3) | ||
| 2012 | 135 (15.4) | 108 (12.6) | 35 (12.2) | 121 (12.4) | ||
| 2013 | 152 (17.4) | 111 (12.9) | 70 (24.5) | 130 (13.3) | ||
| 2014 | 220 (25.1) | 98 (11.4) | 98 (34.3) | 149 (15.3) | ||
| Male | 765 (87.4) | 779 (90.7) | 0.10 | 262 (91.6) | 919 (94.1) | |
| Charlson comorbidity count | ||||||
| 0 | 621 (71.0) | 534 (62.2) | 0.05 | 197 (68.9) | 608 (62.2) | 0.03 |
| 1 | 171 (19.5) | 191 (22.2) | 63 (22.0) | 206 (21.1) | ||
| 2-3 | 70 (8.0) | 110 (12.8) | 22 (7.7) | 126 (12.9) | ||
| >3 | 13 (1.5) | 24 (2.8) | 4 (1.4) | 37 (3.8) | ||
| Medications used | ||||||
| Azathioprine or mercaptopurine | 283 (32.3) | 326 (38.0) | 0.16 | 100 (35.0) | 336 (34.4) | 0.10 |
| Budesonide | 46 (5.3) | 442 (51.5) | 0.18 | 13 (4.5) | 139 (14.2) | 0.19 |
| Fibrate | 20 (2.3) | 34 (4.0) | 0.05 | 2 (0.7) | 19 (1.9) | 0.08 |
| Methotrexate | 23 (2.6) | 13 (1.5) | 0.09 | 1 (0.3) | 8 (0.8) | 0.07 |
| Metronidazole | 176 (20.1) | 187 (21.8) | 0.08 | 43 (15.0) | 233 (23.8) | 0.03 |
| Narcotic | 348 (39.8) | 364 (42.4) | 0.08 | 81 (28.3) | 375 (38.4) | 0.02 |
| Quinolone | 139 (15.9) | 168 (19.6) | 0.08 | 31 (10.8) | 188 (19.2) | 0.13 |
| Prednisone | 239 (27.3) | 401 (46.7) | 0.28 | 120 (42.0) | 792 (81.1) | 0.14 |
| No hospitalizations for IBD | 803 (91.8) | 759 (88.4) | 0.05 | 270 (94.40) | 828 (84.7) | 0.04 |
| ≥1 Non-IBD hospitalization | 63 (7.2) | 87 (10.1) | 0.09 | 20 (7.0) | 96 (9.8) | 0.03 |
| First drug qualifying for enrollment | ||||||
| Adalimumab | 699 (79.9) | NA | NA | 206 (72.0) | NA | NA |
| Prednisone | NA | 343 (39.9) | NA | NA | 825 (84.4) | NA |
| Infliximab | 120 (13.7) | NA | NA | 79 (27.6) | NA | NA |
| Budesonide | NA | 516 (60.1) | NA | NA | 152 (15.6) | NA |
| Certolizumab | 56 (6.4) | NA | NA | 1 (0.3) | NA | NA |
Abbreviations: CS, corticosteroids; IBD, inflammatory bowel disease; NA, not applicable; SMD, standardized mean difference, after model weights applied; TNF, tumor necrosis factor.