Table 1.
Baseline characteristics of patients with biologic-treated patients with ulcerative colitis, by exposure or non-exposure to concomitant 5-ASA
| Characteristics | All (n= 2183) | Concomitant 5-ASA: No (n=432) | Concomitant 5-ASA: Yes (n=1715) |
|---|---|---|---|
| Age, mean (SD)* | 40.20 (13.67) | 39.98 (14.15) | 40.28 (13.55) |
| Sex: Female | 894 (41.0 %) | 182 (42.1%) | 695 (40.5%) |
| Male | 1289 (59.0 %) | 250 (57.9%) | 1020 (59.5%) |
| Smoking | |||
| • Current | 19 (3.8%) | 7 (5.8%) | 12 (3.3%) |
| • Past (Unknown) | 170 (33.6%) | 34 (28.1%) | 126 (34.8%) |
| • Remote past | 31 (6.1%) | 8 (6.6%) | 21 (5.8%) |
| • Recent past (<1y) | 5 (1.0%) | 0 (0.0%) | 5 (1.4%) |
| • Never | 281 (55.5%) | 72 (59.5%) | 198 (54.7%) |
| Disease extent | |||
| • Limited (up to splenic flexure) | 1253 (57.5%) | 251 (58.4%) | 984 (57.4%) |
| • Extensive (extends beyond splenic flexure) | 926 (42.5%) | 179 (41.6%) | 729 (42.6%) |
| Disease duration, Mean (SD), in y | 4.1 (6.0) | 3.8 (4.9) | 4.1 (6.0) |
| Disease activity | |||
| • Mayo Clinic Score, median (IQR) | 8 (3) | 8 (2) | 8 (3) |
| Severity | |||
| • Mild | 287 (14.9%) | 66 (16.4%) | 216 (14.6%) |
| • Moderate | 1178 (61.3%) | 236 (58.7%) | 923 (62.2%) |
| • Severe | 456 (23.7%) | 100 (24.9%) | 344 (23.2%) |
| Co-interventions | |||
| • Prednisone | 799 (36.8%) | 110 (25.5%) | 689 (40.2%) |
| • Immunomodulators | |||
| ∘ Azathioprine | 439 (20.2%) | 98 (22.7%) | 341 (19.9%) |
| ∘ 6-mercaptopurine | 54 (3.2%) | 21 (4.9%) | 86 (5.0%) |
| ∘ Methotrexate | 71 (3.3%) | 2 (0.6%) | 16 (1.2%) |
| • Biologic agents | |||
| ∘ Infliximab | 506 (23.2%) | 121 (28.0%) | 362 (21.1%) |
| ∘ Golibumab | 1677 (76.8%) | 311 (72.2%) | 1353 (78.9%) |
| Laboratory variables | |||
| • Albumin (g/dL) | |||
| ∘ Mean (SD) | 4.19 (0.44) | 4.14 (0.46) | 4.20 (0.43) |
| ∘ Low | 90 (4.9%) | 23 (6.5%) | 64 (4.5%) |
| • Hemoglobin (g/dL) | |||
| ∘ Mean (SD) | 12.9 (1.9) | 12.8 (2.0) | 12.9 (1.9) |
| ∘ Low | 577 (32.7%) | 124 (35.4%) | 438 (31.7%) |
| • C-reactive protein (mg/L) | |||
| ∘ Mean (SD) | 12.0 (19.3) | 13.0 (19.2) | 11.5 (18.6) |
| ∘ Normal | 794 (37.0%) | 154 (36.4%) | 633 (37.5%) |
| ∘ High | 1352 (63.0%) | 269 (63.6%) | 1055 (62.5%) |
| • Fecal Calprotectin (μg/g) | |||
| ∘ Mean (SD) | 1735.9 (3172.6) | 1973.9 (3379.0) | 1672.0 (3127.0) |
| ∘ Normal | 164 (10.3%) | 25 (8.4%) | 138 (10.8%) |
| ∘ High | 1423 (89.7%) | 271 (91.6%) | 1142 (89.2%) |
*
Age reported in only 3 trials
[Abbreviations: SD=Standard deviation; g=grams; mg=milligrams; dL=decilitre; 5-ASA=5-aminosalicylates]