Table 1.
Sociodemographics, history of comorbidities, disease activity, disease characteristics, and history of extraintestinal manifestations at enrollment for patients with ulcerative colitis.
| Ulcerative colitis therapy groups (at beginning of enrollment visit) | ||||
|---|---|---|---|---|
| Total | 5-ASAsa | BIO/JAKia | Difference (95% CI)b | |
| Sociodemographics | ||||
| Age in years | n = 605 | n = 290 | n = 315 | |
| Mean (SD) | 47.3 (17.0) | 50.9 (17.5) | 44.1 (15.7) | 6.8 (4.1, 9.5) |
| Gender—female | n = 604 | n = 290 | n = 314 | |
| n (%) | 326 (54.0%) | 144 (49.7%) | 182 (58.0%) | −8.3 (−16.2, −0.4) |
| White race | n = 605 | n = 290 | n = 315 | |
| n (%) | 520 (86.0%) | 244 (84.1%) | 276 (87.6%) | −3.5 (−9.0, 2.1) |
| Body mass index (BMI) (kg/m2) categorical, n (%) | n = 602 | n = 289 | n = 313 | |
| Underweight (<18.5) | 12 (2.0%) | 5 (1.7%) | 7 (2.2%) | −0.5 (−2.7, 1.7) |
| Normal (18.5–25) | 201 (33.4%) | 93 (32.2%) | 108 (34.5%) | −2.3 (−9.9, 5.2) |
| Overweight (25–30) | 207 (34.4%) | 95 (32.9%) | 112 (35.8%) | −2.9 (−10.5, 4.7) |
| Obese (≥30) | 182 (30.2%) | 96 (33.2%) | 86 (27.5%) | 5.7 (−1.6, 13.1) |
| Insurance—private | n = 605 | n = 290 | n = 315 | |
| n (%) | 463 (76.5%) | 200 (69.0%) | 263 (83.5%) | −14.5 (−21.2, −7.8) |
| Education—college graduate or higher | n = 602 | n = 289 | n = 313 | |
| n (%) | 313 (52.0%) | 138 (47.8%) | 175 (55.9%) | −8.2 (−16.1, −0.2) |
| History of comorbidities | ||||
| CVD1 | n = 605 | n = 290 | n = 315 | |
| n (%) | 62 (10.2%) | 35 (12.1%) | 27 (8.6%) | 3.5 (−1.4, 8.4) |
| Autoimmune2 | n = 605 | n = 290 | n = 315 | |
| n (%) | 12 (2.0%) | 4 (1.4%) | 8 (2.5%) | −1.2 (−3.4, 1.0) |
| Gastrointestinal3 | n = 605 | n = 290 | n = 315 | |
| n (%) | 9 (1.5%) | 5 (1.7%) | 4 (1.3%) | 0.5 (−1.5, 2.4) |
| Respiratory4 | n = 605 | n = 290 | n = 315 | |
| n (%) | 43 (7.1%) | 20 (6.9%) | 23 (7.3%) | −0.4 (−4.5, 3.7) |
| Digestive/hepatic5 | n = 605 | n = 290 | n = 315 | |
| n (%) | 17 (2.8%) | 7 (2.4%) | 10 (3.2%) | −0.8 (−3.4, 1.9) |
| Cancer6 | n = 605 | n = 290 | n = 315 | |
| n (%) | 35 (5.8%) | 15 (5.2%) | 20 (6.3%) | −1.2 (−4. 9, 2.5) |
| Neurologic7 | n = 605 | n = 290 | n = 315 | |
| n (%) | 14 (2.3%) | 7 (2.4%) | 7 (2.2%) | 0.2 (−2.2, 2.6) |
| Other8 | n = 605 | n = 290 | n = 315 | |
| n (%) | 218 (36.0%) | 89 (30.7%) | 129 (41.0%) | −10.3 (−17.9, −2.7) |
| Infections9 | n = 605 | n = 290 | n = 315 | |
| n (%) | 75 (12.4%) | 30 (10.3%) | 45 (14.3%) | −4.0 (−9.2, 1.3) |
| Modified Charlson Comorbidity Index10 | N = 605 | n = 290 | n = 315 | |
| Mean (SD) | 0.2 (0.5) | 0.2 (0.5) | 0.2 (0.5) | 0.01 (−0.08, 0.09) |
| Disease activity | ||||
| Mayo Score (Partial), w/o physician global assessment (0–6) | n = 579 | n = 286 | n = 293 | |
| Mean (SD) | 1.0 (1.3) | 0.8 (1.2) | 1.2 (1.4) | −0.3 (−0.6, −0.1) |
| Physician’s global assessment, n (%) | n = 578 | n = 285 | n = 293 | |
| Normal or inactive disease (0–1) | 211 (36.5%) | 100 (35.1%) | 111 (37.9%) | −2.8 (−10.6, 5.1) |
| Mild disease (2–4) | 240 (41.5%) | 151 (53.0%) | 89 (30.4%) | 22.6 (14.8, 30.4) |
| Moderate disease (5–6) | 101 (17.5%) | 33 (11.6%) | 68 (23.2%) | −11.6 (−17.7, −5.5) |
| Severe disease (7–9) | 26 (4.5%) | 1 (0.4%) | 25 (8.5%) | −8.2 (−11. 5, −4.9) |
| Disease characteristics | ||||
| Proctitis | n = 605 | n = 290 | n = 315 | |
| n (%) | 97 (16.0%) | 64 (22.1%) | 33 (10.5%) | 11.6 (5.7, 17.4) |
| Left-sided disease | n = 605 | n = 290 | n = 315 | |
| n (%) | 236 (39.01%) | 124 (42.8%) | 112 (35.6%) | 7.2 (−0.57, 14.97) |
| Pancolitis | n = 605 | n = 290 | n = 315 | |
| n (%) | 271 (44.8%) | 99 (34.1%) | 172 (54.6%) | −20.5 (−28.2, −12.7) |
| History of hospitalization for UC-related issues | n = 603 | n = 290 | n = 313 | |
| n (%) | 245 (40.6%) | 85 (29.3%) | 160 (51.1%) | −21.8 (−29.4, −14.2) |
| History of ER use for UC-related issues | n = 602 | n = 289 | n = 313 | |
| n (%) | 225 (37.4%) | 81 (28.0%) | 144 (46.0%) | −18.0 (−25.6, −10.4) |
| Difference in time between symptoms and UC diagnosis (years) | n = 593 | n = 287 | n = 306 | |
| Mean (SD) | 0.9 (3.2) | 0.6 (1.8) | 1.2 (4.0) | −0.5 (−1.0, −0.1) |
| History of extraintestinalmanifestations | ||||
| Arthritis | n = 605 | n = 290 | n = 315 | |
| n (%) | 59 (9.8%) | 15 (5.2%) | 44 (14.0%) | −8.8 (−13.4, −4.2) |
| Skin manifestations | n = 605 | n = 290 | n = 315 | |
| n (%) | 7 (1.2%) | 0 (0.0%) | 7 (2.2%) | −2.2 (−3.9, −0.6) |
| Eye involvement | n = 605 | n = 290 | n = 315 | |
| n (%) | 2 (0.3%) | 0 (0.0%) | 2 (0.6%) | −0.6 (−1.5, 0.2) |
Abbreviations: 5-ASAs, 5-aminosalicylic acids; ER, Emergency Room; ISTs, immunosuppressant therapies; JAKi, Janus kinase inhibitors; 5-ASAs alone (5-ASAs); biologics/JAKi alone or in combination with ISTs or 5-ASAs (BIO/JAKi). 1 includes cardiac revascularization procedure, ventricular arrhythmia, cardiac arrest, myocardial infarction, acute coronary syndrome, unstable angina, coronary artery disease, congestive heart failure, and cerebrovascular disease (stroke, transient ischaemic attack, peripheral vascular disease, peripheral arterial disease); 2 includes alopecia areata, alopecia totalis, autoimmune hepatitis, systemic lupus erythematosus, psoriasis, sarcoidosis, Sjogren’s syndrome, and vasculitis; 3 includes peptic ulcer, gastrointestinal perforation, and small bowel obstruction; 4 includes asthma, interstitial lung disease/pulmonary fibrosis and chronic obstructive pulmonary disease (COPD); 5 includes primary sclerosing cholangitis, cholelithiasis, and other hepatic event (serious or requiring biopsy); 6 includes colonic dysplasia, colon cancer, lymphoma, lung cancer, breast cancer, skin cancer (basal cell), skin cancer (melanoma), premalignancy, and other cancer; 7 includes progressive multifocal leukoencephalopathy, demyelinating disease, amyotrophic lateral sclerosis, multiple sclerosis, fibromyalgia, and other neurological disorder (serious); 8 includes diabetes, osteoporosis, depression, anxiety, and other nonserious medical conditions; 9 includes bronchitis, C. difficile colitis, Candida, diverticulitis, gastroenteritis, herpes zoster, joint/bursa, meningitis/encephalitis, pneumonia, sepsis, sinusitis, upper respiratory infection (URI), urinary tract infection (UTI), tuberculosis (TB), and other infection; 10 The modified Charlson Comorbidity Index (mCCI) was calculated as the sum of prior (history of) physician-reported comorbid conditions in the CorEvitas’ IBD Registry, including myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, COPD, peptic ulcer disease, diabetes mellitus, lymphoma, solid-tumor cancer (excluding nonmelanoma of the skin), mild liver disease (hepatic events), and moderate/severe liver disease (primary sclerosing cholangitis, autoimmune hepatitis). Conditions that were not captured and were excluded from mCCI score include connective tissue disease, dementia, kidney disease, hemiplegia, and acquired immunodeficiency syndrome.
Concomitant (eg, currently taking) use of steroids or antibiotics at the time of enrollment is allowed in the UC therapy groups.
Unadjusted mean difference (95% CI) between groups for continuous variables and difference in percentage points (95% CI) between groups for categorical variables.