Table 1.
Patient demographics and clinical characteristics measured during the baseline perioda—patients with IBD and matched patients with non-immune-mediated disease
| Inflammatory bowel disease | Non-immune-mediated | p value | |
|---|---|---|---|
| (n = 34,687) | (n = 34,687) | ||
| Age at index date (years) | |||
| Mean ± SD | 49.0 ± 16.1 | 49.0 ± 16.1 | 0.14 |
| Sex (female), n (%) | 18,880 (54.4) | 18,880 (54.4) | – |
| Index year, n (%) | |||
| 2015 | 9422 (27.2) | 9422 (27.2) | – |
| 2016 | 9282 (26.8) | 9282 (26.8) | – |
| 2017 | 7945 (22.9) | 7945 (22.9) | – |
| 2018 | 8038 (23.2) | 8038 (23.2) | – |
| Immune-mediated disease, n (%) | |||
| Inflammatory bowel disease | 34,687 (100) | 0 (0) | – |
| Rheumatoid arthritis | 642 (1.9) | 0 (0) | – |
| Psoriasis | 539 (1.6) | 0 (0) | – |
| Ankylosing spondylitis | 238 (0.7) | 0 (0) | – |
| Atopic dermatitis | 180 (0.5) | 0 (0) | – |
| Systemic lupus erythematosus | 162 (0.5) | 0 (0) | – |
| Psoriatic arthritis | 118 (0.3) | 0 (0) | – |
| Multiple sclerosis | 116 (0.3) | 0 (0) | – |
| History of thromboembolic events, n (%) | 1613 (4.7) | 887 (2.6) | < 0.01 |
| Deep vein thrombosis | 810 (2.3) | 326 (0.9) | < 0.01 |
| Ischemic stroke | 443 (1.3) | 327 (0.9) | < 0.01 |
| Pulmonary embolism | 355 (1.0) | 144 (0.4) | < 0.01 |
| Myocardial infarction | 306 (0.9) | 212 (0.6) | < 0.01 |
| Charlson Comorbidity Index | |||
| Mean ± SD | 0.7 ± 1.4 | 0.4 ± 1.1 | < 0.01 |
| Comorbidities, n (%) | |||
| Cancer | 3412 (9.8) | 2318 (6.7) | < 0.01 |
| Cardiovascular diseases | 15,474 (44.6) | 14,622 (42.2) | < 0.01 |
| Atherosclerosis | 2415 (7.0) | 2005 (5.8) | < 0.01 |
| Atrial fibrillation | 1253 (3.6) | 895 (2.6) | < 0.01 |
| Heart failure | 963 (2.8) | 687 (2.0) | < 0.01 |
| Hyperlipidemia | 10,336 (29.8) | 10,350 (29.8) | 0.90 |
| Hypertension | 11,266 (32.5) | 10,582 (30.5) | < 0.01 |
| Chronic kidney disease | 1313 (3.8) | 843 (2.4) | < 0.01 |
| Chronic obstructive pulmonary disease | 1596 (4.6) | 1043 (3.0) | < 0.01 |
| Diabetes | |||
| Type 1 | 457 (1.3) | 405 (1.2) | 0.08 |
| Type 2 | 3782 (10.9) | 3937 (11.4) | 0.05 |
| Fracture (hip or leg) | 224 (0.6) | 221 (0.6) | 0.89 |
| Peripheral vascular disease | 1797 (5.2) | 1096 (3.2) | < 0.01 |
| Pregnancyb | 855 (4.5) | 1077 (5.7) | < 0.01 |
| Common classes of drugs, n (%) | |||
| Non-immune-mediating drugs | |||
| Anticoagulants | 1377 (4.0) | 903 (2.6) | < 0.01 |
| Hormone replacement therapiesb | 1424 (7.5) | 1199 (6.4) | < 0.01 |
| Testosterone replacement therapiesb | 448 (2.8) | 327 (2.1) | < 0.01 |
| Oral contraceptivesb | 2,570 (13.6) | 2133 (11.3) | < 0.01 |
| Immune-mediating drugsc | |||
| Biologics | 4089 (11.8) | 2 (0) | – |
| TNF inhibitors | 3835 (11.1) | 2 (0) | – |
| Interferon beta-1a | 13 (0) | 0 (0) | – |
| Interleukin inhibitors | 194 (0.6) | 0 (0) | – |
| Other biologics | 152 (0.4) | 0 (0) | – |
| JAK inhibitors | 19 (0.1) | 1 (0) | – |
| Non-biologic immunomodulators | 6695 (19.3) | 180 (0.5) | – |
| Methotrexate | 797 (2.3) | 15 (0) | – |
| S1P receptor modulators | 5 (0) | 0 (0) | – |
| Other non-biologic immunomodulators | 6078 (17.5) | 170 (0.5) | – |
| 5-Aminosalicyclic-acid derivative agents | 15,811 (45.6) | 23 (0.1) | – |
| Glucocorticoids | 13,058 (37.6) | 5730 (16.5) | < 0.01 |
| NSAIDs | 5864 (16.9) | 6556 (18.9) | < 0.01 |
JAK Janus kinase, NSAIDs nonsteroidal anti-inflammatory drugs, S1P sphingosine 1-phosphate, SD standard deviation, TNF tumor necrosis factor
aThe baseline period was defined as 1-year period prior to the index date
bThe proportions of patients with pregnancy, hormone replacement therapies and oral contraceptives were reported out of the total number of females in each group. The proportion of patients with testosterone replacement therapies was reported out of the total number of males in each group
cSome of the biologics and other immune-mediating drugs had minimal utilization in the non-immune-mediated cohort. These drugs are occasionally used off-label for conditions that were not included the present study. In addition, there is always a risk of misclassification of patients in a retrospective claims study given the use of real-world data, but such misclassification would likely be inconsequential