Table 4.
Patient demographics and cardiovascular risk factors in patients with and without MACE
| Patients with MACE (N=73) | Patients without MACE (N=3178) | IR (95% CI) | All-bari-RA (N=3251)* |
|
| Patients with ≥1 cardiovascular risk factor, n (%)† | 55 (75.3) | 1725 (54.3) | 0.70 (0.53 to 0.92) | 1780 (54.8) |
| Age, mean (SD) | 58.9 (10.1) | 52.2 (12.2) | 52.3 (12.2) | |
| <50 years, n (%) | 13 (17.8) | 1214 (38.2) | 0.23 (0.12 to 0.40) | 1227 (37.7) |
| ≥50 years, n (%) | 60 (82.2) | 1964 (61.8) | 0.68 (0.52 to 0.88) | 2024 (62.3) |
| Sex | ||||
| Male | 29 (39.7) | 659 (20.7) | 0.93 (0.62 to 1.33) | 688 (21.2) |
| Female | 44 (60.3) | 2519 (79.3) | 0.39 (0.28 to 0.53) | 2563 (78.8) |
| BMI category, n (%) | ||||
| Underweight (<18.5 kg/m2) | 2 (2.8) | 138 (4.3) | 0.35 (0.04. 1.27) | 140 (4.3) |
| Normal or underweight (≥18.5 and <25 kg/m2) | 16 (22.2) | 1156 (36.4) | 0.31 (0.18 to 0.50) | 1172 (36.1) |
| Overweight (≥25 and <30 kg/m2) | 27 (37.5) | 951 (30.0) | 0.62 (0.41 to 0.90) | 978 (30.1) |
| Obese (≥30 kg/m2) | 27 (37.5) | 930 (29.3) | 0.65 (0.43 to 0.94) | 957 (29.5) |
| Current cigarette smoker, n (%) | 22 (30.1) | 581 (18.3) | 0.81 (0.51 to 1.23) | 603 (18.5) |
| Arteriosclerotic cardiovascular disease, n (%)‡ | 6 (8.2) | 68 (2.1) | 2.01 (0.74 to 4.37) | 74 (2.3) |
| Cardiac disorder (SOC), n (%) | 21 (28.8) | 292 (9.2) | 1.60 (0.99 to 2.45) | 313 (9.6) |
| Hypertension, n (%) | 43 (58.9) | 1126 (35.4) | 0.86 (0.62 to 1.15) | 1169 (36.0) |
| Diabetes, n (%) | 14 (19.2) | 283 (8.9) | 1.17 (0.64 to 1.97) | 297 (9.1) |
| Hypercholesterolaemia§, n (%) | 45 (61.6) | 1482 (46.6) | 0.68 (0.49 to 0.91) | 1527 (47.0) |
| Treatment-emergent thrombocytosis, n (%) | 4 (5.5) | 154 (4.8) | 0.57 (0.16 to 1.47) | 162 (5.0) |
| Baseline corticosteroid use, n (%) | 46 (61.6) | 1650 (51.9) | 0.60 (0.44 to 0.80) | 1695 (52.1) |
| HDL cholesterol <40 mg/dL, n (%) | 9 (12.3) | 280 (8.8) | 0.72 (0.33 to 1.37) | 289 (8.9) |
*All-bari-RA for MACE is only from phase II and III studies where MACE was adjudicated.
†The five possible cardiovascular risk factors included in this analysis were current smoker, hypertension, HDL cholesterol <40 mg/dL, diabetes mellitus and ASCVD.
‡Arteriosclerotic cardiovascular disease (ASCVD) is defined at baseline by medical history of myocardial infarction, coronary artery bypass, stroke, transient ischaemic attack or peripheral vascular disease.
§Hypercholesterolaemia was defined by (1) baseline total cholesterol ≥200 mg/dL or LDL ≥130 mg/dL; or (2) preferred terms of ‘blood cholesterol abnormal, blood cholesterol increased, LDL abnormal, LDL increased, very LDL abnormal, very LDL increased, LDL/HDL ratio increased, total cholesterol/HDL ratio increased, total cholesterol/HDL ratio abnormal, lipids abnormal’; and high-level terms of ‘elevated cholesterol, hyperlipidaemias NEC’.
bari, baricitinib; BMI, body mass index; HDL, high-density lipoprotein; HDL, high-density lipoprotein; IR, incidence rate; LDL, low-density lipoprotein; MACE, major adverse cardiovascular event; n, number of patients in the specified category; N, number of patients in the analysis set; RA, rheumatoid arthritis; SOC, system organ class.