Table 2.
Selected baseline demographics and disease characteristics of patients in propensity score-matched VTE cohorts of the largest US and European data sources
| HealthVerity PS20 | ARTIS | SNDS | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Baricitinib (N = 748) | TNFi (N = 748) | Standardized difference | Baricitinib (N = 1685) | TNFi (N = 1685) | Standardized difference | Baricitinib (N = 2859) | TNFi (N = 2859) | Standardized difference | |
| Exposure | |||||||||
| Total, PY | 236 | 378 | 2314 | 2608 | 1855 | 1923 | |||
| Mean (SD), days | 115 (112) | 184 (164) | 0.49 | 502 (346) | 565 (424) | −0.17 | 237 (195) | 246 (206) | −0.04 |
| Median, days | 69 | 129 | 454 | 454 | 173 | 175 | |||
| Min, max, days | 0, 718 | 0, 808 | 1, 1310 | 9, 1458 | 0, 831 | 0, 851 | |||
| Demographics | |||||||||
| Mean age, years (SD) | 55 (11) | 56 (12) | 0.06 | 59 (14) | 59 (14) | −0.01 | 58 (13) | 58 (13) | 0.00 |
| Sex, female; n (%) | 643 (86) | 635 (85) | 0.03 | 1382 (82) | 1393 (83) | 0.02 | 2268 (79) | 2303 (81) | 0.03 |
| Clinical characteristics | |||||||||
| RA Severity; mean (SD)a | 4 (1) | 4 (1) | 0.06 | 5 (1) | 4 (1) | NA | 7 (1) | 6 (1) | 0.03 |
| DAS28 < 2.6; n (%) | – | – | – | 57 (6) | 97 (12) | −0.11 | – | – | – |
| DAS28 < 3.2; n (%) | – | – | – | 73 (8) | 66 (8) | 0.02 | – | – | – |
| DAS28 < 5.2; n (%) | – | – | – | 454 (49) | 376 (48) | 0.11 | – | – | – |
| DAS28 > 5.2; n (%) | – | – | – | 340 (37) | 248 (32) | 0.14 | – | – | – |
| cDMARDs, baseline; n (%) | 352 (47) | 426 (57) | 0.20 | 935 (55) | 1024 (61) | −0.11 | 1945 (68) | 1882 (66) | 0.05 |
| Methotrexate | 218 (29) | 212 (28) | 0.02 | 724 (43) | 727 (43) | 0.00 | 1523 (53) | 1486 (52) | 0.03 |
| Leflunomide | 89 (12) | 108 (14) | 0.08 | 74 (4) | 103 (6) | −0.09 | 361 (13) | 310 (11) | 0.06 |
| Hydroxychloroquine | 110 (15) | 142 (19) | 0.11 | 92 (5) | 123 (7) | −0.07 | 165 (6) | 138 (5) | 0.04 |
| Sulfasalazine | 38 (5) | 50 (7) | 0.07 | 154 (9) | 241 (14) | −0.16 | 101 (4) | 105 (4) | −0.01 |
| bDMARDs, baseline; n (%) | 271 (36) | 716 (96) | 1.61 | 908 (54) | 1039 (62) | −0.16 | 1599 (56) | 1611 (56) | −0.01 |
| cDMARDs concomitant with bDMARD, baseline; n (%) | 158 (21) | 371 (50) | 0.62 | NA | NA | – | 910 (32) | 847 (30) | 0.05 |
| Glucocorticoids, baseline; n (%) | 349 (47) | 353 (47) | 0.01 | 1073 (64) | 1052 (62) | 0.03 | 2026 (71) | 2002 (70) | 0.02 |
| CVD risk factors; n (%) | |||||||||
| Diabetes | 145 (19) | 140 (19) | 0.02 | 141 (8) | 114 (7) | 0.06 | 283 (10) | 271 (10) | 0.01 |
| Antidiabetic agents | 90 (12) | 111 (15) | 0.08 | 141 (8) | 112 (7) | 0.06 | 276 (10) | 253 (9) | 0.03 |
| Atrial arrhythmia/fibrillation | 23 (3) | 20 (3) | 0.02 | < 5 | 7 (0) | −0.4 | 29 (1) | 27 (1) | 0.01 |
| Coronary artery disease | 42 (6) | 33 (4) | 0.06 | < 5 | < 5 | − 0.03 | 127 (4) | 121 (4) | 0.01 |
| Congestive heart failureb | 7 (1) | 2 (0) | 0.09 | < 5 | < 5 | 0.00 | 12 (0.4) | 13 (0.5) | −0.01 |
| Dyslipidemia | 269 (36) | 375 (37) | 0.02 | < 5 | < 5 | – | NA | NA | – |
| Stroke | NA | NA | – | NA | NA | – | 25 (1) | 22 (1) | 0.01 |
| Hypertension | 321 (43) | 338 (45) | 0.05 | 12 (1) | 5 (0) | 0.06 | NA | NA | – |
| Anti-hypertensive medication | 265 (35) | 378 (51) | 0.31 | 718 (43) | 678 (40) | 0.05 | 973 (34) | 976 (34) | −0.00 |
| Statins | 158 (21) | 191 (26) | 0.10 | 228 (14) | 246 (15) | −0.03 | 394 (14) | 372 (13) | 0.02 |
| Aspirin, prescription | 16 (2) | 20 (3) | 0.04 | 157 (9) | 169 (10) | −0.03 | 37 (1) | 35 (1) | 0.01 |
| Anticoagulant | 20 (3) | 18 (2) | 0.02 | 66 (4) | 51 (3) | 0.05 | 130 (5) | 125 (4) | 0.01 |
| HRT | 47 (6) | 38 (5) | 0.05 | 132 (8) | 138 (8) | −0.01 | 213 (8) | 218 (8) | −0.01 |
| Oral contraceptive | 21 (3) | 20 (3) | 0.01 | 61 (4) | 53 (3) | 0.02 | 147 (5) | 153 (5) | −0.01 |
| Cox-2 inhibitor | 36 (5) | 48 (6) | 0.07 | 121 (7) | 108 (6) | 0.03 | 156 (6) | 175 (6) | −0.03 |
| Obesity | 212 (28) | 210 (28) | 0.01 | NA | NA | – | NA | NA | – |
| Smokingc | 111 (15) | 108 (14) | 0.01 | 803 (48) | 738 (44) | 0.08 | NA | NA | – |
| Other comorbidities | |||||||||
| Cancer | 58 (8) | 56 (8) | 0.01 | < 5 | < 5 | −0.02 | 88 (3) | 94 (3) | −0.01 |
ARTIS anti-rheumatic therapy in Sweden, bDMARDs biologic disease-modifying antirheumatic drugs, cDMARDs conventional synthetic disease-modifying antirheumatic drugs, CVD cardiovascular disease, DAS28 Disease Activity Score 28, HRT hormone replacement therapy, max maximum, min minimum, N number in specific category, n number of patients, NA not available, PS20 private source 20, PY person-years, RA rheumatoid arthritis, SD standard deviation, SNDS Système National des Données de Santé, TNFi tumor necrosis factor inhibitor
aDisease severity is based on the claims-based index of rheumatoid arthritis severity (CIRAS index) in HealthVerity PS20, BKK, and SNDS; and DAS28 for ARTIS data
bCongestive heart failure in PS20 and SNDS was defined as congestive heart failure, hospitalized
cSmoking status is not directly available in claims data sources and is based on ICD-10 codes related to smoking cessation and other measures such as tobacco use disorder, counselling visits for smoking, and antismoking prescription medications. In ARTIS, smoking status is collected directly from patients and defined as current or former smoker
For some data sources, low counts (i.e., < 5) were masked as required to maintain data privacy, as required by local regulations