Patient demographics and baseline disease characteristics (D-dimer data set*)
| Controls (n=3678) | VTE cases (n=54) | |||||
| Tofacitinib 5 mg two times per day (N=1243) | Tofacitinib 10 mg two times per day (N=1194)† | TNFi (N=1241) | Tofacitinib 5 mg two times per day (N=14) | Tofacitinib 10 mg two times per day (N=31)† | TNFi (N=9) | |
| Age (years), mean (SD) | 60.5 (6.7) | 61.3 (6.9) | 61.1 (7.4) | 65.1 (6.9) | 63.6 (6.2) | 63.1 (5.6) |
| Female sex, n (%) | 1005 (80.9) | 931 (78.0) | 962 (77.5) | 11 (78.6) | 21 (67.7) | 8 (88.9) |
| White race, n (%) | 970 (78.0) | 943 (79.0) | 952 (76.7) | 14 (100.0) | 27 (87.1) | 8 (88.9) |
| BMI (kg/m2), mean (SD) | 29.7 (6.6) | 29.7 (6.3) | 29.8 (6.7) | 33.2 (9.6) | 34.1 (6.6) | 34.4 (6.9) |
| Current smoker, n (%) | 361 (29.0) | 340 (28.5) | 305 (24.6) | 4 (28.6) | 5 (16.1) | 1 (11.1) |
| Past smoker, n (%) | 253 (20.4) | 230 (19.3) | 279 (22.5) | 3 (21.4) | 14 (45.2) | 2 (22.2) |
| History of hypertension, n (%) | 798 (64.2) | 779 (65.2) | 824 (66.4) | 11 (78.6) | 24 (77.4) | 8 (88.9) |
| History of diabetes mellitus, n (%) | 209 (16.8) | 205 (17.2) | 212 (17.1) | 1 (7.1) | 6 (19.4) | 2 (22.2) |
| History of coronary heart disease, n (%) | 120 (9.7) | 120 (10.1) | 119 (9.6) | 0 | 7 (22.6) | 3 (33.3) |
| History of extra-articular disease, n (%) | 465 (37.4) | 423 (35.4) | 466 (37.6) | 4 (28.6) | 14 (45.2) | 2 (22.2) |
| Baseline HDL-C<40 mg/dL, n (%) | 149 (12.0) | 159 (13.3) | 142 (11.4) | 0 | 6 (19.4) | 1 (11.1) |
| History of VTE (DVT or PE), n (%) | 13 (1.0) | 10 (0.8) | 10 (0.8) | 1 (7.1) | 4 (12.9) | 2 (22.2) |
| Oral contraceptive or HRT at baseline, n (%) | 43 (3.5) | 34 (2.8) | 43 (3.5) | 2 (14.3) | 1 (3.2) | 0 |
| Aspirin at baseline, n (%) | 178 (14.3) | 175 (14.7) | 185 (14.9) | 2 (14.3) | 11 (35.5) | 3 (33.3) |
*Includes patients who had valid D-dimer measurement at baseline and excludes patients who used anticoagulants at baseline (aspirin use was permitted). VTE events were within the 28-day on-treatment risk period.
†For patients assigned to receive tofacitinib at a dose of 10 mg two times per day who had their dose reduced to 5 mg two times per day, the data collected after patients had been switched to 5 mg two times per day were counted in the arm receiving 10 mg two times per day.
BMI, body mass index; DVT, deep vein thrombosis; HDL-C, high-density lipoprotein cholesterol; HRT, hormone replacement therapy; N, number of patients in each treatment arm in the biomarker subpopulation; n, number of patients meeting baseline criteria; PE, pulmonary embolism; TNFi, tumour necrosis factor inhibitor; VTE, venous thromboembolism.