Treatment arm | Baseline | Month 12 | |||
ULN | Controls, n (%) | VTE cases, n (%) | Controls, n (%) | VTE cases, n (%) | |
Tofacitinib 5 mg two times per day | ≥2×ULN <2×ULN | 618 (50) 625 (50) | 9 (64) 5 (36) | 282 (26) 798 (74) | 6 (100) 0 (0) |
Tofacitinib 10 mg two times per day* | ≥2×ULN <2×ULN | 602 (50) 592 (50) | 21 (68) 10 (32) | 290 (29) 717 (71) | 11 (58) 8 (42) |
TNFi | ≥2×ULN <2×ULN | 599 (48) 642 (52) | 6 (67) 3 (33) | 316 (30) 740 (70) | 2 (40) 3 (60) |
*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.
TNFi, tumour necrosis factor inhibitor; ULN, upper limit of normal; VTE, venous thromboembolism.