IRs and HRs of PE and DVT for tofacitinib 5 and 10 mg twice daily versus TNFi (95% CI) from the ad hoc safety analysis of ongoing Study A3921133 (data cut-off: February 2019; database not locked; data not yet source-verified or subjected to standard quality-check procedures that would occur at the time of database lock and may therefore be subject to change)
| Safety endpoint | Tofacitinib 5 mg twice daily | Tofacitinib 10 mg twice daily | TNFi | |
| PE | IR (95% CI) | 0.27 (0.12 to 0.52) | 0.54 (0.32 to 0.87) | 0.09 (0.02 to 0.26) |
| HR versus TNFi (95% CI) | 2.99 (0.81 to 11.06) | 5.96 (1.75 to 20.33) | – | |
| DVT | IR (95% CI) | 0.30 (0.14 to 0.55) | 0.38 (0.20 to 0.67) | 0.18 (0.07 to 0.39) |
| HR versus TNFi (95% CI) | 1.66 (0.60 to 4.57) | 2.13 (0.80 to 5.69) | – | |
| Subgroup analysis in patients with VTE risk factors | ||||
| PE | HR versus TNFi (95% CI) | 3.92 (0.83 to 18.48) | 9.14 (2.11 to 39.56) | – |
DVT, deep vein thrombosis; IR, incidence rate (unique patients with events per 100 patient-years); PE, pulmonary embolism; TNFi, tumour necrosis factor inhibitor; VTE, venous thromboembolism.