Comparison of reported IRs of DVT and PE and the ratio of IR DVT/IR PE
IRs | DVT | PE | IR DVT:IR PE | |
Tofacitinib | ||||
RA all tofacitinib cohort | 5 mg constant | 0.11 | 0.06 | 1.83 |
10 mg constant | 0.13 | 0.15 | 0.87 | |
RA CV risk+ | 5 mg | 0.34 | 0.25 | 1.36 |
10 mg | 0.17 | 0.24 | 0.71 | |
RA VTE risk+ | 5 mg | 0.25 | 0.2 | 1.25 |
10 mg | 0.18 | 0.17 | 1.06 | |
ENTRACTE | Etanercept | 0.3 | 0.2 | 1.50 |
Tocilizumab | 0.2 | 0.06 | 3.33 | |
A3921133 | 5 mg | 0.3 | 0.27 | 1.11 |
10 mg | 0.38 | 0.54 | 0.70 | |
TNF-i | 0.18 | 0.09 | 2.00 | |
PsO all tofacitinib cohort | 5 mg average | 0.06 | 0.13 | 0.46 |
10 mg average | 0.06 | 0.09 | 0.67 | |
PsA all tofacitinib cohort | 5 mg average | 0 | 0.08 | 0.00 |
10 mg average | 0.13 | 0 | ND | |
Ulcerative colitis | 5 mg predominant | 0.00 | 0.00 | ND |
10 mg predominant | 0.05 | 0.21 | 0.24 | |
Trial data (patients not enriched for ATE/VTE risk factors) | ||||
Baricitinib4 | ||||
Extended data set | 2 mg | 0.6 | 0.2 | 3.00 |
4 mg | 0.3 | 0.3 | 1.00 | |
Upadacitinib23 (concurrent DVT/PE) | ||||
Pooled PBO (0) | 0 | 0,4 | 0.00 | |
MTX (0.3) | 0.3 | 0.5 | 0.60 | |
Adalimumab (0)) | 0.2 | 0.9 | 0.22 | |
15 mg (0.2) | 0.3 | 0.5 | 0.60 | |
30 mg (<0.1) | 0.2 | 0.1 | 2.00 |
Data from Mease et al 5 and Sandborn et al 24 for the ulcerative colitis programme. Available data from long-term extension studies of baricitinib5 and the upadacitinib programme23 among patients not enriched for risk factors are shown for comparison.
CV, cardiovascular; DVT, deep vein thrombosis; IR, incidence rate; PBO, placebo; PE, pulmonary embolism; RA, rheumatoid arthritis; VTE, venous thromboembolic event.