Table 2.
Incidence rates for deep vein thrombosis and pulmonary embolism in tofacitinib clinical development studies
Adverse event | Placebo-controlled cohort | Dose-comparison cohort | |||||
---|---|---|---|---|---|---|---|
Tofacitinib 5 mg BID |
Tofacitinib 10 mg BID |
Placebo | Tofacitinib 5 mg BID |
Tofacitinib 10 mg BID |
Adalimumab 40 mg SC q2w |
MTX 20 mg qw |
|
DVT |
0/1849 0 (0–0.9) |
0/2024 0 (0–0.8) |
1/1079 0.4 (0–2.4) |
1/1849 0.1 (0–0.3) |
1/2024 0.1 (0–0.3) |
0/257 0 (0–0.9) |
2/220.7 (0.1–2.5) |
PE |
0/1849 0 (0–0.9) |
0/2024 0 (0–0.8) |
1/1079 0.4 (0–2.4) |
2/1849 0.1 (0–0.4) |
3/2024 0.2 (0–0.4) |
0/257 0 (0–1.9) |
0/223 0 (0–1.3) |
The data include 5368 patients with rheumatoid arthritis and 4440 person-years. Data are presented as n/N and incidence rate (95% confidence interval)
BID twice daily, DVT deep vein thrombosis, IR incidence rates, MTX methotrexate, PE pulmonary embolism, q2w every 2 weeks, qw every week, SC subcutaneous