Table 1
| All P3 Studies (0-12 Months) | LTE Studies | |||
|---|---|---|---|---|
| PBO | *All Dose tofacitinib (5 and 10 mg BID) | ADA 40 mg SC q2w | All Dose tofacitinib (5 and 10 mg BID) | |
| (N=681) | (N=3030) | (N=204) | (N=3227) | |
| Exposure | 202.6 pt-y | 2098.2 pt-y | 178.9 pt-y | 2622.2 pt-y |
| MACE | ||||
| Events (n) | 2 | 14 | 3 | 5 |
| IR per 100 pt-y (95% CI) | 0.99 (0.25, 3.95) | 0.57 (0.33, 1.01) | 1.68 (0.54, 5.20) | 0.19 (0.08, 0.46) |
| CV Mortality | ||||
| Events (n) | 0 | 2 | 1 | 1 |
| IR per 100 pt-y (95% CI) | 0 | 0.10 (0.02, 0.38) | 0.56 (0.08, 3.97) | 0.04 (0.01, 0.27) |
| Non-fatal myocardial infarction | ||||
| Events (n) | 0 | 4 | 2 | 1 |
| IR per 100 pt-y (95% CI) | 0 | 0.19 (0.07, 0.51) | 1.12 (0.28, 4.47) | 0.04 (0.01, 0.27) |
| Non-fatal cerebrovascular accidents | ||||
| Events (n) | 2 | 8 | 0 | 3 |
| IR per 100 pt-y (95% CI) | 0.99 (0.25, 3.95) | 0.33 (0.16, 0.70) | 0 | 0.11 (0.04, 0.36) |
| CHF | ||||
| Events (n) | 0 | 7 | 0 | 3 |
| IR per 100 pt-y (95% CI) | 0 | 0.29 (0.13, 0.64) | 0 | 0.08 (0.02, 0.31) |
*Pts advanced from PBO to tofacitinib are “PBO” until advanced and only in “All Dose” post-advancement.