IRs for AEs of interest (95% CI)
| All tofacitinib doses N=7061 | Average tofacitinib 5 mg BID* N=3066 | Average tofacitinib 10 mg BID* N=3995 | |
|---|---|---|---|
| 22 874.5 PY | 8171.3 PY | 14 703.2 PY | |
| Serious infection events† | 2.5 (2.3 to 2.7) (n=576) | 2.8 (2.5 to 3.2) (n=233) | 2.3 (2.1 to 2.6) (n=343) |
| HZ (non-serious and serious) | 3.6 (3.4 to 3.9) (n=782) | 3.5 (3.1 to 3.9) (n=269) | 3.7 (3.4 to 4.1) (n=513) |
| HZ (serious) | 0.2 (0.2 to 0.3) (n=57) | 0.3 (0.2 to 0.4) (n=23) | 0.2 (0.2 to 0.3) (n=34) |
| Opportunistic infection (excluding TB) | 0.4 (0.3 to 0.5) (n=90) | 0.3 (0.2 to 0.5) (n=28) | 0.4 (0.3 to 0.5) (n=62) |
| TB | 0.2 (0.1 to 0.2) (n=38) | 0.1 (0.1 to 0.2) (n=11) | 0.2 (0.1 to 0.3) (n=27) |
| Malignancy (excluding NMSC) | 0.8 (0.7 to 0.9) (n=177) | 0.8 (0.6 to 1.0) (n=64) | 0.8 (0.6 to 0.9) (n=113) |
| NMSC | 0.6 (0.5 to 0.7) (n=129) | 0.4 (0.3 to 0.6) (n=36) | 0.6 (0.5 to 0.8) (n=93) |
| Breast cancer (female patients) | 0.2 (0.1 to 0.2) (n=30) | 0.2 (0.1 to 0.3) (n=12) | 0.1 (0.1 to 0.2) (n=18) |
| Lung cancer | 0.1 (0.1 to 0.2) (n=30) | 0.1 (0.1 to 0.3) (n=12) | 0.1 (0.1 to 0.2) (n=18) |
| Lymphoma‡ | 0.05 (0.03 to 0.09) (n=12) | 0.01 (0.00 to 0.07) (n=1) | 0.07 (0.04 to 0.13) (n=11) |
| GI perforations | 0.1 (0.1 to 0.2) (n=28) | 0.1 (0.0 to 0.2) (n=6) | 0.2 (0.1 to 0.2) (n=22) |
| DVT | 0.2 (0.1 to 0.2) (n=36) | 0.2 (0.1 to 0.3) (n=13) | 0.2 (0.1 to 0.2) (n=23) |
| PE | 0.1 (0.1 to 0.2) (n=28) | 0.1 (0.0 to 0.2) (n=8) | 0.1 (0.1 to 0.2) (n=20) |
| VTE§ | 0.3 (0.2 to 0.3) (n=59) | 0.2 (0.1 to 0.4) (n=19) | 0.3 (0.2 to 0.4) (n=40) |
| ATE | 0.4 (0.3 to 0.5) (n=84) | 0.3 (0.2 to 0.5) (n=28) | 0.4 (0.3 to 0.5) (n=56) |
| MACE | 0.4 (0.3 to 0.5) (n=85) | 0.4 (0.3 to 0.6) (n=31) | 0.4 (0.3 to 0.5) (n=54) |
* Average dosing was based on average daily dose: patients receiving <15 mg/day were assigned to the tofacitinib 5 mg BID group; patients receiving ≥15 mg/day were assigned to the tofacitinib 10 mg BID group.
† Defined as requiring hospitalisation or parenteral antimicrobial therapy, or otherwise meeting SAE criteria.
‡Lymphoproliferative disorders/lymphoma. In total, 11/12 events were classified as non-Hodgkin lymphoma.
§Patients with a DVT event, a PE event, or both DVT and PE events. A total of five patients experienced a DVT and a PE event (may not have occurred at the same time).
IRs are presented as the unit of patients with events per 100 PY.
AE, adverse event; ATE, arterial thromboembolism; BID, twice daily; DVT, deep vein thrombosis; GI, gastrointestinal; HZ, herpes zoster; IR, incidence rate; MACE, major adverse cardiovascular events; N, number of patients in the treatment group; n, number of unique patients with event; NMSC, non-melanoma skin cancer; PE, pulmonary embolism; PY, patient-years; SAE, serious adverse event; TB, tuberculosis; VTE, venous thromboembolism.