Table 3

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 PY8171.3 PY14 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)
TB0.2 (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)
NMSC0.6 (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 cancer0.1 (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 perforations0.1 (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)
DVT0.2 (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)
PE0.1 (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)
ATE0.4 (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)
MACE0.4 (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.