Table 2

IRs (95% CI) of AEs and SAEs (all-cause)

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
Median PY of exposure3.11.4 4.0
AEs130.3
(127.0 to 133.6)
(n=6117)
129.7
(124.7 to 134.9)
(n=2484)
130.7
(126.5 to 135.0)
(n=3633)
Discontinuations due to AEs7.1 (6.8 to 7.5)
(n=1634)
8.0 (7.4 to 8.7)
(n=664)
6.6 (6.2 to 7.0)
(n=970)
SAEs9.0 (8.6 to 9.4)
(n=1857)
9.6 (8.9 to 10.3)
(n=717)
8.6 (8.1 to 9.1)
(n=1140)
Mortality 0.3 (0.2 to 0.3)
(n=59)
0.3 (0.2 to 0.5)
(n=29)
0.2 (0.1 to 0.3)
(n=30)
  • IRs are presented as the unit of patients with events per 100 PY.

  • * 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.

  • Exposure was lower than previously reported due to the addition of data from two studies using the tofacitinib 5 mg BID dose (protocols A3921187 and A3921237), which led to an increase in the proportion of patients having <1 year exposure in the average tofacitinib 5 mg BID group.

  • Within 28 days of last dose of study drug.

  • AE, adverse event; BID, twice daily; IR, incidence rate; N, number of patients in the treatment group; n, number of unique patients with event; PY, patient-years; SAE, serious adverse event.