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 | |
Median PY of exposure | 3.1 | 1.4† | 4.0 |
AEs | 130.3 (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 AEs | 7.1 (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) |
SAEs | 9.0 (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.