| |
Tofacitinib
|
Tofacitinib
|
All tofacitinib
|
|---|
|
5 mg BID
|
10 mg BID
|
|---|
|
(N = 381)
|
(N = 105)
|
(N = 486)
|
|---|
|
Exposure, patient-years
|
1111.7
|
328.2
|
1439.9
|
|
Patients with events per 100 patient-years (95 % CI)
|
|
Adverse events
|
307.5 (277.0, 340.4)
|
311.8 (255.0, 377.5)
|
308.4 (281.3, 337.4)
|
|
Serious adverse events
|
11.2 (9.2, 13.5)
|
9.2 (6.1, 13.3)
|
10.7 (9.0, 12.6)
|
|
Serious infections
|
3.2 (2.2, 4.5)
|
3.7 (1.9, 6.4)
|
3.3 (2.4, 4.4)
|
|
Herpes zoster (serious and non-serious)
|
7.1 (5.5, 8.9)
|
8.6 (5.6, 12.7)
|
7.4 (6.0, 9.1)
|
|
Serious herpes zoster
|
1.0 (0.5, 1.8)
|
0.9 (0.2, 2.7)
|
1.0 (0.5, 1.6)
|
|
Composite MACEa
|
0.4 (0.1, 1.0)
|
0.3 (0.0, 1.7)
|
0.4 (0.1, 0.9)
|
|
Gastrointestinal perforations
|
0 (0.0, 0.3)
|
0 (0.0, 1.1)
|
0 (0.0, 0.3)
|
|
All malignancy excluding NMSC
|
1.4 (0.8, 2.3)
|
0.3 (0.0, 1.7)
|
1.2 (0.7, 1.9)
|
|
Mortality
|
0.6 (0.3, 1.3)
|
0.0 (0.0, 1.1)
|
0.5 (0.2, 1.0)
|
-
aTotal exposure per group is less than for other safety events as composite major adverse cardiovascular event (MACE) adjudication applies only to data collected after 25 February 2009. Exposure was 1056.1, 325.0, and 1381.1 patient-years for tofacitinib 5 mg twice daily (BID), tofacitinib 10 mg BID and all tofacitinib, respectively
-
NMSC non-melanoma skin cancer
