Tofacitinib, an oral Janus kinase inhibitor, as monotherapy or with background methotrexate, in Japanese patients with rheumatoid arthritis: an open-label, long-term extension study

Table 4 Summary of tofacitinib exposure and incidence rates for safety events of special interest

	Tofacitinib	Tofacitinib	All tofacitinib
	5 mg BID	10 mg BID	All tofacitinib
	(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 MACE^a	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