Efficacy and safety of tofacitinib for treatment of rheumatoid arthritis

Table 4 Summary of safety and tolerability data for tofacitinib from phase 3 clinical trials (final safety analysis) n (%)

	1ORAL solo				1ORAL step				2ORAL standard					2ORAL sync				2ORAL scan				4ORAL start
	Tofacit-inib 5 mg bid (after Placebo)(n = 61)	Tofacit-inib 10 mg bid (after Placebo)(n =61)	Tofacit-inib 5 mg bid(n = 243)	Tofaci-tinib 10 mg bid(n = 245)	Tofacit-inib 5 mg bid (after Placebo)(n = 66)	Tofacit-inib 10 mg bid (after Placebo)(n = 66)	Tofacit-inib 5 mg bid(n = 133)	Tofacit-inib 10 mg bid(n = 134)	Tofacit-inib 5 mg bid (after Placebo )(n = 56)	Tofacitinib 10 mg bid (after Placebo)(n = 52)	Tofacit-inib 5 mg bid(n = 204)	Tofacit-inib 10 mg bid(n = 201)	Adalim-umab 40 mg once Q2W(n = 204)	Tofacit-inib 5 mg bid (after Placebo)(n = 79)	Tofacit-inib 10mg bid (after Placebo)(n = 80)	Tofacit-inib 5 mg bid(n = 315)	Tofacit-inib 10 mg bid(n = 318)	Tofacit-inib 5 mg bid (after Placebo)(n = 81)	Tofacit-inib 10 mg bid (after Placebo)(n = 79)	Tofacit-inib 5 mg bid(n = 321)	Tofacit-inib 10 mg bid(n = 316)	Tofacit-inib 5 mg bid(n = 371)	Tofacit-inib 10 mg bid(n =395)	MTX(n = 186)
Patients with AE	22 (36.1)	24 (39.3)	97 (39.9)	101 (41.2)	24 (36.4)	28 (42.4)	57 (42.9)	58 (43.3)	18 (32.1)	21 (40.4)	89 (43.6)	84 (41.8)	83 (40.7)	34 (43)	29 (36.3)	104 (33)	135 (42.5)	34 (42)	35 (44.3)	166 (51.7)	174 (55.1)	(70.1)5	(74.4)5	(69.9)5
Patients with SAE	1 (1.6)	0	5 (2.1)	6 (2.4)	3 (4.5)	2 (3)	5 (3.8)	6 (4.5)	1 (1.8)	4 (7.7)	10 (4.9)	6 (3)	7 (3.4)	2 (2.5)	0	7 (2.2)	9 (2.8)	1 (1.2)	4 (5.1)	13 (4)	9 (2.8)	(6.5)5	(6.1)5	(7.0)5
Discon- tinuation due to AE	0	0	1 (0.4)	3 (1.2)	1 (1.5)	2 (3)	4 (3)	7 (5.2)	0	2 (3.8)	6 (2.9)	3 (1.5)	4 (2)	0	1 (1.3)	1 (0.3)	9 (2.8)	2 (2.5)	2 (2.5)	9 (2.8)	7 (2.2)	13 (3.5)	17 (4.3)	11 (5.9)
Deaths	0	0	0	1 (0.4)	0	1 (1.5)	0	0	0	0	1 (0.5)	0	1 (0.5)	0	0	2 (0.6)	2 (0.6)	1 (1.2)	0	2 (0.6)	1 (0.3)	See note	See note	0
Patients with serious infection events	1 (1.6)	0	1 (0.4)	3 (1.2)	1 (1.5)	0	2 (1.5)	2 (1.5)	2 (3.6)	0	7 (3.4)	8 (4)	3 (1.5)	0	0	2 (0.6)	7 (2.2)	1 (1.2)	2 (2.5)	11 (3.4)	5 (1.6)	(31.8)6	(38.7)6	(27.4)6
Pulm- onary Tube- rculosis	0	0	0	0	0	0	0	0	0	0	0	2 (1)	0	0	0	0	2 (0.6)	0	0	0	0	0	0	0
3Oppor- tunistic infections	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1 (0.3)	1 (0.3)	0	0	3 (0.9)	4 (1.3)	8 (2.2)	11 (2.8)	3 (1.6)
Malign- ancies	0	0	0	0	0	0	0	0	NR	NR	NR	NR	NR	NR	NR	NR	NR	0	0	5 (1.6)	4 (1.3)	NR	NR	NR

AE: Adverse events; SAE: Serious adverse events; Q2W: Every 2 wk; NR: Not reported. ¹3-6 mo data point; ²6-12 mo data point;

³Excludes pulmonary tuberculosis; ⁴0-12 mo data point;

⁵data reported as total number of events;

⁶All infections and infestations; serious infection events, pulmonary tuberculosis, opportunistic infections, and malignancies reported for all trial data.