Table 2.

Incidence of treatment-emergent adverse events (TEAEs), and the most commonly reported TEAEs (occurring in ≥2 % of patients in any group) during the last 3 months of the double-blind phase 3 study [10] and the first 3 months of the open-label extension [13]

	ADA to tofacitinib		Tofacitinib to tofacitinib
	n = 107		n = 126
	−3 months to switch (ADA)	Switch to +3 months (tofacitinib)	−3 months to switch (tofacitinib)	Switch to +3 months (tofacitinib)
Safety summary
Number of patients (%)
DCs due to AEs	0	3 (2.8)	1 (0.8)	3 (2.4)
Serious AEs	1 (0.9)	8 (7.5)	4 (3.2)	8 (6.3)
Serious infections	0	2 (1.9)	1 (0.8)	2 (1.6)
Deaths	0	2 (1.9)a	0	0
Most commonly reported TEAEs
Number of patients (%)
Abdominal pain upper	0	1 (0.9)	4 (3.2)	1 (0.8)
Arthralgia	0	1 (0.9)	4 (3.2)	2 (1.6)
Bronchitis	4 (3.7)	3 (2.8)	6 (4.8)	2 (1.6)
Cough	0	1 (0.9)	1 (0.8)	3 (2.4)
Depression	0	1 (0.9)	3 (2.4)	1 (0.8)
Fall	1 (0.9)	1 (0.9)	3 (2.4)	1 (0.8)
Hemoglobin decreased	0	3 (2.8)	0	1 (0.8)
Headache	0	2 (1.9)	0	2 (1.6)
Nasopharyngitis	2 (1.9)	4 (3.7)	5 (4.0)	3 (2.4)
Nausea	1 (0.9)	3 (2.8)	1 (0.8)	1 (0.8)
Edema peripheral	1 (0.9)	0	2 (1.6)	3 (2.4)
Oropharyngeal pain	0	0	0	3 (2.4)
Upper respiratory tract infection	3 (2.8)	5 (4.7)	3 (2.4)	6 (4.8)
Urinary tract infection	0	5 (4.7)	2 (1.6)	0
Vomiting	0	2 (1.9)	1 (0.8)	0
Worsening RA	0	0	3 (2.4)	2 (1.6)

Includes patients who completed treatment with adalimumab (ADA) 40 mg every 2 weeks or tofacitinib 10 mg twice daily in the blinded study (or discontinued treatment for reasons other than a tofacitinib-related serious adverse event (AE)) and then enrolled in the extension study and switched treatment with minimal washout (≤2 weeks after their last dose of study drug in the blinded study). ^aOne patient committed suicide 1 day after the first tofacitinib dose in the extension study (it is unknown whether the patient took the study drug on this day). One patient died due to lung malignancy. DC discontinuation, RA rheumatoid arthritis