Safety and efficacy of tofacitinib for up to 9.5 years in the treatment of rheumatoid arthritis: final results of a global, open-label, long-term extension study

Table 3 Summary of actions taken with tofacitinib and MTX during ALT or AST elevations ≥ 3× ULN

Patients with ≥ 3× ULN ALT or AST (N = 109), n (%)
Actions taken with MTX	Actions taken with tofacitinib
Actions taken with MTX	Continued tofacitinib (n = 40)	Permanently discontinued tofacitinib (n = 39)	Discontinued tofacitinib due to AEs^a (n = 2)	Temporarily discontinued tofacitinib and resumed same dose (n = 10)	Temporarily discontinued tofacitinib and resumed reduced dose^b (n = 7)	Reduced tofacitinib dose^b (n = 11)
Permanently discontinued MTX	4 (3.7)	14 (12.8)	1 (0.9)	1 (0.9)	0	2 (1.8)
Temporarily discontinued MTX	1 (0.9)	0	0	0	0	0
Reduced MTX dose	2 (1.8)	0	0	0	1 (0.9)	0
Continued MTX	20 (18.3)	11 (10.1)	0	4 (3.7)	4 (3.7)	2 (1.8)
Patients were not receiving MTX	13 (11.9)	14 (12.8)	1 (0.9)	5 (4.6)	2 (1.8)	7 (6.4)

AE adverse event, ALT alanine aminotransferase, AST aspartate aminotransferase, BID twice daily, MTX methotrexate, ULN upper limit of normal
^aAEs occurring prior to AST elevations
^bReduction in tofacitinib dose from 10 mg BID to 5 mg BID

ISSN: 1478-6362