Fig. 4.

Proportion of patients with ALT and AST ≥ 1, ≥ 2, ≥ 3, ≥ 5, and ≥ 10× ULN by month 3, by treatment group and background MTX dose. (a) ALT (tofacitinib 5 mg BID), (b) ALT (tofacitinib 10 mg BID), (c) ALT (placebo), (d) AST (tofacitinib 5 mg BID), (e) AST (tofacitinib 10 mg BID), and (f) AST (placebo) by month 3. The analysis included all patients who received MTX as background therapy on day 1 in the safety analysis set. Eight patients who used both MTX and other csDMARDs on day 1 were excluded, as were two patients who exceeded the protocol-defined maximum dose of MTX for the analysis (20 mg/week), and one patient without dosing frequency to calculate the dose. ALT, alanine aminotransferase; AST, aspartate aminotransferase; BID, twice daily; csDMARD, conventional synthetic disease-modifying anti-rheumatic drug; MTX, methotrexate or methotrexate sodium; N, number of patients evaluable for changes from baseline in ALT or AST at each visit; ULN, upper limit of normal