Table 3

Patients in phase III studies who experienced ALT elevations according to study exposure group and isoniazid usage 

n (%)
n (%)
n (%)
n (%)
Isoniazid/tofacitinib* (n=263)58 (22.1%)4 (1.5%)1 (0.4%)0
No isoniazid/tofacitinib* (n=3614)550 (15.2%)35 (1.0%)7 (0.2%)2 (<0.1%)
Isoniazid/adalimumab (n=15)3 (20%)000
No isoniazid/adalimumab (n=189)24 (12.7%)2 (1.1%)1 (0.5%)0
Isoniazid/methotrexate (n=8)3 (37.5%)1 (12.5%)00
No isoniazid methotrexate (n=178)19 (10.7%)000
  • In phase III trials, patients diagnosed with LTBI were allowed trial entry 1 month after starting isoniazid therapy.

  • *Includes patients who were randomised to tofacitinib at study start and those randomised to placebo who later took tofacitinib during their isoniazid treatment course.

  • ALT, alanine aminotransferase; LTBI, latent tuberculosis infection; ULN, upper limit of normal.