Patients in phase III studies who experienced ALT elevations according to study exposure group and isoniazid usage
| >1×ULN n (%) | >3×ULN n (%) | >5×ULN n (%) | >10×ULN 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%) | 0 | 0 | 0 |
| 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%) | 0 | 0 |
| No isoniazid methotrexate (n=178) | 19 (10.7%) | 0 | 0 | 0 |
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.