Overview of adverse events, deaths, and liver enzyme elevations* until week 24
| TCZ+MTX | TCZ+PBO | |
|---|---|---|
| N=277 | N=276 | |
| Total tocilizumab exposure (PY) | 118.31 | 116.40 |
| AE | ||
| Total patients with ≥1 AE, % (n) | 70.0% (194) | 72.5% (200) |
| Total no of AE | 581 | 544 |
| Rate of AE (per 100 PY) | 491 | 467 |
| Serious AE | ||
| Total patients with ≥1 serious AE, % (n) | 6.1% (17) | 5.8% (16) |
| Total no of serious AE | 25 | 21 |
| Rate of serious AE (per 100 PY) | 21 | 18 |
| Serious infections | ||
| Total patients with ≥1 serious infections, % (n) | 2.2% (6) | 2.2% (6) |
| Total no of serious infections | 7 | 7 |
| Rate of serious infections (per 100 PY) | 6 | 6 |
| Total no of deaths | 1† | 2 |
| ALT elevations, % (n‡) | N§=244 | N§=243 |
| >ULN–1.5 × ULN | 25.8% (63) | 16.5% (40) |
| >1.5–3 × ULN | 15.2% (37) | 9.9% (24) |
| >3–5 × ULN | 5.7% (14) | 0.8% (2) |
| >5 × ULN | 2.0% (5) | 0.4% (1) |
| AST elevations, % (n‡) | N§=257 | N§=250 |
| >ULN–1.5 × ULN | 21.8% (56) | 14.8% (37) |
| >1.5–3 × ULN | 10.5% (27) | 4.0% (10) |
| >3–5 × ULN | 1.9% (5) | 0.4% (1) |
| >5 × ULN | 0.0% (0) | 0.0% (0) |
↵* Cumulative incidences weeks 1–24, excluding patients with elevations at baseline. Data including non-fasting samples.
↵† An additional patient in this group had an adverse event leading to death but died only after the 24-week cut-off.
‡ Number of patient with a normal baseline and the highest value in the first 24 weeks within the indicated range. ULN=55 U/l for ALT and 40 U/l for AST.
↵§ Number of patients with normal value at baseline.
AE, adverse event; ALT, alanine aminotransferase (glutamate pyruvate transaminase); AST, aspartate aminotransferase (glutamate oxaloacetate transaminase); MTX, methotrexate; PBO, placebo; PY, patient years; TCZ, tocilizumab; ULN, upper limit of normal.