Overview of adverse events, deaths and shift from normal at baseline to worst elevations in liver enzymes through the end of study
| Add-on (N=277) | Switch (N=276) | |
|---|---|---|
| Total TCZ exposure, PY | 433.34 | 431.24 |
| AEs | ||
| Total patients with ≥1 AE, % (n) | 89.5 (248) | 88.4 (244) |
| Total no. of AEs | 1762 | 1558 |
| Rate of AEs (95% CI), per 100 PY | 325.2 (310.2 to 340.7) | 302.5 (287.7 to 317.9) |
| ≥1 AE leading to discontinuation, % (n) | 10.1 (28) | 11.2 (31) |
| SAEs | ||
| Total patients with ≥1 SAE, % (n) | 17.7 (49) | 17.4 (48) |
| Total no. of SAEs | 66 | 77 |
| Rate of SAEs (95% CI), per 100 PY | 12.2 (9.4 to 15.5) | 15.0 (11.8 to 18.7) |
| SIs | ||
| Total patients with ≥1 SI, % (n) | 6.9 (19) | 4.7 (13) |
| Total no. of SIs | 24 | 19 |
| Rate of SIs (95% CI), per 100 PY | 4.4 (2.8 to 6.6) | 3.7 (2.2 to 5.8) |
| Total no. of deaths | 4 | 6 |
| ALT elevations, % (n) | N*=244 | N*=242 |
| >ULN†–1.5×ULN | 27.5 (67) | 24.4 (59) |
| >1.5×ULN–3×ULN | 30.3 (74) | 17.4 (42) |
| >3×ULN–5×ULN | 10.2 (25) | 4.1 (10) |
| >5×ULN | 4.1 (10) | 1.2 (3) |
| AST elevations, % (n) | N*=257 | N*=249 |
| >ULN‡–1.5×ULN | 32.6 (84) | 22.1 (55) |
| >1.5×ULN–3×ULN | 20.2 (52) | 7.6 (19) |
| >3×ULN–5×ULN | 3.9 (10) | 1.6 (4) |
| >5×ULN | 1.2 (3) | 0.4 (1) |
*Number of patients with normal values at baseline.
†ULN=55 U/L.
‡ULN=40 U/L.
AE, adverse event; ALT, alanine aminotransferase; AST; aspartate aminotransferase; ITT, intent-to-treat population; PY, patient-years; SAE, serious adverse event; SI, serious infection; TCZ, tocilizumab; ULN, upper limit of normal.