Overview of adverse events, deaths, liver enzyme elevations and antitocilizumab antibodies until week 52
| Add-on (N=277) | Switch (N=276) | |
|---|---|---|
| Total TCZ exposure | 247.3 | 237.8 |
| Adverse events (AE) | ||
| Total patients with ≥1 AE, % (n) | 83.0% (230) | 83.0% (229) |
| Total number of AEs | 1075 | 984 |
| Rate of AEs (per 100 PY; 95% CI) | 403.6 (379.9 to 428.5) | 384.20 (360.6 to 409.0) |
| ≥1 AE leading to treatment discontinuation, % (n) | 7.6 (21) | 6.5 (18) |
| ≥1 AE leading to dose modification or interruption, % (n) | 39.4 (109) | 31.2 (86) |
| ≥1 AE leading to withdrawal, % (n) | 6.9 (19) | 5.8 (16) |
| Serious adverse events (SAEs) | ||
| Total patients with ≥1 SAE, % (n) | 7.9% (22) | 9.8% (27) |
| Total number of SAEs | 30 | 43 |
| Rate of SAEs (per 100 PY; 95% CI) | 11.3 (7.6 to 16.1) | 16.8 (12.2 to 22.6) |
| Serious infections (SIs) | ||
| Total patients with ≥1 SI, % (n) | 3.6% (10) | 2.9% (8) |
| Total number of SIs | 12 | 14 |
| Rate of SIs (per 100 PY; 95% CI) | 4.5 (2.3 to 7.9) | 5.5 (3.0 to 9.2) |
| Total number of deaths | 2 | 2 |
| ALT elevations, % (n) | N*=244 | N*=242 |
| >ULN†-1.5×ULN | 27% (67) | 17% (41) |
| >1.5×ULN-3×ULN | 25% (60) | 14% (35) |
| >3×ULN-5×ULN | 8% (19) | 2% (6) |
| >5×ULN | 3% (8) | <1% (1) |
| AST elevations, % (n) | N*=257 | N*=249 |
| >ULN‡-1.5×ULN | 30% (78) | 17% (43) |
| >1.5×ULN-3×ULN | 16% (41) | 6% (16) |
| >3×ULN-5×ULN | 3% (7) | 1% (2) |
| >5×ULN | <1% (1) | 0 |
| Antitocilizumab antibodies postbaseline,§ % (n) | N=239 | N=223 |
| Detection of antidrug antibodies | 1.5% (4) | 2.2% (6) |
| Detection of neutralising antidrug antibodies | 0.7% (2) | 1.8% (5) |
*Number of patients with normal values at baseline.
†ULN=55 U/L for ALT.
‡ULN=40 U/L for AST.
§The cut-off for assay positivity was determined using baseline sera from ACT-RAY patients.
ALT, alanine aminotransferase (GPT); AST, aspartate aminotransferase (GOT); PY, patient-years; TCZ, tocilizumab; ULN, upper limit of normal.