Safety summary (safety population)
| Tocilizumab-SC 162 mg qw (n=631) 289.82 PY | Tocilizumab-IV 8 mg/kg q4w (n=631) 288.39 PY | |
|---|---|---|
| AE | ||
| Total AE, n | 1747 | 1697 |
| Patients with ≥1 AE, n (%) | 481 (76.2) | 486 (77.0) |
| Discontinuation due to AE, n (%) | 30 (4.8) | 42 (6.7) |
| SAE | ||
| Total SAE, n | 34 | 43 |
| Patients with ≥1 SAE, n (%) | 29 (4.6) | 33 (5.2) |
| SAE per 100 PY (95% CI) | 11.73 (8.12 to 16.39) | 14.91 (10.79 to 20.08) |
| SI | ||
| Total SI | 9 | 9 |
| Patients with ≥1 SI, n (%) | 9 (1.4) | 9 (1.4) |
| SI per 100 PY (95% CI) | 3.11 (1.25 to 5.89) | 3.47 (1.66 to 6.38) |
| Serious hypersensitivity reactions*, n (%) | 2 (<1) | 3† (<1) |
| ISR | ||
| Patients with ISR, n (%) | 64 (10.1) | 15 (2.4) |
| ISR, n | 168 | 94 |
| Erythema, n (%) | 28 (4.4) | 5 (0.8) |
| Pain, n (%) | 12 (1.9) | 5 (0.8) |
| Pruritus, n (%) | 14 (2.2) | 0 (0) |
| Haematoma, n (%) | 5 (0.8) | 5 (0.8) |
| Dose interruption or study withdrawal because of ISR, n | 0 | 0 |
| Death, n (%) | 0 (0) | 1 (<1) |
*Serious hypersensitivity was defined as an SAE occurring during or within 24 h of the injection or infusion, excluding ISR, and evaluated as ‘related’ to study treatment by the investigator.
†Of the three events in the tocilizumab-IV group, one was cellulitis and one was retinal artery occlusion; these two events were not considered consistent with a serious hypersensitivity reaction.
AE, adverse event; ISR, injection-site reaction; IV, intravenous; PY, patient-years; qw, every week; q4w, every 4 weeks; SAE, serious adverse event; SC, subcutaneous; SI, serious infection.