Safety summary
| Tocilizumab subcutaneous 162 mg/week (n=18) | Placebo (n=18) | |
| Patients with ≥1 AE | 14 (77.8) | 11 (61.1) |
| Events, n | 38 | 31 |
| Patients with ≥1 adverse drug reaction | 5 (27.8) | 3 (16.7) |
| Most frequent AEs by SOC* | ||
| Infections and infestations | 9 (50.0) | 6 (33.3) |
| Gastrointestinal disorders | 3 (16.7) | 5 (27.8) |
| Skin and subcutaneous tissue disorders | 6 (33.3) | 1 (5.6) |
| Eye disorders | 1 (5.6) | 2 (11.1) |
| Nervous system disorders | 2 (11.1) | 1 (5.6) |
| Respiratory, thoracic and mediastinal disorders | 0 | 3 (16.7) |
| Investigations | 0 | 2 (11.1) |
| Psychiatric disorders | 1 (5.6) | 1 (5.6) |
| Patients with ≥1 SAE | 1 (5.6) | 2 (11.1) |
| Events, n | 1 | 3 |
| SAEs by SOC | ||
| Eye disorders | 1 (5.6) | 1 (5.6) |
| Gastrointestinal disorders | 0 | 1 (5.6) |
| Vascular disorders | 0 | 1 (5.6) |
Data are n (%).
No injection site reactions, systemic injection reactions or deaths occurred during the study.
*AEs reported in >1 patient in either treatment group.
AE, adverse event; SAE, serious adverse event; SOC, system organ class.