Treatment-emergent AEs in ROSE over 24 weeks*
| Treatment-emergent events | IV | SC | Pooled IV+SC | |||
|---|---|---|---|---|---|---|
| Placebo (n=41) | Rontalizumab (n=79) | Placebo (n=38) | Rontalizumab (n=77) | Placebo (N=79) | Rontalizumab (N=156) | |
| AE | 33 (80.5%) | 68 (84.0%) | 35 (92.1%) | 60 (76.9%) | 68 (86.1%) | 128 (80.5%) |
| Grade ≥3 | 6 (14.6%) | 16 (19.8%) | 7 (18.4%) | 8 (10.3%) | 13 (16.5%) | 24 (15.1%) |
| Grade ≥4 | 0 | 4 (4.9) | 2 (5.3) | 2 (2.6) | 2 (2.5) | 6 (3.8) |
| SAE | 4 (9.8%) | 10 (12.3%) | 5 (13.2%) | 6 (7.7%) | 9 (11.4%) | 16 (10.1%) |
| Infection AEs | 20 (48.8%) | 43 (53.1%) | 24 (63.2%) | 47 (60.3%) | 44 (55.7%) | 90 (56.6%) |
| AEs within 24 h of dose administration† | 3 (7.3%) | 12 (14.8%) | 12 (31.6%) | 12 (15.4%) | 15 (19.0%) | 24 (15.1%) |
| ≥1 study drug-related AEs within 24 h of dosing | 1 (2.4%) | 8 (9.9%) | 5 (13.2%) | 8 (10.3%) | 6 (7.6%) | 16 (10.1%) |
| Infection SAEs | 1 (2.4) | 0 | 2 (5.3) | 1 (1.3) | 3 (3.8) | 1 (0.6) |
| SLE flares reported as SAEs | 1 (2.4%) | 6 (7.4%) | 0 | 4 (5.1%) | 1 (1.3%) | 10 (6.3%) |
| AE leading to discontinuation of study drug | 3 (7.3%) | 5 (6.2%) | 1 (2.6%) | 1 (1.3%) | 4 (5.1%) | 6 (3.8%) |
| Deaths | 0 | 0 | 0 | 0 | 0 | 0 |
Note: Multiple occurrences of a specific AE for a patient were counted once.
*Values are number and (%) of patients who experienced at least one an AE in each category over 24 weeks of study.
†Includes AEs that were infusion or injection site reactions.
AE, adverse event; IV, intravenous; ROSE, Rontalizumab in Systemic Lupus Erythematosus; SAE, serious adverse event; SC, subcutaneous; SLE, systemic lupus erythematosus.