Table 4

Treatment-emergent AEs in ROSE over 24 weeks*

Treatment-emergent eventsIVSCPooled IV+SC
Placebo (n=41)Rontalizumab (n=79)Placebo (n=38)Rontalizumab (n=77)Placebo (N=79)Rontalizumab (N=156)
AE33 (80.5%)68 (84.0%)35 (92.1%)60 (76.9%)68 (86.1%)128 (80.5%)
Grade ≥36 (14.6%)16 (19.8%)7 (18.4%)8 (10.3%)13 (16.5%)24 (15.1%)
Grade ≥404 (4.9)2 (5.3)2 (2.6)2 (2.5)6 (3.8)
SAE4 (9.8%)10 (12.3%)5 (13.2%)6 (7.7%)9 (11.4%)16 (10.1%)
Infection AEs20 (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 dosing1 (2.4%)8 (9.9%)5 (13.2%)8 (10.3%)6 (7.6%)16 (10.1%)
Infection SAEs1 (2.4)02 (5.3)1 (1.3)3 (3.8)1 (0.6)
SLE flares reported as SAEs1 (2.4%)6 (7.4%)04 (5.1%)1 (1.3%)10 (6.3%)
AE leading to discontinuation of study drug3 (7.3%)5 (6.2%)1 (2.6%)1 (1.3%)4 (5.1%)6 (3.8%)
Deaths000000
  • 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.