ABP 710/ABP 710 (N = 241) n (%) | RP/RP (N = 121) n (%) | RP/ABP 710 (N = 119) n (%) | |
---|---|---|---|
Any AE | 130 (53.9) | 69 (57.0) | 69 (58.0) |
Any grade ≥ 3 AE | 18 (7.5) | 7 (5.8) | 5 (4.2) |
Any TEAE | 48 (19.9) | 29 (24.0) | 26 (21.8) |
Any AE with outcome of death | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Any SAE | 15 (6.2) | 4 (3.3) | 1 (0.8) |
Any AE leading to infusion delay/not administered | 19 (7.9) | 11 (9.1) | 8 (6.7) |
Any TEAE leading to discontinuation of IP | 12 (5.0) | 4 (3.3) | 4 (3.4) |
Adverse events of interest | |||
Any AE of interest | 43 (17.8) | 19 (15.7) | 16 (13.4) |
Infusion reactions including hypersensitivity | 20 (8.3) | 12 (9.9) | 7 (5.9) |
Hepatotoxicity | 11 (4.6) | 4 (3.3) | 0 (0.0) |
Hematological reactions | 10 (4.1) | 6 (5.0) | 8 (6.7) |
Serious infections | 5 (2.1) | 1 (0.8) | 3 (2.5) |
Malignancies | 2 (0.8) | 0 (0.0) | 0 (0.0) |
Congestive heart failure | 1 (0.4) | 1 (0.8) | 0 (0.0) |
Opportunistic infections | 0 (0.0) | 1 (0.8) | 0 (0.0) |
Demyelinating disorders | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Hepatitis B reactivation | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Autoimmunity (systemic lupus erythematosus and sarcoid) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
TEAEs reported in ≥ 5% of patients in any treatment group,n(%) | |||
Upper respiratory tract infection | 23 (9.5) | 9 (7.4) | 14 (11.8) |
Rheumatoid arthritis | 23 (9.5) | 9 (7.4) | 7 (5.9) |
Nasopharyngitis | 13 (5.4) | 11 (9.1) | 8 (6.7) |
Bronchitis | 8 (3.3) | 6 (5.0) | 2 (1.7) |
Pharyngitis | 2 (0.8) | 2 (1.7) | 7 (5.9) |