Table 3 Treatment-emergent adverse events (TEAEs) through week 22
ABP 710 (N = 278) n (%) | RP (N = 278) n (%) | |
|---|---|---|
Any AE | 144 (51.8) | 138 (49.6) |
Any grade ≥ 3 AE | 12 (4.3) | 14 (5.0) |
Any TEAE | 54 (19.4) | 58 (20.9) |
Any AE with outcome of death | 1 (0.4) | 1 (0.4) |
Any SAE | 9 (3.2) | 14 (5.0) |
Any AE leading to infusion delay/not administered | 30 (10.8) | 30 (10.8) |
Any TEAE leading to discontinuation of IP | 16 (5.8) | 18 (6.5) |
Adverse events of interest | ||
Any AE of interest | 39 (14.0) | 49 (17.6) |
Infusion reactions including hypersensitivity | 22 (7.9) | 37 (13.3) |
Hematological reaction | 11 (4.0) | 5 (1.8) |
Hepatotoxicity | 9 (3.2) | 9 (3.2) |
Serious infections | 2 (0.7) | 4 (1.4) |
Malignancies | 2 (0.7) | 2 (0.7) |
Congestive heart failure | 1 (0.4) | 0 (0.0) |
Opportunistic infections | 1 (0.4) | 2 (0.7) |
Demyelinating disorders | 0 (0.0) | 0 (0.0) |
Hepatitis B reactivation | 0 (0.0) | 0 (0.0) |
Autoimmunity (systemic lupus erythematosus and sarcoid) | 0 (0.0) | 1 (0.4) |
TEAEs reported in ≥ 5% of patients in any treatment group,n(%) | ||
Upper respiratory tract infection | 17 (6.1) | 18 (6.5) |
Rheumatoid arthritis | 14 (5.0) | 11 (4.0) |
Nasopharyngitis | 12 (4.3) | 4 (1.4) |
Bronchitis | 9 (3.2) | 4 (1.4) |
Pharyngitis | 8 (2.9) | 3 (1.1) |