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Table 3 Treatment-emergent adverse events (TEAEs) through week 22

From: Comparative clinical efficacy and safety of the proposed biosimilar ABP 710 with infliximab reference product in patients with rheumatoid arthritis

 ABP 710 (N = 278)
n (%)
RP (N = 278)
n (%)
Any AE144 (51.8)138 (49.6)
Any grade ≥ 3 AE12 (4.3)14 (5.0)
Any TEAE54 (19.4)58 (20.9)
Any AE with outcome of death1 (0.4)1 (0.4)
Any SAE9 (3.2)14 (5.0)
Any AE leading to infusion delay/not administered30 (10.8)30 (10.8)
Any TEAE leading to discontinuation of IP16 (5.8)18 (6.5)
Adverse events of interest
 Any AE of interest39 (14.0)49 (17.6)
 Infusion reactions including hypersensitivity22 (7.9)37 (13.3)
 Hematological reaction11 (4.0)5 (1.8)
 Hepatotoxicity9 (3.2)9 (3.2)
 Serious infections2 (0.7)4 (1.4)
 Malignancies2 (0.7)2 (0.7)
 Congestive heart failure1 (0.4)0 (0.0)
 Opportunistic infections1 (0.4)2 (0.7)
 Demyelinating disorders0 (0.0)0 (0.0)
 Hepatitis B reactivation0 (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 infection17 (6.1)18 (6.5)
 Rheumatoid arthritis14 (5.0)11 (4.0)
 Nasopharyngitis12 (4.3)4 (1.4)
 Bronchitis9 (3.2)4 (1.4)
 Pharyngitis8 (2.9)3 (1.1)
  1. Abbreviations: AE adverse event, IP investigational product, RP reference product, SAE serious adverse event, TEAE treatment-related adverse event
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