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Table 4 TEAEs post 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/ABP 710 (N = 241)
n (%)
RP/RP (N = 121)
n (%)
RP/ABP 710 (N = 119)
n (%)
Any AE130 (53.9)69 (57.0)69 (58.0)
Any grade ≥ 3 AE18 (7.5)7 (5.8)5 (4.2)
Any TEAE48 (19.9)29 (24.0)26 (21.8)
Any AE with outcome of death0 (0.0)0 (0.0)0 (0.0)
Any SAE15 (6.2)4 (3.3)1 (0.8)
Any AE leading to infusion delay/not administered19 (7.9)11 (9.1)8 (6.7)
Any TEAE leading to discontinuation of IP12 (5.0)4 (3.3)4 (3.4)
Adverse events of interest
 Any AE of interest43 (17.8)19 (15.7)16 (13.4)
 Infusion reactions including hypersensitivity20 (8.3)12 (9.9)7 (5.9)
 Hepatotoxicity11 (4.6)4 (3.3)0 (0.0)
 Hematological reactions10 (4.1)6 (5.0)8 (6.7)
 Serious infections5 (2.1)1 (0.8)3 (2.5)
 Malignancies2 (0.8)0 (0.0)0 (0.0)
 Congestive heart failure1 (0.4)1 (0.8)0 (0.0)
 Opportunistic infections0 (0.0)1 (0.8)0 (0.0)
 Demyelinating disorders0 (0.0)0 (0.0)0 (0.0)
 Hepatitis B reactivation0 (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 infection23 (9.5)9 (7.4)14 (11.8)
 Rheumatoid arthritis23 (9.5)9 (7.4)7 (5.9)
 Nasopharyngitis13 (5.4)11 (9.1)8 (6.7)
 Bronchitis8 (3.3)6 (5.0)2 (1.7)
 Pharyngitis2 (0.8)2 (1.7)7 (5.9)
  1. Abbreviations: AE adverse event, RP reference product, SAE serious adverse event, TEAE treatment-emergent adverse event