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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 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)

  1. Abbreviations: AE adverse event, RP reference product, SAE serious adverse event, TEAE treatment-emergent adverse event