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Table 3 Treatment-related adverse events reported in at least 1 % of total patients

From: A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study

 

CT-P13 (n = 302)

RP (n = 300)

Total CT-P13 + RP (n = 602)

Infusion-related reaction

30 (9.9)

43 (14.3)

73 (12.1)

Latent TB

22 (7.3)

20 (6.7)

42 (7.0)

Upper respiratory tract infection

23 (7.6)

14 (4.7)

37 (6.1)

Abnormal liver function test

22 (7.3)

14 (4.7)

36 (6.0)

Urinary tract infection

9 (3.0)

11 (3.7)

20 (3.3)

Lower respiratory tract infection

10 (3.3)

9 (3.0)

19 (3.2)

Flare in RA activity

7 (2.3)

5 (1.7)

12 (2.0)

Herpes virus infection

3 (1.0)

7 (2.3)

10 (1.7)

Anemia

4 (1.3)

5 (1.7)

9 (1.5)

Headache

4 (1.3)

5 (1.7)

9 (1.5)

Rash

2 (0.7)

4 (1.3)

6 (1.0)

Pyrexia

1 (0.3)

5 (1.7)

6 (1.0)

  1. RA rheumatoid arthritis, RP reference product (i.e. reference infliximab), TB tuberculosis
  2. Data are presented as count (percentage)