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Table 4 Adverse event reports

From: Experience with etanercept, tocilizumab and interleukin-1 inhibitors in systemic onset juvenile idiopathic arthritis patients from the BIKER registry

 

Etanercept

Tocilizumab

IL-1 inhibitors

n = 143; 355.8PY

Rate per patient year (95&CI)

n = 72; 111.6PY

Rate per patient year (95&CI)

Rate per patient year (95&CI)a

n = 60; 116.8PY

Rate per patient year (95&CI)

Rate per patient year (95&CI)a

AE

71

0.20 (0.16–0.25)

118

1.06 (0.88–1.27)

5.3 (3.9–7.1)

p < 0.0001

81

0.69 (0.56–0.86)

3.5 (2.5–4.7)

p > 0.05

SAE

18

0.05 (0.03–0.08)

14

0.13 (0.07–0.21)

2.5 (1.2–5.0)

p = 0.01

17

0.15 (0.07–0.21)

2.9 (1.5–5.6)

P = 0.002

JIA-Reactivation

4

0.01 (0.00–0.03)

7

0.06 (0.03–1.31)

5.6 (1.6–19.1)

p = 0.006

10

0.86 (0.05–0.16)

7.6 (2.4–24.3)

p = 0.0006

MAS

3

0.01 (0.00–0.03)

5

0.05/0.02–0.11)

5.3 (1.2–22.2)

p = 0.02

3

0.03 (0.01–0.08)

3.0 (0.6–15.1)

p > 0.05

hypersensitivity

5

0.01 (0.01–0.03)

4

0.04 (0.01–0.10)

2.6 (0.7–9.5)

p > 0.05

2

0.02 (0.00–0.07)

1.2 (0.2–6.3)

p > 0.05

infections

16

0.05 (0.03–0.08)

55

0.49 (0.38–0.64)

11.0 (6.3–19.1)

p < 0.0001

39

0.33 (0.24–0.46)

7.4 (4.1–13.3)

p < 0.0001

neutropenia

1

0.00 (0.00–0.02)

6

0.05 (0.02–0.12)

19.1 (2.3–158)

p = 0.006

1

0.01 (0.00–0.06)

3.0 (0.2–48.7)

p > 0.05

thrombocytopenia

1

0.00 (0.00–0.02)

1

0.01 (0.00–0.06)

3.2 (0.2–51)

p > 0.05

1

0.01 (0.00–0.06)

3.0 (0.2–48.7)

p > 0.05

elevated Transaminases

8

0.02 (0.01–0.45)

4

0.04 (0.01–0.10)

1.6 (0.5–5.3)

p > 0.05

1

0.01 (0.00–0.06)

0.4 (0.05–3.0)

p > 0.05

hair loss

4

0.01 (0.00–0.03)

2

0.02 (0.00–0.07)

1.6 (0.3–8.7)

p > 0.05

0

  

skin signs and symptoms

6

0.02 (0.01–0.03)

3

0.03 (0.01–0.08)

1.6 (0.4–6.4)

p > 0.05

0

  

neurol. signs and symptoms

3

0.01 (0.00–0.03)

11

0.10 (0.05–1.78)

11.7(3.3–42.0)

p = 0.0001

0

  
  1. AE adverse event, SAE serious AE, MAS macrophage activation syndrome
  2. aWald test compared to the etanercept cohort