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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