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Table 3 Safety assessment: adverse event (AE) reports

From: Long-term safety and effectiveness of etanercept in JIA: an 18-year experience from the BiKeR registry

  Etanercept, 5988PY Biologic-naïve, 3782PY RR (95% CI) p
E/E/100PY (95% CI) E/E/100PY (95% CI)
AE 2053/34.3 (32.8–35.8) 1345/35.6 (33.7–37.5) 1.0 (0.9–1.03) 0.3
SAE 226/3.8 (3.3–4.3) 52/1.4 (1.1–1.8) 2.8 (2.0–3.7) 0.0001*
Serious infection 54/0.9 (0.7–1.2) 8/0.2 (0.1–0.4) 4.3 (2.0–9.0) 0.0001*
Herpes zoster 24/0.4 (0.3–0.6) 4/0.1 (0.04–0.3) 3.8 (1.3–10.9) 0.01*
Neutropenia 4/0.07 (0.03–0.18) 2/0.05 (0.01–0.2) 1.3 (0.2–6.9) 0.8
MAS 2/0.03 (0.008–0.3) 1/0.03 (0.004–0.19) 1.3 (0.1–13.9) 0.9
High transaminases 97/1.6 (1.3–2.0) 175/4.6 (4.0–5.4) 0.4 (0.3–0.5) 0.0001*
IBD 19/0.3 (0.2–0.5) 1/0.03 (0.004–0.19) 12.0 (1.6–89.7) 0.015*
Uveitis 113/1.9 (1.6–2.3) 54/1.4 (1.1–1.9) 1.3 (0.96–1.8) 0.09
Psoriasis 4/0.07 (0.03–0.18) 1/0.03 (0.004–0.19) 2.5 (0.3–22.6) 0.4
Demyelination 1/0.02 (0.002–0.1) 0/n.a. n.a. n.a.
Depression 15/0.25 (0.2–0.4) 2/0.05 (0.01–0.2) 4.7 (1.1–20.7) 0.04*
Malignancy 3/0.05 (0.02–0.2) 2/0.05 (0.01–0.2) 1.0 (0.2–5.7) 0.95
Death 3/0.05 (0.02–0.2) 1/ 0.03 (0.004–0.19) 1.9 (0.2–18.2) 0.6
  1. PY patient-years, E event, E/100PY rate, CI confidence interval, RR risk ratio, SAE serious adverse event, MAS macrophage activation syndrome, IBD inflammatory bowel disease, n.a. not applicable
  2. By Wald’s test
  3. *p < 0.05