Skip to main content

Table 3 Safety

From: Outcome of children with oligoarticular juvenile idiopathic arthritis compared to polyarthritis on methotrexate- data of the German BIKER registry

  persistent oligoJIA   extended oligoJIA   RF negative PA  
n = 370
738.01 PY
Rate per 100 patient years (95%-CI) n = 221
753.54 PY
Rate per 100 patient years (95%-CI) n = 467
1129.63 PY
Rate per 100 patient years (95%-CI)
AE, total number 194 26.2(22.8–30.2) 247 32.7(28.9–37.1) 541 47.8(44.0–52.1)
infections, total number 26 3.5(2.4–5.2) 60 7.9(6.1–10.2) 143 12.6(10.7–14)
SAE infections 2 0.3(0.07–1.9) 1 0.1(0.02–0.9) 3 0.3(0.09–0.8)
JIA-Reactivation 3 0.4(0.1–1.2) 6 0.7(0.3–1.7) 8 0.7(0.3–1.4)
neutropenia 3 0.4(0.1–1.2) 0   3 0.2(0.08–0.8)
thrombocytopenia 0   0   0  
elevated transaminases 37 5.0(3.6–6.9) 38 5.0 (3.6–6.9) 68 6.0(4.7–7.6)
hair loss 1 0.1(0.01–0.96) 1 0.1(0.01–0.9) 6 0.5(0.2–1.1)
uveitis 16 2.2(1.2–3.5) 15 2.0(1.1–3.3) 4 0.3(0.1–0.9)
  1. AE adverse event, SAE serious AE, MAS macrophage activation syndrome, PY patient years
  2. The Wald test was used for comparison