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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
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Pediatric Rheumatology

ISSN: 1546-0096