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Table 2 Etanercept exposure and TEAEs by JIA category

From: Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis: 6-year efficacy and safety data from an open-label trial

  eoJIA
n = 60
ERA
n = 38
PsA
n = 29
Total
N = 127
Exposure, patient-years 245.6 158.9 119.9 524.4
TEAEs (excluding infections and injection site reactions), n (n/100PY) 244 (99.4) 151 (95.0) 90 (75.0) 485 (92.5)
Infections, n (n/100PY) 351 (142.9) 93 (58.5) 117 (97.5) 561 (107.0)
TEAEs causing withdrawal (excluding infections and injection site reactions), n (n/100PY) 5 (2.0) 8 (5.0) 0 13 (2.5)
Infections causing withdrawal, n (n/100PY) 2 (0.8) 0 1 (0.8) 3 (0.6)
Serious TEAEs, n (n/100PY) 11 (4.5) 17 (10.7) 4 (3.3) 32 (6.1)
Serious infections, n (n/100PY) 5 (2.0) 4 (2.5) 4 (3.3) 13 (2.5)
Opportunistic infectionsa, n (n/100PY) 0 1 (0.6) 1 (0.8) 2 (0.4)
Autoimmune disordersb, n (n/100PY) 4 (1.6) 4 (2.5) 2 (1.7) 10 (1.9)
Malignancies, n (n/100PY) 1 (0.4) 0 0 1 (0.2)
  1. aAll opportunistic infections were herpes zoster (recurrent or > 1 dermatome affected)
  2. bUveitis, n = 7; Crohn’s disease, n = 3
  3. cHodgkin lymphoma
  4. Abbreviations: 100PY, 100 patient-years; eoJIA, extended oligoarticular juvenile idiopathic arthritis; ERA, enthesitis-related arthritis; PsA, psoriatic arthritis; TEAE, treatment-emergent adverse event