Table 2.
Etanercept exposure and TEAEs by JIA category
| 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) |
aAll opportunistic infections were herpes zoster (recurrent or > 1 dermatome affected)
bUveitis, n = 7; Crohn’s disease, n = 3
cHodgkin lymphoma
Abbreviations: 100PY, 100 patient-years; eoJIA, extended oligoarticular juvenile idiopathic arthritis; ERA, enthesitis-related arthritis; PsA, psoriatic arthritis; TEAE, treatment-emergent adverse event