Cumulative safety summary through Week 96a.
| eoJIA, n = 60, EXP = 103.603 | ERA, n = 38, EXP = 61.298 | PsA, n = 29, EXP = 50.185 | Overall, n = 127, EXP = 215.086 | |
|---|---|---|---|---|
| AEb | 136 (131.3) | 112 (182.7) | 52 (103.6) | 300 (139.5) |
| Infections | 219 (211.4) | 60 (97.9) | 76 (151.4) | 355 (165.1) |
| Infection site reactions | 22 (21.2) | 29 (47.3) | 12 (23.9) | 63 (29.3) |
| AE causing withdrawal, n (%)b | 0 | 3 (790) | 0 | 3 (240) |
| Infections causing withdrawal, n (%) | 1 (170) | 0 | 1 (340) | 2 (160) |
| Serious AEb | 2 (1.9) | 11 (17.9) | 3 (6.0) | 16 (7.4) |
| Serious infections | 4 (3.9) | 3 (4.9) | 3 (6.0) | 10 (4.6) |
| Opportunistic infectionsc | 0 | 1 (1.6) | 0 | 1 (0.5) |
| Infections considered preventable by vaccination in patients not previously vaccinated | 5 (4.8) | 1 (1.6) | 1 (2.0) | 7 (3.3) |
| Infections considered preventable by vaccination in patients previously vaccinated | 1 (1.0)d | 0 | 0 | 1 (0.5) |
| Autoimmune disorderse | 1 (1.0) | 2 (3.3) | 1 (2.0) | 4 (1.9) |
↵a All values are reported as no. events (events per 100 patient-yrs of EXP to ETN), unless otherwise stated.
↵b Excluding infections and injection site reactions.
↵c One case of herpes zoster affecting 2 dermatomes was considered an opportunistic infection and 1 case of latent tuberculosis (purified protein derivative conversion) was not considered an opportunistic infection. For the event of latent tuberculosis, which was not an active case of tuberculosis, ETN and MTX therapy were discontinued, isoniazid was initiated, ETN and MTX therapy were subsequently restarted, and the patient completed the 96-week study.
↵d One case of rubella.
↵e Two cases of uveitis (eoJIA and PsA categories), 1 case of iridocyclitis (a type of uveitis; ERA category), and 1 case of Crohn disease (ERA category) were treatment emergent. One case of Crohn’s disease (ERA category) was not considered treatment emergent based on missing last-dose data. AE: adverse event; eoJIA: extended oligoarthritis (in juvenile idiopathic arthritis); ERA: enthesitis-related arthritis; ETN: etanercept; EXP: exposure; MTX: methotrexate; PsA: psoriatic arthritis.