Lovell DJ et al. – The acceptable safety profile of etanercept therapy was maintained for up to 8 years in this population of juvenile rheumatoid arthritis (JRA) patients. Improvements in the signs and symptoms of JRA were also maintained for up to 8 years. Methods
Study to evaluate the safety and efficacy of up to 8 yrs of etanercept treatment in pts with polyarticular-course JRA
Pts with JRA who previously participated in a randomized controlled trial (RCT) of etanercept were eligible to receive etanercept in a long-term open-label extension (OLE) trial
Safety end points included the incidences of serious SAEs, medically important infections (MIIs), and death /li>
Efficacy end points included the ACR Pediatric 30 (Pedi 30), Pedi 50, Pedi 70, Pedi 90, and Pedi 100 criteria for improvement
Results
84% of the RCT pts participated in the OLE, for a total of 318 patient-yrs of etanercept exposure
72% of pts entered the fourth year of continuous etanercept treatment, and 45% entered the eighth year
23% of those entering the RCT reported 39 SAEs
The overall rate of SAEs did not increase with long-term exposure to etanercept
The rate of MIIs remained low; 1 new MII was reported in pts with >=5 yrs of etanercept exposure
No cases of tuberculosis, opportunistic infections, malignancies, lymphomas, lupus, demyelinating disorders, or deaths were reported
An ACR Pedi 70 response or higher was achieved by 100% of pts with 8 yrs of data and by 61% of pts according to the last observation carried forward data
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