- Oral presentation
- Open Access
7.5 Safety data from over 1,200 patients-years of methotrexate and/or etanercept treatment in children with polyarticular or systemic juvenile rheumatoid arthritis
Pediatric Rheumatologyvolume 6, Article number: S15 (2008)
Etanercept has approval for use in children with polyarticular juvenile rheumatoid arthritis (JRA). Here we evaluate the safety of etanercept in children with polyarticular or systemic JRA.
This 3-year, open-label, non-randomized registry included patients age 2–18, with a diagnosis of polyarticular or systemic JRA. Patients treated with methotrexate (MTX), etanercept (ETN), or methotrexate/etanercept in combination (MTX/ETN) were eligible. Co-administration of non-biologic DMARDs was allowed. MTX was administered at 0.3 to 1 mg/kg/wk and etanercept was administered at 0.4 mg/kg (max 25 mg) twice weekly or 0.8 mg/kg (max 50 mg) weekly.
602 patients enrolled; 198 received MTX, 105 received ETN, and 299 received MTX/ETN. A total of 33%, 31%, and 35% of patients have completed the 3-year registry for a total of 388, 210, and 610 subject-years of exposure for the MTX, ETN, and MTX/ETN groups, respectively. In the MTX, ETN, and MTX/ETN groups, 18%, 8%, and 19% discontinued due to insufficient therapeutic effect while 2%, 2%, and 0.3% discontinued due to adverse events. The rates of serious adverse events and medically important infections per 100 patient-years were 4.4, 7.6, 5.7 and 1.3, 1.9, and 2.1 for patients receiving MTX, ETN, or MTX/ETN. One case of lupus (MTX) and 2 cases of sepsis (ETN and MTX/ETN) were reported. No cases of lymphoma, malignancy, tuberculosis, or death were reported.
These data suggest etanercept is safe as a long-term, continuous therapy for treatment of JRA.
Funded by Immunex, a wholly-owned subsidiary of Amgen Inc., and by Wyeth Pharmaceutical.