The study was designed to evaluate the safety of ENBREL in children with polyarticular or systemic JIA. This 3-year, open-label, non-randomised registry included patients between the ages of 2-18, and is an analysis of more than 800 years of ENBREL patient data. ENBREL has an established safety profile in patients with JIA as young as 4 years of age who have had an inadequate response to, or who have proved intolerant to methotrexate. These new results add to the body of evidence supporting the use of ENBRELas long-term, continuous therapy for the treatment of JIA.(1)
JIA is an autoimmune system disease that strikes children from 3 to 16 years age and can cause painful joint swelling, deformity, stunted growth and increased mortality. JIA affects approximately 6 in 10,000 children and adolescents.
Prof Pat Woo, PRES Congress President & Consultant at London's Great Ormond Street Hospital for Sick Children, commenting on the results, noted: "Unless JIA is effectively managed, these children are at risk of delayed development and the possibility of pain and disability during their adult life. When ENBREL was approved in 2000, it helped change significantly the outcome of the disease in many children. ENBREL is an effective treatment option for this debilitating condition, and this new study further supports its use as the most widely (prescribed) anti-TNF with a proven safety track record."
Key study findings and overview:(1)
- Patients were 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 ETN 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, ENT, and MTX/ENT 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 ETN/MTX) were reported. No cases of lymphoma, malignancy, tuberculosis, or death were reported.
About ENBREL (2)
ENBREL is a fully human soluble tumour necrosis factor (TNF) receptor antagonist. ENBREL was first approved in 1998 for moderate to rheumatoid arthritis and has since been used in nearly 500,000 patients worldwide across indications.
ENBREL in the EU is approved for the following indications:
ENBREL in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. ENBREL can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. ENBREL is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. ENBREL, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Polyarticular juvenile idiopathic arthritis
Treatment of active polyarticular juvenile idiopathic arthritis in children and adolescents aged 4 to 17 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. ENBREL has not been studied in children aged less than 4 years.
Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. ENBREL has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA
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1. Giannini et al. Safety data from over 1,200 patients-years of methotrexate and/or etanercept treatment in children with polyarticular or systemic juvenile rheumatoid arthritis. PRES Congress 2008
2. Enbrel EMEA SPC