Wyeth announced study results from last week's 15th Paediatric
Rheumatology European Congress (PRES) in London which highlight the safety
record of etanercept (ENBREL(R)) as a continuous therapy in children and
adolescents with juvenile idiopathic arthritis (JIA).(1)
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:
Rheumatoid arthritis
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.
Psoriatic arthritis
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.
Ankylosing spondylitis
Treatment of adults with severe active ankylosing spondylitis who have
had an inadequate response to conventional therapy.
Plaque psoriasis
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
About WYETH
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the
areas of women's health care, infectious disease, gastrointestinal health,
central nervous system, inflammation, transplantation, hemophilia, oncology,
vaccines and nutritional products.
Wyeth is one of the world's largest research-driven pharmaceutical and
health care products companies. It is a leader in the discovery, development,
manufacturing and marketing of pharmaceuticals, vaccines, biotechnology
products, nutritionals and non-prescription medicines that improve the
quality of life for people worldwide. The Company's major divisions include
Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal
Health.
wyeth.eu
References
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
Wyeth Pharmaceuticals
View drug information on Enbrel.
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