New Data Supports the Safety Record of ENBREL(R) as a Continuous Therapy in Children and Adolescents With Juvenile Idiopathic Arthritis

Maidenhead, England (ots/PRNewswire) -

- Data Represents More than 800 Patient Years of Experience

Wyeth today 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.

To access further media information relating to this press
release, additional information on and future media announcements,
please log on to the media centre at http://www.wyeth.eu.

Notes to Editors

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.

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

For further information, please contact:
Wyeth:
Gill Markham, Communications - Europe, Middle East and Africa
Direct Tel: +44(0)1628-692536
Email: markhagl@wyeth.com
OgilvyHealthPR:
Karen Crum Christina Mavroleon
Tel: +44-207-108-6411 Tel: +44-207-108-6069
Email: karen.crum@ohpr.com Email: Christina.mavroleon@ohpr.com

ots Originaltext: Wyeth Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For further information, please contact: Wyeth: Gill Markham,
Communications - Europe, Middle East and Africa, Direct Tel:
+44(0)1628-692536, Email: markhagl@wyeth.com; OgilvyHealthPR: Karen
Crum, Tel: +44-207-108-6411, Email: karen.crum@ohpr.com; Christina
Mavroleon, Tel: +44-207-108-6069, Email: Christina.mavroleon@ohpr.com