New Data From the PRESTA Trial Demonstrate the Benefit of Enbrel(R) in Patients With Psoriasis and Psoriatic Arthritis

Maidenhead, England (ots/PRNewswire) -

- Data Presented at the 18th EADV Congress add to the
Comprehensive Long-Term Data set as Enbrel Reaches Five-Year
Anniversary in Treating Patients With Plaque Psoriasis in Europe

Data signalling that Enbrel(R) (etanercept) can improve the
quality of life for people with psoriasis and psoriatic arthritis
were presented at the 18th Congress of the European Academy of
Dermatology and Venereology (EADV), as Enbrel(R) (etanercept) reached
its five-year anniversary since its approval in Europe as a treatment
for psoriasis.

People with psoriasis - a distressing skin condition
characterised by red scaly patches - can often feel stigmatised as a
result of their condition. They may feel anxious or depressed and
some people with psoriasis experience a very low quality of life
similar to, or even worse than, those individuals with other chronic
medical diseases.(1)

Recent results from the PRESTA study, one of the most extensive
trials to evaluate patients with psoriatic arthritis, were presented
at the EADV congress. These data focused on aspects of quality of
life and improvement in potentially debilitating features such as
dactylitis (inflammation of fingers and toes) and enthesitis
(inflammation where bone meets ligament).

Data from the PRESTA study show that before starting Enbrel
therapy, patients with both psoriasis and psoriatic arthritis had
poor quality of life. A total of 95 per cent reported pain or
discomfort, 71 per cent reported problems with mobility and 68 per
cent reported problems conducting usual activities. Patients then
took either 50mg Enbrel once (QW) or twice weekly (BiW) for 12 weeks,
after which all patients took 50mg Enbrel once weekly for an
additional 12 weeks. Improvement in quality of life for both groups
was seen after the first three weeks on Enbrel, with a 36 per cent
improvement achieved after 24 weeks of treatment. At that point, the
proportion of patients reporting no pain or discomfort had increased
by 35 per cent, patients reporting no problem with mobility had
increased by 41 per cent and those reporting no problem conducting
usual activities had increased by 37 per cent.(2)

Between six and 42 per cent of people with psoriasis also suffer
from psoriatic arthritis,(3) a debilitating condition that can cause
pain, swelling and stiffness in the hands and feet, larger joints
such as the hips and knees, or the spine.(4)

"Severe psoriasis can be 'unsightly' and the painful arthritic
symptoms of psoriatic arthritis are physically disabling, often
stopping us from carrying out day-to-day activities. However, it is
important to remember that psoriasis is more than a skin and joint
disease, which also affects patients psychologically as well as
physically," said Birgitte Snedker-Sørensen, psoriatic arthritis
patient and Danmarks Psoriasis Forening representative. "The impact
of these conditions can often make us feel embarrassed, depressed or
anxious and withdraw from social interactions.

The PRESTA study also demonstrated that those patients receiving
Enbrel showed a significant decrease in enthesitis and dactylitis at
both 12 and 24 weeks:(5)

- Of the patients presenting with enthesitis*, 66 per cent in
the Enbrel BiW/QW and 65 per cent in the Enbrel QW/QW groups had no
enthesitis at 12 weeks, and
- 75 per cent and 76 per cent respectively achieved this response
at week 24
- The mean total Dermatology Life Quality Index (DLQI) score in
patients with enthesitis was more than halved at weeks 12 and 24 in
both the Enbrel BiW/QW and QW/QW groups, reflecting a change in mean
DLQI score from a very large effect on patient's life to a small effect
On patient's life (13.4/12.6 at week 0 in the Enbrel BiW/QW groups to
4.6/5.5 at 12 weeks and 4.0/3.6 at 24 weeks respectively)
- Of the patients presenting with dactylitis, at week 12, the
dactylitis mean per cent improvement from baseline was 74.3 per cent in
the Enbrel BiW/QW and 68.8 per cent in the Enbrel QW/QW, and
- At week 24, the dactylitis mean per cent improvement from
baseline was 82.2 per cent in the Enbrel BiW/QW and 76.6 per cent in
the Enbrel QW/QW

* 41 per cent of patients in the Enbrel BiW/QW group and 35 per
cent in the Enbrel QW/QW had enthesitis at baseline.

In 2004, Enbrel was the first biologic treatment to be approved
in Europe for the treatment of adults with moderate to severe plaque
psoriasis where treatment with systemic agents is unsuitable, and has
since been approved for the treatment of the same condition in
children from the age of eight. Five years of 'real-life' experience
demonstrating its effectiveness as a psoriasis treatment over the
long-term was further confirmed with the recent approval in Europe of
a continuous dosing indication.

"Over the five years that Enbrel has been available in Europe as
a treatment for psoriasis, it has consistently proven to be a safe
and effective treatment for psoriatic patients. Now, psoriatic
patients stand to benefit from a greater choice of treatment: these
data presented at EADV and the recent approval of the continuous
dosing regimen for Enbrel, give patients and doctors the opportunity
to tailor treatment in response to the severity of the patient's
psoriasis and their ongoing response to treatment," said Professor Dr
Wolfram Sterry, Humboldt University, Berlin, Germany.

Enbrel has been studied in over 3,000 adult and paediatric plaque
psoriasis patients with clinical data now extending over 4 years.

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Notes to Editors

About Enbrel(6)

Enbrel is a fully human soluble tumour necrosis factor (TNF)
receptor. Enbrel was first approved in the EU in 2000 for moderate to
severe rheumatoid arthritis and polyarticular juvenile idiopathic
arthritis, and has since been used in 505,000 patients(7) 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 from the age of 4 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 ciclosporin,
methotrexate or PUVA.

Paediatric plaque psoriasis

Treatment of chronic severe plaque psoriasis in children and
adolescents from the age of 8 years who are inadequately controlled
by, or are intolerant to, other systemic therapies or phototherapies.

About Wyeth

Wyeth is one of the world's largest research-based pharmaceutical
and health care products companies. It is a leader in the discovery,
development, manufacturing, and marketing of prescription drugs and
over-the-counter medications. It is also a global leader in vaccines,
biotechnology and animal health care.

References:

1. Richards HL et al. The contribution of perceptions of
stigmatization to disability in patients with psoriasis. J Psychosom
Res. 2001;50:11-15

2. Thaci D. et al. Rapid improvement of poor quality of life with
etanercept therapy in subjects with both psoriasis and psoriatic
arthritis (PRESTA trial). Presented at the 18th Congress of the
European Academy of Dermatology and Venereology 2009.- Abstract:
A-156-0013-01005 (P116)

3. Gladman DD. et al. Psoriatic arthritis: epidemiology, clinical
features, course and outcome. Ann Rheum Dis. 2005;64 (Suppl II)

4. Spondylitis Association of America. Psoriatic Arthritis (PsA)
http://www.spondylitis.org/about/psoriatic.aspx (Last accessed Jan
2009)

5. Kirkham B. et al. Etanercept therapy improves enthesitis and
dactylitis in subjects with psoriasis and psoriatic arthritis: The
PRESTA trial. Presented at the 18th Congress of the European Academy
of Dermatology and Venereology 2009. Abstract: A-156-0013-00363 / 9
October 2009

6. Enbrel EMEA SPC.
http://www.emea.europa.eu/humandocs/PDFs/EPAR/Enbrel/H-262-PI-en.pdf

7. Wyeth data on file

ots Originaltext: Wyeth Europa
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