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Enbrel(R) Shown to Deliver Long-Lasting Improvements in Psoriasis Patients' Quality of Life

Geschrieben am 18-09-2008

Maidenhead, England (ots/PRNewswire) -

- New Study Results Further Support That Enbrel Effectively
Clears Skin, Reduces the Prevalence of Depression and Anxiety and
Improves Patients' Quality of Life

Data demonstrating the significant positive impact of Enbrel
(etanercept) on the quality of life of psoriasis patients were
presented today at the European Academy of Dermatology and
Venereology (EADV) Congress, Paris. The pivotal CRYSTEL* study
(Clinical Randomized Year-long STudy assessing the safety and
efficacy of EnbreL in psoriasis) showed that Enbrel significantly
improves the physical symptoms of psoriasis, accompanied with an
improvement in the prevalence of depression and anxiety symptoms and
a significant improvement in patients' quality of life, all
sustained over time.

"Psoriasis is more than just a skin disease" says Mr Ottfrid
Hillmann, a psoriasis patient and President of EUROPSO, the
federation of psoriasis patients' associations in Europe. "Patients
with psoriasis may have a quality of life comparable to, or even
worse than those individuals with other chronic medical disorders,
including heart disease. In addition, those with psoriasis can also
experience serious co-morbidities: approximately one third of
psoriasis patients suffer from some form of depression or anxiety.
This is a worrying thought which should lead us to early diagnosis
and patient-centred management of the condition."

The new results from the CRYSTEL study show that after taking
Enbrel for a year, either as continuous or intermittent therapy,
patients experienced significant skin clearance as well as:

- Up to 26% improvement in health related quality of life(1)

- Up to 30% improvement in the prevalence of depression
symptoms(2)

- Up to 27% improvement in the prevalence of anxiety symptoms(2)

- Up to 53% reduction in joint pain(3)

Dr Herve Bachelez, Dermatologist and Professor of Clinical
Medicine at the Hôpital Saint-Louis, Paris, France commented on the
new study results: "By combining these patient reported outcomes,
together with the established safety profile and reliable skin
clearance, we are now seeing a more complete picture of the benefits
of etanercept in patients with psoriasis. Furthermore, the CRYSTEL
study results complement the existing belief that by treating the
disease early and aggressively, we can provide patients with
meaningful, long-lasting improvements to their daily lives"

Data from another psoriasis trial** recently published in the
British Journal of Dermatology4 online demonstrates that the
newly-approved European once-weekly dosing regimen of Enbrel provides
sustained improvements in patients' quality of life, while at the
same time offering a more flexible and convenient treatment option.
The results also showed that patients taking Enbrel 50mg once a week
experienced a significant improvement in skin clearance, sustained
over time.(4)

No differences were observed in rates of serious infections or
malignancies among patients in any groups in either of the trials.

Enbrel has a long-established safety profile with over 16 years
of proven clinical experience, and is currently the number one
prescribed biologic worldwide.

Wyeth 'Advances in Psoriasis Research Grant' Programme

At the EADV 2008 Congress in Paris, Wyeth announced the names of
the first six winners of its 'Advances in Psoriasis Research Grant'
programme. Wyeth has an ongoing commitment to support innovative
psoriasis research and develop optimal treatments to ultimately
improve psoriasis patients' quality of life. Each winner will receive
a grant towards research into the causes of psoriasis and TNF-related
skin disorders.

For further information please visit:
http://www.advancesinpsoriasis.com

To access further media information relating to this press
release, additional information on Enbrel and future media
announcements, please register on the media centre at
http://www.wyeth.eu. If you subscribe to receive our emails you will
get updates as soon as new content is added to the site. Please note
you will be able to unsubscribe at any time and we will not pass your
details to any third party.

Notes to Editors

*CRYSTEL Study Details(1-3)

In the CRYSTEL study, patients with moderate-to-severe psoriasis
were randomised in an open-label study and received Enbrel, either
continuously for 54 weeks or in a 'paused' fashion.

- Both continuous and paused Enbrel therapy treatment regimens
improved the clinical aspects of psoriasis. The mean Psoriasis Area
and Severity Index (PASI) improved significantly from a baseline of
22 for the continuous group and 23 for the paused group to 7 and 9,
respectively, at week 54.(2)

- Improvement in the prevalence of depression and anxiety
symptoms was seen as early as week 12 and was sustained for up to 54
weeks with both continuous and paused Enbrel regimens:


- The number of patients with at least mild symptoms of depression
significantly reduced from a baseline of 30% for the continuous
group and 37% for the paused group to 18% and 23%, respectively, at
week 54.(2)
- The number of patients with at least mild symptoms of anxiety
significantly reduced from a baseline of 40% for the continuous
group and 49% for the paused group to 25% and 32%, respectively, at
week 54.(2)


- Furthermore, the CRYSTEL study showed that patients taking
Enbrel experienced 42%-53% reduction in joint pain at week 54.(3)

- The CRYSTEL study showed that at the start of treatment (at
baseline), patients experienced a low health-related quality of life
(HRQoL), similar to or even worse than those individuals with other
chronic medical disorders including heart disease, stroke, severe
chronic obstructive pulmonary disease (COPD), and diabetes. After
being treated with Enbrel for 54 weeks, patients experienced a
significant improvement in their HRQoL.

** Enbrel Once-Weekly 318 Study Details(4)

The 318 study design comprised a primary endpoint of 75%
improvement in Psoriasis Area and Severity Index (PASI 75) score and
included a number of measures to determine moderate-to-severe
psoriasis patients' quality of life. For 12 weeks one group received
50mg of Enbrel once-weekly whilst the other group was given placebo.
After 12 weeks all patients were then prescribed Enbrel in an open
label period for a further 12 weeks. Study 318 achieved its primary
endpoint at week 12, however patients continued to improve over time.
Results showed:

- At week 24, nearly three quarters of patients (71%) with
moderate-to-severe psoriasis receiving Enbrel achieved significant
improvement in disease severity (PASI 75), compared to 44% in the
other group, who received placebo for 12 weeks followed by Enbrel.

- In addition, mean improvements in DLQI from baseline in the
Enbrel group were 71% in patients who received 24 weeks of Enbrel
treatment.

Assessment Terminology

Physician Global Assessment (PGA) is a 6-point scale used to
measure disease severity. The PGA scale is scored from 0 to 5, with 0
indicating no signs of psoriasis (clear) and higher scores indicating
more severe disease.

Psoriasis Area and Severity Index (PASI) is a measure of the
average redness, thickness and scaliness of the lesions (each graded
on a 0-4 scale), which is weighted by the extent of plaque coverage
on the head, trunk, and upper and lower extremities. The PASI ranges
from 0 to 72, with higher scores indicating more severe disease.

Health-related quality of life (HRQoL) refers to a person or
group's perceived physical and mental health over time, and is used
to better understand how an illness interferes with a person's
day-to-day life.

- EuroQOL-5D (EQ-5D) questionnaire measures HRQoL and evaluates 5
dimensions of health: mobility, self-care, usual activities,
pain/discomfort and anxiety/depression. The severity of impairment
for each dimension is rated as "no problem," "some problem," and
"extreme problem."

- Dermatology Life Quality Index (DLQI) is a compact
self-reported questionnaire to measure HRQoL over time in patients
with skin diseases. It consists of 10 items covering symptoms and
feelings, daily activities, leisure, work and school, personal
relationships and treatment. Each item is scored on a four point
scale, with higher scores indicating greater impairment in HRQoL.

Advances in Psoriasis Research Awards

The Advances in Psoriasis Research Grant Programme was launched
by Wyeth Pharmaceuticals on 29 October 2007 to mark World Psoriasis
Day 2007. The programme this year was open to researchers in Europe,
the Middle East and Africa, and offered six lab-based or clinical
investigators the opportunity to receive a EURO 100,000 grant to
support high-quality and innovative research into the inflammatory
pathogenesis of psoriasis and TNF-related skin disorders.

All applications were judged by an expert panel of international
leaders in dermatology and grants were awarded on the basis of robust
scientific rationale, combined with the potential advancements that
may be achieved in the understanding of the mechanism of psoriasis
and related conditions. The Awards further reinforce Wyeth's
commitment to the study of psoriasis, the development of optimal
treatments for skin clearance and overall improvements in patients'
quality of life.

For further information please visit:
http://www.advancesinpsoriasis.com

About Enbrel(5)

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
(JIA) 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. The European Commission recently approved a new
50mg Enbrel once-weekly dosage regimen as an alternative to the
currently approved 25mg Enbrel twice-weekly regimen for the treatment
of patients with moderate-to-severe plaque psoriasis.

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, haemophilia, 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. Poster FP 1465 from the European Association for Dermatology
and Venereology Congress, September 2008. Cardoso, J. et al. Both
continuous and intermittent etanercept therapy improve health-related
quality of life in patients with moderate-to-severe psoriasis

2. Poster FP1359 from the European Association for Dermatology
and Venereology Congress, September 2008. Lambert, J. et al.
Sustained improvements in depression and anxiety symptoms with
etanercept therapy for up to 54 weeks in patients with moderate to
severe psoriasis: results of the CRYSTEL study

3. Poster FP 1391 from the European Association for Dermatology
and Venereology Congress, September 2008. Peyri, J. et al. Effect of
etanercept on joint pain in patients with moderate-to-severe
psoriasis: intermittent versus continuous dose regimens

4. Van de Kerkhof, PCM. et al. Once weekly administration of
etanercept 50 mg is efficacious and well tolerated in patients with
moderate-to-severe plaque psoriasis: a randomized controlled trial
with open-label extension. British Journal of Dermatology, published
online: 31 July 2008.

5. Enbrel EMEA SPC

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

Contact:
For further information, please contact: Wyeth: Gill Markham,
Communications, Tel: +44-777-082-7753, Email: markhagl@wyeth.com.
Danielle Halstrom, Communications, Global, Europe, Middle East and
Africa, Tel: +1-215-280-3898, Email: halstrd@wyeth.com.
OgilvyHealthPR: Mary Barrington-Ward, Tel: +44-207-108-6066, Email:
mary.barrington-ward@ohpr.com. Nerea Hinzpeter, Tel: +1-646-407-9015,
Email: nerea.hinzpeter@ohpr.com


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