2008-09-18

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


Maidenhead, England (ots/PRNewswire) -

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

Data demonstrating the significant positive impact of Enbrel(etanercept) on the quality of life of psoriasis patients werepresented today at the European Academy of Dermatology andVenereology (EADV) Congress, Paris. The pivotal CRYSTEL* study(Clinical Randomized Year-long STudy assessing the safety andefficacy of EnbreL in psoriasis) showed that Enbrel significantlyimproves the physical symptoms of psoriasis, accompanied with animprovement in the prevalence of depression and anxiety symptoms anda significant improvement in patients' quality of life, allsustained over time.

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

The new results from the CRYSTEL study show that after takingEnbrel 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 depressionsymptoms(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 ClinicalMedicine at the Hôpital Saint-Louis, Paris, France commented on thenew study results: "By combining these patient reported outcomes,together with the established safety profile and reliable skinclearance, we are now seeing a more complete picture of the benefitsof etanercept in patients with psoriasis. Furthermore, the CRYSTELstudy results complement the existing belief that by treating thedisease early and aggressively, we can provide patients withmeaningful, long-lasting improvements to their daily lives"

Data from another psoriasis trial** recently published in theBritish Journal of Dermatology4 online demonstrates that thenewly-approved European once-weekly dosing regimen of Enbrel providessustained improvements in patients' quality of life, while at thesame time offering a more flexible and convenient treatment option.The results also showed that patients taking Enbrel 50mg once a weekexperienced a significant improvement in skin clearance, sustainedover time.(4)

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

Enbrel has a long-established safety profile with over 16 yearsof proven clinical experience, and is currently the number oneprescribed biologic worldwide.

Wyeth 'Advances in Psoriasis Research Grant' Programme

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

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

To access further media information relating to this pressrelease, additional information on Enbrel and future mediaannouncements, please register on the media centre athttp://www.wyeth.eu. If you subscribe to receive our emails you willget updates as soon as new content is added to the site. Please noteyou will be able to unsubscribe at any time and we will not pass yourdetails to any third party.

Notes to Editors

*CRYSTEL Study Details(1-3)

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

- Both continuous and paused Enbrel therapy treatment regimensimproved the clinical aspects of psoriasis. The mean Psoriasis Areaand Severity Index (PASI) improved significantly from a baseline of22 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 anxietysymptoms was seen as early as week 12 and was sustained for up to 54weeks 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 takingEnbrel experienced 42%-53% reduction in joint pain at week 54.(3)

- The CRYSTEL study showed that at the start of treatment (atbaseline), patients experienced a low health-related quality of life(HRQoL), similar to or even worse than those individuals with otherchronic medical disorders including heart disease, stroke, severechronic obstructive pulmonary disease (COPD), and diabetes. Afterbeing treated with Enbrel for 54 weeks, patients experienced asignificant 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 andincluded a number of measures to determine moderate-to-severepsoriasis patients' quality of life. For 12 weeks one group received50mg of Enbrel once-weekly whilst the other group was given placebo.After 12 weeks all patients were then prescribed Enbrel in an openlabel period for a further 12 weeks. Study 318 achieved its primaryendpoint at week 12, however patients continued to improve over time.Results showed:

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

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

Assessment Terminology

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

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

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

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

- Dermatology Life Quality Index (DLQI) is a compactself-reported questionnaire to measure HRQoL over time in patientswith skin diseases. It consists of 10 items covering symptoms andfeelings, daily activities, leisure, work and school, personalrelationships and treatment. Each item is scored on a four pointscale, with higher scores indicating greater impairment in HRQoL.

Advances in Psoriasis Research Awards

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

All applications were judged by an expert panel of internationalleaders in dermatology and grants were awarded on the basis of robustscientific rationale, combined with the potential advancements thatmay be achieved in the understanding of the mechanism of psoriasisand related conditions. The Awards further reinforce Wyeth'scommitment to the study of psoriasis, the development of optimaltreatments 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 moderateto rheumatoid arthritis and has since been used in nearly 500,000patients worldwide across indications.

Enbrel in the EU is approved for the following indications:

Rheumatoid arthritis

Enbrel in combination with methotrexate is indicated for thetreatment of moderate to severe active rheumatoid arthritis in adultswhen the response to disease-modifying antirheumatic drugs, includingmethotrexate (unless contraindicated), has been inadequate. Enbrelcan be given as monotherapy in case of intolerance to methotrexate orwhen continued treatment with methotrexate is inappropriate. Enbrelis also indicated in the treatment of severe, active and progressiverheumatoid arthritis in adults not previously treated withmethotrexate. Enbrel, alone or in combination with methotrexate, hasbeen shown to reduce the rate of progression of joint damage asmeasured 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 aninadequate response to, or who have proved intolerant of,methotrexate. Enbrel has not been studied in children aged less than4 years.

Psoriatic arthritis

Treatment of active and progressive psoriatic arthritis in adultswhen the response to previous disease-modifying antirheumatic drugtherapy has been inadequate. Enbrel has been shown to improvephysical function in patients with psoriatic arthritis, and to reducethe rate of progression of peripheral joint damage as measured byX-ray in patients with polyarticular symmetrical subtypes of thedisease.

Ankylosing spondylitis

Treatment of adults with severe active ankylosing spondylitis whohave had an inadequate response to conventional therapy.

Plaque psoriasis

Treatment of adults with moderate to severe plaque psoriasis whofailed to respond to, or who have a contraindication to, or areintolerant to other systemic therapy including cyclosporine,methotrexate or PUVA. The European Commission recently approved a new50mg Enbrel once-weekly dosage regimen as an alternative to thecurrently approved 25mg Enbrel twice-weekly regimen for the treatmentof patients with moderate-to-severe plaque psoriasis.

About Wyeth:

Wyeth Pharmaceuticals, a division of Wyeth, has leading productsin the areas of women's health care, infectious disease,gastrointestinal health, central nervous system, inflammation,transplantation, haemophilia, oncology, vaccines and nutritionalproducts.

Wyeth is one of the world's largest research-drivenpharmaceutical and health care products companies. It is a leader inthe discovery, development, manufacturing and marketing ofpharmaceuticals, vaccines, biotechnology products, nutritionals andnon-prescription medicines that improve the quality of life forpeople worldwide. The Company's major divisions include WyethPharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge AnimalHealth.

References

1. Poster FP 1465 from the European Association for Dermatologyand Venereology Congress, September 2008. Cardoso, J. et al. Bothcontinuous and intermittent etanercept therapy improve health-relatedquality of life in patients with moderate-to-severe psoriasis

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

3. Poster FP 1391 from the European Association for Dermatologyand Venereology Congress, September 2008. Peyri, J. et al. Effect ofetanercept on joint pain in patients with moderate-to-severepsoriasis: intermittent versus continuous dose regimens

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

5. Enbrel EMEA SPC

ots Originaltext: Wyeth PharmaceuticalsIm 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

Wyeth Pharmaceuticals

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

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