COMUNICADO: Enbrel(R) Shown to Deliver Long-Lasting Improvements in Psoriasis Patients' Quality of Life (1)

Actualizado 18/09/2008 15:05:20 CET

MAIDENHEAD, England, September 18 /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.

(CONTINUA)

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