Enbrel(REG) Improved Some Measures Of Quality Of Life And Skin Symptoms In Patients With Psoriasis As Early As One Week

Main Category: Eczema / Psoriasis
Article Date: 23 Feb 2005 - 8:00 PDT


New data presented at the American Academy of Dermatology annual meeting, held over the weekend in New Orleans, Louisiana, showed that at three months, nearly 30% of psoriasis patients taking Enbrel* (etanercept) in a phase III clinical trial reported that they were "not at all" bothered by their psoriasis.1

This was indicated by achieving a "zero," the lowest possible score, on the Dermatology Life Quality Index (DLQI).1 Additionally, patients treated with Enbrel experienced a significant improvement from baseline in DLQI scores as early as week one, a result primarily driven by improvements in their symptoms and how they felt about their ability to manage their disease.1

"People with moderate to severe psoriasis may face a lifetime of physical and emotional challenges that can have a devastating impact on their personal lives, even leading to extreme embarrassment and social isolation," said Allison Jeynes - Ellis, Wyeth UK Medical Director, "We know that Enbrel can be effective in treating the physical symptoms of the disease, and it is impressive to see that treatment with Enbrel also helped improve important aspects of patients' personal lives."

The DLQI is a validated patient questionnaire that measures the impact of disease on feelings, daily activities, leisure activities, work and school, personal relationships as well as how patients feel about treatment and their symptoms. The DLQI has 10 questions and a total score range from 0 - 30, with lower score indicating better health status.1

A score of zero on the DLQI, achieved by nearly 30% of patients treated with Enbrel, indicates that patients attained better health status.1 On average, the patients receiving Enbrel continued to experience improvements over the course of the 12-week double-blind segment of this study.1

In addition to the significant physical impact, moderate to severe psoriasis can also affect people's feelings, behaviours, and experiences. People with psoriasis often feel helpless, self-conscious, and angry about their disease.2 The impact of psoriasis on patient health-related quality of life has been well documented in the scientific literature.3

Response to treatment with Enbrel was rapid and sustained. At 12 weeks patients treated with etanercept demonstarted statistically significant improvements in certain quality of life parameters.1 These new data are consistent with previous studies that show that treatment with Enbrel can provide rapid and significant relief of psoriasis skin3 and quality-of-life symptoms. 4

In the new phase III double-blind, placebo-controlled, multi centre study conducted at 39 sites in the United States and Canada, 620 patients were randomised to either 50 mg of Enbrel twice a week or placebo twice a week. Before study entry, patients had to discontinue previous psoriasis therapies. 1 Patients were stratified at randomisation into two groups: patients who previously received phototherapy or systemic psoriasis therapy and patients who received neither therapy.

ENDS

For further information please contact:

Di Burrows on 0202 7611 3520 or Katharine Parmigiani on 020 7611 3559 at Ketchum

Dianne.burrows@ketchum.com/katharine.parmigiani@ketchum.com or Press Office, Wyeth on 01628 604377.

References:

1. Gottlieb AB, et al. Treatment with Etanercept improves patient reported outcomes in patients with moderate to severe psoriasis. Abstract for presentation at American Academy of Dermatology 2005, New Orleans, Louisana,USA.

2. Koo, J. Population-based epidemiologic study of psoriasis with emphasis on quality of life assessment. Dermatologic Clinics. 1996; 14:485-496.

3. Choi J, Koo M. Quality of life issues in psoriasis. J Am Acad Dermatol. 2003;57-61.

4. Summary of product characteristics; ZENB556/11/04; Section 5.1; September 2004

5. Christophers E, Psoriasis - epidemiology and clinical spectrum. Clinical and Experimental Dermatology 2001,26.314-320.

6. CCD version 1.0, Market Background Statements, bullet 1); Weinstein

7. CCD v.1, Market Background Statements, bullets 1&4; Weinstein and Krueger 2001.

8. CCD version 1.0, MOA, 2nd bullet, Bonifati et al 1994

9. Data on file, Amgen, Thousand Oaks, Calif.Global Safety Memorandum, December 17, 2004 Post-market Patient Exposure Numbers for Enbrel - October 2004

PSORIASIS

Psoriasis is estimated to affect about two percent of the world's population. In Europe, an estimated 5.1 million people have psoriasis.5 The disease is characterised by chronic inflammation of the skin.6 This inflammation leads to the formation of red, itchy skin plaques that are often painful and disfiguring.7 Tumor necrosis factor (TNF) is found at increased levels in psoriatic plaques 8 and is thought to be involved in their formation and maintenance.5

* ENBREL® (etanercept)

In the European Union, Enbrel is approved for the 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. Enbrel is also approved for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate.

Physicians have become familiar with the benefits and long-term tolerability profile of Enbrel since it became commercially available nearly five years ago. More than 284,000 patients have been treated worldwide across its approved indications.9

WYETH

Wyeth is one of the world's leading pharmaceutical companies with a major focus on developing innovative new medicines to improve health and well-being. In the UK, Wyeth is one of the largest pharmaceutical companies with a broad portfolio of leading products across a wide range of treatment areas, including rheumatology, gastro-intestinal disease, mental health, women's healthcare, haemophilia, prostate cancer, rheumatology, infectious disease, and transplantation. Wyeth is also a major force in preventative medicine, with a range of paediatric and adult vaccines.

Wyeth Biotechnology
Huntercombe Lane South
Taplow, Maidenhead
Berkshire, SL6 0PH
Tel: +44 (0)1628 604377
Fax: +44 (0)1628 666368

• Additional
• References
• Citations