Healthcare Industry News: Methotrexate
News Release - September 18, 2008
Enbrel(R) Shown to Deliver Long-Lasting Improvements in Psoriasis Patients' Quality of LifeNew Study Results Further Support That Enbrel Effectively Clears Skin,
Reduces the Prevalence of Depression and Anxiety and Improves Patients'Quality of Life
MAIDENHEAD, England, September 18 (HSMN NewsFeed) -- 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 H˘pital 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
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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.
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
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:
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.
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.
Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
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.
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.
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
Source: Wyeth Pharmaceuticals
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