Actualizado 27/10/2008 09:02
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New Study Shows ENBREL(R) (etanercept) Is More Effective than a DMARD in the Treatment of Symptoms of Ankylosing Spondyl

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Notes to editors

About Ankylosing Spondylitis

AS is a chronic, painful and progressive inflammatory disease affecting the spine; it is a highly debilitating condition that tends to affect people before the age of 30, and is more common in men. (4)

In patients with AS, tissue is gradually replaced by fibrocartilage which then becomes ossified. When these lesions occur in the spine, it causes irreversible damage as the outer fibres are replaced by bone and the vertebrae become fused.(7)

The diagnosis of AS is commonly delayed by 8 to 11 years, after the onset of symptoms. Diagnosing AS early before irreversible damage has occurred is difficult as radiological proof of the disease is a late feature.(7)

Individuals with AS suffer pain and disability similar to that of patients with rheumatoid arthritis. Other symptoms include: lower back pain and stiffness, early morning stiffness and pain, bone tenderness and asymmetric arthritis of other joints and lower limbs.(7)

ABOUT ENBREL(8)

ENBREL is a fully human soluble tumour necrosis factor (TNF) receptor antagonist.

ENBREL is approved in the EU 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.

Important Safety Information(8)

Serious infections, including tuberculosis, and sepsis have been reported. Some of these infections have been fatal.

Do not start ENBREL in the presence of allergy to ENBREL or its components.

There have been rare reports of CNS demyelinating disorders, although the causal relationship to ENBREL remains unclear.

Rare cases of pancytopenia, and very rare cases of aplastic anemia, some fatal, have been reported in patients treated with ENBREL. Exercise caution in patients who have a previous history of significant hematologic abnormalities. Although the causal relationship to ENBREL remains unclear, advise patients to seek immediate medical attention if they develop signs or symptoms of blood dyscrasias or infection. If significant hematologic abnormalities are confirmed, discontinue ENBREL.

Reports of malignancies affecting various sites have been received in the postmarketing period. Effects of ENBREL therapy on the development or course of infection and malignancy are unknown. In clinical trials of TNF antagonists, more cases of lymphoma were seen compared to control patients; however, the risk of lymphoma may be higher in RA patients.

Before initiation of therapy with ENBREL, any patient at increased risk for tuberculosis (TB) should be evaluated for active or latent infection. Prophylaxis of latent TB infection should be initiated prior to therapy with ENBREL. Applicable local guidelines should be consulted.

Reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus who are receiving anti-TNF agents, including ENBREL, has been reported. Patients at risk for HBV infection should be evaluated for prior evidence of the virus before initiating anti-TNF therapy. Although a causal relationship has not been established for ENBREL, caution should be exercised when administering ENBREL for patients identified as carriers for HBV.

There have been reports of worsening of hepatitis C in patients receiving ENBREL, although a causal relationship with ENBREL has not been established.

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. Braun, J. et al. Assessment of Clinical Efficacy in a Randomized, Double-Blind Study of Etanercept and Sulphasalazine in Patients With Ankylosing Spondylitis. Abstract 08-A-2496-ACR from the American College of Rheumatology (ACR) Scientific Meeting in San Francisco, CA 24-29 October 2008.

2. Mola, E.M. et al. Five-Year Efficacy and Safety, Including Patient-Reported Outcomes, With Etanercept in Ankylosing Spondylitis. Abstract 08-A-591-ACR from the American College of Rheumatology (ACR) Scientific Meeting in San Francisco, CA 24-29 October 2008.

3. Final Abbreviated Report: A Randomized, Double-blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects with Ankylosing Spondylitis (ASCEND) CSR-72737.

4. Braun J. et al. Ankylosing spondylitis. Lancet. 2007 Apr 21;369(9570):1379-90. Review.

5. NY Presbyterian Hospital Website (Ankylosing Spondylitis). Last accessed at http://www.childrensnyp.org/mschony/fp/health/ankylosing-spo... on September 25, 2008.

6. Shaikh S. Ankylosing spondylitis: Recent breakthroughs in diagnosis and treatment. JCCA J Can Chiropr Assoc. 2007 Dec;51(4):249-60

7. Sieper J, Braun J et al. Ankylosing spondylitis: an overview. Ann Rheum Dis 2002; 61 (Supple III):iii8-iii18.

8. ENBREL EMEA SPC.

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