Leading Rheumatologists Agree Clinical Remission a Key Goal in Rheumatoid Arthritis

- Improved Remission Rates Lead to Fewer Sick Days and Increased Productivity at Work

MADRID, March 17/PRNewswire/ -- Leading rheumatologists have highlighted the importance of early intervention in rheumatoid arthritis to achieve clinical remission, a key goal in the management of the disease. In the first major rheumatoid arthritis trial to use clinical remission as a primary endpoint, over 50% of patients with less than two years of early active rheumatoid arthritis who received a combination of Enbrel (etanercept) and methotrexate achieved clinical remission.(1)

Data from the COMET study (COmbination of Methotrexate and ETanercept in Active Early Rheumatoid Arthritis), also demonstrated the impact of early intervention on a rheumatoid arthritis patient's quality of life, including reducing disability to normal rates (HAQ < 5) in more than half of patients.(2)

Commenting on the data, lead investigator Professor Paul Emery, Professor of Rheumatology at the University of Leeds said, "These results now validate current clinical thinking, which we hope will encourage rheumatologists to aim for clinical remission as an achievable and realistic goal for patients with early active rheumatoid arthritis. The quality of life benefits for patients are very much welcomed but there is also a significant impact in limiting disease progression on reducing work disability. We saw that patients taking methotrexate alone lost three times more work days than patients on the Enbrel/methotrexate combination therapy which shows early, effective treatment can have a long term effect not only on an individual patient's health, but also benefits the wider community."

The importance of early intervention in the treatment of rheumatoid arthritis is further underlined by co-morbidity studies which have associated the condition with psychological complications such as anxiety and depression. Linked to coping with a chronic disease and a reduced quality of life, these complications tend to begin early after onset of rheumatoid arthritis.(3) Compounding this, is the increased number of sick days taken off work by rheumatoid arthritis patients due to pain and inflammation.(4) The adverse impact on psychological function of being unable to work is well established:(5)

- Research has shown that 66% of patients with rheumatoid arthritis have lost an average of 39 work days over the last year(4)

- In monetary terms, this equates to a mean productivity loss per person of EUR7,217 for women and EUR8,443 for men(6)

- Data from COMET have shown that 55% of patients treated with Enbrel and methotrexate achieved normal disability rates using the Health Assessment Questionnaire Disability Index (HAQ < 5), compared to 39% of patients treated with methotrexate only(2)

- Patients who were in employment at the beginning of the COMET trial and were treated with etanercept and methotrexate combination showed a three-fold decrease in the number of work days missed over the period of a year compared to patients treated with methotrexate alone (15 vs. 4.8 P< 0.05)

The psychological co-morbidities associated with rheumatoid arthritis tend to begin early after onset of the condition.(3) Treatments such as Enbrel halt the progression of the disease and if administered early, may result in fewer work days lost and contribute to an overall better quality of life for patients.(1)

Professor Ferdinand Breedveld, Professor of Rheumatology, Medical Faculty, University of Leiden and COMET investigator said, "Receiving a diagnosis of rheumatoid arthritis is distressing - patients can become depressed and anxious about their condition, added to which is the worrying issue of not being able to work due to pain and sickness. By treating rheumatoid arthritis patients earlier with Enbrel, before the disease progresses and the damage becomes irreversible, we can see a direct improvement in their quality of life, from regaining pain-free physical function to the psychological benefits of being able to contribute to the society in which they live."

Notes to Editors

About Enbrel(7)

ENBREL is a fully human soluble tumour necrosis factor (TNF) receptor antagonist. ENBREL was first approved in 1998 for moderate to severe 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:

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 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.

COMET Study Details:(1)

This study was designed to compare the clinical efficacy and safety of ENBREL and methotrexate combination therapy with methotrexate alone in patients with active early rheumatoid arthritis.(1) Patients in this study had disease duration of less than or equal to 2 years, had not previously received methotrexate, and had active disease based on DAS28 (more than or equal to 3.2) and elevation of erythrocyte sedimentation rate (more than or equal to 28 mm/hr) or C-reactive protein (more than or equal to 20 mg/L). Patients were randomised to receive either ENBREL plus methotrexate (n = 274) or methotrexate alone (n = 268).1 The primary endpoint was proportion of patients achieving DAS28 clinical remission (< 2.6) at Week 52.1 Secondary endpoints included proportions of patients achieving ACR 20, ACR 50 and ACR 70 at week 52.1 This double-blind, randomised, multicenter study consists of two 12-month periods.(1) The data presented at ACR is from the first 12-month period (52 weeks).

About Wyeth:

Wyeth is one of the world's largest research-based pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of prescription drugs and over-the-counter medications. It is also a global leader in vaccines, biotechnology and animal health care.

1. Abstract L17 from the American College of Rheumatology congress, November 2007. Emery P. et al. Remission rates with the combination of etanercept and methotrexate compared with methotrexate monotherapy in subjects with active early rheumatoid arthritis: 1-year COMET randomised double-blind results

2. Oral presentation. Emery P. et al. Remission Rates in Subjects With Active Early Rheumatoid Arthritis - 1 Year Results of COMET: Combination of Methotrexate and Etanercept in Active Early Rheumatoid Arthritis. Slide presentation at the American College of Rheumatology congress, November 2007.

3. Isik A et al Clinical Rheum. 2007;26:872-878

4. Burton W et al. Occup Med. 2006:56:18-27

5. Linn W et al Am J Public Health. 1985;75:502-506

6. Puolakka K et al, ARD. 2006;65:899-904

7. Enbrel EMEA SPC

Source: Wyeth Pharmaceuticals Limited

For further information, please contact: Wyeth: Gill Markham, Communications - Europe, Middle East and Africa, Direct tel +44-1628-692536, Email: markhagl@wyeth.com; OgilvyHealthPR: Karen Crum, Direct Tel: +44-207-108-6411, Email: karen.crum@ohpr.com; Jodi Lewis, Direct Tel: +44-207-108-6086, Email: jodi.lewis@ohpr.com

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Posted: March 2008

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