MADRID, March 17 /PRNewswire/ --
- Improved Remission Rates Lead to Fewer Sick Days and Increased
Productivity at Work
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
Wyeth Pharmaceuticals Limited
