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
Posted: March 2008
