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New Data Demonstrates Joint Damage is Inhibited With Wyeth's Biologic Enbrel(R) Plus Methotrexate in Patients With Early Active Rheumatoid Arthritis

Maidenhead, England (ots/PRNewswire)

- Study Results Provide Further Evidence That Early Treatment of
Rheumatoid Arthritis With Enbrel(R) Plus Methotrexate in Moderate to
Severe Patients can Stop the Disease From Progressing, and Helps
Patients Return to More Normal and Productive Lives
Data presented today show that 80% of patients with early active
rheumatoid arthritis achieved radiographic remission (or
non-progression defined as a change in TSS is less than or equal to
0.5) at one year when treated with Enbrel (etanercept) and
methotrexate, compared to 59% when treated with methotrexate
alone(1). COMET* (COmbination of Methotrexate and ETanercept in
Active Early Rheumatoid Arthritis) is the first major trial to use
remission as its primary endpoint in patients with early active
rheumatoid arthritis treated with a biologic. Data from the landmark
COMET study were presented today at the European League Against
Rheumatism (EULAR) Annual Meeting in Paris.
The COMET trial also showed that 50% of patients taking this
Enbrel combination achieved clinical remission (DAS28<2.6), and
nearly 55% achieved functional remission (HAQ <0.5), compared to 28%
and 39% respectively when treated by methotrexate alone(1).
"Until recently, we did not know whether remission was a
realistic or even achievable goal", said Professor Paul Emery, lead
COMET trial investigator and Professor of Rheumatology, University of
Leeds, UK. "We now have results which show that not only is clinical
remission achievable in a significant number of patients, but
radiographic and functional remission are also achievable. These
exciting results lead to the next therapeutic step in aiming for
multiple measures of remission as our treatment goal, no longer just
one. Given that these levels of remission have not previously been
seen and represent the optimal goal, these results will lead to the
need for treatment of RA with an anti-TNF treatment option such as
etanercept at the earliest appropriate opportunity to halt disease
progression."
Enbrel's ability to achieve remission in many of the patients
treated, irrespective of how it is measured, provides real-life
benefits for the patient by stopping the disease from progressing
whilst at the same time helping them to continue normal day-to-day
functioning. Further data from the COMET trial show that the number
of lost work days in patients treated with the Enbrel combination was
approximately half that of patients receiving methotrexate alone(2).
No differences were observed in rates of serious infections or
malignancies among patients in the Enbrel plus methotrexate group
compared with the methotrexate-only group.
The economic data from another study called DART** were also
presented at the EULAR Annual Meeting(3), complementing the results
from the COMET study. DART trial investigator Professor Robert Moots,
Professor of Rheumatology, University of Liverpool, United Kingdom
commented: "The DART study confirms that whilst all of the TNF
inhibitors are highly effective in reducing disease activity in RA,
in normal clinical usage there may be a need to increase the dose of
infliximab and adalimumab, but not etanercept, to maintain this
beneficial effect. Similarly, the COMET results also demonstrate
Enbrel's value by enabling more patients to stay at work than those
taking methotrexate alone. In conclusion, these results, coupled with
previous studies, demonstrate that Enbrel can not only protect joints
from further damage but also permit optimisation of the long-term
management of patients with RA, due to a predictable dosing and hence
more predictable cost."
To access further media information relating to this press
release, additional information on Enbrel and future media
announcements, please log on to the media centre at
http://www.wyeth.eu.
Notes to editors
About ENBREL(4)
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:
This study was designed to compare the clinical efficacy and
safety of ENBREL and methotrexate combination therapy with
methotrexate alone in patients with early active rheumatoid
arthritis. 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 levels (more than or equal to 20 mg/L).
Patients were randomised to receive either ENBREL plus methotrexate
(n = 274) or methotrexate alone (n = 268). Primary efficacy endpoints
were:
1) The radiographic change at week 52 from baseline assessed by
using an X-ray measurement of changes in joint damage, the modified
Total Sharp Score (mTSS). Radiographic remission was assessed with
the TSS, with non-progression defined as a change in TSS less than or
equal to 0.5. Patients receiving Enbrel with methotrexate experienced
significantly less progression of joint damage with a 0.27 unit mean
change from baseline at one year in TSS, compared with a 2.44 unit
mean change in those treated with methotrexate alone which translates
into nine times less joint damage with the Enbrel combination versus
methotrexate alone (1).
2) The proportion of patients achieving clinical remission, as
measured by disease activity score (DAS28 less than 2.6). DAS28 is a
measure of joint swelling and tenderness (based on 28 joints), as
well as overall disease activity measured by a global health
assessment and an objective marker of inflammation (erythrocyte
sedimentation rate). DAS28 is a validated tool used in clinical
trials.
Other endpoints included low disease activity (DAS28 less than or
equal to 3.2), radiographic non-progression (mTSS less than or equal
to 0.5), and the number of patients achieving functional remission as
measured by Health Assessment Questionnaire (HAQ). This double-blind,
randomised, multicenter study consists of two 12-month periods. The
data presented at EULAR is from the first 12-month period (52 weeks).
**DART study details:
The DART (Anti-TNF Drug utilization and dosing patterns
Assessment: a Retrospective observational study of subjects Treated
for rheumatoid arthritis) study is a retrospective observational
study involving 739 patients in 44 European centres treated with
monoclonal antibodies to TNF-alpha or soluble TNF-alpha receptor over
is greater than or equal to 12 month period. The study was designed
to assess potential dose escalation and other associated treatment
costs on routine clinical practice. Eligible subjects were required
to be continuously treated with prescribed anti-TNF agent (ATA) for
is greater than or equal to 12 months and have no concurrent
diagnosis of any other TNF-mediated conditions.
Participating investigators completed a questionnaire on
treatment strategies to overcome loss of response or failure to
achieve initial response and whether there were restrictions on dose
escalation.
           Dosing Patterns and Clinical and Economic Outcomes at Year 1
                                    Etanercept     Adalimumab      Infliximab
             DAS 28 (0-10)              3.3            3.4           3.7
        EULAR Good Response (%)          46             47            31
        ATA Dose Escalation (%)          <1             8(i)          29(i)
     ATA or DMARD intensification         7            16(ii)         36(ii)
                  (%)
    ATA or Steroid Intensification        6            15(ii)         32(ii)
                  (%)
         Inpatient Visit Rate          0.29 (-47)    0.22 (-38)     0.93 (41)
       (% change from baseline)
         Outpatient visit rate          5.4 (17)      6.3 (29)       8.0 (54)
       (% change from baseline)
          Total cost of care     EUR 19,775    EUR 23,253*    EUR 20,348
    *p<0.05; (i)p<0.001; (ii)p<0.01
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, hemophilia, 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) Abstract OP-0008 from the European League Against Rheumatism
(EULAR) congress, 12 June 2008. Emery P. et al. Clinical Remission,
Radiographic Non-Progression, And Normalized Function With The
Combination Of Etanercept And Methotrexate In The Treatment Of Early
Active Rheumatoid Arthritis: 1-Year Results Of The COMET Trial
(2) Abstract OP-0096 from the European League Against Rheumatism
(EULAR) congress, 12 June 2008. Anis. A. et al. Work-Related Outcomes
In Early Active Rheumatoid Arthritis: Results From The COMET Trial
(3) Abstract FRI0139 from the European League Against Rheumatism
(EULAR) congress, 13 June 2008. Moots, R. et al. Dose Escalation
Accounts For Differences In Cost Of Care In 739 Patients With
Rheumatoid Arthritis (RA) Treated With Anti-TNF Agents (ATAs):
Results From The DART Study
(4) Enbrel EMEA SPC (eMC last accessed 25/05/08)

Contact:

For further information, please contact: Wyeth: Gill Markham,
Communications - Europe, Middle East and Africa, Direct Tel:
+44(0)1628-692536, Email: markhagl@wyeth.com; Danielle Halstrom,
Communications - Global, Mobile: +1-215-280-3898, Email:
halstrd@wyeth.com; OgilvyHealthPR: Nerea Hinzpeter, Tel:
+1-646-407-9015, Email: nerea.hinzpeter@ohpr.com; Christina
Mavroleon, Tel: +44-207-108-6069, Email: Christina.mavroleon@ohpr.com

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