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Wyeth Pharmaceuticals

Wyeth Presents New Analyses of Data From Three Studies of ENBREL(R) at the European League Against Rheumatism (EULAR) Annual Meeting

12.06.2009 – 10:20

Maidenhead, England (ots/PRNewswire)

  • Two-year Data From COMET Study in Early Active Moderate-to-Severe Rheumatoid Arthritis Indicated Sustained Halt of Progressive Joint Damage
  • New Analyses From ASCEND Study in Ankylosing Spondylitis Indicated Improvement in Patients With and Without Peripheral Joint Involvement
  • Results From PRESTA Study in Psoriatic Arthritis Indicated Improvement in Joint and Skin Symptoms
Analyses of data from three studies provide insight into the use
of ENBREL(R) (etanercept) in the treatment of three conditions for
which ENBREL is indicated: moderate-to-severe rheumatoid arthritis
(RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS).
These analyses, presented this week during the European League
Against Rheumatism (EULAR) Annual Meeting in Copenhagen, add to the
body of evidence that supports treatment with ENBREL for patients
with these conditions.
To view the Multimedia News Release, please click:
http://www.prnewswire.com/mnr/wyeth/38737/
Analyses from three separate trials of ENBREL -- COMET*, ASCEND**
and PRESTA*** -- showed that:
- The group of patients with early-active moderate-to-severe RA treated
      with ENBREL and methotrexate, who achieved and sustained a halt of
      progressive joint damage, maintained this level at two years, according
      to the COMET study
    - In patients with AS (including those with and without peripheral joint
      involvement), ENBREL therapy significantly improved signs, symptoms,
      function, and mobility when compared to treatment with the DMARD
      sulfasalazine, according to the ASCEND study
    - At step-down and usual doses, ENBREL provided significant improvement
      in joint symptoms compared to baseline in patients with active PsA in
      addition to achieving clearer skin, according to the PRESTA study
"Inflammatory diseases such as rheumatoid arthritis, ankylosing
spondylitis and psoriatic arthritis significantly impact the daily
lives of the patients who live with these conditions. These analyses
support the role of etanercept therapy in the management of these
diseases. The EULAR congress provides an important platform to
present new information regarding ENBREL as a treatment option for
patients with rheumatoid arthritis, ankylosing spondylitis and
psoriatic arthritis," said Maxime Dougados, Professor of
Rheumatology, Rene Descartes University Paris, France.
*The COMET Study
The COMET (COmbination of Methotrexate and ETanercept in early
rheumatoid arthritis) study was designed to compare the clinical
efficacy and safety of ENBREL and methotrexate combination therapy
(EM) with methotrexate alone (M) on clinical disease activity and
progressive joint damage in patients with early active rheumatoid
arthritis. COMET was the first published study to use clinical
remission as a primary endpoint.
Subjects were randomised at baseline. Those who completed 1 year
of treatment entered year 2 (n=411). The original combination group
either continued combination (EM/EM; n=111) or received ENBREL
monotherapy (EM/E; n=111) in year 2; the original methotrexate
monotherapy group either received combination (M/EM; n=90) or
continued monotherapy (M/M; n=99). Efficacy endpoints included
clinical remission (DAS28<2.6) and radiographic non-progression
(change in mTSS smaller than or equal to 0.5) at year 2.
Following are the year 2 COMET study results:
- From the end of year 1 to the end of year 2, fifty percent of
      patients receiving ENBREL monotherapy achieved clinical remission
      compared to 35 percent of methotrexate monotherapy patients
    - The percentage of subjects achieving clinical remission was
      significantly greater in the groups containing ENBREL (continued
      combination therapy EM/EM, E/ME and delayed combination M/EM) than
      in the continued methotrexate monotherapy (M/M) group (using both
      LOCF and NRI measurements)
    - Non-progression of joint damage was achieved by a
      significantly greater percentage in the continued combination group
      compared with all other groups (P<0.01; LOCF)
    - No new safety signals or clinically important between-group
      differences in serious adverse events were seen
    - Patients who achieved clinical remission had an almost
      two-fold greater improvement in patient reported outcomes than
      patients who did not achieve clinical remission, measured using the
      Health Assessment Questionnaire (HAQ), pain visual analogue scale,
      fatigue VAS, EuroQoL-5D, EQ-5D utility and the Short Form-36
Professor Paul Emery, lead COMET trial investigator and Professor
of Rheumatology, University of Leeds, UK, said: "These study results
indicated that when treating moderate-to-severe RA with etanercept,
clinical remission is achievable and, as such, should be a primary
treatment goal. These data highlight the importance of treating early
with etanercept which can help stop progressive joint damage and
provide the opportunity to maintain quality of life."
**The ASCEND Study
Ankylosing spondylitis (AS) is a debilitating condition that
affects three times as many men as women. It typically causes
inflammation and pain in the spine (known as axial disease), but can
also affect the peripheral joints. As a result of this pain, patients
with AS are three times more likely to stop working than the general
population.
The ASCEND study compared the efficacy of ENBREL with the DMARD
sulfasalazine in subjects with AS, including those with peripheral
joint involvement. It was the first published study to use an active
comparator.
A post-hoc analysis compared the efficacy of ENBREL 50 mg once
weekly with sulfasalazine up to 3 g daily in subjects with and
without swollen peripheral joint involvement from a 10-week
randomized, double-blind study in subjects with AS.
Regardless of swollen peripheral joint involvement, subjects
receiving ENBREL showed significantly greater improvement than
subjects receiving sulfasalazine in all efficacy assessments,
including physical function and spinal mobility. In particular, 76
percent of patients taking ENBREL versus 53 percent of patients
taking sulfasalazine, achieved an ASAS 20 (p<0.001)
Patient-reported outcomes presented at EULAR showed a
significantly greater improvement in the ENBREL group than in the
sulfasalazine group at week 16 of treatment in all of the domains
that the Short-Form-36 (SF-36, range 0-100) measures.
"These new analyses suggest the potential benefit of etanercept
in the treatment of peripheral joint disease associated with AS,"
said Maxime Dougados, Professor of Rheumatology, Rene Descartes
University Paris, France. "That the clinical improvements seen in
patients treated with etanercept bore a direct correlation in
improvement in patient quality of life, highlights the importance of
including etanercept in the treatment of AS."
***The PRESTA Study
Psoriatic arthritis (PsA) is a disabling form of arthritis that
occurs in up to 30 per cent of patients with plaque psoriasis.
The PRESTA study was designed to determine the efficacy of two
ENBREL dosing regimens in treating PsA, as measured by PsA response
criteria (PsARC), arthritic symptoms, skin manifestations and
physical function of subjects with psoriasis and PsA over 24 weeks.
In this study, a randomised double-blind phase was followed by an
open-label period. Patients received either ENBREL 50 mg once weekly
(QW) or 50 mg twice weekly (BIW) for 12 weeks (double blind),
followed by 50 mg QW for all patients for 12 weeks (open label).
Data from the trial showed that at usual doses as well as at
step-down doses (i.e., 50 mg once a week or 50 mg twice a week for
first 12 weeks, then 50 mg once a week), ENBREL provided significant
improvement compared to baseline in joint symptoms in patients with
active psoriatic arthritis in addition to achieving clearer skin.
Furthermore, the new data showed that ENBREL significantly
relieved two painful and difficult-to-treat features of psoriatic
arthritis, in which inflammation occurs in the fingers (dactylitis)
and/or at any point where a tendon or ligament is inserted into bone,
particularly the heel of the foot (enthesitis).
Efficacy results presented at EULAR showed - for joints:
- For physician global assessment of arthritis, HAQ and subject
      global assessment of joint pain, arthritis activity and stiffness,
      within-group improvements from baseline for the 2 regimens were
      significant (p<0.001) at 12 and 24 weeks; between-group differences
      were not
    - In the ENBREL 50 mg BIW group, 77 percent were PsARC
      responders at week 12 versus 76 percent in the ENBREL 50 mg QW group
      (p=0.264). At week 24, PsARC responders were 82 percent and 80 percent
      respectively (p=0.722).
Efficacy results presented at EULAR showed - for enthesitis and
dactylitis:
- At weeks 12 and 24, patients with dactylitis at baseline from
      both study groups showed comparable improvement, with the mean
      number of digits affected substantially lower than at baseline:
      ENBREL 50 mg BIW/QW 1.5 and 1.6 for ENBREL 50 mg QW/QW at week 12,
      and ENBREL 50 mg BIW/QW 1.2 and 1.3 for ENBREL 50 mg QW/QW at
      week 24
    - In those patients with enthesitis at baseline, both step-down
      and usual dose ENBREL regimens provided comparable improvements in
      > 1 tendon or ligament insertion at weeks 12 and 24: 74 percent for
      ENBREL 50 mg BIW/QW versus 70 percent 50mg QW/QW at week 12 and 81
      percent for both groups at week 24. These improvements were
      accompanied by improved quality of life
Efficacy results presented at EULAR showed - for skin:
- At week 24, PASI 75 improvement was achieved by 70 percent in
      the BIW/QW group and 62 percent in the QW/QW group
    - Similarly at week 24, the percentage of psoriasis responders,
      clear or almost clear on the physician global assessment, was 56
      percent for the ENBREL 50 mg BIW group and 50 percent for the 50
      mg QW group
To participate in a virtual on-demand press briefing where you
can hear expert commentary relating to the above data, please log on
to the media centre at http://www.wyeth.eu. Further media information
relating to this press release, additional information on ENBREL and
future media announcements can also be found on the site.
Notes to editors
About ENBREL
ENBREL is a fully human soluble tumour necrosis factor (TNF)
receptor antagonist. ENBREL was first approved in 1998 for moderate
to rheumatoid arthritis and has since been used in 505,000 patients
worldwide across indications.
ENBREL 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. ENBREL is also licensed in the European Union
for treatment of chronic severe plaque psoriasis in children and
adolescents from the age of 8 years who are inadequately controlled
by, or are intolerant to, other systemic therapies or phototherapies.
ABOUT WYETH:
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gastrointestinal health, central nervous system, inflammation,
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products.
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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.

Contact:

For further information, please contact: Wyeth: Gill Markham,
Communications - Europe, Middle East and Africa, Direct Tel:
+44(0)1628-692536, Mob: +44(0)777-082-7753, Email:
markhagl@wyeth.com; Danielle Halstrom, Communications ? Global,
Mobile: +1-215-280-3898, Email: halstrd@wyeth.com; OgilvyHealthPR:
Mary Barrington-Ward, Tel: +44-207-108-6066, Email:
mary.barrington-ward@ohpr.com

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