Maidenhead, England (ots/PRNewswire) -
- New Dosing Option Provides Greater Flexibility and Convenience
for Patients to Effectively Control the Debilitating Symptoms of
The European Commission announced today a new 50 mg Enbrel(R)
(etanercept) once weekly dosage regimen as an alternative to the
currently approved 25 mg Enbrel(R) twice weekly regimen for the
treatment of patients with moderate-to-severe plaque psoriasis. Based
on the outcome of the extensive European 318 study in adult patients
with moderate-to-severe plaque psoriasis, the European Commission
issued the marketing authorisation for the European Union for a once
weekly 50mg Enbrel(R) dosing.(1)
Commenting on the outcome Stevo Knezevic, MD, PhD, Chief Medical
Officer of Wyeth Europe said: "Psoriasis impacts greatly on the daily
lives of patients, as demonstrated in the 318 study where patients
prior to etanercept treatment reported quality of life scores
comparable to those of severe chronic obstructive pulmonary disease
(COPD). The study results confirm that Enbrel can achieve sustained
efficacy both in the short and longer term. Furthermore the European
Commission's announcement today affirms the important role that
Enbrel can play in optimally managing the condition whilst providing
greater flexibility and convenience for patients."
Enbrel(R) once-weekly 318 study details(1),(2)
Patients with moderate-to-severe psoriasis entered this trial
with serious patient-reported outcome (PRO) impairment, with a mean
Dermatology Life Quality Index (DLQI) score, (a QoL index) comparable
to that of patients with severe chronic obstructive pulmonary disease
(COPD). The 318 study design comprised a primary endpoint of 75 per
cent improvement in Psoriasis Area and Severity Index (PASI 75) score
and included a number of measures to determine moderate-to-severe
psoriasis patients' quality of life. For 12 weeks one group received
etanercept whilst the other group was given placebo. After 12 weeks
all patients were then prescribed etanercept in an open label period
for a further 12 weeks. Study 318 achieved its primary endpoint at
week 12, however patients continued to improve with etanercept
treatment at week 24 demonstrating serious PRO impairment was largely
abated with 64 per cent "clear" or "almost clear.
Impact of Psoriasis
Across Europe 5.1 million people are estimated to have
psoriasis(3), a distressing chronic inflammatory disease.
Approximately 80 per cent of these patients have plaque psoriasis,
which is characterised by red, scaly patches.(4) Psoriasis can be
extremely distressing and has a significant impact on patients'
quality of life. It is a condition which is frequently physically and
psychologically disabling - in adults it is associated with
co-morbidities such as increased risk of obesity,(5) type 2
diabetes,(5) liver disease(5) and clinical depression.(5)
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NOTES TO EDITORS
Enbrel is a fully human soluble tumour necrosis factor (TNF)
receptor. 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:
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
Enbrel is also indicated in the treatment of severe, active and
progressive rheumatoid arthritis in adults not previously treated
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
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
Treatment of adults with severe active ankylosing spondylitis who
have had an inadequate response to conventional therapy.
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
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. Siegfried S et al. Etanercept 50 mg once weekly improves
patient-reported outcomes in patients with moderate-to-severe plaque
psoriasis. Presented at the 5th European Academy of Dermatology and
Venereology (EADV) Spring Symposium, Istanbul, Turkey; Abstract
2. Wyeth data on file
3. Christophers E. Psoriasis - Epidemiology and Clinical
Spectrum. Clin Exp Dermatol 2001;26:314-320
4. National Psoriasis Fund. Plaque Psoriasis. December 2005.
Available at http://www.psoriasis.org/about/psoriasis/plaque.php.
Accessed May 2008.
5. Mrowietz, U et al. The importance of disease associations and
concomitant therapy for the long-term management of Psoriasis
patients Arch Dermatol Res (2006)
6. Enbrel EMEA SPC.
ots Originaltext: Wyeth Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.ch
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