Healthcare Industry News: Methotrexate
News Release - July 9, 2008
European Commission Announces Marketing Authorisation for 50mg Once Weekly Enbrel(R) for Patients With Moderate-to-Severe PsoriasisNew Dosing Option Provides Greater Flexibility and Convenience for Patients to Effectively Control the Debilitating Symptoms of their Condition(1)
MAIDENHEAD, England, July 9 (HSMN NewsFeed) -- The European Commission announced today a new 50 mg EnbrelŪ (etanercept) once weekly dosage regimen as an alternative to the currently approved 25 mg EnbrelŪ 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 EnbrelŪ 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."
EnbrelŪ 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 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.
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.
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 #FC08-6
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. http://www.emea.europa.eu/humandocs/PDFs/EPAR/Enbrel/H-262-PI-en.pdf)
Source: Wyeth Pharmaceuticals
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