Healthcare Industry News: Methotrexate
News Release - May 23, 2008
New Evidence Advocates the use of Enbrel to Combat and Effectively Control the Debilitating Symptoms of PsoriasisNew Studies Provide Clinical Support for More Flexible and Convenient Dosing Options for Patients
ISTANBUL, Turkey, May 23 (HSMN NewsFeed) -- New data from key clinical trials presented today at the 5th European Academy of Dermatology and Venereology (EADV) Spring Symposium in Istanbul, demonstrate that EnbrelŪ (etanercept) is a convenient and effective treatment which helps patients achieve sustained and repeatable reprieve from the physically and psychologically debilitating symptoms of psoriasis.
Results from two key clinical trials were reported:
- CRYSTEL study showed that continuous Enbrel therapy was at least as effective and safe as paused therapy in psoriasis patients and both treatment regimens improved Physician Global Assessment (PGA) scores and patient satisfaction.
- The 318 study investigated patients with serious patient-reported outcome (PRO) impairment and showed that administration of Enbrel 50mg once weekly resulted in significant PRO improvements.
Commenting on the overall impact of the new study details, investigator Professor Christopher Griffiths, Professor of Dermatology, University of Manchester, Manchester, UK, noted "Psoriasis can be extremely distressing and requires a life-time of treatment. There is a real need for patient-centred management with early and effective treatment intervention. These study results add to the body of evidence demonstrating that Enbrel (etanercept) is safe and effective as either a continuous or intermittently used therapy in patients with psoriasis. Furthermore, the once-weekly study findings indicate that a more convenient treatment regime is a realistic option in the near future for patients with this disabling disease."
CRYSTEL study details presented at Spring EADV
In the CRYSTEL study, patients with moderate-to-severe psoriasis were randomised in an open-label study and received Enbrel, either continuously for 54 weeks or paused in a treat-to-response fashion.
- Continuous Enbrel therapy was at least as effective and safe as paused therapy in psoriasis patients - both treatment regimens improved PGA scores and patient satisfaction, with satisfaction maintained during the re-treatment period in the paused group.
- Patients treated with Enbrel showed sustained improvements in Dermatology Life Quality Index (DLQI) for up to 54 weeks.
- Significant improvement in nail psoriasis was seen in Enbrel treated patients as early as Week 12 and was sustained for up to 54 weeks. Greater improvement in nail psoriasis was seen with continuous treatment; however, both groups showed continuing and significant improvement over 54 weeks, and the paused arm showed repeat response after re-treatment.
- Significant improvement in scalp psoriasis was seen in Enbrel treated patients as early as Week 3 and was sustained for up to 54 weeks. Greater improvement in Psoriasis Scalp Score (PSS) was seen with continuous treatment; however, improvement in the paused group was also seen and was maintained after re-treatment.
Enbrel once-weekly study details presented at Spring EADV
Data from a separate trial show that the new option of Enbrel once-weekly could also help to provide greater flexibility and convenience to improve the quality of life for patients with moderate-to-severe psoriasis. Patients with moderate-to-severe psoriasis entered this trial with serious PRO impairment, with Dermatology Life Quality Index (DLQI) (QoL indices) comparable to that of patients with severe chronic obstructive pulmonary disease (COPD). At week 12, patients receiving Enbrel 50 mg QW had significant improvements in PROs compared with patients receiving placebo. After 24 weeks of etanercept treatment, patients' serious PRO impairment was largely abated, consistent with improvements in clinical measures reported elsewhere.
Impact of Psoriasis
Across Europe 5.1 million people are estimated to have psoriasis, a distressing chronic inflammatory disease. Approximately 80 per cent of these patients have plaque psoriasis, which is characterised by red, scaly patches. 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 an increased risk of obesity, type 2 diabetes, liver disease and clinical depression.
Mara Maccarone, President of the Pan-European Psoriasis Patients Organisation Forum (PE.Pso.POF) commented, "Recently, research we conduced in the form of a pan-European patient survey highlighted the very real impact that psoriasis has on the daily lives of individuals and how in reality many patients delay seeking treatment. It is important that patients are given appropriate and effective treatments for their psoriasis as early as possible. With the advent of newer systemic treatments psoriasis patients have greater options tailored to their needs that can achieve skin clearance that will dramatically improve their lives. Our survey shows many patients who are eligible for biologics are not getting these treatments and are remaining on sub-optimal treatments for prolonged periods of time"
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
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