11 December 2006: Patients receiving the anti-TNF therapy, Enbrel, may soon find it easier to self-inject with the launch of a new 50 mg pre-filled syringe (PFS)*. This is the first time that Enbrel has been made available to patients with rheumatoid arthritis (RA), psoriatic arthritis and ankylosing spondylitis in a ready-to-use format.
The PFS is now available to all patients already receiving Enbrel via their pharmacist, as well as to all new patients.
Patients receiving Enbrel at home will be switched to the 50mg PFS in March 2007. Patients prescribed twice-weekly Enbrel will have access to a 25mg pre-filled syringe from early next year.
Professor Robert Moots, Professor of Rheumatology at the University of Liverpool, welcomes the launch of the new syringe, “This new once-weekly formulation should be much easier for patients to use, providing greater freedom in the management of their condition and leading to improved compliance. Without the correct treatment, conditions such as rheumatoid arthritis can be most debilitating and an easy to use treatment will have a huge impact on patients’ quality of life.”
Dr Christian Felter, Medical Manager, Wyeth, says, “The pre-filled syringe is premixed and pre-filled, which should make it much easier for patients to self-administer. In addition, the new syringe is likely to ease gripping and handling, which is essential for patients with limited joint movement”.
The efficacy and safety profile of the new Enbrel 50mg PFS formulation has been proven in a rheumatoid arthritis clinical trial1. A range of training and educational materials is available to support both clinician and patient needs.
NICE recommended the use of Enbrel in the treatment of active rheumatoid arthritis in 20022 and for severe psoriasis and severe active psoriatic arthritis in July 20063,4 for the treatment of adults who meet NICE guidance criteria; a decision is expected on ankylosing spondylitis in 2007.
ENBREL has 920,0005 patient years of real world experience and is backed by 14 years of collective clinical experience 6.
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In the European Union, 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 the 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.
Enbrel is also approved for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Enbrel (25 mg only) is indicated for 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.
Enbrel is approved for the 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 approved for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. 7
2.NICE Technology Appraisal Guidance – No. 36 March 2002. Etanercept and infliximab for the treatment of rheumatoid arthritis.
3.NICE Technology Appraisal Guidance – No. 103 July 2006. Etanercept and infliximab for the treatment of adults with psoriasis.
4.NICE Technology Appraisal Guidance – No. 104 July 2006. Etanercept and infliximab for the treatment of adults with psoriatic arthritis.
7.Enbrel Summary of Product Characteristics October 2006