Ten years of Enbrel in Germany
16.04.2010 16:16
Successful TNF-a receptor therapy with etanercept
In Germany, patients with rheumatoid arthritis and polyarticular juvenile idiopathic arthritis have been able to benefit from therapy with the TNF-a receptor etanercept (Enbrel) since 2000. With the development of etanercept, the research-based pharmaceutical company Wyeth Pharma, a Pfizer Group company, has set a milestone in the development of biologics and is therefore part of the medical avant-garde in the areas of rheumatology and dermatology. Thanks to the company's continuous research work, patients with other chronic inflammatory diseases, such as plaque psoriasis, psoriatic arthritis or ankylosing spondylitis, can now also benefit from the innovative therapy principle.
Etanercept is a bioengineered replica of the natural TNF-a receptor. The fully human molecule binds elevated levels of TNF-a and thus inhibits the cytokine signaling cascade. This allows the inflammatory processes that occur in autoimmune diseases such as psoriasis or rheumatoid arthritis to be interrupted. The approval of Enbrel in Europe ten years ago brought significant progress in both rheumatology and dermatology: With the help of this modern active ingredient, it is now possible to achieve remission in the majority of patients, or to maintain the activity of the disease contain it and give patients back their quality of life with functionality. Nearly 600,000 patients worldwide have already been treated with Enbrel.
Approval history highlights success of etanercept
The first and to date only TNF-a receptor etanercept has been approved in Europe since 2000 for the treatment of moderate to severe active and severe active progressive rheumatoid arthritis and active polyarticular juvenile idiopathic arthritis from the age of four (in the USA Market launch two years earlier). Approval for active and progressive psoriatic arthritis followed in 2002, and for severe active ankylosing spondylitis (Bechterew's disease) and chronic severe psoriasis vulgaris of the plaque type in 2005. Since December 2008, Etanercept has also been available for the treatment of juvenile plaque-type Psoriasis indicated from eight years of age.
In addition, Wyeth Pharma makes therapy easier for patients through optimized therapy regimes and innovative application systems. Since summer 2009, self-injection of Enbrel has become even easier and safer: The new pre-filled pen MYCLIC has been approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis and psoriatic arthritis in adults.
Also since the summer of 2009, etanercept can be used in adult patients with plaque psoriasis in addition to intermittent therapy as a long-term treatment without treatment breaks. This approval extension enables treating physicians to have an individual therapy regimen and thus greater flexibility.
Large database through valid studies
A large number of controlled, randomized state-of-the-art studies with etanercept in various indications underline the effectiveness and tolerability of the active ingredient. The largest studies in the field of rheumatology include the COMET study1, which examines the effectiveness of etanercept plus methotrexate in early rheumatoid arthritis, the TEMPO study2, which primarily evaluates the radiological outcome, and the DART study3, which, among other things, takes cost aspects into account became. In dermatology, the focus is currently on the PRESTA study4 for the treatment of psoriatic arthritis. In addition, further studies are underway, for example on polyarticular juvenile idiopathic arthritis (Lovell study5), ankylosing spondylitis (ASCEND study6), plaque psoriasis (318 study) and juvenile plaque psoriasis (211 study). The favorable safety profile of etanercept is demonstrated by data from numerous national registries as well as long-term results of clinical studies, for example from the Canadian study 216, the 4.6-year results of which have recently been available.