NICE backs use of Enbrel and Raptiva to treat severe psoriasis

Jul 26 2006

The UK National Institute for Health and Clinical Excellence (NICE) has today issued guidance for the use of the targeted biological therapies, Enbrel (etanercept) and Raptiva (efalizumab), to treat adult patients with severe plaque psoriasis.

However, top experts have expressed their concerns that many patients across Europe could still be denied treatment with this newest class of drugs due to funding issues.

NICE's announcement comes as welcome relief to the thousands of UK patients who have exhausted current available treatment options and failed to sustain a long-term benefit. It is a positive sign for patients throughout Europe, whose healthcare systems are influenced by NICE decisions. Leeroy Blake in England was fortunate enough to be offered treatment with a biological therapy, after years of trying every other available psoriasis treatment: "For many years, I tried every suitable treatment but nothing seemed to relieve the painful itching. As the itching got worse, I would get more stressed and this only made my condition worse. Following a treatment review with my doctor, I was prescribed a biological therapy and for the first time since developing psoriasis, my skin started to clear and my confidence came back. This treatment might not be suitable for everyone with severe psoriasis, but I think that it's important that patients at least discuss this option with their doctor".

Latest research has dismissed the preconception that psoriasis is merely a skin complaint, with recent data showing that severe psoriasis can affect a patient's quality of life to a similar extent as other prevalent chronic diseases such as diabetes and even heart diseases.

In addition to the impact on a patient's appearance, up to 30% of patients with psoriasis have been reported to have psoriatic arthritis, which causes pain, stiffness and swelling in and around the joints. Coinciding with its decision on the use of biological therapies in moderate to severe psoriasis, NICE has also given its backing for the NHS to use Enbrel and Remicade (infliximab) to treat patients with severe, active psoriatic arthritis. Professor Robert Moots, Professor of Rheumatology at the University of Liverpool, UK welcomes this guidance commenting, "the NICE guidance is a positive step forward for those patients whose condition is severe enough to warrant treatment with biologic therapies" adding that "the onus is now on NHS trusts to take note of this recent recommendation and ensure that the necessary funding is in place to allow patients access to these much-needed therapies."

This latest NICE guidance should now ensure that for adult patients with severe plaque psoriasis, who have failed on standard therapies, these new treatment options can now be made available. Lars Ettarp, President of the International Federation of Psoriasis Associations (IFPA) underlines that "psoriasis is a systemic disease and that IFPA welcomes the new therapies in the treatment of severe psoriasis/psoriatic arthritis. The national healthcare providers must now make funding for these new drugs available in order to help these really sick persons."

Professor Knud Kragballe, Department of Dermatology, Aarhus University Hospital in Denmark, has echoed this call: "Health care providers throughout Europe should take note of these recommendations and ensure that necessary funding is in place to allow access to biological therapies. Psoriasis can be highly debilitating and painful condition. If patients fulfill the criteria for a biological therapy then, I believe, it is important that treatment is started with minimal delay."

Stevo Knezevic, MD, PhD, chief medical officer of Wyeth Europa commented: "This endorsement of biological therapies is excellent news for psoriatic patients across Europe and the healthcare professionals who care for them. It is now vital that healthcare providers take note of the positive NICE decision, the opinion of dermatologists and the needs of psoriatic patients, and make funding for these therapies available as quickly as possible."

Patients who would like to find out more about biological therapy are advised to talk to their dermatologist.

In the European Union, 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 (Psoralen (a light-sensitizing medication) combined with exposure to ultraviolet light A (UVA). 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.

Physicians in Europe have become familiar with the benefits and long-term tolerability profile of Enbrel since it became commercially available over six years ago. More than 400,000 patients have been treated worldwide across indications. Enbrel is a recombinant human tumour necrosis factor (TNF) receptor fusion protein that inhibits the activity of TNF. TNF is a cytokine that is released from T lymphocytes; it mediates inflammation and modulates the cellular immune response. Enbrel is also indicated for treatment of the following:

• Severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
• Active Juvenile Idiopathic Arthritis in children 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.
• Severe active ankylosing spondylitis in adults who have had an inadequate response to conventional therapy.

Since the product was first introduced, serious infections, some involving death, have been reported in patients using Enbrel. Patients should tell their doctor if they currently have an infection or are prone to getting infections. Patients should not start Enbrel if they have an infection of any type or an allergy to Enbrel or its components. Enbrel should be used with caution in patients prone to infection.

There have been reports of serious nervous-system disorders such as multiple sclerosis and/or inflammation of the nerves of the eyes. Patients should inform their doctor if they have ever had any of these disorders or if they develop them after starting Enbrel. Patients should also tell their doctor if they have ever been treated for heart failure. There also have been rare reports of serious blood disorders, some involving death.

Patients should contact their doctor immediately if they develop symptoms such as persistent fever, bruising, bleeding, or paleness. It is unclear if Enbrel has caused these nervous-system or blood disorders. If a patient's doctor confirms serious blood problems, patients may need to stop using Enbrel.