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In a manner similar to the COX inhibitor Vioxx, Raptiva became the latest victim of the pharmaceutical industry world-wide due to the development of serious side-effects in patients. Raptiva was approved in the US in 2003 and in Europe reaping millions of dollars in sales world-wide before being pulled from the market due to the reports of a multitude of side-effects in patients. Raptiva was voluntarily removed by Genetech in February of 2009 as soon as medical reports of two patients taking the drug developed progressive multifocal leukoencephalopathy (PML), a very severe neurodegenerative manifestation caused by a virus. A division of Merck in Europe has finally decided to recommend the suspension of the psoriasis drug Raptiva and to completely remove it from medical shelves. The straw that broke the camel’s back occurred when two additional patients in Germany taking Raptiva developed severe viral forms of PML. One case was not confirmed for the presence of the virus.
Raptiva is an immunosuppressant drug used for the treatment of severe plaque psoriasis in adults. Raptiva is a humanized antibody that targets the CD11 receptor of T lymphocytes and inhibits the activation and trafficking of this subpopulation of lymphocytes. Raptiva inhibits the release of inflammatory factors from T cells. Raptiva was once believed to be a very promising alternative for patients suffering from plaque psoriais that are intolerant to systemic immunosuppressant medication. It was previously known that Raptiva had many side effects which included fever, headaches, chills, and weakness. The report of PML cases came as a big surprise for Merck and Genetech since other immunosuppressants such as methotrexate and cyclosporine have been used in the past without causing a risk to developing infections.
What is psoriasis? Psoriasis is a chronic, relentless, autoimmune disorder that affects about 2-3% of the Western population (about 7 million Americans). It is characterized by the appearance of red scaly patches (psoriatic patches), areas of intense inflammation with a characteristic accumulation of excess skin and exudate matter. There are many forms of psoriasis which include plaque psoriasis, flexural psoriasis (affects wide patches of skin), guttate psoriasis (affects the groin area) and pustular psoriasis. About 80-90% of people with psoriasis are affected by plaque psoriasis which may or may not exhibit psoriatic arthritis. It is known that alcohol, beta-blockers (anti-hypertensive drugs), stress, and other factors that contribute to increasing oxidative stress increases the risk and worsens the clinical manifestations of psoriasis.
The causes of psoriasis are not known but it is thought to be caused by an autoimmune reaction in which a subpopulation of population of T cells (white blood cells involved in the humoral mediated immune response) have been found to be the culprit for mediating inflammation seen in psoriasis. Factors released by this population of T cells include cytokines, tumor necrosis factor and interleukins may contribute to the excessive inflammation and proliferation of skin cells seen in psoriatic plaques. However, one study published in Nature challenged the autoimmune theory of psoriasis as a mouse model that is deficient in T cells still develop psoriasis-like skin disease and arthritis. The disease may be hereditary as the scientific report showed that deleting a specific protein termed JunB in keratinocytes contributes to psoriasis-like inflammation in mice Current treatment for psoriasis include photo-therapy (UV mediated), topical ointments and creams, TNF receptors inhibitors (Adalimumab), interleukin inhibitors and the typical immunosuppressants such as cyclosporine.
Like diabetes, there is no cure for psoriasis. However, novel therapies are being developed every year with the promise to improve the quality of life. The use of immunosuppressants such as cyclosporine may predispose a patient with psoriasis to develop infections. However, targeting the chemicals release by over-activate T cells such as interleukins and cytokines without compromising other important immune functions of these cells may be the most promising therapy at this point. Instead of using systemic immunosuppressants that target T cell function, employing specific combination therapies for the treatment of severe plaque psoriasis that combine anti-interleukin and anti-cytokine humanized antibodies may yield a better prognosis in patients.
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To read the original press release: www.fiercebiotech.com/tags/raptiva-0