Humira approved in Europe as psoriasis treatment

Humira, a biologic treatment already approved in the U.S. and Europe for psoriatic arthritis, has been approved by European regulators for moderate to severe psoriasis. It is expected to receive U.S. Food and Drug Administration approval as a psoriasis treatment in the near future.

Severe Psoriasis Associated with Increased Risk of Death

Psoriasis Cure Now, a nonprofit patient advocacy group, responded to a startling new study showing an association between severe psoriasis and a significantly increased risk of death, by renewing calls for more psoriasis research. The study, by a team of University of Pennsylvania School of Medicine researchers, found patients with severe psoriasis have a 50% increased risk of mortality as compared to comparable people without psoriasis. In sum, the study found women with severe psoriasis died 4.4 years earlier than women without psoriasis, while men with severe psoriasis died an average of 3.5 years earlier than men without the disease.

"This disturbing new finding is further evidence of the need for psoriasis to receive its fair share of federal research funding," said Michael Paranzino, president of Psoriasis Cure Now. "Even as funding for research on other diseases has doubled, psoriasis research funding has been stagnant. This study (available here) should be a wake-up call for Congress that psoriasis research funding is not only about their constituents' health and quality of life but may literally be a life and death matter. One dollar per patient per year is not enough."

He added: "It should also be a wake-up call for psoriasis patients. We have been passive and quiet for too long, and it is time we mobilized."

Here are two places to start, RIGHT NOW: 1) Write your lawmakers about psoriasis. 2) Volunteer!

Ustekinumab (CNTO 1275) FDA approval for psoriasis sought by Centocor

Centocor has filed an application with the U.S. Food and Drug Administration (FDA) seeking approval of its experimental treatment ustekinumab (previously known as CNTO 1275) for the treatment of adult patients with chronic moderate to severe plaque psoriasis. Centocor's Biologics License Application (BLA) submission means that FDA approval of ustekinumab for psoriasis could come as early as 2008. Ustekinumab has, to date, shown strong results with impressive safety in clinical trials.

Ustekinumab is a "new, human monoclonal antibody with a novel mechanism of action that targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are important in regulating immune responses and that are thought to be associated with some immune-mediated inflammatory disorders, including psoriasis," the company said in a statement.

Also today, Janssen-Cilag International NV, which owns the marketing rights for ustekinumab outside of the U.S., filed for European approval of the treatment.