You are here: >

National Psoriasis Foundation YouTube Fundraiser Video

Click here to watch:

http://www.youtube.com/watch?v=fmsGiL5p6cI

New FDA Approval

FDA OKs New Psoriasis Drug Stelara

Stelara Approved to Treat Moderate to Severe Plaque Psoriasis in Adults

By Miranda Hitti
WebMD Health News

Reviewed by Louise Chang, MD

Sept. 25, 2009 -- The FDA today approved a new biologic drug called Stelara for the treatment of moderate to severe plaque psoriasis in adults.

Plaque psoriasis is an immune system disorder that results in the rapid overproduction of skin cells. According to the FDA, about 6 million people in the U.S. have plaque psoriasis, which is characterized by thickened patches of inflamed, red skin, often covered with silvery scales.

Stelara is given by injection. After the first shot, patients get another shot four weeks later, and then a shot every 12 weeks.

An FDA advisory panel recommended the drug for FDA approval in June 2008. At the time, Stelara was referred to by the name of its active ingredient, ustekinumab.

"This approval provides an alternative treatment for people with plaque psoriasis, which can cause significant physical discomfort from pain and itching and result in poor self-image for people who are self-conscious about their appearance," Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, says in a news release.

Stelara is a monoclonal antibody, a lab-made molecule that mimics the body's own antibodies that are produced as part of the immune system. Stelara treats psoriasis by blocking the action of two proteins that contribute to the overproduction of skin cells and inflammation.

The FDA approved Stelara based on three studies of 2,266 patients who either got shots of Stelara or a placebo. Patients who got Stelara were more likely to achieve the studies' benchmark for reduction in psoriasis, according to Centocor Ortho Biotech Inc., which makes Stelara.

In a news release, the FDA notes that because Stelara reduces the immune system's ability to fight infections, the product poses a risk of infection. "Serious infections have been reported in patients receiving the product and some of them have led to hospitalization. These infections were caused by viruses, fungi, or bacteria that have spread throughout the body. There may also be an increased risk of developing cancer," the FDA states.

The FDA is requiring a risk evaluation and mitigation strategy for Stelara that includes a communication plan targeted to health care providers and a medication guide for patients.

Psoriasis Information

WHAT IS PSORIASIS?

Psoriasis is a chronic disease of the immune system that appears on the skin, usually in the form of thick, red, scaly patches. Up to 30 percent of people with psoriasis also develop psoriatic arthritis. Psoriasis is associated with other serious conditions such as diabetes, heart disease and obesity. According to the National Institutes of Health, as many as 7.5 million Americans have psoriasis.

BEYOND THE BOARDS BUZZWORDS….

There are five types of psoriasis: plaque, guttate, inverse, pustular and erythrodermic. The most common form, plaque psoriasis, appears as raised, red patches or lesions covered with a silvery white buildup of dead skin cells, called scale. Psoriasis can occur on any part of the body and as stated above, is associated with other serious health conditions, such as diabetes, heart disease and depression.

Plaque Psoriasis

Guttate Psoriasis

Inverse Psoriasis

Pustular Psoriasis

Erythrodermic Psoriasis

Pictures courtesy of National Psoriasis Foundation

WHAT CAUSES PSORIASIS?

No one knows exactly what causes psoriasis. However, it is understood that the immune system and genetics play major roles in its development. Most researchers agree that the immune system is somehow mistakenly triggered, which causes a series of events, including acceleration of skin cell growth. A normal skin cell matures and falls off the body in 28 to 30 days. A skin cell in a patient with psoriasis takes only 3 to 4 days to mature and instead of falling off (shedding), the cells pile up on the surface of the skin, forming psoriasis lesions.

Scientists believe that at least 10 percent of the general population inherits one or more of the genes that create a predisposition to psoriasis. However, only 2 percent to 3 percent of the population develops the disease. Researchers believe that for a person to develop psoriasis, the individual must have a combination of the genes that cause psoriasis and be exposed to specific external factors known as “triggers.”

TO FIND OUT MORE ABOUT PSORIASIS CHECK OUT THE NATIONAL PSORIASIS FOUNDATION

http://www.psoriasis.org/netcommunity/home

ADVOCACY

Psoriasis Action Network

Psoriasis Awareness

The National Psoriasis Foundation Walk to Cure Psoriasis is a nationwide program designed to generate awareness about psoriasis and psoriatic arthritis and raise money for the National Psoriasis Foundation for education, advocacy and research programs. In just over 2 years, the NPF has raised over $1.3 million for research projects and over 6500 walkers and volunteers have been involved! There are 13 upcoming walks all over the United States!

Please register for the walk today at www.psoriasis.org/walk. On the website, you can form a team for your classmates or your dermatology interest group and each member of the team can help with fundraising. It takes less than 5 minutes to register online! All the information is on the website, which also helps track your team's progress in fundraising. Additionally, you can contact Liz Fischer, Walk Manager at lfischer@psoriasis.org or at 1-800-723-9166 x368 with any questions.

We would really encourage you to form a team and participate in a walk which is close to you. This is a fun way to raise money for a great cause!

2009 Schedule of Walks

Walk Details

Psoriasis at the Summer AAD Meeting

Role of psoriasis as systemic disease examined

Mark Lebwohl, M.D., chair, department of dermatology, Mount Sinai School of Medicine, New York, presented “Psoriasis, A Newly Defined Systemic Illness. Do Treatments Affect Comorbidities?” at the plenary session on July 31. He emphasized that psoriasis is a systemic illness and summarized several studies that demonstrate an increase in myocardial infarctions, strokes, peripheral vascular disease, diabetes, hypertension, hyperlipidemia, markers of inflammation, and in metabolic syndrome in patients who have psoriasis.

Dr. Lebwohl referenced a recent study published in the Journal of the American Medical Association that was conducted by Joel M. Gelfand, M.D., titled, “Risk of Myocardial Infarction in Patients With Psoriasis”.

Because psoriasis is the most common T-helper cell type 1 (T_H1) immunological disease, evidence has linked T_H1 diseases to myocardial infarction. The study concluded that patients who have psoriasis have an increased adjusted relative risk for myocardial infarction that varies by age. For example, the risk of myocardial infarction in psoriasis patients who are 30 years old is increased threefold.

Dr. Lebwohl also noted findings of an increase in peripheral vascular disease, coronary artery calcification, cardiovascular disease and strokes in psoriasis sufferers.

Obesity is another comorbidity of concern. Dr. Lebwohl cited a Utah study that showed 34 percent of psoriasis patients were obese, as opposed to 18 percent in the control group.

In addition, incidence of diabetes is more than double in patients with psoriasis, who also have increased rates of hyperlipidemia and hypertension, as well as smoking.

Another study shows that metabolic syndrome exists in more than 30 percent of psoriasis patients, compared to 20 percent of controls. Also present is a 40 percent increase in ischemic heart disease.

Patients can reduce their risks for these diseases, but Dr. Lebwohl reports that “they seem to be doing the opposite.” He emphasized that psoriasis patients are more likely to smoke, less likely to exercise, and less likely to maintain a healthy diet.

The same markers that show inflammation in psoriasis contribute to the development of cardiovascular disease, including C-reactive protein, leptins, adoponectin and homocysteine.

A few treatments for psoriasis protect against some of the factors that contribute to cardiovascular disease. Etanercept has been shown to improve insulin sensitivity and has been used therapeutically to improve the response to insulin. A recent psoriasis study published by Bruce Strober, M.D., Ph.D., shows that treating patients with etanercept produced a dramatic reduction in C-reactive protein. TNF blockers and methotrexate also can help reduce comorbidities.

A five-year study of the use of TNF blockers in rheumatoid arthritis patients demonstrated a 50 percent reduction in heart attacks.

A British study showed a reduction in heart disease in patients treated with methotrexate. However, Dr. Lebwohl left the audience with one caveat: “Lest I leave here telling you we should prescribe these for heart disease, let me tell you that the data are not there yet. These drugs all have side effects. At least the trend in registries is that there is a reduction in cardiovascular disease in patients treated with methotrexate and TNF blockers.”

Psoriasis Awareness Month

A link to information on Psoriasis Advocacy