FDA Approves New Drug to Treat Psoriasis

The U.S. Food and Drug Administration approved Stelara (ustekinumab), a biologic product for adults who have a moderate to severe form of psoriasis.

Ustekinumab is the first in a new class of biologics, for psoriasis. This new human interleukin-12 and -23 antagonist is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Ustekinumab treats psoriasis by blocking the action of two proteins that contribute to the overproduction of skin cells and inflammation.

Ustekinumab is administered subcutaneously as a weight-based dose. For patients weighing less than 100 kg (220 lbs), the recommended dose is 45 mg initially and four weeks later, followed by 45 mg every 12 weeks. For patients weighing >100 kg (220 lbs), the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks. Nurses should use caution when drawing up and administering the drug to avoid dosing errors as it is available and packaged in two different dosage strengths: 45 mg/0.5 mL in a single-use glass vial and 90 mg/1 mL in a single-use glass vial.

The most common adverse reactions reported include nasopharyngitis, upper respiratory tract infection, headache, and fatigue. Adverse drug reactions may also occur at the site of administration including cellulitis, pain, swelling, pruritus, induration, hemorrhage, bruising, and irritation.

Because ustekinumab reduces the immune system’s ability to fight infections, it poses a risk of infection. Serious infections have been reported with ustekinumab, some leading 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, and ongoing studies are evaluating this risk. Before initiation of therapy, patients should be evaluated for tuberculosis and, if indicated, treated with antitubercular drug therapy before initiating ustekinumab therapy.

Ustekinumab therapy complicates vaccination administration. Non-live vaccines may be ineffective when administered during treatment. Patients receiving ustekinumab therapy must not, however, receive any live vaccines, nor should their household contacts because of the potential risk for shedding from the household contact and transmission to patient.

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FDA OKs New Psoriasis Drug Stelara

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.

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Psoriasis Questions, Answers and Advice

According to the Natural Psoriasis Foundation, between 150,000 and 260,000 new cases of Psoriasis are diagnosed each year and as many as many as 7.5 million Americans have psoriasis. Psoriasis [pronounced sore-EYE-ah-sis] is a noncontagious, auto immune, lifelong skin disease. It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells. Psoriasis is not contagious.

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 is associated with other serious health conditions, such as diabetes, heart disease and depression.

In addition to its physical impact on your skin, psoriasis can also affect your emotional, psychological and social well-being. This visible and lifelong disease may change how you view yourself and interact with others. For the most part, people with psoriasis function normally. Sometimes people experience low self-esteem because of the psoriasis. Psoriasis is often misunderstood by the public, which can make social interactions difficult. This may lead to emotional reactions such as anxiety, anger, embarrassment and depression. Psoriasis can affect the type of work people do if it is visible.

Frequently asked questions about Psoriasis

Psoriasis is an immune-mediated, genetic disease manifesting in the skin and/or the joints. According to the National Institutes of Health, as many as 7.5 million Americans have psoriasis. In plaque psoriasis, the most common type, patches of skin called "lesions" become inflamed and are covered by silvery white scale. Psoriasis can be limited to a few lesions or can involve moderate to large areas of skin. The severity of psoriasis can vary from person to person; however, for most people, psoriasis tends to be mild.

Is psoriasis contagious?

No, psoriasis is not contagious. It is not something you can "catch" or "pass on." The psoriatic lesions may not look good, but they are not infections or open wounds. People with psoriasis pose no threat to the health or safety of others.

What causes psoriasis?

No one knows exactly what causes psoriasis, but it is believed to have a genetic component. Most researchers agree that the immune system is somehow mistakenly triggered, which speeds up the growth cycle of skin cells. A normal skin cell matures and falls off the body's surface in 28 to 30 days. But a psoriatic skin cell takes only three to four days to mature and move to the surface. Instead of falling off (shedding), the cells pile up and form the lesions.

How is psoriasis diagnosed?

No special blood tests or diagnostic tools exist to diagnose psoriasis. The physician or other health care provider usually examines the affected skin and decides if it is from psoriasis. Less often, the physician examines a piece of skin (biopsy) under the microscope.

Is there a cure for psoriasis?

There is no cure, but many different treatments, both topical (on the skin) and systemic (throughout the body) such as Dermasis, can clear psoriasis for periods of time. People often need to try out different treatments before they find one that works for them.

What treatments are the best for me?

The unpredictable nature of psoriasis makes treatment challenging for many people. A wide range of treatments is available. No single psoriasis treatment works for everyone, but something will work for most people. It is hard to predict what will work for a particular individual; however, it is important to be open-minded and willing to work with your doctor to find a treatment that will work for you.

Is all psoriasis alike?

No. There are various forms of psoriasis. Plaque psoriasis is the most common. Other forms are:

* Guttate [GUH-tate], characterized by small dot-like lesions
* Pustular [PUHS-choo-ler], characterized by weeping lesions and intense scaling
* Inverse, characterized by intense inflammation
* Erythrodermic [eh-REETH-ro-der-mik], characterized by intense shedding and redness of the skin

Psoriasis can range from mild to moderate to very severe and disabling.

Can psoriasis affect all parts of the body?

Psoriasis most commonly appears on the scalp, knees, elbows and torso. But psoriasis can develop anywhere, including the nails, palms, soles, genitals and face (which is rare). Often the lesions appear symmetrically, which means in the same place on the right and left sides of the body.

Can psoriasis occur at any age?

Psoriasis often appears between the ages of 15 and 35, but it can develop at any age. Approximately 10 percent to 15 percent of those with psoriasis get it before age 10. Some infants have psoriasis, although this is considered rare.

Is psoriasis more prevalent in men or women, or in different ethnic groups?

Psoriasis occurs nearly equally in men and women across all socioeconomic groups. It is also present in all racial groups, but in varying rates.

What health complications are associated with psoriasis?

The skin, the largest organ in the body, plays an important role. It controls body temperature and serves as a barrier to infection. Large areas of psoriasis can lead to infection, fluid loss and poor blood flow (circulation).

Is psoriasis linked to other diseases?

Psoriatic arthritis is a specific type of arthritis that has been diagnosed in approximately 23 percent of people who have psoriasis, according to the Psoriasis Foundation's 2001 Benchmark Survey. Psoriatic arthritis is similar to rheumatoid arthritis but generally milder. In psoriatic arthritis, the joints and the soft tissue around them become inflamed and stiff. Psoriatic arthritis can affect the fingers and toes and may involve the, neck, lower back, knees and ankles. In severe cases, psoriatic arthritis can be disabling and cause irreversible damage to joints.

If I have psoriasis does that mean I will develop psoriatic arthritis?

Approximately 10 percent to 30 percent of people with psoriasis will develop psoriatic arthritis, although it often may go undiagnosed, particularly in its milder forms. It can develop at any time, but for most people it appears between the ages of 30 and 50. Having psoriasis does not guarantee that you will eventually develop psoriatic arthritis.

How severe can my psoriasis become?

Psoriasis can be mild, moderate or severe. Three percent to 10 percent of the body affected by psoriasis is considered to be a moderate case. More than 10 percent is considered severe. The palm of the hand equals 1 percent of the skin. However, the severity of psoriasis is also measured by how psoriasis affects a person's quality of life. Psoriasis can have a serious impact even if it involves a small area, such as the palms of the hands or soles of the feet.

What are psoriasis triggers?

Triggers can include emotional stress, injury to the skin, some types of infection and reactions to certain drugs. Stress can cause psoriasis to flare for the first time or aggravate existing psoriasis. Psoriasis can also be triggered in areas of the skin that have been injured or traumatized. This is known as the "Koebner phenomenon." Vaccinations, sunburns and scratches can all trigger a Koebner response. The Koebner response can be treated if it is caught early enough. Certain medications, like antimalarial drugs, lithium and certain beta-blockers, are also known to cause people's psoriasis to flare. Other triggers may include weather, diet and allergies. Triggers will vary from person to person and what may cause one person's psoriasis to flare may produce no reaction in another individual.

Why does my psoriasis itch, and how do I control the itching?

Itching that is associated with psoriasis arises when certain chemicals stimulate nerve fibers just below the outer layer of the skin. Itch messages travel to the brain along the same pathways in the nervous system that carry pain messages. Itch messages trigger the urge to scratch.

One of the simplest ways for people with psoriasis to control itch is by keeping the skin moisturized. Dry skin can induce and aggravate itch. Many people also rely on simple, inexpensive measures, such as pressing a wet towel against the itchy spot. Others find cold showers and cold packs offer relief. Other treatments for itch include antihistamines, steroids, capsaicin, topical anesthetics, topical immunomodulators, antidepressants and aspirin.

Will having psoriasis affect my lifestyle or quality of life?

For the most part, people with psoriasis function normally. Sometimes people experience low self-esteem because of the psoriasis. Psoriasis is often misunderstood by the public, which can make social interactions difficult. This may lead to emotional reactions such as anxiety, anger, embarrassment and depression. Psoriasis can affect the type of work people do if it is visible.

What is the financial impact of psoriasis?

Psoriasis is a chronic (life-long) illness. Most people need ongoing treatments and visits to the doctor. In severe cases, people may need to be hospitalized. About 56 million hours of work are lost each year by people who suffer from psoriasis, and between $1.6 billion and $3.2 billion is spent per year to treat psoriasis.

Is there hope for a cure?

Yes. Researchers are studying psoriasis more than ever before. They understand much more about its genetic causes and how it involves the immune system. The National Psoriasis Foundation and the federal government are promoting and funding research to find the cause and cure for psoriasis.

If you have Psoriasis, getting relief for your skin is a top priority. While there is currently no cure, the FDA-approved active ingredient in Dermasis Psoriasis Cream works to help control your skin symptoms in a smooth, non-greasy formula that absorbs quickly—and will not stain your clothes or skin.Dermasis Psoriasis Cream helps fight the symptoms that cause your skin to look red and patchy with a two-fold approach: encouraging shedding of dead skin cells and penetrates deep down to moisturize your skin.

Psoriasis causes your skin cells to replicate at an extremely rapid rate (about 8 times faster than normal), which makes cells build up on your skin's surface—forming thick, unsightly patches (or plaques) of red lesions covered in dead skin. Dermasis's active ingredient, 2% Salicylic Acid, stimulates the shedding of this layer of dead skin cells to help alleviate your psoriasis. It also has ingredients to help deep moisturize your skin.

Dermasis uses gentle moisturizers, essential oils, emollients and PH balancers to help your skin feel smoother and promote healing, including:

Palm Oil: Easily penetrates the skin, and forms a thin, protective layer.

Vitamin E Acetate: A powerful antioxidant that increases moisture of the skin's outer layer and may provide protection against Ultra Violet damage.

Melaleuca Alternifolia (Tea Trea Oil): This essential oil has been used by Australian Aborigines for hundreds of years to promote healthy skin.

If you are ready to sooth the itching, redness, and scaling of Psoriasis then Dermasis Psoriasis cream maybe right for you. To learn more about how this cream can help you visit my website http://prescriptiondrugcafe.com.

by : Simon Jones
Source : www.articlecity.com

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