Stelara™ (ustekinamab) Approved by FDA for Psoriasis Treatment
September 28, 2009
The U.S. Food and Drug Administration recently approved Stelara (ustekinumab), a new "biologic" medication for the treatment of moderate to severe psoriasis in adults.
Stelara is the first of a new type of biologic medication. Stelara's unique mechanism of action blocks interleukin-12 and interleukin-23, immune-system proteins which contribute to inflammation and the overproduction of skin cells. Other biologic medication block different components of the immune system, such as TNF (tumor necrosis factor).
Stelara is injected into the skin twice in the first month, followed by dosing just four times per year. The relatively long duration between treatments (only 5 doses per year) is one of the benefits of Stelara that will be welcomed by many psoriasis patients. Unlike some biologic medications that may be self-injected at home, Stelara should be administered by a medical professional.
Three clinical studies of 2,266 psoriasis patients showed Stelara to be safe and effective for the treatment of moderate to severe psoriasis.
A Stelara clinical trial, published in May 2008 in the medical Journal Lancet and referred to as the "PHOENIX 1" study concluded that "ustekinumab seems to be efficacious for the treatment of moderate-to-severe psoriasis; dosing every 12 weeks maintains efficacy for at least a year in most patients."
Additional studies showed that 2 out of 3 patients treated with Stelara saw at least 75% skin clearance of their psoriasis lesions after 12 weeks of treatment.
"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," said Julie Beitz, M.D., director, Office of Drug Evaluation III, in the FDA's Center for Drug Evaluation and Research.
Stelara is manufactured by Centocor Ortho Biotech Inc., a subsidiary of Johnson & Johnson.
People with Psoriasis At Risk for Other Medical Conditions
September 14, 2009
A new survey by the National Psoriasis Foundation of 5,000 people with psoriasis reveals that people with psoriasis are at risk for developing other serious medical conditions, including heart disease, diabetes and obesity.
According to the patient survey:
- Nearly 70 percent of people with psoriasis are overweight or obese.
- 33 percent have high blood pressure.
- 28 percent have another chronic, inflammatory disease such as lupus, Crohn's disease or multiple sclerosis.
- 24 percent have high cholesterol.
- 11 percent have diabetes.
"Psoriasis is a very serious condition that impacts the body well beyond the skin," said Mark Lebwohl, M.D., professor and chairman of dermatology at the Mount. Sinai School of Medicine and chair of the National Psoriasis Foundation Medical Board. "Like any patient with a chronic disease, people with psoriasis must see their doctor regularly and adopt a healthy lifestyle to lessen their risk of developing another serious disease."
Additionally, up to 30 percent of people with psoriasis develop psoriatic arthritis, which causes pain, swelling and stiffness around the joints. People with mild psoriasis are just as likely to develop psoriatic arthritis as those with moderate or severe forms of the disease.
The National Psoriasis Foundation urges people with psoriasis and psoriatic arthritis to work with their dermatologists to find an appropriate treatment regimen to help manage their disease. Learn more about this psoriasis survey from the National Psoriasis Foundation.
New Psoriasis Treatments Guidelines from the American Academy of Dermatology
July 8, 2009
The American Academy of Dermatology (AAD) has released new care guidelines for the management of psoriasis after an extensive analysis of recent psoriasis studies by psoriasis experts.
The new published in the May 2009 issue of the Journal of the American Academy of Dermatology, serve as recommendations for treating patients with mild to severe cases of psoriasis and psoriatic arthritis.
The 4 published guidelines include (PDFs):
- Treatment of Psoriasis with Biologics
- Treatment of Psoriatic Arthritis with Biologics
- Treatment of Psoriasis with Topical Therapies
- Treatment of Psoriasis with Systemic Agents
In a statement issued by the Academy, AAD President C. William Hanke, M.D., says, "As a result of the impartial analysis of the most current research, physicians now have evidence-based guidelines which will help enhance the quality of care for patients and, ultimately, their safety. The guidelines for psoriasis and psoriatic arthritis, which focus on the use of biologics, are the first phase of the academy’s efforts."
Additional guidelines regarding the treatment of psoriasis with light therapies are being developed.
August is Psoriasis Awareness Month
Sponsored by the National Psoriasis Foundation every August, Psoriasis Awareness Month is dedicated to raising awareness, educating the public and dispelling myths about the disease.
Over 7.5 million people in the United States are diagnosed with psoriasis. This condition can be hard for children and teens to deal with daily as well as for adults. Each year, 1 in 5 people with the condition report being discriminated against at a public pool. This month is your chance to increase awareness about the disease and educate the public that the condition is not contagious. Help spread the word that pools are for recreation, not discrimination. Learn more about the Psoriasis Awareness Month.
Addressing Psoriasis™ Fashion Show
Meet the eight winners who will walk the runway in the Addressing Psoriasis™ Fashion Show. Read their stories and cast your vote for the most inspirational. Vote Now.
Nearly 7 million Americans suffer from the condition, which is a chronic disease of the immune system that causes the skin cells to grow at an accelerated rate. Although there are several types of psoriasis, approximately 80 percent of patients suffer from plaque psoriasis, which causes painful and itchy red, scaly patches. It is a chronic condition that can have a significant impact on the lifestyle of those who live with the disease, including their personal style.
Eight people with moderate to severe plaque psoriasis have won a trip to New York City and will help raise awareness of this condition by walking the runway in the fashion show hosted by Tim Gunn on September 2, 2009.
The campaign was developed to inspire people with plaque psoriasis to be confident and not allow the condition to inhibit their everyday style. The campaign is sponsored by Amgen and Wyeth with participation from the American Academy of Dermatology, the National Psoriasis Foundation and Psoriasis Cure Now.
Vectical® Ointment for Mild-to-Moderate Plaque Psoriasis
Vectical® ointment (calcitriol) is a new a topical treatment for mild-to-moderate plaque psoriasis in adults. Calcitriol is the naturally-occurring, active form of vitamin D3 and is well-tolerated even when applied to sensitive skin fold areas.
Studies compared twice-daily doses of Vectical Ointment to placebo. Improvements in those with mild-to-moderate plaque psoriasis began after 2 weeks among those who used Vectical. By the end of the study, 34 percent of patients using Vectical achieved treatment success, compared with 22 percent of those treated with placebo.
Raptiva Withdrawal
On April 8, 2009, Genentech, Inc. announced a phased voluntary withdrawal of Raptiva from the U.S. Market. The drug was no longer available after June 8, 2009. Other biologic treatments for psoriasis, including Amevive, Enbrel, Humira, and Remicade, remain available by prescription. Learn more about with withdrawal of Raptiva.
Stop Hiding from Psoriasis
The American Academy of Dermatology and the National Psoriasis Foundation (NPF) have joined forces to launch the Stop Hiding from Psoriasis public education campaign. The goals of the campaign are to educate the public and to motivate people suffering from psoriasis to stop hiding and start living. Join the Stop Hiding campaign.
Simponi (golimumab) Receives FDA Approval for Treatment of Psoriatic Arthritis.
The FDA has approved Simponi (golimumab) for the treatment of moderately to severely active psoriatic arthritis. Simponi is an anti-tumor necrosis factor (TNF)-alpha therapy that patients can self-administer once a month. Read more about Simponi.
New Guidelines for the Management of Psoriasis with Topical Therapies
The new psoriasis guidelines present the latest recommendations for treating patients with psoriasis with topical agents (those that are applied to the skin). These include corticosteroids (clobetasol, Clobex, Olux, Vanos), vitamin D analogues (Vectical), combination calcipotriene/betamethasone propionate ointment (Taclonex), tazarotene (Tazorac), and calcineurin inhibitors (Elidel, Protopic)
According to these guidelines, topical therapies can be used safely and effectively in the majority of patients with mild to moderate psoriasis. However, topical therapies should not be used exclusively without other complementary treatments in cases of moderate to severe psoriasis or when the condition is limited but hard to manage.
The guidelines provide dermatologists with the framework for determining if a topical therapy alone or in conjunction with ultraviolet light, systemic or biologic medications will effectively manage a patient's condition. Nonetheless, treatments should be tailored to meet individual patients' needs, which vary depending on body location, characteristics of the psoriasis being treated and patient preferences.
Read more about these psoriasis guidelines at the American Academy of Dermatology (AAD) Website.
More treatment options on the way for people with psoriasis
Biologics have emerged as a promising treatment option for people with moderate to severe psoriasis that have not responded to other treatments. Biologic medications are administered via injection or IV infusion, similar to insulin or vaccines.
There are currently five biologic medications available to treat psoriasis:
That number is likely to rise soon as researchers and pharmaceutical firms work to develop new treatments:
Ustekinumab, a biologic that treats moderate to severe psoriasis, is currently in an extended FDA approval process, which should be completed by December 2008. Ustekinumab is the first interleukin inhibitor designed specifically to treat psoriasis.
Golimumab produced encouraging results during recent Phase 3 trials for people suffering from psoriatic arthritis (as well as two other forms of arthritis), and its manufacturer applied for FDA approval over the summer.
Because psoriasis affects each person differently, not everyone responds the same way to biologic medications. Ustekinumab and golimumab will, hopefully, widen the variety of biologic treatment options.
Find a Dermatologist near you who specializes in the treatment of skin disorders and beauty enhancement.
