Three-Month, Updated FDA Decision Calendar Seeking Alpha, NY - A decision is also possible in December for JNJ and Medarex (MEDX) for a biological agent, Stelara (ustekinumab), in the treatment of psoriasis ? with a FDA ...
Indigo ointment may harbour safe and effective psoriasis cure Newspost Online, India - Nov 30, 2008 ... which is a dark blue plant-based powder used in traditional Chinese medicine, may help treat patients with psoriasis, according to a new report. ...
There?s no cure for psoriasis, but there are treatments Daily Comet, LA - Nov 25, 2008 For most patients, psoriasis is a long-term condition. Although there is no cure, there are many effective treatments. Now, thanks to a surge in new...
Wyeth's new indication for psoriasis drug wins EU positive ... Trading Markets (press release), CA - Nov 24, 2008 Enbrel is currently approved in the EU for the treatment of moderate-to-severe plaque psoriasis in adults, as well as for ankylosing spondylitis, ...
Indigo extract effective treatment for psoriasis Reuters UK, UK - Nov 26, 2008 NEW YORK (Reuters Health) - Taiwanese investigators report that an ointment made from an extract of Indigo naturalis is effective in treatment-resistant ...
Teach old hair new tricks Chicago Tribune, United States - Nov 30, 2008 Psoriasis on scalp. "I'm in a double bind because my scalp feels better if I wash my hair every day, but my hair gets way too dry."
The Culling Fields Business Mirror, Philippines - Sure, it interferes with sex, but so does asthma, not to mention psoriasis and bad breath, which are definite turnoffs. Redundant. ...
Micromet Added to NASDAQ Biotechnology Index MarketWatch - Nov 26, 2008 The Company is focused on developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases. ...TO - MITI - IBB
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New Treatment for Psoriasis: Are We Finally on the Right Track?
There is new hope for over 6 million people in the United States living with psoriasis, a condition that causes an overproduction of skin cells. Once thought of as just a skin condition, doctors now know that psoriasis is a disorder of the immune system. Most people suffer with only mild forms of the disease, and manage symptoms with topical skin medications. But for 1/3 of those living with moderate to severe psoriasis, between 2 and 10% of the body is covered in flaky, itchy patches of skin. Psoriasis is often painful and emotionally taxing, and those with the condition often endure time consuming and inconvenient treatments, which, though effective, can have a widespread impact on the body. But a new treatment option is now offering patients a badly needed alternative. In January 2003, the U.S. Food and Drug Administration (FDA) approved the drug alefacept (brand name Amevive) for the treatment of moderate to severe forms of psoriasis. Alefacept is part of a class of drugs called "biologics." medicines that harness the immune system to change the course of the disease. Below, psoriasis expert and dermatologist Dr. Kenneth Gordon explains how biologics work, and how they stand to improve the lives of people living with serious psoriasis.
What are some of the traditional medications for moderate to severe psoriasis?
People with moderate to severe psoriasis often require drugs to suppress the immune system, such as cyclosporin and methotrexate. These medications can treat your psoriasis, but they’re very nonspecific; they can affect many different organs in the body. Some can cause kidney damage, affect the liver-in some cases, even cause fibrosis and cirrhosis of the liver. They can be used safely in the context of a well-trained dermatologist’s office, but there are clear risks to them.
What are biologic medications?
Biologic medications are proteins that are developed in a laboratory using genetic engineering. They can be directed specifically against molecules in the immune system that affect the cells that cause psoriasis. The medications target specific markers on the immune system, disrupts the processes in the immune system that cause psoriasis, but do not affect other organs in the body.
There are different biologics, and they each have different effects. Alefacept, the molecule that’s recently been approved by the FDA for moderate to severe psoriasis, works by attacking the specific T-cells that are important for the psoriasis itself. It eliminates or decreases the number of cells that cause the disease.
How are biologics given?
Since it is a protein, it would be broken down in the stomach or the digestive tract if administered in pill form, so it must be given in a way to avoid the digestive system. So it’s either given intramuscularly, intravenously or subcutaneously into the skin, and requires that patients come into the doctors office.
Many of these patients are used to coming in for phototherapy, which requires that they come to the office about three times a week. So coming in to receive the biologic treatment is often not a huge change for many patients.
How do these medication cause improvement in psoriasis?
We mark psoriasis improvement with a score that we call the PASI, the Psoriasis Area and Severity Index. A 50% improvement in that score is thought to be a very significant response. With biologics, the great majority of patients will reach that 50% improvement in the psoriasis score, which is the clinically acceptable rate of psoriasis remission.
None of these drugs will actually get rid of psoriasis forever. Moreover, complete clearing of psoriasis is not necessarily a goal either. Very few patients will have no psoriasis on their body when they’re done with the medication. It’s really that PASI 50 that we’re shooting for, and the majority of patients taking the biologics reach that level.
What is the safety profile of the biologics compared to the traditional medical therapies?
To date, biologics in general have been extremely safe. Biologics don’t have those multiorgan toxicities seen with some other agents. We don’t yet have long-term 30-year data with biologics like we do with methotrexate or 20-year data with cyclosporin. However, the biologics that have been used to date on other autoimmune diseases such as rheumatoid arthritis and Crohn’s disease have very good safety profiles.
That said, the purpose of all these medications is to suppress the immune system. So with all the medications, you might be more susceptible to infection and colds.
Treating psoriasis with biologics is very new. Do you think that doctors are open to using these medications?
I think doctors have a lot to learn, just like patients do. I think it will take some time and education for general dermatologists who are treating patients with severe psoriasis to begin to use these medications. But efforts to educate physicians and patients have been effective. I know that in my community, there are many, many physicians who want to hear about the potential of these new medications and how they can be used.
Who are the best candidates for biologics?
Patients with moderate to severe disease. And I include in that category patients who have it extensively over their body and patients who have disease in areas that are very difficult to treat—most commonly, the palms, the soles of feet, and the scalp—which really affect people’s day-to-day lives.
Also potential candidates are those people with other medical problems who may not be able to take the other therapies—for example, people with diabetes or hypertension who cannot be treated with cyclosporin. Patients who like to have a drink, who can’t be on methotrexate are also excellent candidates for biologics, since they don’t have the side effects involving the other organs in the body.
People with chronic infections or cancer should think twice before using any medication that would suppress the immune system.
How long do the effects of biologic therapy last?
People with psoriasis do not want a recurrence of the disease once they’ve gotten some relief with medication. But because of the long-term toxicities of the traditional medications, dermatologists have had to give medication just long enough to make the patient better, then stop. Patients don’t like that; they want to be clear and they want to stay clear. With alefacept, patients are on it for about 12 weeks and then have about 12 weeks off, a treatment-free period. And that cycle can be repeated.
How do you think that biologics will affect the quality of life for psoriasis patients?
There are two elements to the quality of life of psoriasis patients that might be improved by biologics. The first is obvious. If the patient has minimal disease because of the treatment with the biologic and the disease doesn’t come back, obviously all the elements of their lives that are inhibited by their psoriasis will be improved.
But I think there’s a second arm to the quality of life issue that sometimes is overlooked. Patients have traditionally had to spend 30 minutes to an hour a day applying topical therapies for psoriasis. Biologics can save them that time, and I think that it can significantly improve quality of life.
