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Drug Proves Effective Against Psoriasis
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The improvements were sustained for at least a year in many patients, according to a study appearing in this week's issue of the journal The Lancet.
"The data confirms the rapid and dramatic efficacy in severe psoriasis," said Dr. Christopher Griffiths, senior author of the study and a professor of dermatology at the University of Manchester School of Medicine, in England.
"What the study adds is that infliximab can be used to maintain that improvement in the majority of patients with severe psoriasis for at least one year. This is important because psoriasis is currently a chronic, incurable disease that needs long-term treatment," he said
Remicade is currently approved for the treatment of autoimmune disorders such as Crohn's disease, rheumatoid arthritis and psoriatic arthritis, a form of joint disease that affects about one-third of patients with psoriasis. The drug is known to be effective against psoriasis itself but is not yet approved for this use and is therefore prescribed "off label."
The results of the new study may bolster the case for adding psoriasis to the list of approved indications for Remicade, said Dr. Bruce E. Strober, associate director of the dermatopharmacology unit at New York University School of Medicine in New York City.
"This is data we're all aware of but it's nice to see data in literature that's been peer-reviewed," Strober said. "There are many patients for whom we do not have effective therapy. Remicade may represent the only medicine that would work for them. This study shows that Remicade is a very effective medicine for people with psoriasis."
Psoriasis is thought to be an auto-immune disorder, occurring when the body inexplicably begins overproducing skin cells. The extra cells pile up on the surface of the skin before they have a chance to mature, creating bright red patches that cause itching, burning and stinging.
A "comment" article in the journal accompanying the study likened the impact of psoriasis on patients' quality of life to that of other severe disorders, including diabetes, rheumatoid arthritis or cancer.
A pro-inflammatory protein called tumor necrosis factor alpha (TNF alpha) is also thought to play a part in the development of psoriasis. Remicade is a monoclonal antibody that binds to TNF alpha, essentially incapacitating it.
The phase III British study involved 378 patients with moderate to severe psoriasis, assigned to receive either Remicade or a placebo intravenously at intervals for 46 weeks.
Using two different psoriasis indices, the researchers found that, by the tenth week, 80 percent of patients treated with Remicade had achieved at least a 75 percent improvement while 57 percent achieved a 90 percent improvement, compared with 1 and 3 percent, respectively, in the placebo group.
One quarter of the individuals in the Remicade group achieved a complete clearing of their skin psoriasis vs. none in the placebo group.
The benefit was also a sustained one: At week 24, 82 percent of those on Remicade still experienced a 75 percent improvement, versus only 4 percent for placebo patients. And 58 percent of those on Remicade had a 90 percent improvement, compared to just one percent of the placebo group.
At week 50, 61 percent of those on Remicade still had their 75 percent improvement and 45 percent still had a 90 percent improvement.
Participants also experienced improvements in nail psoriasis, which is often considered a sign of treatment-resistant disease. By week 24, people taking Remicade experienced an average 56 percent decrease in this condition -- a level of success that was maintained throughout the trial.
"A key observation was that the nail disease, which affects 50 percent of patients with psoriasis, is also significantly improved," Griffiths stated. "This is one of the very first studies to demonstrate such marked improvement in nail disease."
There were some side effects, including infection, in those taking Remicade. But, the authors stated, the drug "was generally well tolerated in most patients." The majority -- 80 percent -- of participants completed all transfusions.
SOURCES: Christopher Griffiths, M.D., Ph.D., professor of dermatology, University of Manchester School of Medicine, England; Bruce E. Strober, M.D., Ph.D., associate director, dermatopharmacology unit, New York University School of Medicine, New York City; Oct. 14, 2005, The Lancet
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