To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Steroid-Free Eczema Treatment, Protopic (Tacrolimus), Recommended For FDA Approval URL: http://www.pslgroup.com/dg/1EB3CA.htm Doctor's Guide November 17, 2000
DEERFIELD, IL -- November 17, 2000 -- The United States Food and Drug Administration (FDA) Dermatologic and Ophthalmic Advisory Committee found Fujisawa Healthcare's Protopic (tacrolimus) ointment to be safe and effective for the treatment of moderate to severe atopic dermatitis, known as eczema.
The 0.1% concentration of tacrolimus ointment was recommended for the treatment of adults and the lower 0.03% concentration for treatment in both children and adults for long-term intermittent therapy in patients not adequately responsive to, or intolerant of, conventional therapy.
Protopic, the first in a new class of drugs to treat eczema in more than 40 years, is a steroid-free option supported by positive clinical trial results.
"The medical community is constantly looking for new therapeutic options for the treatment of eczema," says Dr. Amy Paller, pediatric dermatologist at Children's Memorial Hospital, Chicago, Illinois. "Today's recommendations regarding the use of Protopic in the 0.1% concentration for adults and the 0.03% concentration in children and adults, takes prescribing physicians one step closer to a steroid-free alternative to help treat all age groups suffering from eczema."
Protopic's safety and effectiveness was based on 28 worldwide clinical studies of more than 4,000 adults and children (as young as 24 months of age) conducted in the United States, Europe and Japan. U.S. clinical trials included randomized, double-blind, placebo-controlled, 12-week studies with patients suffering from moderate to severe eczema. Patients in the study were randomized to apply either 0.03% or 0.1% tacrolimus ointment or placebo as a thin layer twice daily to the skin.
Patients were evaluated at the beginning of the study and at weeks one, three, six, nine, 12 and at two weeks post-treatment. Over one-third of patients were children. The study data reported that both concentrations of Protopic significantly improved or completely cleared the signs and symptoms of the disease in more than two-thirds of the patients. In fact, many patients showed marked improvement in just one week of treatment.
Overall, there was a statistically significant greater efficacy of the 0.1% concentration compared to 0.03% in adults. Furthermore, certain adult subsets achieved an even greater benefit with use of the higher 0.1% concentration.
There was general agreement among the committee members that, because the effect of ultraviolet light on skin treated with tacrolimus ointment is unknown, patients should use safe sun practices to avoid exposure to natural or artificial sunlight. Some patients reported skin burning and itching associated with the application of Protopic, however the incidences of these events decreased as the disease improved.
Protopic is the first in a new class of drugs called topical immunomodulators, or TIMs, in more than 40 years for the treatment of eczema. Protopic works on the skin at the site of the immune imbalance to help stop the redness and itching of the eczema inflammation.
Eczema is a chronic, life-altering disease affecting 15 million children and adults nationwide and is characterized by painfully red, swollen, itchy, flaky skin. In some cases the itching and redness is so vast and intense that sufferers can scratch themselves until they bleed, increasing the risk of secondary infection. The majority of eczema cases are diagnosed early in childhood. While 40 percent of children suffering from eczema outgrow the disease, others live with it throughout their entire lives.
Since 1970 the prevalence of atopic dermatitis has nearly tripled. Studies show that the steady increase of this chronic condition is generally attributed to irritants and allergens that trigger the immune system.
Emotional factors such as stress can also influence and worsen the condition. For sufferers, especially children and teenagers, the visibility of eczema flares can lead to a low self-esteem and often the inability to interact with others. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.