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| |  AAD: Tacrolimus Ointment Safe Alternative For Eczema SAN FRANCISCO, CA -- March 13, 2000 -- Clinical data recently presented at the 58th meeting of the American Academy of Dermatology (AAD) shows that patients with atopic dermatitis (more commonly known as eczema) participating in the Phase III clinical studies of tacrolimus ointment, Fujisawa Healthcare Inc.'s newest dermatological product, experienced significant improvement in their condition. Tacrolimus ointment is the first medication being developed in the United States in the new topical immunomodulator (TIMs) class, the first new class of drugs in more than 40 years that treats eczema. It is not a steroid and works differently than topical steroids, which are currently one of the most common options used today by dermatologists for the treatment of eczema. Tacrolimus ointment works in the skin to stop the immune reaction that leads to red, itchy, inflamed rashes frequently seen with this condition. Clinical trials involving more than 1,500 adults and children (as young as 24 months of age) with eczema, showed that tacrolimus ointment significantly improved or completely cleared the disease -- with a lower incidence of side effects possibly associated with conventional therapies. A preliminary analysis of a 12-week clinical trial in a multi-center study (23 sites) involving 351 patients between twenty-four months and fifteen years of age with eczema, showed that two tacrolimus ointment concentrations (0.03% and 0.1%) performed better than the vehicle in the treatment of atopic dermatitis. A preliminary analysis of a clinical trial involving 255 children between twenty-four months and sixteen years of age with moderate to severe eczema who were treated continuously or intermittently for one year, showed favorable results when the 0.1% ointment was used daily for long-term treatment. Similarly, the results of a preliminary analysis of a 12-week, clinical trial in a multi-center study (21 sites) involving 304 adults with moderate to severe eczema, demonstrate that tacrolimus ointment concentrations (0.03% and 0.1%) showed improvement over the vehicle in the treatment of atopic dermatitis in adults. In these studies, health-related quality of life effects were also assessed. Adult sufferers and children with the assistance of caregivers or parents completed a "Dermatology Quality of Life Index" over the 12-week treatment period. This index was developed by Dr. A.Y. Finlay from the University of Wales, Cardiff, United Kingdom and is a form of measuring the benefits of medications on improving symptoms, everyday activities, relationships and sleep. In the patients studied, significant quality of life improvements were observed with both concentrations of tacrolimus ointment in both the child and adult eczema sufferers. Eczema is a common, chronic and life-altering skin condition that affects nearly 15 million Americans. It is especially prevalent in children and is characterized by dry, scaling, red, itchy skin rashes, which may be localized to one area, but often cover the whole body. While the cause of eczema remains unclear, scientists have recently learned that like asthma and allergies, there is a genetic basis to the disease and it involves an imbalance in the skin's immune system. Scientists are currently focusing on identifying the genes that appear to cause this imbalance in the skin's immune response. "People with eczema, whether they are two years old or 62 years old, are frequently frustrated and dissatisfied with current treatment options," said Dr. Amy Paller, pediatric dermatologist, Children's Memorial Hospital, Chicago, Ill. "As a clinician, I look forward to the introduction of this new class of drugs -- topical immunomodulators (TIMs) and the alternative to current treatment options that it provides."
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