Long-Term Study Supports Safety of Protopic(R) for Atopic Dermatitis Treatment In Children

Long-Term Study Supports Safety of Protopic(R) for Atopic Dermatitis Treatment In Children

		FUJISAWA HEALTHCARE PROTOPIC A two-year-old boy with severe eczema at day 1 (left) shows marked improvement after 12 weeks of treatment with Protopic (tacrolimus ointment) alone (right). Protopic is the first in a new class of drugs called topical immunomodulators (TIMs). More than 15 million Americans suffer from eczema, most of whom are children. More than 13,000 toddlers, children and adults have been treated with Protopic. (PRNewsFoto)[JL] DEERFIELD, IL USA

DEERFIELD, Ill., May 17 /PRNewswire/ -- Data presented at the 60th Annual Meeting of the American Academy of Dermatology further validated the safety of Protopic(R) (tacrolimus ointment) for long-term intermittent treatment of children with atopic dermatitis. (Photo: http://www.newscom.com/cgi-bin/prnh/20020517/CGF033 ) "This study evaluated the risk of adverse events over time and most importantly found no long indication that Protopic has immunosuppressive effects in patients treated up to three years," said Amy Paller, MD, lead investigator, Professor of Dermatology and Pediatrics and Chief of the Division of Dermatology at Children's Memorial Hospital of Northwestern University Medical School in Chicago, Illinois. Tacrolimus ointment is the first in a new class of prescription drugs called topical immunomodulators, or TIMs, to be developed in more than 40 years for the treatment of eczema. The FDA approved the non-steroidal alternative in December 2000 for short-term and intermittent long-term therapy to treat the signs and symptoms of moderate to severe eczema in patients for whom conventional treatment is deemed inadvisable because of the potential risks associated with them, or when patients are not adequately responsive to or intolerant of conventional therapies. The thirty-month, multicenter study included 389 male and female patients two to 15 years old with varying degrees of atopic dermatitis. Patients in the study applied Protopic 0.1 percent concentration ointment twice daily to all affected areas of the skin until one week after symptoms cleared. Among the patients treated, 246 completed two-year follow-up and 57 completed three- year follow-up. The common adverse events included: skin burning, pruritis or an itching sensation, and skin redness. These events were generally of short duration and decreased after a few days of treatment. "This study strengthens Protopic's important role in the mix of safe, effective treatment options available to the medical community for children with eczema," said Ira D. Lawrence, senior vice president, research and development. In some cases of eczema the itching and redness is so vast and intense that sufferers will scratch themselves until they bleed, increasing the risk of secondary infection. The majority of eczema cases are diagnosed in early childhood. While 40 percent of children suffering from eczema outgrow the disease, others live with it throughout their lives. Conventional therapies for eczema have been limited and variable outcomes have been reported. Routine treatment frequently includes the use of steroid creams applied to the skin. Steroids have been associated with side effects including skin thinning, stretch marks and skin discoloration. Physician and patient satisfaction has been disappointing. Protopic is available in two concentrations for adults, 0.03 percent and 0.1 percent. For children ages two to 15, only the 0.03 percent concentration is indicated. Similar to other dermatological products currently on the market, patients should practice safe sun techniques to avoid direct exposure to natural or artificial sunlight when using Protopic. Fujisawa Healthcare, Inc. headquarters in Deerfield, Illinois, develops, manufactures and markets proprietary pharmaceutical products in the United States and abroad. Fujisawa Healthcare, Inc., is a subsidiary of Fujisawa Pharmaceutical Co., Ltd., based in Osaka, Japan. Fujisawa Pharmaceutical Co., Ltd., founded in 1894, is a leading pharmaceutical manufacturer and is actively developing its international operations in North America, Europe and Asia. Additional information on Fujisawa Healthcare, Inc., and its products can be found on the company's web site at http://www.fujisawa.com .