The immunosuppressive drug tacrolimus may have found a new use. In a randomized, double-blind study in the September 18 issue of The New England Journal of Medicine (1997;337:816-821), the European Tacrolimus Multicenter Atopic Dermatitis Study Group reported that they used an ointment form of tacrolimus (FK 506) to successfully treat atopic dermatitis. After three weeks of twice-daily treatment on patches of skin ranging from 200-1000 cm2, the condition was resolved in about three-quarters of 213 patients. The main side effect was a burning sensation at the site of application. A total of 54 of the 213 patients received ointment with 0.03% tacrolimus, another 54 received 0.1% tacrolimus, and 51 received 0.3% tacrolimus. Results were similar in all patients.
Researchers said that although the ointment needs to be tested for longer periods and on larger areas of skin, tacrolimus may represent an alternative to the treatment of atopic dermatitis with corticosteroids. While generally well tolerated, corticosteroids can cause atrophy of the skin and other side effects.
Tacrolimus was approved by the FDA in May 1994 to prevent organ rejection in patients receiving liver transplants.
The study, which was carried out at 16 centers in Europe between April 1995 and March 1996, was funded by a grant from Fujisawa, the Munich-based manufacturer of tacrolimus.
For Your Information:
Thomas Ruzicka, MD
Heinrich Heine University, Department of Dermatology
Moorenstrasse 5, D-40225, Düsseldorf, Germany
http://www.pharminfo.com/pubs/msb/tacrol.html
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