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Intermittent tacrolimus may prevent AD flares.

CHICAGO -- Intermittent treatment with tacrolimus ointment kept atopic dermatitis under control with no need for corticosteroids in children and adolescents aged 2-15 years whose conditions had stabilized.

Because concerns persist about the long-term effects of corticosteroid use by children and teens, safe and effective alternatives for the long-term management of atopic dermatitis (AD) are needed. Because the black box warning attached to tacrolimus (Protopic) says that continuous use should be avoided, Dr. Amy S. Paller of Northwestern University, Chicago, and her colleagues designed a plan that involved applying tacrolimus ointment to the affected skin three times weekly for 40 weeks.

The treatment goal was to prevent flares in patients whose AD had stabilized. The randomized trial of the protocol's safety and effectiveness was sponsored by Astellas Pharma US Inc., and the researchers presented their findings in a poster at the annual meeting of the Society for Pediatric Dermatology.

A total of 206 patients were randomized, but 54 discontinued the study. The most common reason for discontinuation was loss to follow-up (15 patients). Ten children dropped out because of uncontrolled rebound exacerbation of their AD, and five dropped out because of an adverse event.

Overall, the patients who received tacrolimus ointment had significantly fewer relapse days (47) than those who received a control ointment containing alclometasone (76 days). Also, the tacrolimus patients remained stable for significantly more days before their first relapses (116 days vs. 31 days), the investigators reported.

Although there was no difference between the groups in the number of children who relapsed at least once, only 6% of the children in the tacrolimus group relapsed for up to 3 days during the study period. In the control group, 19% of the children relapsed for up to 6 days.

The most common adverse events reported by tacrolimus patients were burning and itching at the application site, which reflects results from previous safety studies. The incidence of adverse events was similar between the two groups.


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Title Annotation:Clinical Rounds
Author:Splete, Heidi
Publication:Pediatric News
Date:Oct 1, 2007
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