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| |  Tacrolimus Prolongs Time to First Flare in Paediatric Atopic Dermatitis: Presented at AAD By Micheal Casasnovas MIAMI BEACH, Fla -- March 10, 2010 -- Tacrolimus 0.03% ointment is effective and well tolerated in children with moderate to severe atopic dermatitis, researchers said here at the 68th Annual Meeting of the American Academy of Dermatology (AAD). “Compared with standard, reactive flare treatment, twice-weekly treatment significantly reduced the number of flares, prolonged time to first flare, and improved signs and symptoms of atopic dermatitis,” said Sakari Reitamo, Hospital for Skin and Allergic Disease, Helsinki University Central Hospital, Helsinki, Finland, in a presentation on March 9. The paediatric Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment (CONTROL) study was a multicentre, randomised, phase 3 trial conducted over 12 months. The original study included 267 children. In the post hoc analysis, Dr. Reitamo identified 166 children aged 2 to 15 years who were diagnosed with active atopic dermatitis lesions. Patients began a screening period of up to 1 week before entering an open-label period of 1 to 6 weeks until the lesions resolved. During the open-label period, patients were treated for active flares twice daily with tacrolimus 0.03% ointment. Researchers eventually evaluated 153 patients with an Investigator’s Global Assessment score of <=2. They assigned 78 patients to a twice-weekly double-blind tacrolimus 0.03% ointment and 75 patients to a vehicle for 12 months. The primary endpoint was the number of major irritations, those needing tacrolimus ointment treatment for more than 7 days to treat an Investigator’s Global Assessment score of 3 to 5, during the 12-month disease-control period. During the trial, 46.2% of the patients receiving maintenance therapy experienced no flares compared with 21.3% of the cohort receiving standard therapy (P < .001). There were less treatment days for the maintenance group (42.3 vs 68.9 days) and a significantly prolonged time to first flare (P < .001). Both treatment groups had similar toleration for the tacrolimus ointment. During the 12-month study, patients receiving twice-weekly treatment used an average of 1.29 g/day or tacrolimus ointment compared with 1.42 g/day for those receiving flare-only ointment. “A treatment regimen with twice-weekly tacrolimus 0.03% ointment was effective and well tolerated compared with a standard, flare-only regimen in children with moderate to severe atopic dermatitis,” said Dr. Reitamo. Funding for this study was provided by Astellas Pharma Europe.
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