Tacrolimus ointment effective for pediatric AD, studies show

October 7, 2008

Data from two large, phase 4 trials indicate that long-term, intermittent, once-daily therapy with tacrolimus ointment is an effective treatment for pediatric patients with stabilized atopic dermatitis, Docguide.com reports.

Paris — Data from two large, phase 4 trials indicate that long-term, intermittent, once-daily therapy with tacrolimus ointment is an effective treatment for pediatric patients with stabilized atopic dermatitis, Docguide.com reports.

Data from the studies were presented here at the 17th Congress of the European Academy of Dermatology and Venereology. Researchers from J.W. Goethe University in Frankfurt, Germany, conducted the trials.

Investigators assessed the efficacy and safety of long-term intermittent treatment with tacrolimus ointment compared with a standard acute-treatment approach for preventing flare-ups in patients 2 to 15 years old.

The two studies were conducted in the United States and Europe. The U.S. study enrolled pediatric patients with moderate to severe AD who were randomized to four days of twice-daily, double-blind therapy with either alclometasone ointment 0.05 percent or tacrolimus 0.03 percent, followed by a stabilization phase of up to 16 weeks with open-label tacrolimus 0.03 percent twice daily.

Patients whose disease stabilized underwent new randomization to double-blind tacrolimus 0.03 percent or vehicle applied once a day, three days a week, for up to 40 weeks as part of a maintenance phase. The primary endpoint was the number of flare-free treatment days.

The European study enrolled pediatric patients with mild to severe AD who achieved an Investigator Global Assessment score of <=2 following a stabilization phase of up to six weeks with open-label tacrolimus 0.03 percent twice daily who were randomized to tacrolimus 0.03 percent or vehicle applied once daily, two days a week for 12 months. The primary endpoint was the number of flares requiring substantial therapeutic intervention.

During the maintenance phase of both studies, flares were treated with tacrolimus 0.03 percent twice daily until cleared. The use of corticosteroids was not allowed.

In the U.S. study, 104 patients who completed the stabilization phase were randomized into a maintenance phase. Tacrolimus maintenance treatment increased the mean number of flare-free days compared with conventional treatment (174 versus 107) and the median time to first flare (116 versus 31 days), while the mean number of exacerbation days was reduced (47 versus 76 days).

In the European study, 250 patients were randomized into the maintenance phase. Tacrolimus maintenance treatment decreased the number of flares that required a substantial therapeutic intervention compared with conventional treatment (50.4 percent versus vs. 29.6 percent).

Safety profiles for the two treatments were similar. Researchers report that the tacrolimus ointment was well-tolerated.

Analysis of the two studies’ results suggest that use of tacrolimus ointment 0.03 percent in children may successfully treat active lesions and subsequently prevent, delay and/or decrease the occurrence of AD flares.

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