NEW YORK Long-term use of tacrolimus ointment was effective in managing atopic dermatitis and preventing disease flares in a group of adults and children, Dr. Alan B. Fleischer said in a poster presented at the American Academy of Dermatology's Academy 2007 meeting.
Dr. Fleischer of Wake Forest University, Winston-Salem, N.C., and his colleagues enrolled 383 patients with at least moderate atopic dermatitis in a study sponsored by Astellas Pharma Inc., manufacturer of tacrolimus (Protopic).
Patients first went through a 16-week, randomized, double-blinded disease-stabilization phase. In the first 4 days, 190 patients received twice-daily doses of tacrolimus ointment (0.1% for adult patients and 0.03% for pediatric patients) and 193 patients received a corticosteroid twice a day. For the remaining portion of the stabilization phase, they received twice-daily open-label tacrolimus ointment until clear or almost clear of disease for at least 2 weeks, up to 16 weeks.
For the maintenance phase of the trial, patients with clear or nearly clear skin were randomly assigned to either tacrolimus ointment (125 patients) or a placebo vehicle (72 patients) in a double-blind fashion. Both were applied three times a week for up to 40 weeks. Patients who relapsed were given up to 8 weeks of open-label tacrolimus twice a day until clear or almost clear of their atopic dermatitis, at which point they returned to the study regimen. Patients whose disease did not achieve this response dropped out of the study.
Use of corticosteroids was permitted only in the initial portion of the stabilization phase.
At the end of 40 weeks, patients receiving tacrolimus ointment had 177 flare-free treatment days (the primary end point) versus 134 for those in the placebo groupa difference that reached statistical significance. Moreover, the time to first relapse was 169 days for patients who received tacrolimus and 43 days in the placebo group, and tacrolimus was associated with fewer total relapse days (45.5 days) than the placebo vehicle (64.5 days). Among patients in the tacrolimus group, 6% experienced disease relapse, compared with 17% in the vehicle group.
Adverse events primarily involved itching and burning and occurred predominantly in the stabilization phase of the study. The only significant difference in adverse events was seen at day 4 of the stabilization phase, with 18% (33 patients) in the tacrolimus group reporting any adverse event versus 9% (17 patients) in the corticosteroid group, Dr. Fleischer said.
Although tacrolimus was effective in this study population, efficacy might vary in other groups, given the widely divergent presentation possible with atopic dermatitis.
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