Treatment with twice-weekly tacrolimus ointment in patients with moderate to severe atopic dermatitis: results from two randomized, multicentre, comparative studies.

BACKGROUND: Twice-weekly tacrolimus ointment for mild to severe atopic dermatitis (AD) significantly reduced the number of flares and prolonged flare-free intervals compared with standard treatment in the CONTROL studies.

METHODS: Post hoc analysis of data from the CONTROL studies was carried out on patients with moderate to severe disease. Patients applied tacrolimus 0.1% (adults; n = 183) or 0.03% (children; n = 166) ointment twice-daily for <or= 6 weeks to treat flares, entering the 12-month disease control period (DCP) when an Investigator Global Assessment (IGA) score of <or= 2 was achieved. Patients were randomized to twice-weekly tacrolimus or vehicle ointment. Disease flares were treated with twice-daily tacrolimus ointment for 1-6 weeks until an IGA <or= 2 was achieved.

RESULTS: Twice-weekly treatment significantly reduced the number of flares and time to first flare (p < 0.001). Around three times as many patients in each study had no flares of any severity throughout the double-blind period in the twice-weekly treatment group compared with the standard treatment group (p < 0.001). Improvements in symptoms and quality of life with twice-weekly treatment were above those observed with standard treatment. Twice-weekly treatment was well tolerated.

CONCLUSIONS: A twice-weekly tacrolimus ointment regimen was effective in adults and children with moderate to severe AD.