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.