OBJECTIVES: To evaluate the impact of secondary prophylactic use (PU) of tacrolimus 0.1% ointment on the quality of life (QoL), outcomes and costs in comparison to standard use (SU) of tacrolimus 0.1% ointment in adults with moderate to severe atopic dermatitis (AD) over one year. METHODS: Data were generated as part of a multi-centre, pan-European, phase III clinical trial. Patients were randomised to tacrolimus 0.1% ointment (PU) or vehicle ointment (SU) twice a week, during a 12-month disease control period. In both groups disease exacerbations were treated with tacrolimus 0.1% ointment twice daily. Data on health-related QoL were obtained by using SF-36 questionnaire. Based on these data, utility values were calculated by using the algorithm by Brazier et al. 2002. Resource consumption data was derived from a patient questionnaire and pooled to estimate the costs using German unit cost data. RESULTS: Seventy-five patients with PU (57% moderately affected) and 59 patients with SU (59% moderately affected) participated. The number of disease exacerbations was 2.4 (PU) vs. 5.5 (SU) (p=0.0014; moderate AD) and 2.3 (PU) vs. 7.4 (SU) (p=0.0002; severe AD). Health-related QoL (utility values) in PU patients increased from 0.71 to 0.79 (p=0.0014; moderate AD) and from 0.66 to 0.75 (p=0.002; severe AD). In the SU arm utility values increased from 0.69 to 0.72 (NS; moderate AD) and from 0.67 to 0.71 (NS; severe AD). In moderately affected patients mean (SD) total annual cost per patient in the PU arm was €1525 (1081) vs. €1729 (1209) in the SU arm. Mean (SD) total annual cost per patient was €2045 (2013) (PU) vs. €2904 (1,510) (SU) in the group of severely affected patients. CONCLUSION: Secondary prophylactic treatment with tacrolimus 0.1% ointment is more effective, leads to cost savings and higher QoL in comparison to standard tacrolimus 0.1% ointment use, especially in patients with severe AD.