Belgian observational drug utilization study of pimecrolimus cream 1% in routine daily practice in atopic dermatitis

Background: For reimbursement purposes of pimecrolimus cream 1%, the Belgian authorities asked to document its consumption, its topical corticosteroid-sparing effect and quality of life within the routine clinical practice. Objectives: We aimed to address the 3 queries of the Belgian authorities. Methods: An open-label, observational, multicentre, 1-year study under drug prescription was performed. Results: A total of 416 consecutive patients were enrolled in 49 centres. The mean annual amount of prescribed pimecrolimus cream 1% per patient was 120.8 g ( SD=117.0), with an estimated consumption of 104.4 g (SD=117.6). The median annual amount prescribed was 90.0 g [ interquartile range ( IQR) = 45 - 150] and the estimated consumption 63.6 g ( IQR = 32.4 132). Topical corticosteroids had been used before the study in 81.7% of the population. With pimecrolimus cream 1% during the study, 83.3% of the previous corticosteroid users stated less topical corticosteroid use than before and 36% of them did not apply topical corticosteroids at all during the study. The mean improvements compared to baseline in Parents' Index Quality of Life- Atopic Dermatitis and Quality of Life Index-Atopic Dermatitis scores were 34.5% (SD=84.3) and 31.2% (SD=70.8), respectively. The median improvements were 50.0% (IQR=12.5-85.7%)and 46.4% ( IQR = 0.0 85.0%), respectively. Conclusions: In routine practice the consumption of pimecrolimus cream 1% is relatively low, with corticosteroid- sparing effect, improvement in quality of life and good tolerability. Copyright (c) 2008 S. Karger AG, Basel.