Belgian Observational Drug Utilization Study of Pimecrolimus Cream 1% in Routine Daily Practice in Atopic Dermatitis

Abstract

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 pimecrolimuscream 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.

Topical Pimecrolimus

“…During this study, topical corticosteroids were not used in 36.0% of the patients with previous topical corticosteroid use and 60.7% of patients without previous use. [77,78] In two 6-week studies, [81] a significant difference in PIQoL-AD score was reported between the topical pimecrolimus and vehicle groups (table IV). [79] Topical pimecrolimus was more effective than vehicle in improving the HR-QOL of parents whose children had atopic dermatitis in short-term, continuous-use studies [80,81] and longer term, intermittent-use studies.…”

“…[77][78][79] After 1 year of intermittent treatment, the mean CDLQI score was significantly lower in the topical pimecrolimus than in the vehicle group (table IV). [78] In a postmarketing study, [79] topical pimecrolimus for 4-6 weeks (1.73% of patients received topical corticosteroids) was associated with improvement in HR-QOL in 1438 pediatric patients (aged ‡2 to <17 years) with atopic dermatitis (baseline disease severity not stated) [CDLQI at study end was 4.7; baseline CDLQI was 12.2]. During this study, topical corticosteroids were not used in 36.0% of the patients with previous topical corticosteroid use and 60.7% of patients without previous use.…”

“…The effects of topical pimecrolimus on the HR-QOL of pediatric patients with atopic dermatitis [77][78][79] or their parents [77,78,80,81] have been investigated in several studies. Data have been obtained from randomized, double-blind, vehiclecontrolled studies, [77,80,81] an open-label, noncomparative study in clinical practice, [78] and a postmarketing study.…”

“…Topical pimecrolimus was associated with improvements in the HR-QOL of pediatric patients with atopic dermatitis. In a 1-year, noncomparative study, [78] the mean QoLIAD score at study end was 3.7 in 136 pediatric patients (median age 11.0 years [range 4-23 years]) who received topical pimecrolimus, with baseline QoLIAD of 6.8 (n = 171). In a 1-year, noncomparative study, [78] the mean QoLIAD score at study end was 3.7 in 136 pediatric patients (median age 11.0 years [range 4-23 years]) who received topical pimecrolimus, with baseline QoLIAD of 6.8 (n = 171).…”

Spotlight on Topical Pimecrolimus in Pediatric Atopic Dermatitis†

“…The use of topical pimecrolimus was associated with improvements in the HR-QOL of pediatric patients with atopic dermatitis in a large postmarketing study. [26] The HR-QOL of parents whose children had atopic dermatitis was associated with greater improvements in the topical pimecrolimus group compared with the vehicle group, in short-term, continuoususe [27,28] and longer term, intermittent-use [25,29] trials.…”